Objective:Little progress has been made in recent years using first-line chemotherapy,including gemcitabine combined with nab-paclitaxel,FOLFIRINOX,and NALIRIFOX,for advanced pancreatic adenocarcinoma(APC).In addition...Objective:Little progress has been made in recent years using first-line chemotherapy,including gemcitabine combined with nab-paclitaxel,FOLFIRINOX,and NALIRIFOX,for advanced pancreatic adenocarcinoma(APC).In addition,the optimal second-line chemotherapy regimen has not been determined.This study aimed to compare the effectiveness of different types of second-line chemotherapy for APC.Methods:Patients with APC who received first-line treatment from January 2008 to January 2021 were considered eligible for this retrospective analysis.The primary and secondary endpoints were overall survival(OS)and progression-free survival(PFS),respectively.Results:Four hundred and thirty-seven and 617 patients were treated with 5-fluorouracil-and gemcitabine-based chemotherapy as first-line treatment,respectively.Demographic and clinical features,except age and liver metastasis,were comparable between the two groups(P<0.05).The median OS was 8.8 and 7.8 months in patients who received a 5-fluorouracil-and gemcitabine-based combined regimen for first-line therapy,respectively(HR=1.244,95%CI=1.090–1.419;P<0.001).The median OS was 5.6 and 1.9 months in patients who received second-line chemotherapy and supportive care,respectively(HR=0.766,95%CI=0.677–0.867;P<0.001).The median PFS was not significantly differently between gemcitabine or 5-fluorouracil monotherapy and combination therapy.Conclusions:A 5-fluorouracil-or gemcitabine-based combined regimen was shown to be as effective as a single 5-fluorouracil or gemcitabine regimen as second-line therapy for patients with APC.展开更多
BACKGROUND Although chronic erosive gastritis(CEG)is common,its clinical characteristics have not been fully elucidated.The lack of consensus regarding its treatment has resulted in varied treatment regimens.AIM To ex...BACKGROUND Although chronic erosive gastritis(CEG)is common,its clinical characteristics have not been fully elucidated.The lack of consensus regarding its treatment has resulted in varied treatment regimens.AIM To explore the clinical characteristics,treatment patterns,and short-term outcomes in CEG patients in China.METHODS We recruited patients with chronic non-atrophic or mild-to-moderate atrophic gastritis with erosion based on endoscopy and pathology.Patients and treating physicians completed a questionnaire regarding history,endoscopic findings,and treatment plans as well as a follow-up questionnaire to investigate changes in symptoms after 4 wk of treatment.RESULTS Three thousand five hundred sixty-three patients from 42 centers across 24 cities in China were included.Epigastric pain(68.0%),abdominal distension(62.6%),and postprandial fullness(47.5%)were the most common presenting symptoms.Gastritis was classified as chronic non-atrophic in 69.9%of patients.Among those with erosive lesions,72.1%of patients had lesions in the antrum,51.0%had multiple lesions,and 67.3%had superficial flat lesions.In patients with epigastric pain,the combination of a mucosal protective agent(MPA)and proton pump inhibitor was more effective.For those with postprandial fullness,acid regurgitation,early satiety,or nausea,a MPA appeared more promising.CONCLUSION CEG is a multifactorial disease which is common in Asian patients and has non-specific symptoms.Gastroscopy may play a major role in its detection and diagnosis.Treatment should be individualized based on symptom profile.展开更多
BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastroint...BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care.The primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product reported.Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.展开更多
Object:The aim is to evaluate how effective Traditional Chinese Medicine(TCM)is in treating patients who have central retinal vein occlusion with macular edema(CRVO-ME)in a real-world study.Furthermore,the objective o...Object:The aim is to evaluate how effective Traditional Chinese Medicine(TCM)is in treating patients who have central retinal vein occlusion with macular edema(CRVO-ME)in a real-world study.Furthermore,the objective of the research was to examine the TCM prescription trends in the management of CRVO-ME.Method:A single-center real-world study(RWS)was carried out over a span of 19 years,following the established design.The study encompassed 113 patients diagnosed with CRVO-ME.Out of these,74 patients received TCM treatment,while the remaining individuals underwent a combined therapy involving TCM and anti-VEGF drugs through intravitreal injection.The patients were matched using propensity score matching(PSM).The result measured in the RWS was BCVA.The oral prescriptions for CRVO-ME that led to observable and effective outcomes were collected.Excel and the TCM Inheritance Auxiliary Platform V2.5 were utilized to optimize mutual information,hierarchical clustering based on entropy,and other techniques to extract medication regulations and features.Result:After applying PSM,each group comprised 29 cases.Both groups exhibited improved BCVA following treatment;however,there was no statistically significant distinction in BCVA or effectiveness between the two groups(all P>0.05).Apart from the analysis of oral prescriptions for CRVO-ME,the investigation pinpointed the most frequently used TCMs,namely Flos Carthami,Semen Persicae,Radix Angelica sinensis,Radix Rehmanniae,and Radix et Rhizoma Notoginseng.Frequently utilized medications tended to possess cold,warm,or mild attributes and exhibited a taste profile that was either bitter or sweet.The primary meridians associated with the medicines employed in treating CRVO-ME were liver,spleen,stomach,heart,and lung.Through the application of association rule analysis,it was discerned that there were 195 commonly employed combinations of medicines.Additionally,a complex system entropy cluster analysis unveiled 13 key combinations of medicines.By employing an unsupervised entropy hierarchical clustering analysis,a novel prescription was formulated.Conclusion:Within a real-world population of CRVO-ME patients,TCM exhibited its effectiveness.The treatment approach for CRVO-ME predominantly involved the regulation of qi(Qi is an exceedingly subtle substance within the human body,brimming with vitality and ceaseless motion.It constitutes the fundamental element that shapes and sustains the various processes of human life.)and blood as well as the resolution of dampness.The oral prescriptions frequently targeted the meridians of liver,spleen,stomach,heart,and lungs.展开更多
Objective To provide references for improving the authenticity and reliability of the retrospective study results,thus improving the quality of evidence in the real world and strengthening drug supervision and decisio...Objective To provide references for improving the authenticity and reliability of the retrospective study results,thus improving the quality of evidence in the real world and strengthening drug supervision and decision-making.Methods Literature review was used to study the data sources,the characteristics of retrospective research,the sources and the corrections of selective bias in the real world.Results and Conclusion The biases in retrospective study mainly come from admission rate bias,patient rate bias,survivors bias,health user bias and symptom bias.展开更多
Objective To introduce the design of observational trials under real-world study(RWS),and to provide guidance for clinical development of new research trials and reference for real-world researchers.Methods Relevant l...Objective To introduce the design of observational trials under real-world study(RWS),and to provide guidance for clinical development of new research trials and reference for real-world researchers.Methods Relevant literature of RWS and observational experiments at home and abroad were reviewed and analyzed,and then the design of observational studies was summarized under RWS.Results and Conclusion The data and information provided in observational studies not only help to further verify the clinical study results obtained by randomized controlled trial(RCT)in clinical practice,but also objectively reflect the real situation in the process of clinical research and application.展开更多
BACKGROUND Lenvatinib has become an indispensable part of treatment regimens for patients with advanced hepatocellular carcinoma(aHCC).Several recent real-world studies appear to have confirmed this;however,there are ...BACKGROUND Lenvatinib has become an indispensable part of treatment regimens for patients with advanced hepatocellular carcinoma(aHCC).Several recent real-world studies appear to have confirmed this;however,there are etiological differences.This necessitates further real-world studies of lenvatinib across diverse populations,such as in China.AIM To investigate the efficacy and safety of lenvatinib in a Chinese HCC patient population under real-world conditions.METHODS This is a retrospective and multiregional study involving patients with aHCC receiving lenvatinib monotherapy.Efficacy was assessed using the Response Evaluation Criteria in Solid Tumors version 1.1.Baseline characteristics and adverse events(AEs)were recorded throughout the entire study.RESULTS In total,54 HCC patients treated with lenvatinib monotherapy were included for final analysis.The objective response rate was 22%(n=12)with a progressionfree survival(PFS)of 168 d;however,AEs occurred in 92.8%of patients.Multivariate analysis showed that the Barcelona Clinic Liver Cancer stage[hazard ratio(HR)0.465;95%CI:0.23-0.93;P=0.031],portal vein tumor thrombus(HR 0.38;95%CI:0.15-0.94;P=0.037)and Child-Pugh classifications(HR 0.468;95%CI:and specificity(83.3%)of decreasing serum biomarkers including alphafetoprotein were calculated in order to predict tumor size reduction.Gene sequencing also provided insights into potential gene mutation signatures related to the effect of lenvatinib.CONCLUSION Our findings confirm previous evidence from the phase III REFLECT study.The majority of patients in this Chinese sample were suffering from concomitant hepatitis B virus-related HCC.However,further analysis suggested that baseline characteristics,changes in serum biomarkers and gene sequencing may hold the key for predicting lenvatinib responses.Further large-scale prospective studies that incorporate more basic medical science measures should be conducted.展开更多
