BACKGROUND The incidence of chronic kidney disease among patients with diabetes mellitus(DM)remains a global concern.Long-term obesity is known to possibly influence the development of type 2 diabetes mellitus.However...BACKGROUND The incidence of chronic kidney disease among patients with diabetes mellitus(DM)remains a global concern.Long-term obesity is known to possibly influence the development of type 2 diabetes mellitus.However,no previous meta-analysis has assessed the effects of body mass index(BMI)on adverse kidney events in patients with DM.AIM To determine the impact of BMI on adverse kidney events in patients with DM.METHODS A systematic literature search was performed on the PubMed,ISI Web of Science,Scopus,Ovid,Google Scholar,EMBASE,and BMJ databases.We included trials with the following characteristics:(1)Type of study:Prospective,retrospective,randomized,and non-randomized in design;(2)participants:Restricted to patients with DM aged≥18 years;(3)intervention:No intervention;and(4)kidney adverse events:Onset of diabetic kidney disease[estimated glomerular filtration rate(eGFR)of<60 mL/min/1.73 m2 and/or microalbuminuria value of≥30 mg/g Cr],serum creatinine increase of more than double the baseline or end-stage renal disease(eGFR<15 mL/min/1.73 m2 or dialysis),or death.RESULTS Overall,11 studies involving 801 patients with DM were included.High BMI(≥25 kg/m2)was significantly associated with higher blood pressure(BP)[systolic BP by 0.20,95%confidence interval(CI):0.15–0.25,P<0.00001;diastolic BP by 0.21 mmHg,95%CI:0.04–0.37,P=0.010],serum albumin,triglycerides[standard mean difference(SMD)=0.35,95%CI:0.29–0.41,P<0.00001],low-density lipoprotein(SMD=0.12,95%CI:0.04–0.20,P=0.030),and lower high-density lipoprotein(SMD=–0.36,95%CI:–0.51 to–0.21,P<0.00001)in patients with DM compared with those with low BMIs(<25 kg/m2).Our analysis showed that high BMI was associated with a higher risk ratio of adverse kidney events than low BMI(RR:1.22,95%CI:1.01–1.43,P=0.036).CONCLUSION The present analysis suggested that high BMI was a risk factor for adverse kidney events in patients with DM.展开更多
We conducted a comprehensive review of existing prediction models pertaining to the efficacy of immune-checkpoint inhibitor(ICI)and the occurrence of immune-related adverse events(irAEs).The predictive potential of ne...We conducted a comprehensive review of existing prediction models pertaining to the efficacy of immune-checkpoint inhibitor(ICI)and the occurrence of immune-related adverse events(irAEs).The predictive potential of neutrophil-to-lymphocyte ratio(NLR)and platelet-to-lymphocyte ratio(PLR)in determining ICI effectiveness has been extensively investigated,while limited research has been conducted on predicting irAEs.Furthermore,the combined model incor-porating NLR and PLR,either with each other or in conjunction with additional markers such as carcinoembryonic antigen,exhibits superior predictive capabilities compared to individual markers alone.NLR and PLR are promising markers for clinical applications.Forthcoming models ought to incorporate established efficacious models and newly identified ones,thereby constituting a multifactor composite model.Furthermore,efforts should be made to explore effective clinical application approaches that enhance the predictive accuracy and efficiency.展开更多
BACKGROUND Prediabetes is a well-established risk factor for major adverse cardiac and cerebrovascular events(MACCE).However,the relationship between prediabetes and MACCE in atrial fibrillation(AF)patients has not be...BACKGROUND Prediabetes is a well-established risk factor for major adverse cardiac and cerebrovascular events(MACCE).However,the relationship between prediabetes and MACCE in atrial fibrillation(AF)patients has not been extensively studied.Therefore,this study aimed to establish a link between prediabetes and MACCE in AF patients.AIM To investigate a link between prediabetes and MACCE in AF patients.METHODS We used the National Inpatient Sample(2019)and relevant ICD-10 CM codes to identify hospitalizations with AF and categorized them into groups with and without prediabetes,excluding diabetics.The primary outcome was MACCE(all-cause inpatient mortality,cardiac arrest including ventricular fibrillation,and stroke)in AF-related hospitalizations.RESULTS Of the 2965875 AF-related hospitalizations for MACCE,47505(1.6%)were among patients with prediabetes.The prediabetes cohort was relatively younger(median 75 vs 78 years),and often consisted of males(56.3%vs 51.4%),blacks(9.8%vs 7.9%),Hispanics(7.3%vs 4.3%),and Asians(4.7%vs 1.6%)than the non-prediabetic cohort(P<0.001).The prediabetes group had significantly higher rates of hypertension,hyperlipidemia,smoking,obesity,drug abuse,prior myocardial infarction,peripheral vascular disease,and hyperthyroidism(all P<0.05).The prediabetes cohort was often discharged routinely(51.1%vs 41.1%),but more frequently required home health care(23.6%vs 21.0%)and had higher costs.After adjusting for baseline characteristics or comorbidities,the prediabetes cohort with AF admissions showed a higher rate and significantly higher odds of MACCE compared to the non-prediabetic cohort[18.6%vs 14.7%,odds ratio(OR)1.34,95%confidence interval 1.26-1.42,P<0.001].On subgroup analyses,males had a stronger association(aOR 1.43)compared to females(aOR 1.22),whereas on the race-wise comparison,Hispanics(aOR 1.43)and Asians(aOR 1.36)had a stronger association with MACCE with prediabetes vs whites(aOR 1.33)and blacks(aOR 1.21).CONCLUSION This population-based study found a significant association between prediabetes and MACCE in AF patients.Therefore,there is a need for further research to actively screen and manage prediabetes in AF to prevent MACCE.展开更多
BACKGROUND Liver transplant(LT)patients have become older and sicker.The rate of post-LT major adverse cardiovascular events(MACE)has increased,and this in turn raises 30-d post-LT mortality.Noninvasive cardiac stress...BACKGROUND Liver transplant(LT)patients have become older and sicker.The rate of post-LT major adverse cardiovascular events(MACE)has increased,and this in turn raises 30-d post-LT mortality.Noninvasive cardiac stress testing loses accuracy when applied to pre-LT cirrhotic patients.AIM To assess the feasibility and accuracy of a machine learning model used to predict post-LT MACE in a regional cohort.METHODS This retrospective cohort study involved 575 LT patients from a Southern Brazilian academic center.We developed a predictive model for post-LT MACE(defined as a composite outcome of stroke,new-onset heart failure,severe arrhythmia,and myocardial infarction)using the extreme gradient boosting(XGBoost)machine learning model.We addressed missing data(below 20%)for relevant variables using the k-nearest neighbor imputation method,calculating the mean from the ten nearest neighbors for each case.The modeling dataset included 83 features,encompassing patient and laboratory data,cirrhosis complications,and pre-LT cardiac assessments.Model performance was assessed using the area under the receiver operating characteristic curve(AUROC).We also employed Shapley additive explanations(SHAP)to interpret feature impacts.The dataset was split into training(75%)and testing(25%)sets.Calibration was evaluated using the Brier score.We followed Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis guidelines for reporting.Scikit-learn and SHAP in Python 3 were used for all analyses.The supplementary material includes code for model development and a user-friendly online MACE prediction calculator.RESULTS Of the 537 included patients,23(4.46%)developed in-hospital MACE,with a mean age at transplantation of 52.9 years.The majority,66.1%,were male.The XGBoost model achieved an impressive AUROC of 0.89 during the training stage.This model exhibited accuracy,precision,recall,and F1-score values of 0.84,0.85,0.80,and 0.79,respectively.Calibration,as assessed by the Brier score,indicated excellent model calibration with a score of 0.07.Furthermore,SHAP values highlighted the significance of certain variables in predicting postoperative MACE,with negative noninvasive cardiac stress testing,use of nonselective beta-blockers,direct bilirubin levels,blood type O,and dynamic alterations on myocardial perfusion scintigraphy being the most influential factors at the cohort-wide level.These results highlight the predictive capability of our XGBoost model in assessing the risk of post-LT MACE,making it a valuable tool for clinical practice.CONCLUSION Our study successfully assessed the feasibility and accuracy of the XGBoost machine learning model in predicting post-LT MACE,using both cardiovascular and hepatic variables.The model demonstrated impressive performance,aligning with literature findings,and exhibited excellent calibration.Notably,our cautious approach to prevent overfitting and data leakage suggests the stability of results when applied to prospective data,reinforcing the model’s value as a reliable tool for predicting post-LT MACE in clinical practice.展开更多
Objective:To access the level of knowledge,perceptions,and practice towards adverse events following immunization(AEFI)surveillance among vaccination workers in Zhejiang province,China.Methods:This was a cross-section...Objective:To access the level of knowledge,perceptions,and practice towards adverse events following immunization(AEFI)surveillance among vaccination workers in Zhejiang province,China.Methods:This was a cross-sectional survey involving 768 vaccination workers.Data were collected using self-administered questionnaires and analyzed by using SAS 9.3 software.Knowledge,perceptions,and practice on AEFI surveillance were summarized using frequency tables.The mean±SD value was used as the cut-off for defining good(values≥mean)and poor(values<mean)knowledge,perceptions or practice.Binary logistic regression analysis was used to determine sociodemographic variables associated with knowledge,perceptions,and practice towards AEFI.Results:The proportions of good knowledge,perceptions and practice on AEFI surveillance were 78.13%,57.81%and 66.15%,respectively.Having a higher education background,longer years of experience,previous training on AEFI and≥30 years of age were factors associated with good knowledge,perceptions and practice on AEFI surveillance among vaccination workers.Conclusions:Over half of the respondents had good knowledge,perceptions and practice on AEFI surveillance work.Interventions on improving the vaccination workers’knowledge,perceptions and practice on AEFI surveillance should be considered in order to develop a more effective surveillance system.展开更多
