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
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
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
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 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
BACKGROUND Endoscopic retrograde cholangiopancreatography(ERCP)is a valuable therapeutic technique for pancreatobiliary diseases,and its application in the elderly is no longer limited.However,a higher incidence of pr...BACKGROUND Endoscopic retrograde cholangiopancreatography(ERCP)is a valuable therapeutic technique for pancreatobiliary diseases,and its application in the elderly is no longer limited.However,a higher incidence of procedure difficulty and periprocedural adverse events might be expected in elderly patients due to the presence of other medical disorders and the poor general condition of this population.AIM To evaluate the incidence,causes,and management of difficult biliary cannulation during ERCP in elderly patients and the role of difficult cannulation as a risk factor for adverse events.METHODS A total of 614 patients who underwent ERCP during the study period were prospectively studied and divided into two groups based on their age.One hundred and forty-six patients were aged 80 years or older and 468 patients were aged less than 80 years.The primary outcome measurements were cannulation difficulty,cannulation success rate,ERCP procedure time,and related adverse events.RESULTS There was no difference in the incidence of difficult cannulation among the two groups(32.9%vs 34.4%,P=0.765),as well as in the cannulation success rate(96.6%vs 96.8%,P=0.54).The cannulation techniques were shown to be safe and efficient in achieving successful cannulation.Logistic regression analysis showed that patients aged 80 years or older were not associated with increased adverse events;however,difficult cannulation cases[adjusted odds ratio(AOR)=3.478;95%confidence interval(CI):1.877-6.442;P<0.001]and patients with Charlson Comorbidity Index≥2(AOR=1.824;95%CI:0.993-3.349;P=0.045)were more likely to develop adverse events.In contrast,other factors including age≤65(AOR=3.460;95%CI:1.511-7.922;P=0.003),female gender(AOR=2.362;95%CI=1.089-5.124;P=0.030),difficult cannulation(AOR=4.527;95%CI:2.078-9.860;P<0.001),and patients with cholangitis(AOR=3.261;95%CI:1.204-8.832;P=0.020)were strongly associated with a higher rate of post-ERCP pancreatitis.CONCLUSION Advanced age has not been proved to be a risk factor for difficult cannulation,and secondary cannulation techniques can be safely and efficaciously utilized in this group.Patients with a Charlson Comorbidity Index≥2 and difficult cannulation are associated with an increased overall adverse events rate,while age≥80 years is not.展开更多
AIM: To evaluate the medical quality of ophthalmologic perioperative period during 2010-2012 in our hospital.·METHODS: The relevant data of perioperative period were collected in our hospital during 2010-2012, an...AIM: To evaluate the medical quality of ophthalmologic perioperative period during 2010-2012 in our hospital.·METHODS: The relevant data of perioperative period were collected in our hospital during 2010-2012, and the medical quality of perioperative period was evaluated by using the traditional evaluation indexes and adverse events. Whereby, the traditional indicators include vision changes, improving of intraocular pressure, diagnostic accordance rate before and after operation, cure improvement rate, successful rescue rate, and incidence of surgical complications, etc. Adverse events are associated with ophthalmologic perioperative events including pressure sores, postoperative wound infection,drug adverse events, and equipment related adverse events.·RESULTS: There were 1483, 1662 and 1931 ophthalmic operations in our hospital in the year 2010, 2011 and2012, respectively. From traditional index analysis, the proportions of vision improvement for each year were96.43%, 96.76% and 97.32%, respectively; the rates of intraocular pressure improvement were 87.50%, 85.72%and 90.17%, respectively(P <0.05); the diagnostic accordance rates before and after operation were 99.86%,99.94% and 99.90%, respectively; cure improvement rates were 99.73%, 99.93% and 99.84%, respectively; the successful rescue rates were 82.98%, 81.46% and76.66%, respectively; the complications incidence rates were 18.44%, 17.52% and 17.97%, respectively. The