Objective:Several studies have demonstrated different benefits for patients whose disease progressed despite previous trastuzumab treatment.Due to limited real-world data,we evaluate the effectiveness of anti-human ep...Objective:Several studies have demonstrated different benefits for patients whose disease progressed despite previous trastuzumab treatment.Due to limited real-world data,we evaluate the effectiveness of anti-human epidermal growth factor receptor 2(HER2)therapy(lapatinib or trastuzumab)plus chemotherapy or chemotherapy alone in patients who were previously treated with trastuzumab-containing regimens and investigate factors associated with effectiveness.And we further show the effectiveness of the two anti-HER2 therapy groups.Methods:A total of 342 HER2-positive metastatic breast cancer(MBC)patients whose disease progressed during prior anti-HER2(trastuzumab)and standard chemotherapy therapy from Department of Breast Oncology,the Fifth Medical Center of Chinese PLA General Hospital,from August 2010 to December 2016 were included.Seventy-eight patients received standard chemotherapy only,148 patients continued to receive trastuzumab and switched to other chemotherapy drugs,and 116 patients received tyrosine-kinase inhibitors(TKIs;lapatinib)and chemotherapy.The main outcome measures were progression-free survival(PFS),overall response rate(ORR),and clinical benefit rate(CBR).Subgroup analyses were conducted to identify patient characteristics associated with the greatest clinical benefit.Results:After a median follow-up of 26.2(range,2.0-56.0)months,PFS significantly improved with anti-HER2 therapy compared with chemotherapy alone:median 6.0 months with lapatinib[95%confidence interval(95%CI),4.53-7.47],4.5 months with trastuzumab(95%CI,3.99-5.01)vs.3.0 months with chemotherapy alone(95%CI,2.42-3.58);stratified hazard ratio(HR)=0.70,95%CI,0.60-0.81;P<0.0001.The ORR values were 33.6%,25.0%and 12.8%,respectively,the CBR values were 60.3%,48.6%and 26.9%,respectively.The effectiveness of lapatinib group and trastuzumab group were further analyzed.In multivariate analysis,lapatinib group was associated with a longer PFS,after controlling other potential confounders(HR=0.68,95%CI,0.52-0.90;P=0.006).Conclusions:The combination of TKIs and chemotherapy was effective in this cohort previously treated with trastuzumab treatment.Therefore,TKIs combined with chemotherapy is an option for Chinese HER2-positive MBC patients previously treated with trastuzumab treatment.展开更多
Objective Our objective was to analyze the traditional Chinese medicine(TCM)syndrome and treatment laws of diabetic kidney disease(DKD)and the action mechanism of high-frequency Chinese herbs in the treatment of DKD b...Objective Our objective was to analyze the traditional Chinese medicine(TCM)syndrome and treatment laws of diabetic kidney disease(DKD)and the action mechanism of high-frequency Chinese herbs in the treatment of DKD based on realworldstudy.MethodsThe data of patients with DKD who had been treated in the First Hospital Affiliated to Henan Universityof ChineseMedicine from January1,2014to December 31,2021 were retrospectively analyzed through the hospital information management system.The contents of the cases were statistically analyzed using IBM SPsS Statistics 25 software,and the laws of DKDtreatment were summarized.Network pharmacology and molecular docking were used to analyze the action mechanism of high-frequency Chinese herbs in the treatment of DKD.ResultsThe data of a total of 1,201 patients with DKD were included,involving 72 kinds of TCM syndromes.Nine disease nature elements and six disease location elements were extracted,involving 405 Chinese herbs.The top five high-frequency Chinese herbs were Baizhu(Atractylodis Macrocephalae Rhizoma),Fuling(Poria),Huangqi(Astragali Radix),Chuanxiong(Chuanxiong Rhizoma),and Danshen(Salviae Miltiorrhizae Radix et Rhizoma).Thirty kinds of Chinese herbs with the frequency of≥100 were mainly deficiency-tonifying herbs and blood-activating and stasis-eliminating herbs.The medicinal properties were mainly warm and mild,and the medicinal flavors were sweet and bitter mostly.For the meridian tropism,the main meridian tropism of these herbs is spleen meridian and lung meridian.The clustering method.展开更多
Objective To study the research on real-world data and to provide new ideas and methods for the inheritance and development of empirical prescriptions of traditional Chinese medicine(TCM).Methods The disadvantages of ...Objective To study the research on real-world data and to provide new ideas and methods for the inheritance and development of empirical prescriptions of traditional Chinese medicine(TCM).Methods The disadvantages of using randomized controlled trials for empirical prescriptions of TCM and the advantages of using real-world study(RWS)were analyzed by summarizing the previous RWS and the empirical prescriptions.Meanwhile,the methods for marketing of new TCMs derived from empirical prescriptions of TCM,the data source and trial design of the RWS were discussed.Results and Conclusion RWS can provide new ideas for the listing of new TCMs.With the improvement of relevant laws and regulations,RWS will promote the development of TCM greatly.To promote the application of RWS in the inheritance and development of empirical prescriptions of TCM,the government should improve laws and regulations as soon as possible,and enterprises and research institutions should strengthen patient privacy protection and clarify the responsible parties.展开更多
BACKGROUND Colon cancer is one the most common forms of cancer in both sexes.Due to important progress in the field of early detection and effective treatment,colon and rectal cancer survivors currently account for 10...BACKGROUND Colon cancer is one the most common forms of cancer in both sexes.Due to important progress in the field of early detection and effective treatment,colon and rectal cancer survivors currently account for 10%of cancer survivors worldwide.However,the effects of anti-cancer treatments,especially oxaliplatinbased chemotherapy,on the quality of life(QoL)have been less evaluated.Although the incidence of severe chemotherapy-induced neuropathy(CIPN)in clinical studies is below 20%,data from real-world studies is scarce,and CIPN is probably under-reported due to patient selection and the patients’fear that reporting side-effects might lead to treatment cessation.AIM To determine the impact of CIPN on QoL in colorectal cancer patients with a recent history of oxaliplatin-based chemotherapy.METHODS We performed a prospective cross-sectional study in two major Romanian oncology tertiary hospitals—the Regional Institute of Oncology Ia?i(Iasi,Romania)and the Fundeni Clinical Oncology Institute(Bucharest,Romania).All consecutive patients with colon or rectal cancer,undergoing Oxaliplatin-based chemotherapy that consented to enroll in the study,were assessed by means of two questionnaires—the EORTC QQ-CR29(quality of life in colon and rectal cancer patients)and the QLQ-CIPN20(assessment of neuropathy).Several demographical,social,clinical and treatment data were also collected.Statistical analysis was performed by means of SPSS v20.The student t test was used to assess the relationship between the QLQ-CIPN20 and QLQ-CR29 results.Kaplan Meyer-curves were used to report 3-year progression-free survival(PFS)in patients that discontinued chemotherapy vs those that completed the recommended course.RESULTS Of the 267 patients that fulfilled the inclusion criteria in the pre-specified time frame,101(37.8%)agreed to participate in the clinical study.At the time of the enrolment in the study,over 50%of the patients had recently interrupted their oxaliplatin-based chemotherapy,most often due to neuropathy.Almost 85%of the responders reported having tingling or numbness in their fingers or hands,symptoms that were associated with pain in over 20%of the cases.When comparing the scores in the two questionnaires,a statistically significant relationship(P<0.001)was found between the presence of neuropathic symptoms and a decreased quality of life.This correlation was consistent when the patients were stratified by sex,disease stage,comorbidities and the presence of stoma or treatment type,suggesting that neuropathy in itself may be a reason for a decreased quality of life.At the 3 year final assessment,median recurrence-free survival in stageⅢpatients was 26.88 mo.When stratified by completion of chemotherapy,median recurrence freesurvival of stageⅢpatients that completed chemotherapy was 28.27 mo vs 24.33 mo in patients that discontinued chemotherapy due to toxicity,a difference that did not reach statistical significance.CONCLUSION CIPN significantly impacts QoL in colorectal cancer patients.CIPN is also the most frequent reason for treatment discontinuation.Physicians should actively assess for CIPN in order to prevent chronic neuropathy.展开更多