BACKGROUND Although immune checkpoint inhibitor(ICI)therapy has improved the prognosis of unresectable hepatocellular carcinoma(HCC),it has also resulted in unique immune-related adverse events(irAEs).The relationship...BACKGROUND Although immune checkpoint inhibitor(ICI)therapy has improved the prognosis of unresectable hepatocellular carcinoma(HCC),it has also resulted in unique immune-related adverse events(irAEs).The relationship between irAE and treatment outcomes in ICI-treated unresectable HCC patients remains unknown.AIM To elucidate the correlation between immune-related toxic effects and prognosis in patients with unresectable HCC treated with pembrolizumab.METHODS From March 2019 to February 2021,a total of 190 unresectable HCC(Barcelona Clinic Liver Cancer C)patients receiving pembrolizumab treatment were retrospectively reviewed.Overall survival(OS)was the primary endpoint,while objective response rate(ORR),disease control rate(DCR),and time to progression(TTP)were secondary evaluation indexes.We assessed demographics,irAEs,and outcomes by retrospective review.RESULTS One hundred and forty-three males and 47 females were included in the study.The ORR and DCR were 12.1%(23/190)and 52.1%(99/190),respectively.The median OS was 376 d[95%confidence interval(CI):340-411 d]and the median TTP was 98 d(95%CI:75-124 d).The overall incidence of treatment-related adverse events was 72.6%(138/190)and 10.0%of them were severe irAEs(grade≥3).Child-Pugh B class,portal vein tumor thrombus,extrahepatic metastasis,and hypothyroidism were the independent risk factors for survival.Patients with hypothyroidism showed a longer OS[517 d(95%CI:423-562)vs 431 d(95%CI:412-485),P=0.011]and TTP[125 d(95%CI:89-154)vs 87 d(95%CI:61-98),P=0.004]than those without irAEs.CONCLUSION Pembrolizumab-treated patients with unresectable HCC who experienced hypothyroidism have promising ORR and durable response.Hypothyroidism,an irAE,may be used as a clinical evaluation parameter of response to ICIs in unresectable HCC.展开更多
Lymphoma,which is highly malignant,stems from lymph nodes and lymphoid tissue.Lymphoma cells express programmed death-ligand 1/2(PD-L1/PD-L2),which binds with programmed cell death 1 protein(PD-1)to establish inhibito...Lymphoma,which is highly malignant,stems from lymph nodes and lymphoid tissue.Lymphoma cells express programmed death-ligand 1/2(PD-L1/PD-L2),which binds with programmed cell death 1 protein(PD-1)to establish inhibitory signaling that impedes the normal function of T cells and allows tumor cells to escape immune system surveillance.Recently,immune checkpoint inhibitor immunotherapies such as PD-1 inhibitors(nivolumab and pembrolizumab)have been introduced into the lymphoma treatment algorithm and have shown remarkable clinical efficacy and greatly improve prognosis in lymphoma patients.Accordingly,the number of lymphoma patients who are seeking treatment with PD-1 inhibitors is growing annually,which results in an increasing number of patients developing immune-related adverse events(irAEs).The occurrence of irAEs inevitably affects the benefits provided by immunotherapy,particularly when PD-1 inhibitors are applied.However,the mechanisms and characteristics of irAEs induced by PD-1 inhibitors in lymphoma need further investigation.This review article summarizes the latest research advances in irAEs during treatment of lymphoma with PD-1 inhibitors.A comprehensive understanding of irAEs incurred in immunotherapy can help to achieve better efficacy with PD-1 inhibitors in lymphoma.展开更多
Introduction: Despite the many efforts made to combat preventable maternal deaths, these still remain high in Benin. It was therefore important to revisit the causes but especially the adverse events associated with c...Introduction: Despite the many efforts made to combat preventable maternal deaths, these still remain high in Benin. It was therefore important to revisit the causes but especially the adverse events associated with care (EIS) in maternity. Objective: Determine the incidence, adverse events associated with care and causes of intra hospital maternal mortality in cotonou. Methods: This was a cross-sectional maternal mortality review study with retrospective data collection. It covered all cases of maternal death recorded between 2017 and 2021 in two (2) reference university maternities in Cotonou. Adverse events associated with care and the patient were analyzed using the maternal death audit grid validated for Benin. SPSS.26 software was used for data analysis. Results: The in-hospital maternal mortality ratio in Cotonou was 2028 maternal deaths per 100,000 live births in 2021. Only 7.2% (n = 36) of deaths were audited. The deceased mothers were 29.8 ± 7.4 years old, with no fixed monthly income in 82.7% (n = 420). Serious adverse events associated with care were: delay in decision to refer in 37% (n = 188), non-medical referral in 85.8% (n = 436) of cases, inadequate pre-referral treatment in 25.7% of cases. In receiving maternities, delay in diagnosis and inappropriate treatment at the receiving maternity were noted respectively in 22.9% and 28.6% of cases of maternal death. The direct causes of maternal death were dominated by serious obstetric hemorrhage in 43.9% (n = 223). As for the indirect causes, they were dominated by anemia excluding obstetric hemorrhages in 21.5% (n = 109). Conclusion: The in-hospital maternal mortality ratio was very high in Cotonou. The main cause was severe obstetric hemorrhage. There were several serious healthcare-associated adverse events whose correct management would significantly reduce the incidence of maternal deaths.展开更多
Objective:This systematized review aimed to synthesize the results of empirical studies focused on the types and factors of adverse events(AEs)that contribute to them in long-term care(LTC)settings.Methods:The search ...Objective:This systematized review aimed to synthesize the results of empirical studies focused on the types and factors of adverse events(AEs)that contribute to them in long-term care(LTC)settings.Methods:The search was conducted in Pro Quest,Scopus,and Pub Med in January 2021 and resulted in 1057 records.The content analysis method was used in the data analysis.Results:In all,35 studies were identified as relevant for the review.The analysis revealed 133 different types of AEs and 60 factors that contributed to them.Conclusions:In LTC,various AEs occur,most of which are preventable,while many factors that influence their occurrence could be significantly modifiable.Through an effective analysis of AEs in LTC,it is possible to minimize their occurrence and,at the same time,minimize their negative impact on all par ties concerned.展开更多
Colonoscopy is a widely used method for diagnosing and treating colonic disease. The number of colonoscopies is increasing worldwide, and concerns about associated adverse events are growing. Large-scale studies using...Colonoscopy is a widely used method for diagnosing and treating colonic disease. The number of colonoscopies is increasing worldwide, and concerns about associated adverse events are growing. Large-scale studies using big data for post-colonoscopy complications have been reported. A colon perforation is a severe complication with a relatively high mortality rate. The perforation rate, as reported in large studies(≥ 50,000 colonoscopies) published since 2000, ranges from 0.005-0.085%. The trend in the overall perforation rate in the past 15 years has not changed significantly. Bleeding is a more common adverse event than perforation. Recent large studies(≥ 50,000 colonoscopies) have reported postcolonoscopy bleeding occurring in 0.001-0.687% of cases. Most studies about adverse events related to colonoscopy were performed in the West, and relatively few studies have been conducted in the East. The incidence of post-colonoscopy complications increases in elderly patients or patients with inflammatory bowel diseases. It is important to use a unified definition and refined data to overcome the limitations of previous studies. In addition, a structured training program for endoscopists and a systematic national management program are needed to reduce post-colonoscopy complications. In this review, we discuss the current trends in colonoscopy related to adverse events, as well as the challenges to be addressed through future research.展开更多
AIM: To identify severe adverse events (SAEs) leading to treatment discontinuation that occur during antiviral therapy in hepatitis C virus (HCV)-infected cirrhotic patients. METHODS: We identified all the articles pu...AIM: To identify severe adverse events (SAEs) leading to treatment discontinuation that occur during antiviral therapy in hepatitis C virus (HCV)-infected cirrhotic patients. METHODS: We identified all the articles published prior to December 2011 in the PubMed, Medline, Lilacs, Scopus, Ovid, EMBASE, Cochrane and Medscape databases that presented these data in cirrhotic patients. These studies evaluated the rate of SAEs leading to discontinuation of standard care treatment: Pegylated interferon (PegIFN) alpha 2a (135-180 μg/wk) or PegIFN alpha 2b (1 or 1.5 μg/kg per week) and ribavirin (800-1200 mg/d). Patients with genotype 1 + 4 underwent treatment for 48 wk, whereas those with genotypes 2 + 3 were treated for 24 wk.RESULTS: We included 17 papers in this review, comprising of 1133 patients. Treatment was discontinued due to SAEs in 14.5% of the patients. The most common SAEs were: severe thrombocytopenia and/or neutropenia (23.2%), psychiatric disorders (15.5%), decompensation of liver cirrhosis (12.1%) and severe anemia (11.2%). The proportion of patients who needed to discontinue their therapy due to SAEs was significantly higher in patients with Child-Pugh class B and Cvs those with Child-Pugh class A: 22%vs 11.4% (P = 0.003). A similar discontinuation rate was found in cirrhotic patients treated with PegIFN alpha 2a and those treated with PegIFN alpha 2b, in combination with ribavirin: 14.2%vs 13.7% (P = 0.96). The overall sustained virological response rate in cirrhotic patients was 37% (95%CI: 33.5-43.1) but was significantly lower in patients with genotype 1 + 4 than in those with genotype 2 + 3: 20.5% (95%CI: 17.9-24.8) vs 56.5% (95%CI: 51.5-63.2), (P < 0.0001). CONCLUSION: Fourteen point five percent of HCV cirrhotic patients treated with PegIFN and ribavirin needed early discontinuation of therapy due to SAEs, the most common cause being hematological disorders.展开更多