negative factor analysis results showed that: among all the patients of ophthalmic surgeries in our hospitalduring 2010 and 2012, only one case of postoperative wound infection was found in 2011, and also only one case of tumbling in 2010. The adverse drug events for each year were 1 case(0.07%), 2 cases(0.12%), and 4cases(0.21%), respectively; the medical device adverse events for each year were 3 cases(0.20%), 5 cases(0.30%), and 6 cases(0.31%), respectively. Noticeably,only one case with postoperative infection of endophthalmitis was found in 2011. Moreover, no pulmonary infection or pulmonary embolism occurred during the three years. The perioperative adverse event rates for each year were 0.34%(5/1483), 0.48%(8/1662)and 0.52%(10/1931), respectively. Though incidence was rising during the three years, no statistical significance was observed(P >0.05). It is the same case with drugs and medical devices adverse events(P >0.05).·CONCLUSION: Traditional indicators reflect an excellent operation of the perioperative ophthalmologic quality, whereas adverse events analysis indicates some underlying problems. Compared with the traditional indexes for medical quality evaluation, the index of adverse events is more reasonable and easier to make an objective evaluation for medical quality of ophthalmologic perioperation, facilitating further refine analysis. Reasonable application of the adverse events indicators helps hospital to make the detailed quality control measures.展开更多
BACKGROUND Pancreatic adenoma can potentially transform into adenocarcinoma, so it is recommended to be resected surgically or endoscopically. Endoscopic papillectomy is one of the main treatments for papillary adenom...BACKGROUND Pancreatic adenoma can potentially transform into adenocarcinoma, so it is recommended to be resected surgically or endoscopically. Endoscopic papillectomy is one of the main treatments for papillary adenoma, and bleeding, perforation, and pancreatitis are the most frequent and critical adverse events that restrict its wider use. There is no standard procedure for endoscopic papillectomy yet. The procedure is relevant to postoperative adverse events.AIM To reduce the postoperative adverse event rates and improve patients' postoperative condition, we developed a standard novel procedure for endoscopic papillectomy.METHODS The novel endoscopic papillectomy had two main modifications based on the conventional method: The isolation of bile from pancreatic juice with a bile duct stent and wound surface protection with metal clips and fibrin glue. We performed a single-center retrospective comparison study on the novel and conventional methods to examine the feasibility of the novel method for reducing postoperative adverse events.RESULTS A total of 76 patients, of whom 23 underwent the novel procedure and 53 underwent the conventional procedure, were retrospectively evaluated in this study. The postoperative bleeding and pancreatitis rates of the novel method were significantly lower than those of the conventional method(0 vs 20.75%, P = 0.028, and 17.4% vs 41.5%, P = 0.042, respectively). After applying the novel method, the most critical adverse event, perforation, was entirely prevented, compared to a prevalence of 5.66% with the conventional method. Several postoperative symptoms, including fever, rapid pulse, and decrease in hemoglobin level, were significantly less frequent in the novel group(P = 0.042, 0.049, and 0.014, respectively). Overall, the total adverse event rate of the novel method was lower(0 vs 24.5%, P = 0.007) than that of the conventional method.CONCLUSION Patients who underwent the novel procedure had lower postoperative adverse event rates. This study demonstrates the potential efficacy and safety of the novel endoscopic papillectomy in reducing postoperative adverse events.展开更多