Objective: To assess the outcomes after acupoint application in patients with pharyngeal pain in a real-world settings, and analyze the characteristics of effective population and prescription characteristics of acupo...Objective: To assess the outcomes after acupoint application in patients with pharyngeal pain in a real-world settings, and analyze the characteristics of effective population and prescription characteristics of acupoint application. Methods: Based on CHUNBO platform, patients with pharyngeal pain who were candidates for acupoint application on the basis of physician-evaluation, were enrolled in a nationwide, prospective, 69-week multicenter observational study from August 2020 to February 2022. Propensity score matching(PSM) was used to match the confounding factors and the association rules were used to analyze the characteristics of effective population and prescription characteristics of acupoint application. Outcome assessments included the disappearance rate of pharyngeal pain(within 3, 7, and 14 days), disappearance time of pharyngeal pain, as well as adverse events. Results: Of 7,699 enrolled participants, 6,693(86.9%) received acupoint application and 1,450(21.7%) with non-acupoint application. After PSM, there were 1,004 patients each in the application group(AG) and non-application group(NAG). The disappearance rate of pharyngeal pain in the AG at 3, 7, and 14 days were all higher than those in the NAG(P<0.05). The disappearance time of pharyngeal pain in the AG were shorter than that in the NAG(logrank P<0.001, hazard ratio=1.51, 95% confidence interval: 1.41–1.63). The median age of effective cases was 4 years, mainly 3–6 years old(40.21%). The disappearance rate of pharyngeal pain in the application group with tonsil diseases was 2.19 times higher than that in the NAG(P<0.05). The commonly used acupoints for the effective cases were Tiantu(RN 22), Shenque(RN 8) and Dazhui(DU 14). The commonly used herbs for the effective cases were Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae. Among them, Natrii sulfas was applied to RN 8 most frequently(support 84.39%). A total of 1,324(17.2%) patients experienced AEs, and mainly occurred in the AG, with significant difference in the incidence of AEs between goups(P<0.05). All AEs reported were the first grade, and the average regression time of AEs was 2.8 days. Conclusions: Acupoint application in patients with pharyngeal pain resulted in improved effective rate and shortened duration, especially children aged 3–6 years old, and those with tonsil diseases. Acupoint of RN 22, RN 8 and DU 14, herbs of Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae were the most commonly used in the treatment of pharyngeal pain.展开更多
Objective To describe the treatment patterns and survival status of advanced gastric cancer(AGC)in China in the past two decades,and objectively evaluate the impact of standardized Chinese medicine(CM)treatment on the...Objective To describe the treatment patterns and survival status of advanced gastric cancer(AGC)in China in the past two decades,and objectively evaluate the impact of standardized Chinese medicine(CM)treatment on the survival of AGC patients.Methods This multicenter registry designed and propensity score analysis study described the diagnosis characteristics,treatment-pattern development and survival status of AGC from 10 hospitals in China between January 1,2000 and July 31,2021.Overall survival(OS)was evaluated between non-CM cohort(standard medical treatment)and CM cohort(integrated standard CM treatment≥3 months).Propensity score matching(PSM)and inverse probability of treatment weighting(IPTW)were performed to adjust any difference in average outcomes for bias.Results A total of 2,001 patients histologically confirmed locally advanced and/or metastasis stomach and gastroesophageal junction adenocarcinoma were enrolled.Among them,1,607 received systemic chemotherapy,215(10.74%)accepted molecular targeted therapy,44(2.2%)received checkpoint inhibitor therapy,and 769(38.43%)received CM.Two-drug regimen was the main choice for first-line treatment,with fluoropyrimidine plus platinum as the most common regimen(530 cases,60.09%).While 45.71%(16 cases)of patients with HER2 amplification received trastuzumab in first-line.The application of apatinib increased(33.33%)in third-line.The application of checkpoint inhibitors has increased since 2020.COX analysis showed that Lauren mixed type(P=0.017),cycles of first-line treatment>6(P=0.000),CM(P=0.000),palliative gastrectomy(P=0.000),trastuzumab(P=0.011),and apatinib(P=0.008)were independent prognostic factors for the OS of AGC.After PSM and IPTW,the median OS of CM cohort and non-CM cohort was 18.17 and 12.45 months,respectively(P<0.001).Conclusions In real-world practice for AGC in China,therapy choices consisted with guidelines.Two-drug regimen was the main first-line choice.Standardized CM treatment was an independent prognostic factor and could prolong the OS of Chinese patients with AGC.(Registration No.NCT02781285)展开更多
Objective:Real-world diagnostic and treatment data for pancreatic cancer in China are lacking.As such,the present study investigated the clinical characteristics,diagnosis,and treatment of advanced pancreatic cancer(i...Objective:Real-world diagnostic and treatment data for pancreatic cancer in China are lacking.As such,the present study investigated the clinical characteristics,diagnosis,and treatment of advanced pancreatic cancer(including locally advanced and metastatic disease)in the Hospital-based Advanced Pancreatic Cancer Cohort in China of the China Pancreas Data Center database.Methods:A total of 5349 Chinese patients with advanced pancreatic cancer were identified from a database.The entire course of real-world pancreatic cancer management was analyzed.Results:The proportion of patients with advanced pancreatic cancer was higher among males than females(62.4%vs 37.6%,respectively).Patients typically had a history of hypertension(30.8%),diabetes(21.6%),and cholangitis(20.2%).Abdominal pain(51.6%),abdominal distension(27.1%),jaundice(20.1%),and weight loss(16.3%)were the main symptoms observed in patients with advanced pancreatic cancer in this cohort.Serum carbohydrate antigen(CA)19-9 is one of the most common tumor markers.In the present study,2562 patients underwent first-line therapy.The median progression-free survival(PFS)for patients undergoing first-line therapy was 4.1 months.The major options for first-line therapy included gemcitabine(GEM)plus S-1(GS/X)(23.4%),nab-paclitaxel plus GEM(AG)(18.1%),oxaliplatin,irinotecan,and leucovorin-modulated fluorouracil(FOLFIRINOX;11.9%),nab-paclitaxel plus S-1(AS)(8.9%),and GEM combined with oxaliplatin/cisplatin(GEMOX/GP)(7.6%).The AS and GS/X regimens were associated with the highest PFS rates.Conclusion:This is the first study to report multicenter,real-world data regarding advanced pancreatic cancer in China.Results revealed that real-world treatment options differed from guideline recommendations,and PFS was shorter than that in previously reported data.Improving intelligent follow-up systems and standardizing diagnosis and treatment of pancreatic cancer is recommended.展开更多
Real-world engineering design problems with complex objective functions under some constraints are relatively difficult problems to solve.Such design problems are widely experienced in many engineering fields,such as ...Real-world engineering design problems with complex objective functions under some constraints are relatively difficult problems to solve.Such design problems are widely experienced in many engineering fields,such as industry,automotive,construction,machinery,and interdisciplinary research.However,there are established optimization techniques that have shown effectiveness in addressing these types of issues.This research paper gives a comparative study of the implementation of seventeen new metaheuristic methods in order to optimize twelve distinct engineering design issues.The algorithms used in the study are listed as:transient search optimization(TSO),equilibrium optimizer(EO),grey wolf optimizer(GWO),moth-flame optimization(MFO),whale optimization algorithm(WOA),slimemould algorithm(SMA),harris hawks optimization(HHO),chimp optimization algorithm(COA),coot optimization algorithm(COOT),multi-verse optimization(MVO),arithmetic optimization algorithm(AOA),aquila optimizer(AO),sine cosine algorithm(SCA),smell agent optimization(SAO),and seagull optimization algorithm(SOA),pelican optimization algorithm(POA),and coati optimization algorithm(CA).As far as we know,there is no comparative analysis of recent and popular methods against the concrete conditions of real-world engineering problems.Hence,a remarkable research guideline is presented in the study for researchersworking in the fields of engineering and artificial intelligence,especiallywhen applying the optimization methods that have emerged recently.Future research can rely on this work for a literature search on comparisons of metaheuristic optimization methods in real-world problems under similar conditions.展开更多