AIM To investigate indications and outcomes of endoscopic retrograde cholangiopancreatography(ERCP) in cirrhotics, especially adverse events. Patients with cirrhosis undergoing ERCP are believed to have increased risk...AIM To investigate indications and outcomes of endoscopic retrograde cholangiopancreatography(ERCP) in cirrhotics, especially adverse events. Patients with cirrhosis undergoing ERCP are believed to have increased risk. However, there is a paucity of literature describing the indications and outcomes of ERCP procedures in patients with cirrhosis, especially focusing on adverse events.METHODS We performed a systematic appraisal of major literature databases, including PubMed and EMBASE, with a manual search of literature from their inception until April 2017.RESULTS A total of 6,505 patients from 15 studies were analyzed(male ratio 59%, mean age 59 years), 11% with alcoholic and 89% with non-alcoholic cirrhosis, with 56.2% Child-Pugh class A, and 43.8% class B or C. Indications for ERCP included choledocholithiasis 60.9%, biliary strictures 26.2%, gallstone pancreatitis 21.1% and cholangitis 15.5%. Types of interventions included endoscopic sphincterotomy 52.7%, biliary stenting 16.7% and biliary dilation 4.6%. Individual adverse events included hemorrhage in 4.58%(95%CI: 2.77-6.75%, I^2 = 85.9%), post-ERCP pancreatitis(PEP) in 3.68%(95%CI: 1.83-6.00%, I^2 = 89.5%), cholangitis in 1.93%(95%CI: 0.63-3.71%, I^2 = 87.1%) and perforation in 0.00%(95%CI: 0.00-0.23%, I^2 = 37.8%). Six studies were used for comparison of ERCPrelated complications in cirrhosis vs non-cirrhosis, which showed higher overall rates of complications in cirrhosis patients with pooled OR of 1.63(95%CI: 1.27-2.09, I2 = 65%): higher rates of hemorrhage with OR of 2.05(95%CI: 1.62-2.58, I^2 = 2.1%) and PEP with OR of 1.33(95%CI: 1.04-1.70, I2=65%), but similar cholangitis rates with OR of 1.23(95%CI: 0.67-2.26, I^2 = 44.3%).CONCLUSION There is an overall higher rate of adverse events related to ERCP in patients with cirrhosis, especially hemorrhage and PEP. A thorough risk/benefit assessment should be performed prior to undertaking ERCP in patients with cirrhosis.展开更多
Despite growing attention to patients,safety worldwide,no data were available on the impact of adverse respiratory events(AREs)on post-anesthesia care and post-operation care in China.This study evaluated the occurren...Despite growing attention to patients,safety worldwide,no data were available on the impact of adverse respiratory events(AREs)on post-anesthesia care and post-operation care in China.This study evaluated the occurrence of AREs,the impact of AREs on length of stay(LOS)in post-anesthesia care unit(PACU)and postoperative time in hospital,and PACU cost and in patient healthcare costs.A retrospective,matched-cohort study was conducted by prospectively collecting the data of 159 AREs in PACU during 2016-2017 in an university hospital in China.Records were reviewed by pre-trained,qualified nurses and/or anesthesiologists.The incidence and the impact of AREs were analyzed.The LOS in PACU and postoperative time in hospital and the costs in PACU and inpatient healthcare costs were also obtained.Results showed that there were 253 AREs involving 156 patients.Hypoxia(n=141,55.73%)and respiratory depression(n=70,27.67%)were the most common AREs.Measurement data including body mass index(BMI)(22.85±4.36 vs.22.32±3.83),duration of procedure(138.47±77.33 min vs.137.44±72.33 min),duration of anesthesia(176.35±82.66 min vs.174.61±78.08 min),LOS(16.53±10.65 days vs.16.57±9.56 days),inpatient healthcare costs($9465.57±9416.33 vs.$8166.51±5762.01),and postoperative LOS(11.26±8.77 days vs.11.9±8.30 days)showed no significant differences between ARE and matched groups(P<0.05).Duration(81.65±54.79 min vs.38.89±26.09 min)and costs($31.99±17.80 vs.$18.72±8.39)in PACU were significantly different in ARE group from those in matched group(P<0.001).Proportion of patients with prolonged stay in PACU was significantly higher in ARE group than in matched group(18.59%vs.1.28%),with an odds ratio(after matching)of 17.58(95%CI=4.11 to 75.10;P<0.001).The AREs that occurred during the immediate postoperative period in PACU increased the incidence rate of prolonged stay,delayed the PACU stay,and increased the costs in PACU,resulting in the need of higher levels of postoperative care than anticipated,but the postoperative LOS and inpatient healthcare costs were unchanged.展开更多
AIM To evaluate the rate of adverse events(AEs) during consecutive gastric and duodenal polypectomies in several Spanish centers. METHODS Polypectomies of protruded gastric or duodenal polyps ≥ 5 mm using hot snare w...AIM To evaluate the rate of adverse events(AEs) during consecutive gastric and duodenal polypectomies in several Spanish centers. METHODS Polypectomies of protruded gastric or duodenal polyps ≥ 5 mm using hot snare were prospectively included. Prophylactic measures of hemorrhage were allowed in predefined cases. AEs were defined and graded according to the lexicon recommended by the American Society for Gastrointestinal Endoscopy. Patients were followed for 48 h, one week and 1 mo after theprocedure. RESULTS308 patients were included and a single polypectomy was performed in 205. Only 36(11.7%) were on prior anticoagulant therapy. Mean polyp size was 15 ± 8.9 mm(5-60) and in 294 cases(95.4%) were located in the stomach. Hemorrhage prophylaxis was performed in 219(71.1%) patients. Nine patients presented AEs(2.9%), and 6 of them were bleeding(n = 6, 1.9%)(in 5 out of 6 AE, different types of endoscopic treatment were performed). Other 24 hemorrhagic episodes could be managed without any change in the outcome of the endoscopy and, consequently, were considered incidents. We did not find any independent risk factor of bleeding.CONCLUSION Gastroduodenal polypectomy using prophylactic measures has a rate of AEs small enough to consider this procedure a safe and effective method for polyp resection independently of the polyp size and location.展开更多
AIM To study the type and frequency of adverse events associated with anti-tumor necrosis factor(TNF)therapy and evaluate for any serologic and genetic associations.METHODS This study was a retrospective review of pat...AIM To study the type and frequency of adverse events associated with anti-tumor necrosis factor(TNF)therapy and evaluate for any serologic and genetic associations.METHODS This study was a retrospective review of patients attending the inflammatory bowel disease(IBD) centers at Cedars-Sinai IBD Center from 2005-2016. Adverse events were identified via chart review. IBD serologies were measured by ELISA. DNA samples were genotyped at Cedars-Sinai using Illumina Infinium Immunochipv1 array per manufacturer's protocol. SNPs underwent methodological review and were evaluated using several SNP statistic parameters to ensure optimal allele-calling. Standard and rigorous QC criteria were applied to the genetic data, which was generated using immunochip. Genetic association was assessed by logistic regression after correcting for population structure.RESULTS Altogether we identified 1258 IBD subjects exposed to anti-TNF agents in whom Immunochip data were available. 269/1258 patients(21%) were found to have adverse events to an anti-TNF-α agent that required the therapy to be discontinued. 25% of women compared to 17% of men experienced an adverse event. All adverse events resolved after discontinuing the antiTNF agent. In total: n = 66(5%) infusion reactions; n = 49(4%) allergic/serum sickness reactions; n = 19(1.5%) lupus-like reactions, n = 52(4%) rash, n = 18(1.4%) infections. In Crohn's disease, Ig A ASCA(P = 0.04) and Ig G-ASCA(P = 0.02) levels were also lower in patients with any adverse events, and anti-I2 level in ulcerative colitis was significantly associated with infusion reactions(P = 0.008). The logistic regression/human annotation and network analyses performed on the Immunochip data implicated the following five signaling pathways: JAK-STAT(Janus Kinase-signal transducer and activator of transcription), measles, IBD, cytokine-cytokine receptor interaction, and toxoplasmosis for any adverse event. CONCLUSION Our study shows 1 in 5 IBD patients experience an adverse event to anti-TNF therapy with novel serologic, genetic, and pathways associations.展开更多
AIM: To determine the incidence and predictors of thiopurine-related adverse events. METHODS: Subjects with Crohn's disease who were followed in the Alberta Inflammatory Bowel Disease Consortium patient database r...AIM: To determine the incidence and predictors of thiopurine-related adverse events. METHODS: Subjects with Crohn's disease who were followed in the Alberta Inflammatory Bowel Disease Consortium patient database registry were identified. Retrospective chart review was conducted between August 5th, 2010 and June 1st, 2012. We collected data on: age at diagnosis; sex; disease location and behaviour at time of prescribing thiopurine; perianal fistulising disease at or prior to thiopurine prescription; smoking status at time of thiopurine prescription, use of corticosteroid within 6 mo of diagnosis; dosage, age at onset, and cessation of 5-aminosalicyclic acid(5-ASA); anti-tumour necrosis factor medication exposure and intestinal resection before thiopurine prescription. The primary outcome of interest was the first adverse event that led to discontinuation of the first thiopurine medication used. Logistic regression models were used to associate clinical characteristics with outcomes after adjusting for potential confounders. Risk estimates were presented as odds ratios(OR) with 95% CI. Effect modification by age and sex were explored.RESULTS: Our cohort had a median follow-up duration of 5.8 years [interquartile range(IQR 25th-75th) 2.7-9.1]. Thiopurine therapy was discontinued in 31.3% of patients because of: hypersensitivity reactions(7.1%), acute pancreatitis(6.2%), gastrointestinal intolerance(5.4%), leucopenia(3.7%), hepatotoxicity(3.4%), infection(1.1%) and other reasons(4.3%). A higher incidence of thiopurine withdrawal was observed in patients over the age of 40(39.4%, P = 0.007). A sexby-age interaction(P = 0.04) was observed. Females older than 40 years of age had an increased risk of thiopurine discontinuation due to an adverse event(age above 40 vs age below 40, adjusted OR = 2.8; 95%CI: 1.4-5.6). In contrast, age did not influence thiopurine withdrawal in males(age above 40 vs below 40, adjusted OR = 0.9; 95%CI: 0.4-2.1). Other clinical variables(disease location and phenotype, perianal disease, smoking history, history of intestinal resection and prior 5-ASA or corticosteroid use) were not associated with an increased risk an adverse event leading to therapy cessation. CONCLUSION: Thiopurine withdrawal due to adverse events is commoner in women over the age of 40 at prescription. These findings need to be replicated in other cohorts.展开更多
