BACKGROUND Bariatric and metabolic surgery have been routinely performed following the rapid increase in obesity and metabolic diseases worldwide.Of all evolving procedures,Roux-en-Y gastric bypass(RYGB)is considered ...BACKGROUND Bariatric and metabolic surgery have been routinely performed following the rapid increase in obesity and metabolic diseases worldwide.Of all evolving procedures,Roux-en-Y gastric bypass(RYGB)is considered the gold standard for surgical treatment of patients with type 2 diabetes mellitus(T2DM)and obesity.RYGB was introduced in China nearly 20 years ago,but the number of RYGB surgeries only accounts for 3.1%of the total number of weight loss and metabolic surgeries in China,it’s effect on Chinese people still needs further study.AIM To investigate the effect and safety of a modified gastric bypass performed in Chinese patients with T2DM.METHODS Patients with obesity and T2DM who underwent modified gastric bypass,with>5-year follow-up data,were analyzed.RESULTS All 37 patients underwent uneventful laparoscopic surgery,no patient was switched to laparotomy during the surgery,and no severe complications were reported.Average weight and body mass index of the patients reduced from 84.6±17.3(60.0–140.0)kg and 30.9±5.0(24.7–46.2)kg/m2 to 67.1±12.2(24.7–46.2)kg and 24.6±3.9(17.7–36.5)kg/m2,respectively,and fasting plasma glucose and glycated hemoglobin decreased from 7.4±3.4 mmol/L and 8.2%±1.7%preoperatively to 6.5±1.3 mmol/L and 6.5%±0.9%5-years postoperatively,respectively.Only 29.7%(11/37)of the patients used hypoglycemic drugs 5-years postoperatively,and the complete remission rate of T2DM was 29.7%(11/37).Triglyceride level reduced significantly but high-density lipoprotein increased significantly(both P<0.05)compared with those during the preoperative period.Liver and renal function improved significantly postoperatively,and binary logistic regression analysis revealed that the patients’preoperative history of T2DM and fasting C-peptide were significant prognostic factors influencing complete T2DM remission after RYGB(P=0.006 and 0.012,respectively).CONCLUSION The modified gastric bypass is a safe and feasible procedure for Chinese patients with obesity and T2DM,exhibiting satisfactory amelioration of weight problems,hyperglycemia,and combination disease.展开更多
AIM:To determine the role of diabetes mellitus(DM) and other associated factors in Chinese hepatocellular carcinoma(HCC) patients with cirrhosis,compared with those HCC patients without cirrhosis,in the single setting...AIM:To determine the role of diabetes mellitus(DM) and other associated factors in Chinese hepatocellular carcinoma(HCC) patients with cirrhosis,compared with those HCC patients without cirrhosis,in the single setting of hepatitis B virus(HBV) infection,after other known concomitant diseases were excluded.METHODS:A total of 482 patients,treated at the China-Japan Friendship Hospital,Ministry of Health(Beijing,China),in the period January 2003 to June 2009,and with a hospital discharge diagnosis of HCC,were included.Demographic,clinical,laboratory,metabolic and instrumental features were analyzed.RESULTS:Of the total,310 patients were diagnosed with HBV infection and,following the inclusion and exclusion criteria,224 were analyzed,including 122 patients(54.5%) with cirrhosis(the case group) and 102 patients without cirrhosis(the control group).Twentyseven patients(12.1%) were diabetic,including 19 in the case group and 8 in the control group(19/122=15.6% vs 8/102=7.8%,P=0.077).Thirty-one possible relevant parameters were compared by univariate analysis,and 9 variables were selected for multivariable analysis,including DM(P=0.077),past history of HBV infection(P=0.005),total bilirubin(P<0.001),albumin level(P<0.001),international normalized ratio(INR)(P<0.001),alanine aminotransferase(P=0.050),platelet(P<0.001),total cholesterol(P= 0.047),and LDL cholesterol(P=0.002) levels.Diabetes showed a statistical difference by multivariable analysis [odds ratio(OR) 4.88,95% confidence interval(CI):1.08-21.99,P=0.039],although no significant difference was found in univariate analysis.In addition,three cirrhosis-related parameters remained statistically different,including INR(OR 117.14,95% CI:4.19-3272.28,P=0.005),albumin(OR 0.89,95% CI:0.80-0.99,P=0.027),and platelet count(OR 0.992,95% CI:0.987-0.999,P=0.002).CONCLUSION:Besides the three cirrhosis-related parameters,DM was found to be the sole independent factor associated with HCC in patients with HBV-related cirrhosis,compared with those without cirrhosis.展开更多
BACKGROUND Sarcopenia is a nutrition-related disease and has a profound effect on the longterm overall survival(OS)of patients with gastric cancer.Its diagnostic criterion is critical to clinical diagnosis and treatme...BACKGROUND Sarcopenia is a nutrition-related disease and has a profound effect on the longterm overall survival(OS)of patients with gastric cancer.Its diagnostic criterion is critical to clinical diagnosis and treatment.However,previous research reported widely differing sarcopenia prevalence due to different criteria.AWGS2019 and EWGSOP2 are the two latest and widely adopted criteria.AIM To compare the effects of AWGS2019 and EWGSOP2 on the long-term OS of Chinese gastric cancer patient after radical gastrectomy.METHODS An observational study was conducted from July 2014 to January 2017,which included 648 consecutive gastric cancer patients who underwent radical gastrectomy.The sarcopenia elements(skeletal muscle index,handgrip strength,and gait speed)were measured within 1 mo or 7 d before surgery.The patients were followed at fixed intervals to gain the outcomes.Multivariate Cox regression analysis was performed to determine the association between sarcopenia and the long-term OS of these patients according to the two criteria separately.The predictive performance of the models with AWGS2019 and EWGSOP2 were evaluated by the concordance index(C-index)and area under the time-dependent receiver operating characteristic curve(AUC).The Akaike information criterion(AIC)was applied to compare model fits.RESULTS The prevalence of sarcopenia was 20.5%and 11.3%according to AWGS2019 and EWGSOP2,respectively.Sarcopenia was an independent risk factor for the longterm OS no matter based on AWGS2019 or EWGSOP2,but AWGS2019-sarcopenia in multivariate model had a higher hazard ratio(HR)[2.150(1.547-2.988)]than EWGSOP2-sarcopenia[HR 1.599(1.092-2.339)].Meanwhile,the model with AWGS2019-sarcopenia[C-index 0.773(0.742-0.804);AIC 2193.7;time-dependent AUC 0.812(0.756-0.867)for 1-year OS,0.815(0.778-0.852)for 3-year OS,and 0.809(0.759-0.859)for 5-year OS]had better predictive power and model fits than the model with EWGSOP2-sarcopenia[C-index 0.762(0.729-0.795);AIC 2215.2;timedependent AUC 0.797(0.741-0.854)for 1-year OS,0.804(0.767-0.842)for 3-year OS,and 0.799(0.748-0.850)for 5-year OS].CONCLUSION Sarcopenia is an independent risk factor for the long-term OS in Chinese gastric cancer patients undergoing radical gastrectomy.The prediction model with AWGS2019-sarcopenia has better predictive power and model fits than the prediction model with EWGSOP2-sarcopenia.AWGS2019 may be more appropriate for diagnosing sarcopenia in these Chinese patients than EWGSOP2.展开更多