Human epidermal growth factor receptor 2(HER2)amplification or activating mutations are found in 1.6%–4%of non-small cell lung cancer(NSCLC).Pyrotinib has been reported to have better potency in NSCLC patients with H...Human epidermal growth factor receptor 2(HER2)amplification or activating mutations are found in 1.6%–4%of non-small cell lung cancer(NSCLC).Pyrotinib has been reported to have better potency in NSCLC patients with HER2 exon 20 insertion(ex20ins)mutations;however,more clinical evidence is urgently needed to guide pyrotinib-based therapy in NSCLC with HER2 amplification or heterogeneous mutations.We retrospectively analyzed advanced NSCLC patients with HER2 amplification or mutations who were treated with pyrotinib-based therapy between September 25,2018 and October 30,2020 in our hospital.Molecular dynamics simulation was used to explore the bioactive conformation and binding mechanisms of pan-ErbB tyrosine kinase inhibitors(TKIs)including pyrotinib for different HER2 ex20ins variants.In this study,79 eligible patients were included with 70 ex20ins variants,6 missense mutations and 3 primary HER2 amplifications identified.A775_G776insYVMA insertion was the most common observed subtype.The median progression-free survival(mPFS)was 5.8(95%CI:4.1–7.4)months.Use of pyrotinib-based therapy in first-/second-line settings showed a significantly better prognosis than that observed in third-line settings or above(mPFS:9.1 vs.4.4 months;P=0.0003).Compared with HER2 amplification and exon 20 non-YVMA insertion variants,patients with HER2 missense mutations had a visible mPFS benefit(12.2 vs.6.8 vs.5.2 months).Computational docking simulations revealed that pyrotinib failed to interact with the specific insertion variant P780_Y781insGSP.These results indicated that pyrotinib-based therapy exhibited good anti-tumor activity and acceptable safety profile in HER2-altered advanced NSCLC.展开更多
OBJECTIVE:To explore the differences in Traditional Chinese Medicine(TCM)diagnosis and treatment rules for coronavirus disease 2019(COVID-19)between Northern and Southern China based on the real-world data from 982 CO...OBJECTIVE:To explore the differences in Traditional Chinese Medicine(TCM)diagnosis and treatment rules for coronavirus disease 2019(COVID-19)between Northern and Southern China based on the real-world data from 982 COVID-19 patients.METHODS:All consecutive cases of COVID-19 admitted to the TCM department of designated COVID-19 hospitals in eight provinces and cities were retrospectively analyzed.Patients were divided into a Northern and a Southern group according to the location of the admitting hospital.The symptoms,syndrome elements,syndrome distribution and herbal treatments were analyzed.The core prescriptions were extracted using the multiscale backbone-based network comparison algorithm(msbNC).RESULTS:The distribution of syndrome elements showed that dampness was common in Northern and Southern China,wind and heat were more often present in the South,while fire toxin and spleen deficiency were more often encountered in the North.The distribution of syndromes showed that the South was dominated by heat dampness accumulating in the lung(55.69%),while the North was dominated by dampness-toxin stagnating in the lung(44.90%).The results of core prescription mining showed that dispelling dampness,dispersing wind,clearing heat and strengthening spleen were the common treatment methods in Northern and Southern China.For mild cases,Jinyinhua(Flos Lonicerae)and Lianqiao(Fructus Forsythiae Suspensae)were often used in the South to clear heat and relieve exterior symptoms,while Chaihu(Radix Bupleuri Chinensis)and Huangqin(Radix Scutellariae Baicalensis)were often used in the North to relieve muscles by expelling heat.For moderate cases,Chaihu(Radix Bupleuri Chinensis),Qinghao(Herba Artemisiae Annuae),and Shigao(Gypsum Fibrosum)were often used to clear heat of Tri-jiao Channel and stomach in the South,while Fuling(Poria),Chenpi(Pericarpium Citri Reticulatae),and Dangshen(Radix Codonopsis)were often used to invigorate spleen and remove dampness in the North.For severe cases,spleen invigoration and dampness removal as well as relaxing the bowels and discharging heat were often used in the North.CONCLUSION:There were certain North-South differences in terms of symptoms,syndrome elements and syndrome distribution of COVID-19,as well as differences in core prescriptions during different periods of the disease.The regional differences in the rules of TCM diagnosis and treatment for COVID-19 should be further considered in the process of optimization and revision of relevant treatment guidance.展开更多
The application of environment-behavior studies plays an important role in studying the renewal of shantytowns.One of the most humane ways of renewal is designing and constructing the necessary urban spatial environme...The application of environment-behavior studies plays an important role in studying the renewal of shantytowns.One of the most humane ways of renewal is designing and constructing the necessary urban spatial environment from the perspective of human daily behavior.Most of the shantytown renovation projects currently carried out in China are mainly focused on demolition and reconstruction,which not only incurs high costs but also damages the original social structure and economic model.During the process of shantytown renewal,it should improve the urban landscape,living environment,and life quality of residents,and ensure the daily life of shantytown residents without increasing their economic burden,and preserve the traces of urban development.In order to achieve this goal,it should explore the renewal strategies of shantytowns from the perspective of environment-behavior studies through behavior maps,on-site research,and literature review.Updating and design from a human perspective often achieve faster and better development;the renewal of shantytowns should be a bottom-up approach and start from a grassroots perspective,completing the renovation design through the composition of the population and behavioral patterns.展开更多
BACKGROUND In recent years,approximately half of the newly diagnosed cases and mortalities attributed to hepatocellular carcinoma(HCC)have been reported in China.Despite the high incidence of HCC,there remains a pauci...BACKGROUND In recent years,approximately half of the newly diagnosed cases and mortalities attributed to hepatocellular carcinoma(HCC)have been reported in China.Despite the high incidence of HCC,there remains a paucity of data regarding the natural growth pattern and the determination of optimal surveillance intervals specific to the Chinese population.AIM To quantify the natural tumor growth pattern of HCC in regional China.METHODS A retrospective analysis was performed on patients from a single institution in Southwest China who had undergone two or more serial dynamic computed tomography or magnetic resonance imaging scans between 2014 and 2020,without having received any anti-cancer therapy.Tumor growth was assessed using tumor volume doubling time(TVDT)and tumor growth rate(TGR),with volumes measured manually by experienced radiologists.Simple univariate linear regression and descriptive analysis were applied to explore associations between growth rates and clinical factors.RESULTS This study identifies the median TVDT for HCC as 163.4 d,interquartile range(IQR)72.1 to 302.3 d,with a daily TGR of 0.42%(IQR 0.206%-0.97%).HCC growth patterns reveal that about one-third of tumors grow indolently with TVDT exceeding 270 d,another one-third of tumors exhibit rapid growth with TVDT under 90 d,and the remaining tumors show intermediate growth rates,with TVDT ranging between 3 to 9 months.CONCLUSION The identified TGRs support biannual surveillance and follow-up for HCC patients in certain regions of China.Given the observed heterogeneity in HCC growth,further investigation is warranted.展开更多
BACKGROUND Hepatocellular carcinoma(HCC) is a common malignant tumor worldwide. Many regions across the world have issued various HCC diagnosis and treatment protocols to improve the diagnosis and targeted treatment o...BACKGROUND Hepatocellular carcinoma(HCC) is a common malignant tumor worldwide. Many regions across the world have issued various HCC diagnosis and treatment protocols to improve the diagnosis and targeted treatment of patients with HCC. However, real-world studies analysing the practice, application value, and existing problems of the China Liver Cancer(CNLC) staging system are scarce.AIM To analyze the current situation and problems associated with the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China.METHODS We collected the medical records of all patients with HCC admitted to the First Affiliated Hospital of Zhengzhou University from January 1, 2011 to December 31, 2019, and recorded the hospitalization information of those patients until December 31, 2020. All information on the diagnosis and treatment of the target patients was recorded, and their demographic and sociological characteristics, CNLC stages, screening situations, and treatment methods and effects were analyzed. The survival status of the patients was obtained from follow-up data.RESULTS This study included the medical records of 3022 patients with HCC. Among these cases, 304 patients were screened before HCC diagnosis;their early-stage diagnosis rate was 69.08%, which was significantly higher than that of patients with HCC who were diagnosed without screening and early detection(33.74%). Herein, patients with no clinical outcome at discharge were followed up, and the survival information of 1128 patients was obtained. A Cox model was used to analyse independent risk factors affecting overall survival, which were revealed as age > 50 years, no screening, alpha-fetoprotein > 400 ng/mL, Child–Pugh grade B, and middle and late CNLC stages. Based on the Cox model survival analysis, in our study, patients with HCC identified via screening had significant advantages in overall and tumorfree survival after hepatectomy.CONCLUSION Early diagnosis and treatment can be achieved by screening groups at high risk for HCC based on the guidelines;however, real-world compliance is poor.展开更多
基金This work was supported by the National Key Research and Development Program of China(Grant No.2021YFA1201100)the National Natural Science Foundation of China(Grant No.82072657).