Objective:We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events(irAEs)as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpo...Objective:We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events(irAEs)as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpoint inhibitors(ICIs)in patients with advanced pan-cancer in a real-world setting.Methods:We retrospectively analyzed data from 105 patients with advanced pan-cancer treated with multi-type ICIs at the First Hospital of Jilin University between January 1,2016 and August 1,2020.We used logistic regression analyses to investigate the associations of irAEs with clinical baseline characteristics,blood count parameters,and biochemical indicators during treatment.Receiver operating characteristic curves were used to determine cutoff values for parameters and area under the curve values.Kaplan–Meier and Cox multivariate regression analyses were performed to estimate the relationships of baseline characteristics and irAEs with progression-free survival(PFS)and overall survival(OS).Results:A lower relative lymphocyte count(cutoff=28.5%),higher albumin level(cutoff=39.05 g/L),and higher absolute eosinophil count(AEC)(cutoff=0.175×10^(9)/L)were significantly associated with the occurrence of irAEs,among which a higher AEC(cutoff=0.205×10^(9)/L)was strongly associated with skin-related irAEs[odds ratios(ORs)=0.163,P=0.004].Moreover,a higher lactate dehydrogenase level(cutoff=237.5 U/L)was an independent predictor of irAEs of grade≥3(OR=0.083,P=0.023).In immune cell subgroup analysis,a lower absolute count of CD8+CD28−suppressor T cells(OR=0.806;95%confidence interval:0.643–1.011;P=0.062),which are regulatory T lymphocytes,was associated with the occurrence of irAEs,although the difference was not statistically significant.Furthermore,a higher percentage of CD19+B cells was associated with the occurrence of irAEs of grade≥3(P=0.02)and grade≥2(P=0.051).In addition,patients with any grade of irAE had a significantly high PFS(8.37 vs.3.77 months,hazard ratios(HR)=2.02,P=0.0038)and OS(24.77 vs.13.83 months,HR=1.84;P=0.024).Conclusions:This retrospective study reports clinical profile data for irAEs in unselected patients in a real-world setting and explored some parameters that may be potential predictive markers of the occurrence,type,or grade of irAEs in clinical practice.Evidence of a correlation between safety and efficacy may facilitate a complete assessment of the risk-benefit ratio for patients treated with ICIs.展开更多
Background: Research has shown that high-sensitivity C-reactive protein (hs-CRP) is a major inflammatory marker for prediction of acute coronary syndrome (ACS). Myeloperoxidase (MPO) also plays an important role in at...Background: Research has shown that high-sensitivity C-reactive protein (hs-CRP) is a major inflammatory marker for prediction of acute coronary syndrome (ACS). Myeloperoxidase (MPO) also plays an important role in atherosclerosis initiation and development. In present study, the major adverse cardiovascular events (MACEs) of patients with coronary heart disease (CHD) were investigated. Methods: MPO, hs-CRP and ACS-related risk factors from 201 ACS (78 AMI and 123 UAP) and 210 non-ACS (84 SAP and 126 non-CHD) patients confirmed by coronary angiography were detected, and the data were analyzed with receiver operating characteristic (ROC) curve and Spearman’s correlation coefficients. MACEs of 285 CHD patients were investigated during the 4-year period follow-up from March 2010 to May 2014. Results: The areas under ROC curve for diagnosing ACS were 0.888 (95% CI 0.843 - 0.933) for MPO, and 0.862 (95% CI 0.815-0.910) for hs-CRP, respectively. There were significantly correlations between MPO and hs-CRP in both ACS and non-ACS groups. Regarding to ACS patients, both MPO and hs-CRP were positively correlated with BMI, TC, TG, LDL-C and Hcy. Prospective study demonstrated that the incidences of MACEs associated significantly with elevated MPO baseline level (yes vs no, OR 7.383, 95% CI 4.095 - 13.309) and high hs-CRP baseline level (yes vs no, OR 4.186, 95% CI 2.469 - 7.097) in CHD patients. Conclusions: The present study provides the epidemiological evidence that elevated baseline MPO and hs-CRP levels are both valuable predictors of MACEs in CHD patients. MPO and hs-CRP would prompt the progression of atherosclerosis and development from SAP to ACS.展开更多
BACKGROUND Myocardial infarction is one of the most common types of coronary heart disease.It is mainly caused by the rupture of coronary atherosclerotic plaque,which leads to platelet agglutination and thrombosis.The...BACKGROUND Myocardial infarction is one of the most common types of coronary heart disease.It is mainly caused by the rupture of coronary atherosclerotic plaque,which leads to platelet agglutination and thrombosis.The occlusion of coronary arteries and vessels leads to insufficient myocardial blood supply,subsequently causing cardiac interstitial fibrosis,gradual enlargement of ventricles,and heart failure,which affects the quality of life and safety of patients.AIM To investigate the effects of emergency percutaneous interventional therapy(PCI)and delayed stenting in acute myocardial infarction with high thrombotic load and identify factors related to major adverse cardiovascular events(MACE).METHODS A total of 164 patients with acute myocardial infarction and high thrombotic load who received PCI were included.Of them,92 patients were treated with delayed stent implantation(delayed group)and 72 patients received emergency PCI(immediate group).Myocardial perfusion after stent implantation was compared between the two groups.Patients were followed up for 12 mo,and the occurrence of MACE was used as the endpoint.Univariate and multivariate models were used to analyze the factors affecting MACE occurrence.RESULTS After stent implantation,66(71.74%)patients in the delayed group and 40(55.56%)patients in the immediate group had thrombolysis in myocardial infarction(TIMI)flow grade 3(P<0.05),while 61(66.30%)patients in the delayed group and 39(54.17%)patients in the immediate group reached TIMI myocardial perfusion grade 3(P>0.05).MACE occurred in 29 patients.There were statistically significant differences between the MACE and non-MACE groups in diabetes rate,TIMI grading,stent implantation timing,intraoperative use of tirofiban,and the levels of white blood cells(WBC),neutrophils,red blood cell distribution width(RDW),and uric acid,and high-sensitivity C-reactive protein(hs-CRP)at admission(P<0.05).Logistic regression analysis showed that TIMI grade 3 and intraoperative use of tirofiban effectively reduced the risk of MACE(P<0.05),while immediate stent implantation,increased WBC,hs-CRP and RDW on admission increased the risk of MACE(P<0.05).CONCLUSION Delayed stent implantation outweighs emergency PCI in improving postoperative myocardial perfusion in acute myocardial infarction with high thrombotic load,and effectively reduces MACE in these patients.展开更多
AIM: To determine the safety profile of new hepatitis C virus(HCV) treatments in liver transplant(LT) recipients with recurrent HCV infection.METHODS: Forty-two patients were identified with recurrent HCV infection th...AIM: To determine the safety profile of new hepatitis C virus(HCV) treatments in liver transplant(LT) recipients with recurrent HCV infection.METHODS: Forty-two patients were identified with recurrent HCV infection that underwent LT at least 12 mo prior to initiating treatment with a Sofosbuvir-based regimen during December 2013-June 2014. Cases were patients who experienced hepatic decompensation and/or serious adverse events(SAE) during or within one month of completing treatment. Controls had no evidence of hepatic decompensation and/or SAE. HIVinfected patients were excluded. Cumulative incidence of decompensation/SAE was calculated using the Kaplan Meier method. Exact logistic regression analysis was used to identify factors associated with the composite outcome. RESULTS: Median age of the 42 patients was 60 years [Interquartile Range(IQR): 56-65 years], 33%(14/42) were female, 21%(9/42) were Hispanic, and 9%(4/42) were Black. The median time from transplant to treatment initiation was 5.4 years(IQR: 2.1-8.8 years). Thirteen patients experienced one or more episodes of hepatic decompensation and/or SAE. Anemia requiring transfusion, the most common event, occurred in 62%(8/13) patients, while 54%(7/13) decompensated. The cumulative incidence of hepatic decompensation/SAE was 31%(95%CI: 16%-41%). Risk factors for decompensation/SAE included lower pre-treatment hemoglobin(OR = 0.61 per g/d L, 95%CI: 0.40-0.88, P < 0.01), estimated glomerular filtration rate(OR = 0.95 per m L/min per 1.73 m^2, 95%CI: 0.90-0.99, P = 0.01), and higher baseline serum total bilirubin(OR = 2.43 per mg/d L, 95%CI: 1.17-8.65, P < 0.01). The sustained virological response rate for the cohort of 42 patients was 45%, while it was 31% for cases.CONCLUSION: Sofosbuvir/ribavirin will continue to be used in the post-transplant population, including those with HCV genotypes 2 and 3. Management of anemia remains an important clinical challenge.展开更多
基金Supported by Special Project for Improving Science and Technology Innovation Ability of Army Medical University,No.2022XLC09.