Objective： The aim of this study was to investigate the efficacy and safety profiles of cetuximab, the commonly used monoclonal antibody of epidermal growth factor receptor, based on Chinese patients with colorectal ...Objective： The aim of this study was to investigate the efficacy and safety profiles of cetuximab, the commonly used monoclonal antibody of epidermal growth factor receptor, based on Chinese patients with colorectal cancer. Methods： All the papers studied on Chinese patients with gastrointestinal cancer treated by cetuximab and found in both databases of Chinese journal database for fulltext and PubMed were collected. The commonly used efficacy index such as disease control rate （CR ＋ PR ＋ SD） and response rate （CR ＋ PR） were analyzed, and the cetuximab related side effects such acne-like rash and nail change and hypersensitivity were analyzed too. Results： （1） There were 10 original papers contained total 152 patients with gastrointestinal cancer who were the candidates to analyze the safety profiles, and contained 130 patients with colorectal cancer who were candidates to analyze the efficacy. （2） The disease control rate and response rate in the whole group was 73.5% （95% CI： 65.5%-81.5%） and 29.1% （95% CI： 20.9%-37.3%）, respectively; In first-line setting group they were 70.0% （95% CI： 55%-85%） and 41.7% （95% CI： 25.6%-57.8%）, respectively; In non-first line setting group they were 71.6% （95% CI： 61.8%-81.4%） and 23.5% （95% CI： 14.3%-32.7%）, respectively. The disease control rate between the two line-setting groups was insignificant, but the response rate between the two line-setting groups was significant （P = 0.045）. （3） The incidence of acne-like rash was 72.0% （95% CI： 64.8%-79.2%）, the degree Ⅰ-Ⅱ and degree Ⅲ-Ⅳ account for 56.0% （95% CI： 48.1%-63.9%） and 16.0% （95% CI： 10.1%-21.9%）, respectively. No treatment related death, and the hypersensitivity was under control. Conclusion： This study is the first study to summarize the data of Chinese patients with colorectal cancer treated by cetuximab-contained regimen, it showed that the monoclonal antibody was effective and safe for Chinese patients as the West patients with colorectal cancer.展开更多
Background:Immunotherapy has become the fastest-adopting treatment paradigm for lung cancer with improved survival.By binding with its ligand(inducible T-cell costimulator and its ligand[ICOSL]),an inducible T-cell co...Background:Immunotherapy has become the fastest-adopting treatment paradigm for lung cancer with improved survival.By binding with its ligand(inducible T-cell costimulator and its ligand[ICOSL]),an inducible T-cell co-stimulator(ICOS)could contribute to reversing immunosuppression and improving immune response and thus be a potential target for cancer immunotherapy.Methods:We selected 54 formalin-fixed,paraffin-embedded tumor tissues from cases with stage I–III lung adenocarcinoma cancer.Immunohistochemical expression of ICOS and ICOSL was evaluated.The correlation with clinical parameters in Chinese patients was also compared with TCGA results.Results:The positive rates of ICOS and ICOSL were 68%and 81.5%,respectively,in lung tumor tissues.Of these,9 cases had a low expression of ICOS,and 22 cases had a high expression of ICOS;ICOSL expression was low in 20 cases and high in 24 cases.According to the International Association for the Study of Lung Cancer(8th edition),phase I lesions were detected in 21 cases,phase II lesions in 15 cases,and phase III lesions in 18 cases.The median survival time of all patients was 44.5 months,and the median disease-free survival was 32 months.Univariate analysis showed that the factors significantly associated with overall survival were tumor size,regional lymph node involvement,stage,and expression level of ICOS/ICOSL.Survival analysis using log-rank test indicated that the lower ICOS+cell infiltration may predict poor prognosis,whereas lower ICOSL protein expression may be associated with better prognosis,but ICOSL data need further validation in larger samples due to inconsistency in TCGA mRNA prediction.Conclusion:ICOS/ICOSL might be associated with prognosis of lung cancer,and ICOS and its ligand may be potential therapeutic targets in non-small cell lung cancer.展开更多
Oral anticoagulation therapy with warfarin is used to prevent and treat venous and arterial thrombosis and embolism. Its narrow therapeutic index should be monitored carefully in order to reach the desired outcomes. T...Oral anticoagulation therapy with warfarin is used to prevent and treat venous and arterial thrombosis and embolism. Its narrow therapeutic index should be monitored carefully in order to reach the desired outcomes. The complexity of the pharmacokinetic and pharmacodynamics profile of warfarin makes it a challenge to use during treatment. Its manufacturing characteristics play a key role in its dosage. The aim of this study is to examine and evaluate the effect of two different warfarin regimens in Chinese patients. A cross-sectional study design was adopted. Medical records of all patients （n = 368） who received warfarin therapy in cardio-thoracic surgery wards between Sep. 2008 and Dec. 2009 were reviewed. Details of antithrombotic results of international normalized ratio （INR） monitoring were obtained. Statistical analysis was performed to assess factors predictive of INR therapeutic range at patients＇ discharge time according to different warfarin regimens （2.5 mg in China and 3.0 mg in USA）. The patients＇ mean age was （48.23~12.96） years. The percentage of patients within the INR therapeutic range in the group treated with 2.5 mg warfarin （35.17%） was much lower than that in group treated with 3.0 mg warfarin （47.72%）. Therefore, a significance difference was observed （P = 0.032〈0.05）. In this study, statistical values have shown that most of the patients were related to medical case requesting INR target range of 1.8-2.2 and 2.0-2.5, respectively. There was a statistically significant difference between the two groups. The study showed that the 2.5 mg-warfarin regimen was less suitable than the 3.0 mg-warfarin regimen. Medication regimen should be simplified as much as possible, especially during different treatment period.展开更多
Background Glycemic control prevents onset and progression of diabetes-related long-term complications. The objective of this study was to demonstrate that twice daily insulin lispro low mix 25 is noninferior to twice...Background Glycemic control prevents onset and progression of diabetes-related long-term complications. The objective of this study was to demonstrate that twice daily insulin lispro low mix 25 is noninferior to twice daily human insulin mix 30/70 in achieving glycemic control as measured by hemoglobin Alc （HbAlc）, from baseline to endpoint, in patients with type 1 or 2 diabetes. Methods In this phase IV, crossover, open-label, multicenter study, 117 Chinese patients with diabetes were randomly assigned to one of two treatment sequence groups. One group received 12-week treatment with twice daily human insulin mix 30/70 followed by 12-week treatment with twice daily insulin lispro low mix 25, while the other group received the reverse treatment sequence. HbAlc, baseline-to-endpoint change in HbAlc, proportion of patients achieving target HbAlc ≤ 7% and 〈 6.5%, fasting blood glucose, and daily insulin doses were measured for each period. Safety and tolerability were also assessed. Results A statistically significant reduction （P≤0.0001） of HbAlc was achieved after each treatment （human insulin mix 30/70： mean HbA1c=7.91% （95% CI： 7,67%, 8.15%）; insulin lispro low mix 25： mean HbA1c=7.96% （95% CI： 7.72%, 8.20%））. The 95% Cl （-0.20, 0.10） of the difference between the two treatments satisfied the prespecified noninferiority margin of 0.3% （lower limit of 95% CI 〉 -0.3%）. No statistically significant differences between treatments were observed for any of the secondary efficacy measures. The incidence of treatment-emergent adverse events and hypoglycemia between the two treatments and treatment sequence groups was similar. Three serious adverse events were reported （human insulin mix 30/70 group： 2 patients （1.7%, hypoglycemic coma and cardiac failure）; insulin lispro low mix 25 group： 1 patient （0.9%, stroke））. All serious adverse events were resolved and no patients died during the study. Conclusion The results support noninferiority of twice daily insulin lispro low mix 25 versus twice daily human insulin mix 30/70 in HbAlc control in Chinese patients with type 1 or 2 diabetes.展开更多