文摘Objective:Little progress has been made in recent years using first-line chemotherapy,including gemcitabine combined with nab-paclitaxel,FOLFIRINOX,and NALIRIFOX,for advanced pancreatic adenocarcinoma(APC).In addition,the optimal second-line chemotherapy regimen has not been determined.This study aimed to compare the effectiveness of different types of second-line chemotherapy for APC.Methods:Patients with APC who received first-line treatment from January 2008 to January 2021 were considered eligible for this retrospective analysis.The primary and secondary endpoints were overall survival(OS)and progression-free survival(PFS),respectively.Results:Four hundred and thirty-seven and 617 patients were treated with 5-fluorouracil-and gemcitabine-based chemotherapy as first-line treatment,respectively.Demographic and clinical features,except age and liver metastasis,were comparable between the two groups(P<0.05).The median OS was 8.8 and 7.8 months in patients who received a 5-fluorouracil-and gemcitabine-based combined regimen for first-line therapy,respectively(HR=1.244,95%CI=1.090–1.419;P<0.001).The median OS was 5.6 and 1.9 months in patients who received second-line chemotherapy and supportive care,respectively(HR=0.766,95%CI=0.677–0.867;P<0.001).The median PFS was not significantly differently between gemcitabine or 5-fluorouracil monotherapy and combination therapy.Conclusions:A 5-fluorouracil-or gemcitabine-based combined regimen was shown to be as effective as a single 5-fluorouracil or gemcitabine regimen as second-line therapy for patients with APC.
基金the National Key Clinical Specialty Construction Project,No.ZK108000CAMS Innovation Fund for Medical Sciences,No.2021-I2M-C&T-A-001 and No.2022-I2M-C&T-B-012.
文摘BACKGROUND Although chronic erosive gastritis(CEG)is common,its clinical characteristics have not been fully elucidated.The lack of consensus regarding its treatment has resulted in varied treatment regimens.AIM To explore the clinical characteristics,treatment patterns,and short-term outcomes in CEG patients in China.METHODS We recruited patients with chronic non-atrophic or mild-to-moderate atrophic gastritis with erosion based on endoscopy and pathology.Patients and treating physicians completed a questionnaire regarding history,endoscopic findings,and treatment plans as well as a follow-up questionnaire to investigate changes in symptoms after 4 wk of treatment.RESULTS Three thousand five hundred sixty-three patients from 42 centers across 24 cities in China were included.Epigastric pain(68.0%),abdominal distension(62.6%),and postprandial fullness(47.5%)were the most common presenting symptoms.Gastritis was classified as chronic non-atrophic in 69.9%of patients.Among those with erosive lesions,72.1%of patients had lesions in the antrum,51.0%had multiple lesions,and 67.3%had superficial flat lesions.In patients with epigastric pain,the combination of a mucosal protective agent(MPA)and proton pump inhibitor was more effective.For those with postprandial fullness,acid regurgitation,early satiety,or nausea,a MPA appeared more promising.CONCLUSION CEG is a multifactorial disease which is common in Asian patients and has non-specific symptoms.Gastroscopy may play a major role in its detection and diagnosis.Treatment should be individualized based on symptom profile.
文摘BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care.The primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product reported.Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.
基金the support of the foundation projects:CACMS Innovation Fund(No.CI2021A02606).
文摘Object:The aim is to evaluate how effective Traditional Chinese Medicine(TCM)is in treating patients who have central retinal vein occlusion with macular edema(CRVO-ME)in a real-world study.Furthermore,the objective of the research was to examine the TCM prescription trends in the management of CRVO-ME.Method:A single-center real-world study(RWS)was carried out over a span of 19 years,following the established design.The study encompassed 113 patients diagnosed with CRVO-ME.Out of these,74 patients received TCM treatment,while the remaining individuals underwent a combined therapy involving TCM and anti-VEGF drugs through intravitreal injection.The patients were matched using propensity score matching(PSM).The result measured in the RWS was BCVA.The oral prescriptions for CRVO-ME that led to observable and effective outcomes were collected.Excel and the TCM Inheritance Auxiliary Platform V2.5 were utilized to optimize mutual information,hierarchical clustering based on entropy,and other techniques to extract medication regulations and features.Result:After applying PSM,each group comprised 29 cases.Both groups exhibited improved BCVA following treatment;however,there was no statistically significant distinction in BCVA or effectiveness between the two groups(all P>0.05).Apart from the analysis of oral prescriptions for CRVO-ME,the investigation pinpointed the most frequently used TCMs,namely Flos Carthami,Semen Persicae,Radix Angelica sinensis,Radix Rehmanniae,and Radix et Rhizoma Notoginseng.Frequently utilized medications tended to possess cold,warm,or mild attributes and exhibited a taste profile that was either bitter or sweet.The primary meridians associated with the medicines employed in treating CRVO-ME were liver,spleen,stomach,heart,and lung.Through the application of association rule analysis,it was discerned that there were 195 commonly employed combinations of medicines.Additionally,a complex system entropy cluster analysis unveiled 13 key combinations of medicines.By employing an unsupervised entropy hierarchical clustering analysis,a novel prescription was formulated.Conclusion:Within a real-world population of CRVO-ME patients,TCM exhibited its effectiveness.The treatment approach for CRVO-ME predominantly involved the regulation of qi(Qi is an exceedingly subtle substance within the human body,brimming with vitality and ceaseless motion.It constitutes the fundamental element that shapes and sustains the various processes of human life.)and blood as well as the resolution of dampness.The oral prescriptions frequently targeted the meridians of liver,spleen,stomach,heart,and lungs.
基金Special Fund of the National Medical Products Administration’s Drug Regulatory Science Research Base-Research Institute of Drug Regulatory Science of Shenyang Pharmaceutical University(No.2020jgkx005).
文摘Objective To provide references for improving the authenticity and reliability of the retrospective study results,thus improving the quality of evidence in the real world and strengthening drug supervision and decision-making.Methods Literature review was used to study the data sources,the characteristics of retrospective research,the sources and the corrections of selective bias in the real world.Results and Conclusion The biases in retrospective study mainly come from admission rate bias,patient rate bias,survivors bias,health user bias and symptom bias.
文摘Objective To introduce the design of observational trials under real-world study(RWS),and to provide guidance for clinical development of new research trials and reference for real-world researchers.Methods Relevant literature of RWS and observational experiments at home and abroad were reviewed and analyzed,and then the design of observational studies was summarized under RWS.Results and Conclusion The data and information provided in observational studies not only help to further verify the clinical study results obtained by randomized controlled trial(RCT)in clinical practice,but also objectively reflect the real situation in the process of clinical research and application.
基金Supported by the International Science and Technology Cooperation Projects,No.2016YFE0107100the Capital Special Research Project for Health Development,No.2014-2-4012+2 种基金the Beijing Natural Science Foundation,No.L172055 and No.7192158the National Tenthousand Talent Program,the Fundamental Research Funds for the Central Universities,No.3332018032and the CAMS Innovation Fund for Medical Science(CIFMS),No.2017-I2M-4-003 and No.2018-I2M-3-001.
文摘BACKGROUND Lenvatinib has become an indispensable part of treatment regimens for patients with advanced hepatocellular carcinoma(aHCC).Several recent real-world studies appear to have confirmed this;however,there are etiological differences.This necessitates further real-world studies of lenvatinib across diverse populations,such as in China.AIM To investigate the efficacy and safety of lenvatinib in a Chinese HCC patient population under real-world conditions.METHODS This is a retrospective and multiregional study involving patients with aHCC receiving lenvatinib monotherapy.Efficacy was assessed using the Response Evaluation Criteria in Solid Tumors version 1.1.Baseline characteristics and adverse events(AEs)were recorded throughout the entire study.RESULTS In total,54 HCC patients treated with lenvatinib monotherapy were included for final analysis.The objective response rate was 22%(n=12)with a progressionfree survival(PFS)of 168 d;however,AEs occurred in 92.8%of patients.Multivariate analysis showed that the Barcelona Clinic Liver Cancer stage[hazard ratio(HR)0.465;95%CI:0.23-0.93;P=0.031],portal vein tumor thrombus(HR 0.38;95%CI:0.15-0.94;P=0.037)and Child-Pugh classifications(HR 0.468;95%CI:and specificity(83.3%)of decreasing serum biomarkers including alphafetoprotein were calculated in order to predict tumor size reduction.Gene sequencing also provided insights into potential gene mutation signatures related to the effect of lenvatinib.CONCLUSION Our findings confirm previous evidence from the phase III REFLECT study.The majority of patients in this Chinese sample were suffering from concomitant hepatitis B virus-related HCC.However,further analysis suggested that baseline characteristics,changes in serum biomarkers and gene sequencing may hold the key for predicting lenvatinib responses.Further large-scale prospective studies that incorporate more basic medical science measures should be conducted.