文摘BACKGROUND The incidence of chronic kidney disease among patients with diabetes mellitus(DM)remains a global concern.Long-term obesity is known to possibly influence the development of type 2 diabetes mellitus.However,no previous meta-analysis has assessed the effects of body mass index(BMI)on adverse kidney events in patients with DM.AIM To determine the impact of BMI on adverse kidney events in patients with DM.METHODS A systematic literature search was performed on the PubMed,ISI Web of Science,Scopus,Ovid,Google Scholar,EMBASE,and BMJ databases.We included trials with the following characteristics:(1)Type of study:Prospective,retrospective,randomized,and non-randomized in design;(2)participants:Restricted to patients with DM aged≥18 years;(3)intervention:No intervention;and(4)kidney adverse events:Onset of diabetic kidney disease[estimated glomerular filtration rate(eGFR)of<60 mL/min/1.73 m2 and/or microalbuminuria value of≥30 mg/g Cr],serum creatinine increase of more than double the baseline or end-stage renal disease(eGFR<15 mL/min/1.73 m2 or dialysis),or death.RESULTS Overall,11 studies involving 801 patients with DM were included.High BMI(≥25 kg/m2)was significantly associated with higher blood pressure(BP)[systolic BP by 0.20,95%confidence interval(CI):0.15–0.25,P<0.00001;diastolic BP by 0.21 mmHg,95%CI:0.04–0.37,P=0.010],serum albumin,triglycerides[standard mean difference(SMD)=0.35,95%CI:0.29–0.41,P<0.00001],low-density lipoprotein(SMD=0.12,95%CI:0.04–0.20,P=0.030),and lower high-density lipoprotein(SMD=–0.36,95%CI:–0.51 to–0.21,P<0.00001)in patients with DM compared with those with low BMIs(<25 kg/m2).Our analysis showed that high BMI was associated with a higher risk ratio of adverse kidney events than low BMI(RR:1.22,95%CI:1.01–1.43,P=0.036).CONCLUSION The present analysis suggested that high BMI was a risk factor for adverse kidney events in patients with DM.
文摘We conducted a comprehensive review of existing prediction models pertaining to the efficacy of immune-checkpoint inhibitor(ICI)and the occurrence of immune-related adverse events(irAEs).The predictive potential of neutrophil-to-lymphocyte ratio(NLR)and platelet-to-lymphocyte ratio(PLR)in determining ICI effectiveness has been extensively investigated,while limited research has been conducted on predicting irAEs.Furthermore,the combined model incor-porating NLR and PLR,either with each other or in conjunction with additional markers such as carcinoembryonic antigen,exhibits superior predictive capabilities compared to individual markers alone.NLR and PLR are promising markers for clinical applications.Forthcoming models ought to incorporate established efficacious models and newly identified ones,thereby constituting a multifactor composite model.Furthermore,efforts should be made to explore effective clinical application approaches that enhance the predictive accuracy and efficiency.
文摘BACKGROUND Prediabetes is a well-established risk factor for major adverse cardiac and cerebrovascular events(MACCE).However,the relationship between prediabetes and MACCE in atrial fibrillation(AF)patients has not been extensively studied.Therefore,this study aimed to establish a link between prediabetes and MACCE in AF patients.AIM To investigate a link between prediabetes and MACCE in AF patients.METHODS We used the National Inpatient Sample(2019)and relevant ICD-10 CM codes to identify hospitalizations with AF and categorized them into groups with and without prediabetes,excluding diabetics.The primary outcome was MACCE(all-cause inpatient mortality,cardiac arrest including ventricular fibrillation,and stroke)in AF-related hospitalizations.RESULTS Of the 2965875 AF-related hospitalizations for MACCE,47505(1.6%)were among patients with prediabetes.The prediabetes cohort was relatively younger(median 75 vs 78 years),and often consisted of males(56.3%vs 51.4%),blacks(9.8%vs 7.9%),Hispanics(7.3%vs 4.3%),and Asians(4.7%vs 1.6%)than the non-prediabetic cohort(P<0.001).The prediabetes group had significantly higher rates of hypertension,hyperlipidemia,smoking,obesity,drug abuse,prior myocardial infarction,peripheral vascular disease,and hyperthyroidism(all P<0.05).The prediabetes cohort was often discharged routinely(51.1%vs 41.1%),but more frequently required home health care(23.6%vs 21.0%)and had higher costs.After adjusting for baseline characteristics or comorbidities,the prediabetes cohort with AF admissions showed a higher rate and significantly higher odds of MACCE compared to the non-prediabetic cohort[18.6%vs 14.7%,odds ratio(OR)1.34,95%confidence interval 1.26-1.42,P<0.001].On subgroup analyses,males had a stronger association(aOR 1.43)compared to females(aOR 1.22),whereas on the race-wise comparison,Hispanics(aOR 1.43)and Asians(aOR 1.36)had a stronger association with MACCE with prediabetes vs whites(aOR 1.33)and blacks(aOR 1.21).CONCLUSION This population-based study found a significant association between prediabetes and MACCE in AF patients.Therefore,there is a need for further research to actively screen and manage prediabetes in AF to prevent MACCE.
文摘BACKGROUND Liver transplant(LT)patients have become older and sicker.The rate of post-LT major adverse cardiovascular events(MACE)has increased,and this in turn raises 30-d post-LT mortality.Noninvasive cardiac stress testing loses accuracy when applied to pre-LT cirrhotic patients.AIM To assess the feasibility and accuracy of a machine learning model used to predict post-LT MACE in a regional cohort.METHODS This retrospective cohort study involved 575 LT patients from a Southern Brazilian academic center.We developed a predictive model for post-LT MACE(defined as a composite outcome of stroke,new-onset heart failure,severe arrhythmia,and myocardial infarction)using the extreme gradient boosting(XGBoost)machine learning model.We addressed missing data(below 20%)for relevant variables using the k-nearest neighbor imputation method,calculating the mean from the ten nearest neighbors for each case.The modeling dataset included 83 features,encompassing patient and laboratory data,cirrhosis complications,and pre-LT cardiac assessments.Model performance was assessed using the area under the receiver operating characteristic curve(AUROC).We also employed Shapley additive explanations(SHAP)to interpret feature impacts.The dataset was split into training(75%)and testing(25%)sets.Calibration was evaluated using the Brier score.We followed Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis guidelines for reporting.Scikit-learn and SHAP in Python 3 were used for all analyses.The supplementary material includes code for model development and a user-friendly online MACE prediction calculator.RESULTS Of the 537 included patients,23(4.46%)developed in-hospital MACE,with a mean age at transplantation of 52.9 years.The majority,66.1%,were male.The XGBoost model achieved an impressive AUROC of 0.89 during the training stage.This model exhibited accuracy,precision,recall,and F1-score values of 0.84,0.85,0.80,and 0.79,respectively.Calibration,as assessed by the Brier score,indicated excellent model calibration with a score of 0.07.Furthermore,SHAP values highlighted the significance of certain variables in predicting postoperative MACE,with negative noninvasive cardiac stress testing,use of nonselective beta-blockers,direct bilirubin levels,blood type O,and dynamic alterations on myocardial perfusion scintigraphy being the most influential factors at the cohort-wide level.These results highlight the predictive capability of our XGBoost model in assessing the risk of post-LT MACE,making it a valuable tool for clinical practice.CONCLUSION Our study successfully assessed the feasibility and accuracy of the XGBoost machine learning model in predicting post-LT MACE,using both cardiovascular and hepatic variables.The model demonstrated impressive performance,aligning with literature findings,and exhibited excellent calibration.Notably,our cautious approach to prevent overfitting and data leakage suggests the stability of results when applied to prospective data,reinforcing the model’s value as a reliable tool for predicting post-LT MACE in clinical practice.