Background:Patients with relapsed/refractory B-cell lymphomas have limited treatment options.GERSHWIN is an open-label,single-arm,phase Ib study of obinutuzumab monotherapy in Chinese patients with histologically docu...Background:Patients with relapsed/refractory B-cell lymphomas have limited treatment options.GERSHWIN is an open-label,single-arm,phase Ib study of obinutuzumab monotherapy in Chinese patients with histologically docu-mented CD20+relapsed/refractory chronic lymphocytic leukemia(CLL),diffuse large B-cell lymphoma(DLBCL),or follicular lymphoma(FL).The primary outcome measure of pharmacokinetics has been previously reported.We now present data on the secondary endpoint measures(e.g.,safety,and efficacy and pharmacodynamics).Methods:Patients received 1000 mg obinutuzumab intravenously on days 1,8,and 15 of cycle 1(CLL patients;first dose split over 2 days),and on day 1 of cycles 2-8.Each cycle lasted for 21 days;the treatment period was 24 weeks.All subjects receiving at least one dose of obinutuzumab were included in the analysis of safety,efficacy,as well as pharmacodynamics.Results:A total of 48 patients(>18 years of age)were enrolled(CLL:12;DLBCL:23;FL:13).The subjects received a median of two lines of anticancer treatment prior to the enrollment.Thirty-five patients(72.9%)had at least one adverse event(AE).The most frequent AE was infusion-related reactions(15 patients;31.3%),followed by pyrexia(11 patients;22.9%).Treatment-related AEs were reported in 28 patients(58.3%),and included one death(interstitial lung disease).End-of-treatment(EoT)response rate was 33.3%.Best overall response rate was 47.9%.Most CLL patients achieved a partial response at EoT(58.3%).CD19+depletion occurred in 75.0%of the patients with CLL,and all patients with FL and DLBCL.Conclusions:The safety and efficacy of obinutuzumab monotherapy in Chinese patients with B-cell lymphomas were similar to that observed in previous studies in non-Chinese patients;no new safety signals were observed.展开更多
Background The efficacy of pemetrexed in the second-line treatment of Chinese patients with advanced non-small cell lung cancer （NSCLC） has been shown to be similar to that of docetaxel in a recent study; additional...Background The efficacy of pemetrexed in the second-line treatment of Chinese patients with advanced non-small cell lung cancer （NSCLC） has been shown to be similar to that of docetaxel in a recent study; additionally, pemetrexed was associated with much better safety and toxicity profiles. Here, the survival without common toxicity criteria grade 3/4 toxicity （SWT） data from a post hoc analysis of this recent prospective NSCLC study in Chinese patients is reported. This post hoc analysis differs from the main study; it focuses on the nonsquamous population to align with the current approval for pemetrexed in China. Methods A total of 154 patients with nonsquamous NSCLC received either pemetrexed （500 mg/m2 intravenously （IV）） or docetaxel （75 mg/m2 IV） on day 1 of 21-day cycles. SWT was analyzed using Kaplan-Meier and univariate Cox methods. Results Patients treated with pemetrexed had a longer median SWT than patients treated with docetaxel （7.4 months versus 1.2 months; unadjusted hazard ratio =0.59, 95% confidence interval CCI}： 0.41-0.84; P=0.003）. At 12 and 18months, the SWT event-free probability for pemetrexed patients （18 months： 24.5%, 95%C/ 13.9%-36.6%, vs. 12.3%, 95% CI 4.8%-23.6%） was greater than that for docexatel patients （12 months： 37.3%, 95% CI 26.5%- 48.0%, vs. 23.3%, 95% CI 14.4-33.4）. The progression- free survival without common toxicity criteria grade 3/4 toxicity （PFS-WT） was also statistically significantly longer for patients treated with pemetrexed than patients treated with docetaxel （1.9 months vs. 1.1 months, P=0.002）. Conclusions Chinese patients with nonsquamous NSCLC disease treated with pemetrexed had improved SWT beyond 6 months than those receiving docetaxel. This analysis supports a benefit-to-risk profile that favors pemetrexed over docetaxel in the second-line treatment of Chinese nonsquamous NSCLC patients.展开更多
Erythropoietic protoporphyria（EPP）, an autosomal dominant disease, is caused by partial deficiency of ferrochelatase（FECH）, which catalyzes the terminal step of heme biosynthesis because of loss-of-function mutati...Erythropoietic protoporphyria（EPP）, an autosomal dominant disease, is caused by partial deficiency of ferrochelatase（FECH）, which catalyzes the terminal step of heme biosynthesis because of loss-of-function mutations in the FECH gene. To date, only a few cases have been described in Asia. In this study, we describe the clinical features of two Chinese patients with EPP, with diagnosis confirmed by the increase of free protoporphyrin in erythrocytes, detection of plasma fluorescence peak at 630–634 nm, and analysis of FECH gene mutations. Using gene scanning, we identified a small deletion in the FECH gene（c.973 delA） in one proband（patient A） and a pathogenic FECH mutation（c.1232 GT） in the other（patient B） and also observed some nucleotide variations（c.798 CG, c.921 AG, IVS1-23 CT, IVS3＋23 AG, IVS9＋35 CT, and IVS3-48 TC） in these patients. The family pedigree of patient A was then established by characterization of the genotype of the patient＇s relatives. We also analyzed the potential perniciousness of the missense mutation with bioinformatic software, Polyphen and Sift. In summary, Chinese EPP patients have similar manifestations to those of Caucasians, and identification of the Chinese FECH gene mutations expands the FECH genotypic spectrum and may contribute to genetic counseling.展开更多
Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small s...Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small sample size and single institute experience. The aim of this study was to provide overall view of characteristics of Chinese patients with MBC by means of summarizing all related papers published in Chinese journals. Methods: An online search was made in CBM,VIP,CNKI,and CBA databases to find all published articles of interest on Chinese patients with MBC. And eight subjects including the proportion of MBC in all breast cancer,age,tumor location,clinical stages,pathological subtypes,treatment modalities,ER/PR expression,and 5-year survival rate were selected to calculate the proportion and their 95% interval confidence. Results: There were 122 papers with 2584 patients enrolled. The basic features of Chinese patients with MBC included:(1) MBC only with a proportion of 1.06% of all the breast cancer; (2) The mean age at diagnosis was 57.6 years old; (3) Tumor mainly located in the areolar region (74.83%) with obvious nipple and/or skin involvement; (4) Nearly 62.62% patients were in early stage before accepting treatment; (5) Infiltrating ductal carcinoma accounted for 79.05% of all pathological subtypes; (6) ER/PR expression rate was 65.86%; (7) Radical resection was up to 86.06% in all surgical modalities; (8) The 5-year survival rate was 57.33%. Conclusion: The results showed in this study were an overall view of Chinese patients with MBC whose characteristics were similar to that reported in the West. Though this study provided a little bit stronger confidence than a single study collected in this paper,studies with more powerful evidence are urgently demanding in China.展开更多