基金Capital Clinical Medicine Special Project(No.Z181100001718215)National Natural Science Foundation of China(No.81602314).Research number:CSCO-BC RWS 16002。
文摘Objective:Several studies have demonstrated different benefits for patients whose disease progressed despite previous trastuzumab treatment.Due to limited real-world data,we evaluate the effectiveness of anti-human epidermal growth factor receptor 2(HER2)therapy(lapatinib or trastuzumab)plus chemotherapy or chemotherapy alone in patients who were previously treated with trastuzumab-containing regimens and investigate factors associated with effectiveness.And we further show the effectiveness of the two anti-HER2 therapy groups.Methods:A total of 342 HER2-positive metastatic breast cancer(MBC)patients whose disease progressed during prior anti-HER2(trastuzumab)and standard chemotherapy therapy from Department of Breast Oncology,the Fifth Medical Center of Chinese PLA General Hospital,from August 2010 to December 2016 were included.Seventy-eight patients received standard chemotherapy only,148 patients continued to receive trastuzumab and switched to other chemotherapy drugs,and 116 patients received tyrosine-kinase inhibitors(TKIs;lapatinib)and chemotherapy.The main outcome measures were progression-free survival(PFS),overall response rate(ORR),and clinical benefit rate(CBR).Subgroup analyses were conducted to identify patient characteristics associated with the greatest clinical benefit.Results:After a median follow-up of 26.2(range,2.0-56.0)months,PFS significantly improved with anti-HER2 therapy compared with chemotherapy alone:median 6.0 months with lapatinib[95%confidence interval(95%CI),4.53-7.47],4.5 months with trastuzumab(95%CI,3.99-5.01)vs.3.0 months with chemotherapy alone(95%CI,2.42-3.58);stratified hazard ratio(HR)=0.70,95%CI,0.60-0.81;P<0.0001.The ORR values were 33.6%,25.0%and 12.8%,respectively,the CBR values were 60.3%,48.6%and 26.9%,respectively.The effectiveness of lapatinib group and trastuzumab group were further analyzed.In multivariate analysis,lapatinib group was associated with a longer PFS,after controlling other potential confounders(HR=0.68,95%CI,0.52-0.90;P=0.006).Conclusions:The combination of TKIs and chemotherapy was effective in this cohort previously treated with trastuzumab treatment.Therefore,TKIs combined with chemotherapy is an option for Chinese HER2-positive MBC patients previously treated with trastuzumab treatment.
基金supported by the National Key Research Project(2020YFE0201800)Henan Province Science and Technology Program for Tackling Key Problems(21210230347)2021 Postgraduate Scientifc Re-search Innovation Progrpm of Henan Universityof Chinese Medicine(2021KYCX008).
文摘Objective Our objective was to analyze the traditional Chinese medicine(TCM)syndrome and treatment laws of diabetic kidney disease(DKD)and the action mechanism of high-frequency Chinese herbs in the treatment of DKD based on realworldstudy.MethodsThe data of patients with DKD who had been treated in the First Hospital Affiliated to Henan Universityof ChineseMedicine from January1,2014to December 31,2021 were retrospectively analyzed through the hospital information management system.The contents of the cases were statistically analyzed using IBM SPsS Statistics 25 software,and the laws of DKDtreatment were summarized.Network pharmacology and molecular docking were used to analyze the action mechanism of high-frequency Chinese herbs in the treatment of DKD.ResultsThe data of a total of 1,201 patients with DKD were included,involving 72 kinds of TCM syndromes.Nine disease nature elements and six disease location elements were extracted,involving 405 Chinese herbs.The top five high-frequency Chinese herbs were Baizhu(Atractylodis Macrocephalae Rhizoma),Fuling(Poria),Huangqi(Astragali Radix),Chuanxiong(Chuanxiong Rhizoma),and Danshen(Salviae Miltiorrhizae Radix et Rhizoma).Thirty kinds of Chinese herbs with the frequency of≥100 were mainly deficiency-tonifying herbs and blood-activating and stasis-eliminating herbs.The medicinal properties were mainly warm and mild,and the medicinal flavors were sweet and bitter mostly.For the meridian tropism,the main meridian tropism of these herbs is spleen meridian and lung meridian.The clustering method.
基金Special Fund of the National Medical Products Administration’s Drug Regulatory Science Research Base-Research Institute of Drug Regulatory Science of Shenyang Pharmaceutical University(No.2020jgkx005).
文摘Objective To study the research on real-world data and to provide new ideas and methods for the inheritance and development of empirical prescriptions of traditional Chinese medicine(TCM).Methods The disadvantages of using randomized controlled trials for empirical prescriptions of TCM and the advantages of using real-world study(RWS)were analyzed by summarizing the previous RWS and the empirical prescriptions.Meanwhile,the methods for marketing of new TCMs derived from empirical prescriptions of TCM,the data source and trial design of the RWS were discussed.Results and Conclusion RWS can provide new ideas for the listing of new TCMs.With the improvement of relevant laws and regulations,RWS will promote the development of TCM greatly.To promote the application of RWS in the inheritance and development of empirical prescriptions of TCM,the government should improve laws and regulations as soon as possible,and enterprises and research institutions should strengthen patient privacy protection and clarify the responsible parties.
文摘BACKGROUND Colon cancer is one the most common forms of cancer in both sexes.Due to important progress in the field of early detection and effective treatment,colon and rectal cancer survivors currently account for 10%of cancer survivors worldwide.However,the effects of anti-cancer treatments,especially oxaliplatinbased chemotherapy,on the quality of life(QoL)have been less evaluated.Although the incidence of severe chemotherapy-induced neuropathy(CIPN)in clinical studies is below 20%,data from real-world studies is scarce,and CIPN is probably under-reported due to patient selection and the patients’fear that reporting side-effects might lead to treatment cessation.AIM To determine the impact of CIPN on QoL in colorectal cancer patients with a recent history of oxaliplatin-based chemotherapy.METHODS We performed a prospective cross-sectional study in two major Romanian oncology tertiary hospitals—the Regional Institute of Oncology Ia?i(Iasi,Romania)and the Fundeni Clinical Oncology Institute(Bucharest,Romania).All consecutive patients with colon or rectal cancer,undergoing Oxaliplatin-based chemotherapy that consented to enroll in the study,were assessed by means of two questionnaires—the EORTC QQ-CR29(quality of life in colon and rectal cancer patients)and the QLQ-CIPN20(assessment of neuropathy).Several demographical,social,clinical and treatment data were also collected.Statistical analysis was performed by means of SPSS v20.The student t test was used to assess the relationship between the QLQ-CIPN20 and QLQ-CR29 results.Kaplan Meyer-curves were used to report 3-year progression-free survival(PFS)in patients that discontinued chemotherapy vs those that completed the recommended course.RESULTS Of the 267 patients that fulfilled the inclusion criteria in the pre-specified time frame,101(37.8%)agreed to participate in the clinical study.At the time of the enrolment in the study,over 50%of the patients had recently interrupted their oxaliplatin-based chemotherapy,most often due to neuropathy.Almost 85%of the responders reported having tingling or numbness in their fingers or hands,symptoms that were associated with pain in over 20%of the cases.When comparing the scores in the two questionnaires,a statistically significant relationship(P<0.001)was found between the presence of neuropathic symptoms and a decreased quality of life.This correlation was consistent when the patients were stratified by sex,disease stage,comorbidities and the presence of stoma or treatment type,suggesting that neuropathy in itself may be a reason for a decreased quality of life.At the 3 year final assessment,median recurrence-free survival in stageⅢpatients was 26.88 mo.When stratified by completion of chemotherapy,median recurrence freesurvival of stageⅢpatients that completed chemotherapy was 28.27 mo vs 24.33 mo in patients that discontinued chemotherapy due to toxicity,a difference that did not reach statistical significance.CONCLUSION CIPN significantly impacts QoL in colorectal cancer patients.CIPN is also the most frequent reason for treatment discontinuation.Physicians should actively assess for CIPN in order to prevent chronic neuropathy.