基金funded by medical and health science and technology project of Zhejiang province (Grant number:2023KY633)
文摘Objective:To access the level of knowledge,perceptions,and practice towards adverse events following immunization(AEFI)surveillance among vaccination workers in Zhejiang province,China.Methods:This was a cross-sectional survey involving 768 vaccination workers.Data were collected using self-administered questionnaires and analyzed by using SAS 9.3 software.Knowledge,perceptions,and practice on AEFI surveillance were summarized using frequency tables.The mean±SD value was used as the cut-off for defining good(values≥mean)and poor(values<mean)knowledge,perceptions or practice.Binary logistic regression analysis was used to determine sociodemographic variables associated with knowledge,perceptions,and practice towards AEFI.Results:The proportions of good knowledge,perceptions and practice on AEFI surveillance were 78.13%,57.81%and 66.15%,respectively.Having a higher education background,longer years of experience,previous training on AEFI and≥30 years of age were factors associated with good knowledge,perceptions and practice on AEFI surveillance among vaccination workers.Conclusions:Over half of the respondents had good knowledge,perceptions and practice on AEFI surveillance work.Interventions on improving the vaccination workers’knowledge,perceptions and practice on AEFI surveillance should be considered in order to develop a more effective surveillance system.
文摘BACKGROUND Although immune checkpoint inhibitor(ICI)therapy has improved the prognosis of unresectable hepatocellular carcinoma(HCC),it has also resulted in unique immune-related adverse events(irAEs).The relationship between irAE and treatment outcomes in ICI-treated unresectable HCC patients remains unknown.AIM To elucidate the correlation between immune-related toxic effects and prognosis in patients with unresectable HCC treated with pembrolizumab.METHODS From March 2019 to February 2021,a total of 190 unresectable HCC(Barcelona Clinic Liver Cancer C)patients receiving pembrolizumab treatment were retrospectively reviewed.Overall survival(OS)was the primary endpoint,while objective response rate(ORR),disease control rate(DCR),and time to progression(TTP)were secondary evaluation indexes.We assessed demographics,irAEs,and outcomes by retrospective review.RESULTS One hundred and forty-three males and 47 females were included in the study.The ORR and DCR were 12.1%(23/190)and 52.1%(99/190),respectively.The median OS was 376 d[95%confidence interval(CI):340-411 d]and the median TTP was 98 d(95%CI:75-124 d).The overall incidence of treatment-related adverse events was 72.6%(138/190)and 10.0%of them were severe irAEs(grade≥3).Child-Pugh B class,portal vein tumor thrombus,extrahepatic metastasis,and hypothyroidism were the independent risk factors for survival.Patients with hypothyroidism showed a longer OS[517 d(95%CI:423-562)vs 431 d(95%CI:412-485),P=0.011]and TTP[125 d(95%CI:89-154)vs 87 d(95%CI:61-98),P=0.004]than those without irAEs.CONCLUSION Pembrolizumab-treated patients with unresectable HCC who experienced hypothyroidism have promising ORR and durable response.Hypothyroidism,an irAE,may be used as a clinical evaluation parameter of response to ICIs in unresectable HCC.
基金the 2022 Project of Innovation Foundation of Outstanding Graduate Students of Gansu Provincethe Graduate Innovation Foundation of Major Project of Education Department of Gansu Province,No.lccx2021001+2 种基金the Gansu Provincial Science and Technology Plan Project Assignment(Innovation Base and Talent Plan),No.21JR7RA013the Gansu Province Innovation Base and Talent Plan(Gansu Province Leukemia Clinical Research Center),No.21JR7RA015the 2022 Hospital Project of The 940th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army,No.2022yxky015.
文摘Lymphoma,which is highly malignant,stems from lymph nodes and lymphoid tissue.Lymphoma cells express programmed death-ligand 1/2(PD-L1/PD-L2),which binds with programmed cell death 1 protein(PD-1)to establish inhibitory signaling that impedes the normal function of T cells and allows tumor cells to escape immune system surveillance.Recently,immune checkpoint inhibitor immunotherapies such as PD-1 inhibitors(nivolumab and pembrolizumab)have been introduced into the lymphoma treatment algorithm and have shown remarkable clinical efficacy and greatly improve prognosis in lymphoma patients.Accordingly,the number of lymphoma patients who are seeking treatment with PD-1 inhibitors is growing annually,which results in an increasing number of patients developing immune-related adverse events(irAEs).The occurrence of irAEs inevitably affects the benefits provided by immunotherapy,particularly when PD-1 inhibitors are applied.However,the mechanisms and characteristics of irAEs induced by PD-1 inhibitors in lymphoma need further investigation.This review article summarizes the latest research advances in irAEs during treatment of lymphoma with PD-1 inhibitors.A comprehensive understanding of irAEs incurred in immunotherapy can help to achieve better efficacy with PD-1 inhibitors in lymphoma.
文摘Introduction: Despite the many efforts made to combat preventable maternal deaths, these still remain high in Benin. It was therefore important to revisit the causes but especially the adverse events associated with care (EIS) in maternity. Objective: Determine the incidence, adverse events associated with care and causes of intra hospital maternal mortality in cotonou. Methods: This was a cross-sectional maternal mortality review study with retrospective data collection. It covered all cases of maternal death recorded between 2017 and 2021 in two (2) reference university maternities in Cotonou. Adverse events associated with care and the patient were analyzed using the maternal death audit grid validated for Benin. SPSS.26 software was used for data analysis. Results: The in-hospital maternal mortality ratio in Cotonou was 2028 maternal deaths per 100,000 live births in 2021. Only 7.2% (n = 36) of deaths were audited. The deceased mothers were 29.8 ± 7.4 years old, with no fixed monthly income in 82.7% (n = 420). Serious adverse events associated with care were: delay in decision to refer in 37% (n = 188), non-medical referral in 85.8% (n = 436) of cases, inadequate pre-referral treatment in 25.7% of cases. In receiving maternities, delay in diagnosis and inappropriate treatment at the receiving maternity were noted respectively in 22.9% and 28.6% of cases of maternal death. The direct causes of maternal death were dominated by serious obstetric hemorrhage in 43.9% (n = 223). As for the indirect causes, they were dominated by anemia excluding obstetric hemorrhages in 21.5% (n = 109). Conclusion: The in-hospital maternal mortality ratio was very high in Cotonou. The main cause was severe obstetric hemorrhage. There were several serious healthcare-associated adverse events whose correct management would significantly reduce the incidence of maternal deaths.
文摘Objective:This systematized review aimed to synthesize the results of empirical studies focused on the types and factors of adverse events(AEs)that contribute to them in long-term care(LTC)settings.Methods:The search was conducted in Pro Quest,Scopus,and Pub Med in January 2021 and resulted in 1057 records.The content analysis method was used in the data analysis.Results:In all,35 studies were identified as relevant for the review.The analysis revealed 133 different types of AEs and 60 factors that contributed to them.Conclusions:In LTC,various AEs occur,most of which are preventable,while many factors that influence their occurrence could be significantly modifiable.Through an effective analysis of AEs in LTC,it is possible to minimize their occurrence and,at the same time,minimize their negative impact on all par ties concerned.
基金Supported by the National R&D Program for Cancer Control,No.HA17C0046the Korean National Health Clinical Research(NHCR)Project,No.HC16C2320
文摘Colonoscopy is a widely used method for diagnosing and treating colonic disease. The number of colonoscopies is increasing worldwide, and concerns about associated adverse events are growing. Large-scale studies using big data for post-colonoscopy complications have been reported. A colon perforation is a severe complication with a relatively high mortality rate. The perforation rate, as reported in large studies(≥ 50,000 colonoscopies) published since 2000, ranges from 0.005-0.085%. The trend in the overall perforation rate in the past 15 years has not changed significantly. Bleeding is a more common adverse event than perforation. Recent large studies(≥ 50,000 colonoscopies) have reported postcolonoscopy bleeding occurring in 0.001-0.687% of cases. Most studies about adverse events related to colonoscopy were performed in the West, and relatively few studies have been conducted in the East. The incidence of post-colonoscopy complications increases in elderly patients or patients with inflammatory bowel diseases. It is important to use a unified definition and refined data to overcome the limitations of previous studies. In addition, a structured training program for endoscopists and a systematic national management program are needed to reduce post-colonoscopy complications. In this review, we discuss the current trends in colonoscopy related to adverse events, as well as the challenges to be addressed through future research.
文摘AIM: To identify severe adverse events (SAEs) leading to treatment discontinuation that occur during antiviral therapy in hepatitis C virus (HCV)-infected cirrhotic patients. METHODS: We identified all the articles published prior to December 2011 in the PubMed, Medline, Lilacs, Scopus, Ovid, EMBASE, Cochrane and Medscape databases that presented these data in cirrhotic patients. These studies evaluated the rate of SAEs leading to discontinuation of standard care treatment: Pegylated interferon (PegIFN) alpha 2a (135-180 μg/wk) or PegIFN alpha 2b (1 or 1.5 μg/kg per week) and ribavirin (800-1200 mg/d). Patients with genotype 1 + 4 underwent treatment for 48 wk, whereas those with genotypes 2 + 3 were treated for 24 wk.RESULTS: We included 17 papers in this review, comprising of 1133 patients. Treatment was discontinued due to SAEs in 14.5% of the patients. The most common SAEs were: severe thrombocytopenia and/or neutropenia (23.2%), psychiatric disorders (15.5%), decompensation of liver cirrhosis (12.1%) and severe anemia (11.2%). The proportion of patients who needed to discontinue their therapy due to SAEs was significantly higher in patients with Child-Pugh class B and Cvs those with Child-Pugh class A: 22%vs 11.4% (P = 0.003). A similar discontinuation rate was found in cirrhotic patients treated with PegIFN alpha 2a and those treated with PegIFN alpha 2b, in combination with ribavirin: 14.2%vs 13.7% (P = 0.96). The overall sustained virological response rate in cirrhotic patients was 37% (95%CI: 33.5-43.1) but was significantly lower in patients with genotype 1 + 4 than in those with genotype 2 + 3: 20.5% (95%CI: 17.9-24.8) vs 56.5% (95%CI: 51.5-63.2), (P < 0.0001). CONCLUSION: Fourteen point five percent of HCV cirrhotic patients treated with PegIFN and ribavirin needed early discontinuation of therapy due to SAEs, the most common cause being hematological disorders.