Membrane-associated guanylate kinase(MAGUK)family protein MAGUK invert 2(MAGI-2)has been demonstrated to be involved in the tumorigenic mechanism of prostate cancer.The objective of this study was to investigate the e...Membrane-associated guanylate kinase(MAGUK)family protein MAGUK invert 2(MAGI-2)has been demonstrated to be involved in the tumorigenic mechanism of prostate cancer.The objective of this study was to investigate the expression of MAGI・2 at mRNA and protein levels.The prog no stic value of MAGI-2 in Han Chin ese patie nts with prostate cancer was also investigated.The expression data of MAGI・2 were assessed through database retrieval,analysis of sequencing data from our group,and tissue immunohistochemistry using digital scoring system(H・score).The clinical,pathological,and follow-up data were collected.The expression of MAGI-2 in prostate tumor tissues and prostate normal tissues was evaluated and compared.MAGI-2 expression was associated with clinical parameters including tumor stage,lymph node status,Gleason score,PSA level,and biochemical recurrenee of prostate cancer.The relative expression of MAGI-2 mRNA was lower in the tumor tissue in The Cancer Genome Atlas(TCGA)database and sequencing data(P<0.001).There was no difference in MAGI-2 protein expression between tumor and normal tissues in tissue microarray(TMA)results.MAGI-2 expression was associated with pathological tumor stage(P=0.02),Gleason score(P=0.05),and preoperation prostate-specific antigen(PSA;P=0.04).A positive correlation was identified between MAGI-2 and phosphatase and tensin homolog deleted on chromosome 10(PTEN)expressions through the analysis of TCGA and TMA data(P<0.0001).Patients with higher MAGI-2 expression had longer biochemical recurrence-free survival in the univariate analysis(P=0.005),which in dicates an optimal prog no stic value of MAGI-2 in Han Chin ese patie nts with prostate can cer.I n con elusion,MAGI-2 expressi on gradually decreases with tumor progression,and can be used as a predictor of tumor recurrence in Chinese patients.展开更多
Objective: The aim of this study was to investigate the efficacy and safety profiles of bevacizumab, the commonly used monoclonal antibody and its safety profiles were challenging, based on Chinese cancer patients. Me...Objective: The aim of this study was to investigate the efficacy and safety profiles of bevacizumab, the commonly used monoclonal antibody and its safety profiles were challenging, based on Chinese cancer patients. Methods: All the papers studied on Chinese cancer patients treated by bevacizumab were found in both databases of Chinese journal database for fulltext and PubMed were collected. The commonly used efficacy index such as disease control rate (CR + PR + SD) and response rate (CR + PR) were analyzed, and the bevacizumab related side effects were analyzed too. Results: (1) There were ten original papers contained total 199 patients who were the candidates to analyze the safety profiles, and 115 patients with colorectal cancer in five papers who were candidates to analyze the efficacy. (2) Nine in ten papers set the dose of bevacizumab in 2.5 mg/kg/week - 5 mg/kg/week, and the biweekly was the standard chemotherapy interval. (3) The disease control rate and response rate in Chinese colorectal cancer patients were 85% (95% CI: 79%-92%) and 61% (95% CI: 52%-70%), respectively. (4) The side effects related to bevacizumab were rare and most of them were grades 1-2, and only one case with grade 4 bleeding was recorded and only two cases with discontinuation of bevacizumab since hemoplysis. Also, the grades 3-4 side effects related cytotoxic agents were not common. Conclusion: This study summarized the data of Chinese cancer patients treated by bevacizumab-contained regimens, and it showed that the monoclonal antibody was effective and safe for Chinese patients as the West patients.展开更多
The aim of this study was to evaluate the effect of an individual nurse-led educational intervention for patients with psoriatic arthritis (PsA). This was a case-control study. The case group consisted of six individu...The aim of this study was to evaluate the effect of an individual nurse-led educational intervention for patients with psoriatic arthritis (PsA). This was a case-control study. The case group consisted of six individual educational sessions delivered by a nurse. A total of 40 patients with PsA joined in this study: the case group (n = 20) and the control group (n = 18). After a 6-week intervention, the case group had significantly better management for the severity of arthritis symptoms (p < 0.05), better psychological well-being and significant lower levels of anxiety (p < 0.05), and depression score (p < 0.01), and reported better improvement of physical and psychological domain of quality of life (QOL) (both p values < 0.05) than the control group. In conclusion, this nurse-led individual education intervention has statistically significant benefits for the management of clinical symptoms of arthritis and for psychological well-being and QOL in patients with PsA.展开更多
AIM:To explore the relationship between ocular and systemic conditions and the impact of ocular complications on the quality of life(QOL)in patients after allogeneic hematopoietic stem cell transplantation(ALLO-HSCT)....AIM:To explore the relationship between ocular and systemic conditions and the impact of ocular complications on the quality of life(QOL)in patients after allogeneic hematopoietic stem cell transplantation(ALLO-HSCT).METHODS:Forty-four patients with severe hematopoietic disease were enrolled after ALLO-HSCT at our center from July 2018 to October 2020.They completed two questionnaires:the Ocular Surface Disease Index(OSDI)and the quality-of-life scale for Chinese patients with visual impairment(SQOL-DV1).Ocular conditions and systemic conditions were also assessed.RESULTS:Eye damage was correlated with total bilirubin(P=0.005),and gamma-glutamyl transferase(GGT)(P=0.021).There was no significant correlation between the overall QOL score and OSDI(P=0.8226)or SQOLDV1(P=0.9526)scores.The OSDI and the overall QOL score were not correlated with ocular conditions,including best-corrected visual acuity(BCVA),intraocular pressure,Schirmer tear test II,sodium fluorescein staining,tear film breakup time,and tear meniscus height.SQOLDV1 was correlated with BCVA(P=0.0007),sodium fluorescein staining(P=0.007),and tear film breakup time(P=0.0146).CONCLUSION:In some patients,early ocular symptoms are not evident after ALLO-HSCT,while ocular surface complications can be observed after a comprehensive ophthalmological examination.Especially for those with elevated total bilirubin or GGT,regular ophthalmic follow-up visits are essential to diagnose and treat ocular graft versus host disease(o GVHD),especially for patients with elevated total bilirubin or GGT.展开更多
Objective To evaluate the prognostic value of JAK2,MPL and CALR mutations in Chinese patients with primary myelofibrosis(PMF).Methods Four hundred and two Chinese patients with PMF were retrospectively analyzed.The Ka...Objective To evaluate the prognostic value of JAK2,MPL and CALR mutations in Chinese patients with primary myelofibrosis(PMF).Methods Four hundred and two Chinese patients with PMF were retrospectively analyzed.The Kaplan-Meier method,the Log-rank test,the likelihood ratio test and the Cox展开更多
Objective To explore the impact of patient reported outcome of tyrosine kinase inhibitor(TKI)related side effects on daily life in Chinese patients with chronic myceloid leukemia(CML)in the chronic phase(CP).Methods F...Objective To explore the impact of patient reported outcome of tyrosine kinase inhibitor(TKI)related side effects on daily life in Chinese patients with chronic myceloid leukemia(CML)in the chronic phase(CP).Methods From May to November in 2014。展开更多
In the present study,we aimed to determine the pharmacokinetics(PK),pharmacodynamics(PD),adverse events(AEs),and their relationships in Chinese patients with schizophrenia after a single dose of long-acting risperidon...In the present study,we aimed to determine the pharmacokinetics(PK),pharmacodynamics(PD),adverse events(AEs),and their relationships in Chinese patients with schizophrenia after a single dose of long-acting risperidone.Schizophrenic patients(six females and seven males)were enrolled in this study.Serial blood samples were collected after drug administration during 63 d,and the drug concentrations were analyzed by LC-MS/MS.Safety and tolerance were evaluated by monitoring the AEs,changes in clinical laboratory results,12-lead ECG,vital signs,physical examination,and injection-site reactions.The extrapyramidal symptoms were evaluated using the ESRS.Efficacy was evaluated by the PANSS and BPRS.Twelve out of the 13 participants completed the trial.There were few clinically meaningful changes in mean clinical laboratory values,vital signs,or ECG parameters,except for the prolactin level and body weight.There were no serious AEs,and those observed were reversible.Significant clinical improvements in PANSS and PANSS-derived BPRS total scores were observed.The mean(standard deviation,coefficient of variation)values for these PK parameters were as follows:C_(max),8.954(8.059,90.0%)ng/mL;area under the curve AUC_(0-t),2453(1156,47.1%)ng·h/mL;AUC_(0-∞),2472(1160,46.9%)ng·h/mL;t_(max),830.0(min:744.0,max:984.0,11.8%)h;and t_(1/2),68.56(10.77,15.7%)h.The PK characteristics of long-acting risperidone showed a high level of inter-individual variation,while there were no clear correlations between PK,efficacy and AEs among the patients in the present study.展开更多