基金Supported by Science and Technology Innovation Project of China Academy of Chinese Medical Sciences (No. CI2021A04701)。
文摘Objective: To assess the outcomes after acupoint application in patients with pharyngeal pain in a real-world settings, and analyze the characteristics of effective population and prescription characteristics of acupoint application. Methods: Based on CHUNBO platform, patients with pharyngeal pain who were candidates for acupoint application on the basis of physician-evaluation, were enrolled in a nationwide, prospective, 69-week multicenter observational study from August 2020 to February 2022. Propensity score matching(PSM) was used to match the confounding factors and the association rules were used to analyze the characteristics of effective population and prescription characteristics of acupoint application. Outcome assessments included the disappearance rate of pharyngeal pain(within 3, 7, and 14 days), disappearance time of pharyngeal pain, as well as adverse events. Results: Of 7,699 enrolled participants, 6,693(86.9%) received acupoint application and 1,450(21.7%) with non-acupoint application. After PSM, there were 1,004 patients each in the application group(AG) and non-application group(NAG). The disappearance rate of pharyngeal pain in the AG at 3, 7, and 14 days were all higher than those in the NAG(P<0.05). The disappearance time of pharyngeal pain in the AG were shorter than that in the NAG(logrank P<0.001, hazard ratio=1.51, 95% confidence interval: 1.41–1.63). The median age of effective cases was 4 years, mainly 3–6 years old(40.21%). The disappearance rate of pharyngeal pain in the application group with tonsil diseases was 2.19 times higher than that in the NAG(P<0.05). The commonly used acupoints for the effective cases were Tiantu(RN 22), Shenque(RN 8) and Dazhui(DU 14). The commonly used herbs for the effective cases were Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae. Among them, Natrii sulfas was applied to RN 8 most frequently(support 84.39%). A total of 1,324(17.2%) patients experienced AEs, and mainly occurred in the AG, with significant difference in the incidence of AEs between goups(P<0.05). All AEs reported were the first grade, and the average regression time of AEs was 2.8 days. Conclusions: Acupoint application in patients with pharyngeal pain resulted in improved effective rate and shortened duration, especially children aged 3–6 years old, and those with tonsil diseases. Acupoint of RN 22, RN 8 and DU 14, herbs of Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae were the most commonly used in the treatment of pharyngeal pain.
基金Supported by National Natural Science Foundation of China(No.82004133)"Three-Year Action Plan"of Shanghai Traditional Chinese Medicine Development Office of Shanghai Health Commission(No.ZY3-CCCX-3-2003)Shanghai"Science and Technology Innovation Action Plan"Medical Innovation Research Project,Shanghai Clinical Research Center of Traditional Chinese Medicine Oncology(No.21MC1930500)。
文摘Objective To describe the treatment patterns and survival status of advanced gastric cancer(AGC)in China in the past two decades,and objectively evaluate the impact of standardized Chinese medicine(CM)treatment on the survival of AGC patients.Methods This multicenter registry designed and propensity score analysis study described the diagnosis characteristics,treatment-pattern development and survival status of AGC from 10 hospitals in China between January 1,2000 and July 31,2021.Overall survival(OS)was evaluated between non-CM cohort(standard medical treatment)and CM cohort(integrated standard CM treatment≥3 months).Propensity score matching(PSM)and inverse probability of treatment weighting(IPTW)were performed to adjust any difference in average outcomes for bias.Results A total of 2,001 patients histologically confirmed locally advanced and/or metastasis stomach and gastroesophageal junction adenocarcinoma were enrolled.Among them,1,607 received systemic chemotherapy,215(10.74%)accepted molecular targeted therapy,44(2.2%)received checkpoint inhibitor therapy,and 769(38.43%)received CM.Two-drug regimen was the main choice for first-line treatment,with fluoropyrimidine plus platinum as the most common regimen(530 cases,60.09%).While 45.71%(16 cases)of patients with HER2 amplification received trastuzumab in first-line.The application of apatinib increased(33.33%)in third-line.The application of checkpoint inhibitors has increased since 2020.COX analysis showed that Lauren mixed type(P=0.017),cycles of first-line treatment>6(P=0.000),CM(P=0.000),palliative gastrectomy(P=0.000),trastuzumab(P=0.011),and apatinib(P=0.008)were independent prognostic factors for the OS of AGC.After PSM and IPTW,the median OS of CM cohort and non-CM cohort was 18.17 and 12.45 months,respectively(P<0.001).Conclusions In real-world practice for AGC in China,therapy choices consisted with guidelines.Two-drug regimen was the main first-line choice.Standardized CM treatment was an independent prognostic factor and could prolong the OS of Chinese patients with AGC.(Registration No.NCT02781285)
基金funded by the National Natural Science Foundation of China(Grant nos.81874048,82171824,82272906)Shanghai Municipal Commission of Health and Family Planning Grant 2018ZHYL0223+6 种基金Shanghai Municipal Education Commission—Gao Feng Clinical Medicine Grant Support(Grant no.20161312)Scientific and Technological Innovation Project of Science and Technology Commission of Shanghai Municipality(Grant no.21JC1404300)Clinical Research Plan of SHDC(Grant no.SHDC2020CR1035B)Innovation Group Project of Shanghai Municipal Health Commission(Grant no.2019CXJQ03)National Key R&D Program of China(Grant no.2019YFC1315900)Project from CSCO Clinical Oncology Research Foundation(Grant no.Y-2019AZZD-0513)the Innovative Research Team of High-Level Local Universities in Shanghai(Grant no.SHSMU-ZDCX20210802).
文摘Objective:Real-world diagnostic and treatment data for pancreatic cancer in China are lacking.As such,the present study investigated the clinical characteristics,diagnosis,and treatment of advanced pancreatic cancer(including locally advanced and metastatic disease)in the Hospital-based Advanced Pancreatic Cancer Cohort in China of the China Pancreas Data Center database.Methods:A total of 5349 Chinese patients with advanced pancreatic cancer were identified from a database.The entire course of real-world pancreatic cancer management was analyzed.Results:The proportion of patients with advanced pancreatic cancer was higher among males than females(62.4%vs 37.6%,respectively).Patients typically had a history of hypertension(30.8%),diabetes(21.6%),and cholangitis(20.2%).Abdominal pain(51.6%),abdominal distension(27.1%),jaundice(20.1%),and weight loss(16.3%)were the main symptoms observed in patients with advanced pancreatic cancer in this cohort.Serum carbohydrate antigen(CA)19-9 is one of the most common tumor markers.In the present study,2562 patients underwent first-line therapy.The median progression-free survival(PFS)for patients undergoing first-line therapy was 4.1 months.The major options for first-line therapy included gemcitabine(GEM)plus S-1(GS/X)(23.4%),nab-paclitaxel plus GEM(AG)(18.1%),oxaliplatin,irinotecan,and leucovorin-modulated fluorouracil(FOLFIRINOX;11.9%),nab-paclitaxel plus S-1(AS)(8.9%),and GEM combined with oxaliplatin/cisplatin(GEMOX/GP)(7.6%).The AS and GS/X regimens were associated with the highest PFS rates.Conclusion:This is the first study to report multicenter,real-world data regarding advanced pancreatic cancer in China.Results revealed that real-world treatment options differed from guideline recommendations,and PFS was shorter than that in previously reported data.Improving intelligent follow-up systems and standardizing diagnosis and treatment of pancreatic cancer is recommended.
文摘Real-world engineering design problems with complex objective functions under some constraints are relatively difficult problems to solve.Such design problems are widely experienced in many engineering fields,such as industry,automotive,construction,machinery,and interdisciplinary research.However,there are established optimization techniques that have shown effectiveness in addressing these types of issues.This research paper gives a comparative study of the implementation of seventeen new metaheuristic methods in order to optimize twelve distinct engineering design issues.The algorithms used in the study are listed as:transient search optimization(TSO),equilibrium optimizer(EO),grey wolf optimizer(GWO),moth-flame optimization(MFO),whale optimization algorithm(WOA),slimemould algorithm(SMA),harris hawks optimization(HHO),chimp optimization algorithm(COA),coot optimization algorithm(COOT),multi-verse optimization(MVO),arithmetic optimization algorithm(AOA),aquila optimizer(AO),sine cosine algorithm(SCA),smell agent optimization(SAO),and seagull optimization algorithm(SOA),pelican optimization algorithm(POA),and coati optimization algorithm(CA).As far as we know,there is no comparative analysis of recent and popular methods against the concrete conditions of real-world engineering problems.Hence,a remarkable research guideline is presented in the study for researchersworking in the fields of engineering and artificial intelligence,especiallywhen applying the optimization methods that have emerged recently.Future research can rely on this work for a literature search on comparisons of metaheuristic optimization methods in real-world problems under similar conditions.