文摘AIM To investigate indications and outcomes of endoscopic retrograde cholangiopancreatography(ERCP) in cirrhotics, especially adverse events. Patients with cirrhosis undergoing ERCP are believed to have increased risk. However, there is a paucity of literature describing the indications and outcomes of ERCP procedures in patients with cirrhosis, especially focusing on adverse events.METHODS We performed a systematic appraisal of major literature databases, including PubMed and EMBASE, with a manual search of literature from their inception until April 2017.RESULTS A total of 6,505 patients from 15 studies were analyzed(male ratio 59%, mean age 59 years), 11% with alcoholic and 89% with non-alcoholic cirrhosis, with 56.2% Child-Pugh class A, and 43.8% class B or C. Indications for ERCP included choledocholithiasis 60.9%, biliary strictures 26.2%, gallstone pancreatitis 21.1% and cholangitis 15.5%. Types of interventions included endoscopic sphincterotomy 52.7%, biliary stenting 16.7% and biliary dilation 4.6%. Individual adverse events included hemorrhage in 4.58%(95%CI: 2.77-6.75%, I^2 = 85.9%), post-ERCP pancreatitis(PEP) in 3.68%(95%CI: 1.83-6.00%, I^2 = 89.5%), cholangitis in 1.93%(95%CI: 0.63-3.71%, I^2 = 87.1%) and perforation in 0.00%(95%CI: 0.00-0.23%, I^2 = 37.8%). Six studies were used for comparison of ERCPrelated complications in cirrhosis vs non-cirrhosis, which showed higher overall rates of complications in cirrhosis patients with pooled OR of 1.63(95%CI: 1.27-2.09, I2 = 65%): higher rates of hemorrhage with OR of 2.05(95%CI: 1.62-2.58, I^2 = 2.1%) and PEP with OR of 1.33(95%CI: 1.04-1.70, I2=65%), but similar cholangitis rates with OR of 1.23(95%CI: 0.67-2.26, I^2 = 44.3%).CONCLUSION There is an overall higher rate of adverse events related to ERCP in patients with cirrhosis, especially hemorrhage and PEP. A thorough risk/benefit assessment should be performed prior to undertaking ERCP in patients with cirrhosis.
文摘Despite growing attention to patients,safety worldwide,no data were available on the impact of adverse respiratory events(AREs)on post-anesthesia care and post-operation care in China.This study evaluated the occurrence of AREs,the impact of AREs on length of stay(LOS)in post-anesthesia care unit(PACU)and postoperative time in hospital,and PACU cost and in patient healthcare costs.A retrospective,matched-cohort study was conducted by prospectively collecting the data of 159 AREs in PACU during 2016-2017 in an university hospital in China.Records were reviewed by pre-trained,qualified nurses and/or anesthesiologists.The incidence and the impact of AREs were analyzed.The LOS in PACU and postoperative time in hospital and the costs in PACU and inpatient healthcare costs were also obtained.Results showed that there were 253 AREs involving 156 patients.Hypoxia(n=141,55.73%)and respiratory depression(n=70,27.67%)were the most common AREs.Measurement data including body mass index(BMI)(22.85±4.36 vs.22.32±3.83),duration of procedure(138.47±77.33 min vs.137.44±72.33 min),duration of anesthesia(176.35±82.66 min vs.174.61±78.08 min),LOS(16.53±10.65 days vs.16.57±9.56 days),inpatient healthcare costs($9465.57±9416.33 vs.$8166.51±5762.01),and postoperative LOS(11.26±8.77 days vs.11.9±8.30 days)showed no significant differences between ARE and matched groups(P<0.05).Duration(81.65±54.79 min vs.38.89±26.09 min)and costs($31.99±17.80 vs.$18.72±8.39)in PACU were significantly different in ARE group from those in matched group(P<0.001).Proportion of patients with prolonged stay in PACU was significantly higher in ARE group than in matched group(18.59%vs.1.28%),with an odds ratio(after matching)of 17.58(95%CI=4.11 to 75.10;P<0.001).The AREs that occurred during the immediate postoperative period in PACU increased the incidence rate of prolonged stay,delayed the PACU stay,and increased the costs in PACU,resulting in the need of higher levels of postoperative care than anticipated,but the postoperative LOS and inpatient healthcare costs were unchanged.
文摘AIM To evaluate the rate of adverse events(AEs) during consecutive gastric and duodenal polypectomies in several Spanish centers. METHODS Polypectomies of protruded gastric or duodenal polyps ≥ 5 mm using hot snare were prospectively included. Prophylactic measures of hemorrhage were allowed in predefined cases. AEs were defined and graded according to the lexicon recommended by the American Society for Gastrointestinal Endoscopy. Patients were followed for 48 h, one week and 1 mo after theprocedure. RESULTS308 patients were included and a single polypectomy was performed in 205. Only 36(11.7%) were on prior anticoagulant therapy. Mean polyp size was 15 ± 8.9 mm(5-60) and in 294 cases(95.4%) were located in the stomach. Hemorrhage prophylaxis was performed in 219(71.1%) patients. Nine patients presented AEs(2.9%), and 6 of them were bleeding(n = 6, 1.9%)(in 5 out of 6 AE, different types of endoscopic treatment were performed). Other 24 hemorrhagic episodes could be managed without any change in the outcome of the endoscopy and, consequently, were considered incidents. We did not find any independent risk factor of bleeding.CONCLUSION Gastroduodenal polypectomy using prophylactic measures has a rate of AEs small enough to consider this procedure a safe and effective method for polyp resection independently of the polyp size and location.
文摘AIM To study the type and frequency of adverse events associated with anti-tumor necrosis factor(TNF)therapy and evaluate for any serologic and genetic associations.METHODS This study was a retrospective review of patients attending the inflammatory bowel disease(IBD) centers at Cedars-Sinai IBD Center from 2005-2016. Adverse events were identified via chart review. IBD serologies were measured by ELISA. DNA samples were genotyped at Cedars-Sinai using Illumina Infinium Immunochipv1 array per manufacturer's protocol. SNPs underwent methodological review and were evaluated using several SNP statistic parameters to ensure optimal allele-calling. Standard and rigorous QC criteria were applied to the genetic data, which was generated using immunochip. Genetic association was assessed by logistic regression after correcting for population structure.RESULTS Altogether we identified 1258 IBD subjects exposed to anti-TNF agents in whom Immunochip data were available. 269/1258 patients(21%) were found to have adverse events to an anti-TNF-α agent that required the therapy to be discontinued. 25% of women compared to 17% of men experienced an adverse event. All adverse events resolved after discontinuing the antiTNF agent. In total: n = 66(5%) infusion reactions; n = 49(4%) allergic/serum sickness reactions; n = 19(1.5%) lupus-like reactions, n = 52(4%) rash, n = 18(1.4%) infections. In Crohn's disease, Ig A ASCA(P = 0.04) and Ig G-ASCA(P = 0.02) levels were also lower in patients with any adverse events, and anti-I2 level in ulcerative colitis was significantly associated with infusion reactions(P = 0.008). The logistic regression/human annotation and network analyses performed on the Immunochip data implicated the following five signaling pathways: JAK-STAT(Janus Kinase-signal transducer and activator of transcription), measles, IBD, cytokine-cytokine receptor interaction, and toxoplasmosis for any adverse event. CONCLUSION Our study shows 1 in 5 IBD patients experience an adverse event to anti-TNF therapy with novel serologic, genetic, and pathways associations.
基金the Alberta Inflammatory Bowel Disease Consortium and the Alberta Innovates Health Solutions for funding support for this project
文摘AIM: To determine the incidence and predictors of thiopurine-related adverse events. METHODS: Subjects with Crohn's disease who were followed in the Alberta Inflammatory Bowel Disease Consortium patient database registry were identified. Retrospective chart review was conducted between August 5th, 2010 and June 1st, 2012. We collected data on: age at diagnosis; sex; disease location and behaviour at time of prescribing thiopurine; perianal fistulising disease at or prior to thiopurine prescription; smoking status at time of thiopurine prescription, use of corticosteroid within 6 mo of diagnosis; dosage, age at onset, and cessation of 5-aminosalicyclic acid(5-ASA); anti-tumour necrosis factor medication exposure and intestinal resection before thiopurine prescription. The primary outcome of interest was the first adverse event that led to discontinuation of the first thiopurine medication used. Logistic regression models were used to associate clinical characteristics with outcomes after adjusting for potential confounders. Risk estimates were presented as odds ratios(OR) with 95% CI. Effect modification by age and sex were explored.RESULTS: Our cohort had a median follow-up duration of 5.8 years [interquartile range(IQR 25th-75th) 2.7-9.1]. Thiopurine therapy was discontinued in 31.3% of patients because of: hypersensitivity reactions(7.1%), acute pancreatitis(6.2%), gastrointestinal intolerance(5.4%), leucopenia(3.7%), hepatotoxicity(3.4%), infection(1.1%) and other reasons(4.3%). A higher incidence of thiopurine withdrawal was observed in patients over the age of 40(39.4%, P = 0.007). A sexby-age interaction(P = 0.04) was observed. Females older than 40 years of age had an increased risk of thiopurine discontinuation due to an adverse event(age above 40 vs age below 40, adjusted OR = 2.8; 95%CI: 1.4-5.6). In contrast, age did not influence thiopurine withdrawal in males(age above 40 vs below 40, adjusted OR = 0.9; 95%CI: 0.4-2.1). Other clinical variables(disease location and phenotype, perianal disease, smoking history, history of intestinal resection and prior 5-ASA or corticosteroid use) were not associated with an increased risk an adverse event leading to therapy cessation. CONCLUSION: Thiopurine withdrawal due to adverse events is commoner in women over the age of 40 at prescription. These findings need to be replicated in other cohorts.