From January 2001 to January 2002, 50 patients of candidal vaginitis were treated by Kushen powder (KSP,苦参散) combined with Canesten as the treatment group, and controlled by a control group including another 50 pat...From January 2001 to January 2002, 50 patients of candidal vaginitis were treated by Kushen powder (KSP,苦参散) combined with Canesten as the treatment group, and controlled by a control group including another 50 patients treated with Canesten alone. The therapeutic results were satisfactory and reported as follows.展开更多
文摘BACKGROUND Bariatric and metabolic surgery have been routinely performed following the rapid increase in obesity and metabolic diseases worldwide.Of all evolving procedures,Roux-en-Y gastric bypass(RYGB)is considered the gold standard for surgical treatment of patients with type 2 diabetes mellitus(T2DM)and obesity.RYGB was introduced in China nearly 20 years ago,but the number of RYGB surgeries only accounts for 3.1%of the total number of weight loss and metabolic surgeries in China,it’s effect on Chinese people still needs further study.AIM To investigate the effect and safety of a modified gastric bypass performed in Chinese patients with T2DM.METHODS Patients with obesity and T2DM who underwent modified gastric bypass,with>5-year follow-up data,were analyzed.RESULTS All 37 patients underwent uneventful laparoscopic surgery,no patient was switched to laparotomy during the surgery,and no severe complications were reported.Average weight and body mass index of the patients reduced from 84.6±17.3(60.0–140.0)kg and 30.9±5.0(24.7–46.2)kg/m2 to 67.1±12.2(24.7–46.2)kg and 24.6±3.9(17.7–36.5)kg/m2,respectively,and fasting plasma glucose and glycated hemoglobin decreased from 7.4±3.4 mmol/L and 8.2%±1.7%preoperatively to 6.5±1.3 mmol/L and 6.5%±0.9%5-years postoperatively,respectively.Only 29.7%(11/37)of the patients used hypoglycemic drugs 5-years postoperatively,and the complete remission rate of T2DM was 29.7%(11/37).Triglyceride level reduced significantly but high-density lipoprotein increased significantly(both P<0.05)compared with those during the preoperative period.Liver and renal function improved significantly postoperatively,and binary logistic regression analysis revealed that the patients’preoperative history of T2DM and fasting C-peptide were significant prognostic factors influencing complete T2DM remission after RYGB(P=0.006 and 0.012,respectively).CONCLUSION The modified gastric bypass is a safe and feasible procedure for Chinese patients with obesity and T2DM,exhibiting satisfactory amelioration of weight problems,hyperglycemia,and combination disease.
基金Supported by Grant No 30772859 from the National Natural Science Foundation of China
文摘AIM:To determine the role of diabetes mellitus(DM) and other associated factors in Chinese hepatocellular carcinoma(HCC) patients with cirrhosis,compared with those HCC patients without cirrhosis,in the single setting of hepatitis B virus(HBV) infection,after other known concomitant diseases were excluded.METHODS:A total of 482 patients,treated at the China-Japan Friendship Hospital,Ministry of Health(Beijing,China),in the period January 2003 to June 2009,and with a hospital discharge diagnosis of HCC,were included.Demographic,clinical,laboratory,metabolic and instrumental features were analyzed.RESULTS:Of the total,310 patients were diagnosed with HBV infection and,following the inclusion and exclusion criteria,224 were analyzed,including 122 patients(54.5%) with cirrhosis(the case group) and 102 patients without cirrhosis(the control group).Twentyseven patients(12.1%) were diabetic,including 19 in the case group and 8 in the control group(19/122=15.6% vs 8/102=7.8%,P=0.077).Thirty-one possible relevant parameters were compared by univariate analysis,and 9 variables were selected for multivariable analysis,including DM(P=0.077),past history of HBV infection(P=0.005),total bilirubin(P<0.001),albumin level(P<0.001),international normalized ratio(INR)(P<0.001),alanine aminotransferase(P=0.050),platelet(P<0.001),total cholesterol(P= 0.047),and LDL cholesterol(P=0.002) levels.Diabetes showed a statistical difference by multivariable analysis [odds ratio(OR) 4.88,95% confidence interval(CI):1.08-21.99,P=0.039],although no significant difference was found in univariate analysis.In addition,three cirrhosis-related parameters remained statistically different,including INR(OR 117.14,95% CI:4.19-3272.28,P=0.005),albumin(OR 0.89,95% CI:0.80-0.99,P=0.027),and platelet count(OR 0.992,95% CI:0.987-0.999,P=0.002).CONCLUSION:Besides the three cirrhosis-related parameters,DM was found to be the sole independent factor associated with HCC in patients with HBV-related cirrhosis,compared with those without cirrhosis.
基金Supported by Zhejiang Provincial Health Department Medical Support Discipline-Nutrition,No.11-ZC24Wenzhou Municipal Science and Bureau,No.Y2020732.
文摘BACKGROUND Sarcopenia is a nutrition-related disease and has a profound effect on the longterm overall survival(OS)of patients with gastric cancer.Its diagnostic criterion is critical to clinical diagnosis and treatment.However,previous research reported widely differing sarcopenia prevalence due to different criteria.AWGS2019 and EWGSOP2 are the two latest and widely adopted criteria.AIM To compare the effects of AWGS2019 and EWGSOP2 on the long-term OS of Chinese gastric cancer patient after radical gastrectomy.METHODS An observational study was conducted from July 2014 to January 2017,which included 648 consecutive gastric cancer patients who underwent radical gastrectomy.The sarcopenia elements(skeletal muscle index,handgrip strength,and gait speed)were measured within 1 mo or 7 d before surgery.The patients were followed at fixed intervals to gain the outcomes.Multivariate Cox regression analysis was performed to determine the association between sarcopenia and the long-term OS of these patients according to the two criteria separately.The predictive performance of the models with AWGS2019 and EWGSOP2 were evaluated by the concordance index(C-index)and area under the time-dependent receiver operating characteristic curve(AUC).The Akaike information criterion(AIC)was applied to compare model fits.RESULTS The prevalence of sarcopenia was 20.5%and 11.3%according to AWGS2019 and EWGSOP2,respectively.Sarcopenia was an independent risk factor for the longterm OS no matter based on AWGS2019 or EWGSOP2,but AWGS2019-sarcopenia in multivariate model had a higher hazard ratio(HR)[2.150(1.547-2.988)]than EWGSOP2-sarcopenia[HR 1.599(1.092-2.339)].Meanwhile,the model with AWGS2019-sarcopenia[C-index 0.773(0.742-0.804);AIC 2193.7;time-dependent AUC 0.812(0.756-0.867)for 1-year OS,0.815(0.778-0.852)for 3-year OS,and 0.809(0.759-0.859)for 5-year OS]had better predictive power and model fits than the model with EWGSOP2-sarcopenia[C-index 0.762(0.729-0.795);AIC 2215.2;timedependent AUC 0.797(0.741-0.854)for 1-year OS,0.804(0.767-0.842)for 3-year OS,and 0.799(0.748-0.850)for 5-year OS].CONCLUSION Sarcopenia is an independent risk factor for the long-term OS in Chinese gastric cancer patients undergoing radical gastrectomy.The prediction model with AWGS2019-sarcopenia has better predictive power and model fits than the prediction model with EWGSOP2-sarcopenia.AWGS2019 may be more appropriate for diagnosing sarcopenia in these Chinese patients than EWGSOP2.