基金supported by the China Society of Clinical Oncology(CSCO)-Hengrui foundation(Grant No.Y-HR2018-239).
文摘Human epidermal growth factor receptor 2(HER2)amplification or activating mutations are found in 1.6%–4%of non-small cell lung cancer(NSCLC).Pyrotinib has been reported to have better potency in NSCLC patients with HER2 exon 20 insertion(ex20ins)mutations;however,more clinical evidence is urgently needed to guide pyrotinib-based therapy in NSCLC with HER2 amplification or heterogeneous mutations.We retrospectively analyzed advanced NSCLC patients with HER2 amplification or mutations who were treated with pyrotinib-based therapy between September 25,2018 and October 30,2020 in our hospital.Molecular dynamics simulation was used to explore the bioactive conformation and binding mechanisms of pan-ErbB tyrosine kinase inhibitors(TKIs)including pyrotinib for different HER2 ex20ins variants.In this study,79 eligible patients were included with 70 ex20ins variants,6 missense mutations and 3 primary HER2 amplifications identified.A775_G776insYVMA insertion was the most common observed subtype.The median progression-free survival(mPFS)was 5.8(95%CI:4.1–7.4)months.Use of pyrotinib-based therapy in first-/second-line settings showed a significantly better prognosis than that observed in third-line settings or above(mPFS:9.1 vs.4.4 months;P=0.0003).Compared with HER2 amplification and exon 20 non-YVMA insertion variants,patients with HER2 missense mutations had a visible mPFS benefit(12.2 vs.6.8 vs.5.2 months).Computational docking simulations revealed that pyrotinib failed to interact with the specific insertion variant P780_Y781insGSP.These results indicated that pyrotinib-based therapy exhibited good anti-tumor activity and acceptable safety profile in HER2-altered advanced NSCLC.
基金National Key Research and Development Plan:Study on TCM Syndrome Regularity and Optimization of Coronavirus Disease 2019 Diagnosis and Treatment Plan(No.2021YFC1712901)。
文摘OBJECTIVE:To explore the differences in Traditional Chinese Medicine(TCM)diagnosis and treatment rules for coronavirus disease 2019(COVID-19)between Northern and Southern China based on the real-world data from 982 COVID-19 patients.METHODS:All consecutive cases of COVID-19 admitted to the TCM department of designated COVID-19 hospitals in eight provinces and cities were retrospectively analyzed.Patients were divided into a Northern and a Southern group according to the location of the admitting hospital.The symptoms,syndrome elements,syndrome distribution and herbal treatments were analyzed.The core prescriptions were extracted using the multiscale backbone-based network comparison algorithm(msbNC).RESULTS:The distribution of syndrome elements showed that dampness was common in Northern and Southern China,wind and heat were more often present in the South,while fire toxin and spleen deficiency were more often encountered in the North.The distribution of syndromes showed that the South was dominated by heat dampness accumulating in the lung(55.69%),while the North was dominated by dampness-toxin stagnating in the lung(44.90%).The results of core prescription mining showed that dispelling dampness,dispersing wind,clearing heat and strengthening spleen were the common treatment methods in Northern and Southern China.For mild cases,Jinyinhua(Flos Lonicerae)and Lianqiao(Fructus Forsythiae Suspensae)were often used in the South to clear heat and relieve exterior symptoms,while Chaihu(Radix Bupleuri Chinensis)and Huangqin(Radix Scutellariae Baicalensis)were often used in the North to relieve muscles by expelling heat.For moderate cases,Chaihu(Radix Bupleuri Chinensis),Qinghao(Herba Artemisiae Annuae),and Shigao(Gypsum Fibrosum)were often used to clear heat of Tri-jiao Channel and stomach in the South,while Fuling(Poria),Chenpi(Pericarpium Citri Reticulatae),and Dangshen(Radix Codonopsis)were often used to invigorate spleen and remove dampness in the North.For severe cases,spleen invigoration and dampness removal as well as relaxing the bowels and discharging heat were often used in the North.CONCLUSION:There were certain North-South differences in terms of symptoms,syndrome elements and syndrome distribution of COVID-19,as well as differences in core prescriptions during different periods of the disease.The regional differences in the rules of TCM diagnosis and treatment for COVID-19 should be further considered in the process of optimization and revision of relevant treatment guidance.
文摘The application of environment-behavior studies plays an important role in studying the renewal of shantytowns.One of the most humane ways of renewal is designing and constructing the necessary urban spatial environment from the perspective of human daily behavior.Most of the shantytown renovation projects currently carried out in China are mainly focused on demolition and reconstruction,which not only incurs high costs but also damages the original social structure and economic model.During the process of shantytown renewal,it should improve the urban landscape,living environment,and life quality of residents,and ensure the daily life of shantytown residents without increasing their economic burden,and preserve the traces of urban development.In order to achieve this goal,it should explore the renewal strategies of shantytowns from the perspective of environment-behavior studies through behavior maps,on-site research,and literature review.Updating and design from a human perspective often achieve faster and better development;the renewal of shantytowns should be a bottom-up approach and start from a grassroots perspective,completing the renovation design through the composition of the population and behavioral patterns.
基金Supported by Cultivate Project for the National Natural Science Foundation of China,No.gyfynsfc[2020]-27and National Natural Science Foundation of China,No.81960328.
文摘BACKGROUND In recent years,approximately half of the newly diagnosed cases and mortalities attributed to hepatocellular carcinoma(HCC)have been reported in China.Despite the high incidence of HCC,there remains a paucity of data regarding the natural growth pattern and the determination of optimal surveillance intervals specific to the Chinese population.AIM To quantify the natural tumor growth pattern of HCC in regional China.METHODS A retrospective analysis was performed on patients from a single institution in Southwest China who had undergone two or more serial dynamic computed tomography or magnetic resonance imaging scans between 2014 and 2020,without having received any anti-cancer therapy.Tumor growth was assessed using tumor volume doubling time(TVDT)and tumor growth rate(TGR),with volumes measured manually by experienced radiologists.Simple univariate linear regression and descriptive analysis were applied to explore associations between growth rates and clinical factors.RESULTS This study identifies the median TVDT for HCC as 163.4 d,interquartile range(IQR)72.1 to 302.3 d,with a daily TGR of 0.42%(IQR 0.206%-0.97%).HCC growth patterns reveal that about one-third of tumors grow indolently with TVDT exceeding 270 d,another one-third of tumors exhibit rapid growth with TVDT under 90 d,and the remaining tumors show intermediate growth rates,with TVDT ranging between 3 to 9 months.CONCLUSION The identified TGRs support biannual surveillance and follow-up for HCC patients in certain regions of China.Given the observed heterogeneity in HCC growth,further investigation is warranted.
基金Supported by The Major Project of Science and Technology in Henan Province,No. 161100311400
文摘BACKGROUND Hepatocellular carcinoma(HCC) is a common malignant tumor worldwide. Many regions across the world have issued various HCC diagnosis and treatment protocols to improve the diagnosis and targeted treatment of patients with HCC. However, real-world studies analysing the practice, application value, and existing problems of the China Liver Cancer(CNLC) staging system are scarce.AIM To analyze the current situation and problems associated with the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China.METHODS We collected the medical records of all patients with HCC admitted to the First Affiliated Hospital of Zhengzhou University from January 1, 2011 to December 31, 2019, and recorded the hospitalization information of those patients until December 31, 2020. All information on the diagnosis and treatment of the target patients was recorded, and their demographic and sociological characteristics, CNLC stages, screening situations, and treatment methods and effects were analyzed. The survival status of the patients was obtained from follow-up data.RESULTS This study included the medical records of 3022 patients with HCC. Among these cases, 304 patients were screened before HCC diagnosis;their early-stage diagnosis rate was 69.08%, which was significantly higher than that of patients with HCC who were diagnosed without screening and early detection(33.74%). Herein, patients with no clinical outcome at discharge were followed up, and the survival information of 1128 patients was obtained. A Cox model was used to analyse independent risk factors affecting overall survival, which were revealed as age > 50 years, no screening, alpha-fetoprotein > 400 ng/mL, Child–Pugh grade B, and middle and late CNLC stages. Based on the Cox model survival analysis, in our study, patients with HCC identified via screening had significant advantages in overall and tumorfree survival after hepatectomy.CONCLUSION Early diagnosis and treatment can be achieved by screening groups at high risk for HCC based on the guidelines;however, real-world compliance is poor.