基金This work was supported by grants from the National Key R&D Program of China(Grant No.2016YFC1303800)Jilin Provincial Key Laboratory of Biological Therapy(Grant No.20170622011JC)+1 种基金Jilin Provincial Science and Technology Department(Grant No.20190303146SF)Jilin Province Finance Department(Grant No.2018SCZWSZX-010).
文摘Objective:We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events(irAEs)as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpoint inhibitors(ICIs)in patients with advanced pan-cancer in a real-world setting.Methods:We retrospectively analyzed data from 105 patients with advanced pan-cancer treated with multi-type ICIs at the First Hospital of Jilin University between January 1,2016 and August 1,2020.We used logistic regression analyses to investigate the associations of irAEs with clinical baseline characteristics,blood count parameters,and biochemical indicators during treatment.Receiver operating characteristic curves were used to determine cutoff values for parameters and area under the curve values.Kaplan–Meier and Cox multivariate regression analyses were performed to estimate the relationships of baseline characteristics and irAEs with progression-free survival(PFS)and overall survival(OS).Results:A lower relative lymphocyte count(cutoff=28.5%),higher albumin level(cutoff=39.05 g/L),and higher absolute eosinophil count(AEC)(cutoff=0.175×10^(9)/L)were significantly associated with the occurrence of irAEs,among which a higher AEC(cutoff=0.205×10^(9)/L)was strongly associated with skin-related irAEs[odds ratios(ORs)=0.163,P=0.004].Moreover,a higher lactate dehydrogenase level(cutoff=237.5 U/L)was an independent predictor of irAEs of grade≥3(OR=0.083,P=0.023).In immune cell subgroup analysis,a lower absolute count of CD8+CD28−suppressor T cells(OR=0.806;95%confidence interval:0.643–1.011;P=0.062),which are regulatory T lymphocytes,was associated with the occurrence of irAEs,although the difference was not statistically significant.Furthermore,a higher percentage of CD19+B cells was associated with the occurrence of irAEs of grade≥3(P=0.02)and grade≥2(P=0.051).In addition,patients with any grade of irAE had a significantly high PFS(8.37 vs.3.77 months,hazard ratios(HR)=2.02,P=0.0038)and OS(24.77 vs.13.83 months,HR=1.84;P=0.024).Conclusions:This retrospective study reports clinical profile data for irAEs in unselected patients in a real-world setting and explored some parameters that may be potential predictive markers of the occurrence,type,or grade of irAEs in clinical practice.Evidence of a correlation between safety and efficacy may facilitate a complete assessment of the risk-benefit ratio for patients treated with ICIs.
文摘Background: Research has shown that high-sensitivity C-reactive protein (hs-CRP) is a major inflammatory marker for prediction of acute coronary syndrome (ACS). Myeloperoxidase (MPO) also plays an important role in atherosclerosis initiation and development. In present study, the major adverse cardiovascular events (MACEs) of patients with coronary heart disease (CHD) were investigated. Methods: MPO, hs-CRP and ACS-related risk factors from 201 ACS (78 AMI and 123 UAP) and 210 non-ACS (84 SAP and 126 non-CHD) patients confirmed by coronary angiography were detected, and the data were analyzed with receiver operating characteristic (ROC) curve and Spearman’s correlation coefficients. MACEs of 285 CHD patients were investigated during the 4-year period follow-up from March 2010 to May 2014. Results: The areas under ROC curve for diagnosing ACS were 0.888 (95% CI 0.843 - 0.933) for MPO, and 0.862 (95% CI 0.815-0.910) for hs-CRP, respectively. There were significantly correlations between MPO and hs-CRP in both ACS and non-ACS groups. Regarding to ACS patients, both MPO and hs-CRP were positively correlated with BMI, TC, TG, LDL-C and Hcy. Prospective study demonstrated that the incidences of MACEs associated significantly with elevated MPO baseline level (yes vs no, OR 7.383, 95% CI 4.095 - 13.309) and high hs-CRP baseline level (yes vs no, OR 4.186, 95% CI 2.469 - 7.097) in CHD patients. Conclusions: The present study provides the epidemiological evidence that elevated baseline MPO and hs-CRP levels are both valuable predictors of MACEs in CHD patients. MPO and hs-CRP would prompt the progression of atherosclerosis and development from SAP to ACS.
基金Supported by Quanzhou Science and Technology Bureau Approved the Project,Quanzhou Science and Technology Plan Project,No.2019N008S
文摘BACKGROUND Myocardial infarction is one of the most common types of coronary heart disease.It is mainly caused by the rupture of coronary atherosclerotic plaque,which leads to platelet agglutination and thrombosis.The occlusion of coronary arteries and vessels leads to insufficient myocardial blood supply,subsequently causing cardiac interstitial fibrosis,gradual enlargement of ventricles,and heart failure,which affects the quality of life and safety of patients.AIM To investigate the effects of emergency percutaneous interventional therapy(PCI)and delayed stenting in acute myocardial infarction with high thrombotic load and identify factors related to major adverse cardiovascular events(MACE).METHODS A total of 164 patients with acute myocardial infarction and high thrombotic load who received PCI were included.Of them,92 patients were treated with delayed stent implantation(delayed group)and 72 patients received emergency PCI(immediate group).Myocardial perfusion after stent implantation was compared between the two groups.Patients were followed up for 12 mo,and the occurrence of MACE was used as the endpoint.Univariate and multivariate models were used to analyze the factors affecting MACE occurrence.RESULTS After stent implantation,66(71.74%)patients in the delayed group and 40(55.56%)patients in the immediate group had thrombolysis in myocardial infarction(TIMI)flow grade 3(P<0.05),while 61(66.30%)patients in the delayed group and 39(54.17%)patients in the immediate group reached TIMI myocardial perfusion grade 3(P>0.05).MACE occurred in 29 patients.There were statistically significant differences between the MACE and non-MACE groups in diabetes rate,TIMI grading,stent implantation timing,intraoperative use of tirofiban,and the levels of white blood cells(WBC),neutrophils,red blood cell distribution width(RDW),and uric acid,and high-sensitivity C-reactive protein(hs-CRP)at admission(P<0.05).Logistic regression analysis showed that TIMI grade 3 and intraoperative use of tirofiban effectively reduced the risk of MACE(P<0.05),while immediate stent implantation,increased WBC,hs-CRP and RDW on admission increased the risk of MACE(P<0.05).CONCLUSION Delayed stent implantation outweighs emergency PCI in improving postoperative myocardial perfusion in acute myocardial infarction with high thrombotic load,and effectively reduces MACE in these patients.
基金Supported by National Institutes of Health,No.DA031095 and No.DK090317
文摘AIM: To determine the safety profile of new hepatitis C virus(HCV) treatments in liver transplant(LT) recipients with recurrent HCV infection.METHODS: Forty-two patients were identified with recurrent HCV infection that underwent LT at least 12 mo prior to initiating treatment with a Sofosbuvir-based regimen during December 2013-June 2014. Cases were patients who experienced hepatic decompensation and/or serious adverse events(SAE) during or within one month of completing treatment. Controls had no evidence of hepatic decompensation and/or SAE. HIVinfected patients were excluded. Cumulative incidence of decompensation/SAE was calculated using the Kaplan Meier method. Exact logistic regression analysis was used to identify factors associated with the composite outcome. RESULTS: Median age of the 42 patients was 60 years [Interquartile Range(IQR): 56-65 years], 33%(14/42) were female, 21%(9/42) were Hispanic, and 9%(4/42) were Black. The median time from transplant to treatment initiation was 5.4 years(IQR: 2.1-8.8 years). Thirteen patients experienced one or more episodes of hepatic decompensation and/or SAE. Anemia requiring transfusion, the most common event, occurred in 62%(8/13) patients, while 54%(7/13) decompensated. The cumulative incidence of hepatic decompensation/SAE was 31%(95%CI: 16%-41%). Risk factors for decompensation/SAE included lower pre-treatment hemoglobin(OR = 0.61 per g/d L, 95%CI: 0.40-0.88, P < 0.01), estimated glomerular filtration rate(OR = 0.95 per m L/min per 1.73 m^2, 95%CI: 0.90-0.99, P = 0.01), and higher baseline serum total bilirubin(OR = 2.43 per mg/d L, 95%CI: 1.17-8.65, P < 0.01). The sustained virological response rate for the cohort of 42 patients was 45%, while it was 31% for cases.CONCLUSION: Sofosbuvir/ribavirin will continue to be used in the post-transplant population, including those with HCV genotypes 2 and 3. Management of anemia remains an important clinical challenge.