基金Supported by a grant from Major Science and Technology Project of "National Significant New Drug Creation" (No: 2008ZX09312–002)
文摘Objective： The aim of this study was to investigate the efficacy and safety profiles of cetuximab, the commonly used monoclonal antibody of epidermal growth factor receptor, based on Chinese patients with colorectal cancer. Methods： All the papers studied on Chinese patients with gastrointestinal cancer treated by cetuximab and found in both databases of Chinese journal database for fulltext and PubMed were collected. The commonly used efficacy index such as disease control rate （CR ＋ PR ＋ SD） and response rate （CR ＋ PR） were analyzed, and the cetuximab related side effects such acne-like rash and nail change and hypersensitivity were analyzed too. Results： （1） There were 10 original papers contained total 152 patients with gastrointestinal cancer who were the candidates to analyze the safety profiles, and contained 130 patients with colorectal cancer who were candidates to analyze the efficacy. （2） The disease control rate and response rate in the whole group was 73.5% （95% CI： 65.5%-81.5%） and 29.1% （95% CI： 20.9%-37.3%）, respectively; In first-line setting group they were 70.0% （95% CI： 55%-85%） and 41.7% （95% CI： 25.6%-57.8%）, respectively; In non-first line setting group they were 71.6% （95% CI： 61.8%-81.4%） and 23.5% （95% CI： 14.3%-32.7%）, respectively. The disease control rate between the two line-setting groups was insignificant, but the response rate between the two line-setting groups was significant （P = 0.045）. （3） The incidence of acne-like rash was 72.0% （95% CI： 64.8%-79.2%）, the degree Ⅰ-Ⅱ and degree Ⅲ-Ⅳ account for 56.0% （95% CI： 48.1%-63.9%） and 16.0% （95% CI： 10.1%-21.9%）, respectively. No treatment related death, and the hypersensitivity was under control. Conclusion： This study is the first study to summarize the data of Chinese patients with colorectal cancer treated by cetuximab-contained regimen, it showed that the monoclonal antibody was effective and safe for Chinese patients as the West patients with colorectal cancer.
基金the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences(CIFMS,nos:2022-I2M-JB-011,2022-I2M-1-014)the National Natural Science Foundation of China(82293684)the National Key R&D Program of China(2022YFA0806400).
文摘Background:Immunotherapy has become the fastest-adopting treatment paradigm for lung cancer with improved survival.By binding with its ligand(inducible T-cell costimulator and its ligand[ICOSL]),an inducible T-cell co-stimulator(ICOS)could contribute to reversing immunosuppression and improving immune response and thus be a potential target for cancer immunotherapy.Methods:We selected 54 formalin-fixed,paraffin-embedded tumor tissues from cases with stage I–III lung adenocarcinoma cancer.Immunohistochemical expression of ICOS and ICOSL was evaluated.The correlation with clinical parameters in Chinese patients was also compared with TCGA results.Results:The positive rates of ICOS and ICOSL were 68%and 81.5%,respectively,in lung tumor tissues.Of these,9 cases had a low expression of ICOS,and 22 cases had a high expression of ICOS;ICOSL expression was low in 20 cases and high in 24 cases.According to the International Association for the Study of Lung Cancer(8th edition),phase I lesions were detected in 21 cases,phase II lesions in 15 cases,and phase III lesions in 18 cases.The median survival time of all patients was 44.5 months,and the median disease-free survival was 32 months.Univariate analysis showed that the factors significantly associated with overall survival were tumor size,regional lymph node involvement,stage,and expression level of ICOS/ICOSL.Survival analysis using log-rank test indicated that the lower ICOS+cell infiltration may predict poor prognosis,whereas lower ICOSL protein expression may be associated with better prognosis,but ICOSL data need further validation in larger samples due to inconsistency in TCGA mRNA prediction.Conclusion:ICOS/ICOSL might be associated with prognosis of lung cancer,and ICOS and its ligand may be potential therapeutic targets in non-small cell lung cancer.
文摘Oral anticoagulation therapy with warfarin is used to prevent and treat venous and arterial thrombosis and embolism. Its narrow therapeutic index should be monitored carefully in order to reach the desired outcomes. The complexity of the pharmacokinetic and pharmacodynamics profile of warfarin makes it a challenge to use during treatment. Its manufacturing characteristics play a key role in its dosage. The aim of this study is to examine and evaluate the effect of two different warfarin regimens in Chinese patients. A cross-sectional study design was adopted. Medical records of all patients （n = 368） who received warfarin therapy in cardio-thoracic surgery wards between Sep. 2008 and Dec. 2009 were reviewed. Details of antithrombotic results of international normalized ratio （INR） monitoring were obtained. Statistical analysis was performed to assess factors predictive of INR therapeutic range at patients＇ discharge time according to different warfarin regimens （2.5 mg in China and 3.0 mg in USA）. The patients＇ mean age was （48.23~12.96） years. The percentage of patients within the INR therapeutic range in the group treated with 2.5 mg warfarin （35.17%） was much lower than that in group treated with 3.0 mg warfarin （47.72%）. Therefore, a significance difference was observed （P = 0.032〈0.05）. In this study, statistical values have shown that most of the patients were related to medical case requesting INR target range of 1.8-2.2 and 2.0-2.5, respectively. There was a statistically significant difference between the two groups. The study showed that the 2.5 mg-warfarin regimen was less suitable than the 3.0 mg-warfarin regimen. Medication regimen should be simplified as much as possible, especially during different treatment period.
文摘Background Glycemic control prevents onset and progression of diabetes-related long-term complications. The objective of this study was to demonstrate that twice daily insulin lispro low mix 25 is noninferior to twice daily human insulin mix 30/70 in achieving glycemic control as measured by hemoglobin Alc （HbAlc）, from baseline to endpoint, in patients with type 1 or 2 diabetes. Methods In this phase IV, crossover, open-label, multicenter study, 117 Chinese patients with diabetes were randomly assigned to one of two treatment sequence groups. One group received 12-week treatment with twice daily human insulin mix 30/70 followed by 12-week treatment with twice daily insulin lispro low mix 25, while the other group received the reverse treatment sequence. HbAlc, baseline-to-endpoint change in HbAlc, proportion of patients achieving target HbAlc ≤ 7% and 〈 6.5%, fasting blood glucose, and daily insulin doses were measured for each period. Safety and tolerability were also assessed. Results A statistically significant reduction （P≤0.0001） of HbAlc was achieved after each treatment （human insulin mix 30/70： mean HbA1c=7.91% （95% CI： 7,67%, 8.15%）; insulin lispro low mix 25： mean HbA1c=7.96% （95% CI： 7.72%, 8.20%））. The 95% Cl （-0.20, 0.10） of the difference between the two treatments satisfied the prespecified noninferiority margin of 0.3% （lower limit of 95% CI 〉 -0.3%）. No statistically significant differences between treatments were observed for any of the secondary efficacy measures. The incidence of treatment-emergent adverse events and hypoglycemia between the two treatments and treatment sequence groups was similar. Three serious adverse events were reported （human insulin mix 30/70 group： 2 patients （1.7%, hypoglycemic coma and cardiac failure）; insulin lispro low mix 25 group： 1 patient （0.9%, stroke））. All serious adverse events were resolved and no patients died during the study. Conclusion The results support noninferiority of twice daily insulin lispro low mix 25 versus twice daily human insulin mix 30/70 in HbAlc control in Chinese patients with type 1 or 2 diabetes.
基金GERSHWIN was sponsored by F.Hoffmann-La Roche Ltd.Medical Writing supportunder the direction of the lead author,was provided by Elizabeth Johnson of Gardiner-Caldwell Communications,and was funded by F.Hoffmann-La Roche Ltd.
文摘Background:Patients with relapsed/refractory B-cell lymphomas have limited treatment options.GERSHWIN is an open-label,single-arm,phase Ib study of obinutuzumab monotherapy in Chinese patients with histologically docu-mented CD20+relapsed/refractory chronic lymphocytic leukemia(CLL),diffuse large B-cell lymphoma(DLBCL),or follicular lymphoma(FL).The primary outcome measure of pharmacokinetics has been previously reported.We now present data on the secondary endpoint measures(e.g.,safety,and efficacy and pharmacodynamics).Methods:Patients received 1000 mg obinutuzumab intravenously on days 1,8,and 15 of cycle 1(CLL patients;first dose split over 2 days),and on day 1 of cycles 2-8.Each cycle lasted for 21 days;the treatment period was 24 weeks.All subjects receiving at least one dose of obinutuzumab were included in the analysis of safety,efficacy,as well as pharmacodynamics.Results:A total of 48 patients(>18 years of age)were enrolled(CLL:12;DLBCL:23;FL:13).The subjects received a median of two lines of anticancer treatment prior to the enrollment.Thirty-five patients(72.9%)had at least one adverse event(AE).The most frequent AE was infusion-related reactions(15 patients;31.3%),followed by pyrexia(11 patients;22.9%).Treatment-related AEs were reported in 28 patients(58.3%),and included one death(interstitial lung disease).End-of-treatment(EoT)response rate was 33.3%.Best overall response rate was 47.9%.Most CLL patients achieved a partial response at EoT(58.3%).CD19+depletion occurred in 75.0%of the patients with CLL,and all patients with FL and DLBCL.Conclusions:The safety and efficacy of obinutuzumab monotherapy in Chinese patients with B-cell lymphomas were similar to that observed in previous studies in non-Chinese patients;no new safety signals were observed.
文摘Background The efficacy of pemetrexed in the second-line treatment of Chinese patients with advanced non-small cell lung cancer （NSCLC） has been shown to be similar to that of docetaxel in a recent study; additionally, pemetrexed was associated with much better safety and toxicity profiles. Here, the survival without common toxicity criteria grade 3/4 toxicity （SWT） data from a post hoc analysis of this recent prospective NSCLC study in Chinese patients is reported. This post hoc analysis differs from the main study; it focuses on the nonsquamous population to align with the current approval for pemetrexed in China. Methods A total of 154 patients with nonsquamous NSCLC received either pemetrexed （500 mg/m2 intravenously （IV）） or docetaxel （75 mg/m2 IV） on day 1 of 21-day cycles. SWT was analyzed using Kaplan-Meier and univariate Cox methods. Results Patients treated with pemetrexed had a longer median SWT than patients treated with docetaxel （7.4 months versus 1.2 months; unadjusted hazard ratio =0.59, 95% confidence interval CCI}： 0.41-0.84; P=0.003）. At 12 and 18months, the SWT event-free probability for pemetrexed patients （18 months： 24.5%, 95%C/ 13.9%-36.6%, vs. 12.3%, 95% CI 4.8%-23.6%） was greater than that for docexatel patients （12 months： 37.3%, 95% CI 26.5%- 48.0%, vs. 23.3%, 95% CI 14.4-33.4）. The progression- free survival without common toxicity criteria grade 3/4 toxicity （PFS-WT） was also statistically significantly longer for patients treated with pemetrexed than patients treated with docetaxel （1.9 months vs. 1.1 months, P=0.002）. Conclusions Chinese patients with nonsquamous NSCLC disease treated with pemetrexed had improved SWT beyond 6 months than those receiving docetaxel. This analysis supports a benefit-to-risk profile that favors pemetrexed over docetaxel in the second-line treatment of Chinese nonsquamous NSCLC patients.
基金supported by the National Basic Research Project(973)of China(No.2012CB934000)the National Distinguished Youth Scholar Grant of China(No.31325010)
文摘Erythropoietic protoporphyria（EPP）, an autosomal dominant disease, is caused by partial deficiency of ferrochelatase（FECH）, which catalyzes the terminal step of heme biosynthesis because of loss-of-function mutations in the FECH gene. To date, only a few cases have been described in Asia. In this study, we describe the clinical features of two Chinese patients with EPP, with diagnosis confirmed by the increase of free protoporphyrin in erythrocytes, detection of plasma fluorescence peak at 630–634 nm, and analysis of FECH gene mutations. Using gene scanning, we identified a small deletion in the FECH gene（c.973 delA） in one proband（patient A） and a pathogenic FECH mutation（c.1232 GT） in the other（patient B） and also observed some nucleotide variations（c.798 CG, c.921 AG, IVS1-23 CT, IVS3＋23 AG, IVS9＋35 CT, and IVS3-48 TC） in these patients. The family pedigree of patient A was then established by characterization of the genotype of the patient＇s relatives. We also analyzed the potential perniciousness of the missense mutation with bioinformatic software, Polyphen and Sift. In summary, Chinese EPP patients have similar manifestations to those of Caucasians, and identification of the Chinese FECH gene mutations expands the FECH genotypic spectrum and may contribute to genetic counseling.
文摘Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small sample size and single institute experience. The aim of this study was to provide overall view of characteristics of Chinese patients with MBC by means of summarizing all related papers published in Chinese journals. Methods: An online search was made in CBM,VIP,CNKI,and CBA databases to find all published articles of interest on Chinese patients with MBC. And eight subjects including the proportion of MBC in all breast cancer,age,tumor location,clinical stages,pathological subtypes,treatment modalities,ER/PR expression,and 5-year survival rate were selected to calculate the proportion and their 95% interval confidence. Results: There were 122 papers with 2584 patients enrolled. The basic features of Chinese patients with MBC included:(1) MBC only with a proportion of 1.06% of all the breast cancer; (2) The mean age at diagnosis was 57.6 years old; (3) Tumor mainly located in the areolar region (74.83%) with obvious nipple and/or skin involvement; (4) Nearly 62.62% patients were in early stage before accepting treatment; (5) Infiltrating ductal carcinoma accounted for 79.05% of all pathological subtypes; (6) ER/PR expression rate was 65.86%; (7) Radical resection was up to 86.06% in all surgical modalities; (8) The 5-year survival rate was 57.33%. Conclusion: The results showed in this study were an overall view of Chinese patients with MBC whose characteristics were similar to that reported in the West. Though this study provided a little bit stronger confidence than a single study collected in this paper,studies with more powerful evidence are urgently demanding in China.
基金The authors acknowledge the contribution of Dr.Lin Zhao,Dr.Ya-Sheng Zhu,Dr.Zhe-Xu Cao,and Dr.Chen Ye from the Department of Urology,Changhai Hospital,Naval Medical University(the Second Military Medical University),for their kind help during the experimental process.This study was supported by the National Natural Science Foundation of China(No.81430058)Shanghai Key Laboratory of Cell Engineering(No.14DZ2272300).
文摘Membrane-associated guanylate kinase(MAGUK)family protein MAGUK invert 2(MAGI-2)has been demonstrated to be involved in the tumorigenic mechanism of prostate cancer.The objective of this study was to investigate the expression of MAGI・2 at mRNA and protein levels.The prog no stic value of MAGI-2 in Han Chin ese patie nts with prostate cancer was also investigated.The expression data of MAGI・2 were assessed through database retrieval,analysis of sequencing data from our group,and tissue immunohistochemistry using digital scoring system(H・score).The clinical,pathological,and follow-up data were collected.The expression of MAGI-2 in prostate tumor tissues and prostate normal tissues was evaluated and compared.MAGI-2 expression was associated with clinical parameters including tumor stage,lymph node status,Gleason score,PSA level,and biochemical recurrenee of prostate cancer.The relative expression of MAGI-2 mRNA was lower in the tumor tissue in The Cancer Genome Atlas(TCGA)database and sequencing data(P<0.001).There was no difference in MAGI-2 protein expression between tumor and normal tissues in tissue microarray(TMA)results.MAGI-2 expression was associated with pathological tumor stage(P=0.02),Gleason score(P=0.05),and preoperation prostate-specific antigen(PSA;P=0.04).A positive correlation was identified between MAGI-2 and phosphatase and tensin homolog deleted on chromosome 10(PTEN)expressions through the analysis of TCGA and TMA data(P<0.0001).Patients with higher MAGI-2 expression had longer biochemical recurrence-free survival in the univariate analysis(P=0.005),which in dicates an optimal prog no stic value of MAGI-2 in Han Chin ese patie nts with prostate can cer.I n con elusion,MAGI-2 expressi on gradually decreases with tumor progression,and can be used as a predictor of tumor recurrence in Chinese patients.
文摘Objective: The aim of this study was to investigate the efficacy and safety profiles of bevacizumab, the commonly used monoclonal antibody and its safety profiles were challenging, based on Chinese cancer patients. Methods: All the papers studied on Chinese cancer patients treated by bevacizumab were found in both databases of Chinese journal database for fulltext and PubMed were collected. The commonly used efficacy index such as disease control rate (CR + PR + SD) and response rate (CR + PR) were analyzed, and the bevacizumab related side effects were analyzed too. Results: (1) There were ten original papers contained total 199 patients who were the candidates to analyze the safety profiles, and 115 patients with colorectal cancer in five papers who were candidates to analyze the efficacy. (2) Nine in ten papers set the dose of bevacizumab in 2.5 mg/kg/week - 5 mg/kg/week, and the biweekly was the standard chemotherapy interval. (3) The disease control rate and response rate in Chinese colorectal cancer patients were 85% (95% CI: 79%-92%) and 61% (95% CI: 52%-70%), respectively. (4) The side effects related to bevacizumab were rare and most of them were grades 1-2, and only one case with grade 4 bleeding was recorded and only two cases with discontinuation of bevacizumab since hemoplysis. Also, the grades 3-4 side effects related cytotoxic agents were not common. Conclusion: This study summarized the data of Chinese cancer patients treated by bevacizumab-contained regimens, and it showed that the monoclonal antibody was effective and safe for Chinese patients as the West patients.
文摘The aim of this study was to evaluate the effect of an individual nurse-led educational intervention for patients with psoriatic arthritis (PsA). This was a case-control study. The case group consisted of six individual educational sessions delivered by a nurse. A total of 40 patients with PsA joined in this study: the case group (n = 20) and the control group (n = 18). After a 6-week intervention, the case group had significantly better management for the severity of arthritis symptoms (p < 0.05), better psychological well-being and significant lower levels of anxiety (p < 0.05), and depression score (p < 0.01), and reported better improvement of physical and psychological domain of quality of life (QOL) (both p values < 0.05) than the control group. In conclusion, this nurse-led individual education intervention has statistically significant benefits for the management of clinical symptoms of arthritis and for psychological well-being and QOL in patients with PsA.
基金Supported by Natural Science Foundation of Guangdong Province,China(No.2019A1515011212)Beijing Bethune Charitable Foundation(No.BJ-GY2021014J)。
文摘AIM:To explore the relationship between ocular and systemic conditions and the impact of ocular complications on the quality of life(QOL)in patients after allogeneic hematopoietic stem cell transplantation(ALLO-HSCT).METHODS:Forty-four patients with severe hematopoietic disease were enrolled after ALLO-HSCT at our center from July 2018 to October 2020.They completed two questionnaires:the Ocular Surface Disease Index(OSDI)and the quality-of-life scale for Chinese patients with visual impairment(SQOL-DV1).Ocular conditions and systemic conditions were also assessed.RESULTS:Eye damage was correlated with total bilirubin(P=0.005),and gamma-glutamyl transferase(GGT)(P=0.021).There was no significant correlation between the overall QOL score and OSDI(P=0.8226)or SQOLDV1(P=0.9526)scores.The OSDI and the overall QOL score were not correlated with ocular conditions,including best-corrected visual acuity(BCVA),intraocular pressure,Schirmer tear test II,sodium fluorescein staining,tear film breakup time,and tear meniscus height.SQOLDV1 was correlated with BCVA(P=0.0007),sodium fluorescein staining(P=0.007),and tear film breakup time(P=0.0146).CONCLUSION:In some patients,early ocular symptoms are not evident after ALLO-HSCT,while ocular surface complications can be observed after a comprehensive ophthalmological examination.Especially for those with elevated total bilirubin or GGT,regular ophthalmic follow-up visits are essential to diagnose and treat ocular graft versus host disease(o GVHD),especially for patients with elevated total bilirubin or GGT.
文摘Objective To evaluate the prognostic value of JAK2,MPL and CALR mutations in Chinese patients with primary myelofibrosis(PMF).Methods Four hundred and two Chinese patients with PMF were retrospectively analyzed.The Kaplan-Meier method,the Log-rank test,the likelihood ratio test and the Cox
文摘Objective To explore the impact of patient reported outcome of tyrosine kinase inhibitor(TKI)related side effects on daily life in Chinese patients with chronic myceloid leukemia(CML)in the chronic phase(CP).Methods From May to November in 2014。
基金Foundation items:The National Major Scientific and Technological Special Project for"Significant New Drug Development"during the Twelfth Five-year Planning Period of China(Grant No.2014ZX09303303).
文摘In the present study,we aimed to determine the pharmacokinetics(PK),pharmacodynamics(PD),adverse events(AEs),and their relationships in Chinese patients with schizophrenia after a single dose of long-acting risperidone.Schizophrenic patients(six females and seven males)were enrolled in this study.Serial blood samples were collected after drug administration during 63 d,and the drug concentrations were analyzed by LC-MS/MS.Safety and tolerance were evaluated by monitoring the AEs,changes in clinical laboratory results,12-lead ECG,vital signs,physical examination,and injection-site reactions.The extrapyramidal symptoms were evaluated using the ESRS.Efficacy was evaluated by the PANSS and BPRS.Twelve out of the 13 participants completed the trial.There were few clinically meaningful changes in mean clinical laboratory values,vital signs,or ECG parameters,except for the prolactin level and body weight.There were no serious AEs,and those observed were reversible.Significant clinical improvements in PANSS and PANSS-derived BPRS total scores were observed.The mean(standard deviation,coefficient of variation)values for these PK parameters were as follows:C_(max),8.954(8.059,90.0%)ng/mL;area under the curve AUC_(0-t),2453(1156,47.1%)ng·h/mL;AUC_(0-∞),2472(1160,46.9%)ng·h/mL;t_(max),830.0(min:744.0,max:984.0,11.8%)h;and t_(1/2),68.56(10.77,15.7%)h.The PK characteristics of long-acting risperidone showed a high level of inter-individual variation,while there were no clear correlations between PK,efficacy and AEs among the patients in the present study.
文摘From January 2001 to January 2002, 50 patients of candidal vaginitis were treated by Kushen powder (KSP,苦参散) combined with Canesten as the treatment group, and controlled by a control group including another 50 patients treated with Canesten alone. The therapeutic results were satisfactory and reported as follows.