Immune checkpoint inhibitors(ICIs) targeting cytotoxic T-lymphocyte antigen 4 and programmed cell death protein 1 receptor/ligand have revolutionized cancer treatment, achieving unprecedented efficacy in numerous mali...Immune checkpoint inhibitors(ICIs) targeting cytotoxic T-lymphocyte antigen 4 and programmed cell death protein 1 receptor/ligand have revolutionized cancer treatment, achieving unprecedented efficacy in numerous malignancies. Despite the excellent therapeutic effects of ICIs, medications, such as pembrolizumab, ipilimumab, nivolumab, atezolizumab, avelumab, and durvalumab, typically cause a broad spectrum of toxicity events termed as immune-related adverse events(ir AEs). Out of all ir AEs, ophthalmic adverse events occur infrequently and are not comprehensively recognized. The current understanding of ophthalmic ir AEs is mainly derived from case reports and case series. In this review, based on relevant articles in the literature and current evidence, we summarize the incidences, manifestations, diagnoses, underlying mechanisms, treatments, and outcomes of ophthalmic ir AEs and discuss possible management strategies. A better understanding of these features is critical for managing patients with ICI-associated ophthalmic adverse events.展开更多
BACKGROUND Immune checkpoint inhibitors(ICPi)cause various immune-related adverse events(irAE)with thyroid dysfunction as a commonly reported abnormality.There is increasing evidence showing positive association with ...BACKGROUND Immune checkpoint inhibitors(ICPi)cause various immune-related adverse events(irAE)with thyroid dysfunction as a commonly reported abnormality.There is increasing evidence showing positive association with development of irAE and survival.However,prior trials with ICPi had underrepresentation of minorities with<5%African Americans.AIM To evaluate the association between development of irAE and survival outcomes among a racially diverse patient population.METHODS Data on patients with stage IV solid malignancies treated with programmed cell death-protein 1/programmed death ligand 1 blockers between January 2013 and December 2018 across MedStar Georgetown Cancer Institute facilities were retrospectively reviewed.Patients treated with cytotoxic T-lymphocyte-associated protein 4 inhibitors were excluded.Progression free survival(PFS)and overall survival(OS)were primary endpoints and were calculated using Kaplan-Meier methods and Wilcoxon rank sum test for comparison.RESULTS Out of 293 patients who met eligibility criteria,91 pts(31%)had any grade irAE;most common AE were endocrine(40.7%)specifically TSH elevation,dermatological(23.1%)and rheumatologic(18.7%).Proportion of irAE was significantly higher in Caucasians vs African Americans(60.4%vs 30.8%),in patients with low programmed death ligand 1,lower LDH,older age,and those who had more treatment cycles with ICPi.Rate of progression was lower in patients with irAE(30.8%vs 46.0%,P=0.0140).Median PFS(5.8 vs 3.0 mo,P=0.0204)and OS(17.1 vs 7.2 mo,P<0.0001)were higher with irAE.Statistically significant difference in OS(17.1 vs 8.6 mo,P=0.0002)but not in PFS(5.8 vs 3.3 mo,P=0.0545)was noted with endocrine irAE.No differences in survival were observed among other commonly reported irAE.Differences in survival among subgroups of patients with irAE are described.CONCLUSION Development of irAE positively correlated with improved PFS and OS as reported in previous studies.To our knowledge,this is the first study observing differences in OS favoring endocrine AE and Caucasian race.These factors may be potential surrogate markers of prognosis pending replication of these results in large-scale studies.展开更多
AIM To evaluate the risk profile of sulfur hexafluoride in voiding urosonography(VUS) based on a large cohort of children.METHODS Since 2011 sulfur hexafluoride(SH,SonoV ue?,Bracco,Italy) is the only ultrasound contra...AIM To evaluate the risk profile of sulfur hexafluoride in voiding urosonography(VUS) based on a large cohort of children.METHODS Since 2011 sulfur hexafluoride(SH,SonoV ue?,Bracco,Italy) is the only ultrasound contrast available in the European Union and its use in children has not been approved.Within a 4-year-period,531 children with suspected or proven vesicoureteral reflux(f/m = 478/53; mean age 4.9 years; 1 mo-25.2 years) following parental informed consent underwent VUS with administration of 2.6 ± 1.2 mL SH in a two-center study.A standardizedtelephone survey on adverse events was conducted three days later.RESULTS No acute adverse reactions were observed.The survey revealed subacute,mostly self-limited adverse events in 4.1%(22/531).The majority of observed adverse events(17/22) was not suspected to be caused by an allergic reaction: Five were related to catheter placement,three to reactivated urinary tract infections,five were associated with perineal disinfection before voiding urosonography or perineal dermatitis and four with a common cold.In five patients(0.9%) hints to a potential allergic cause were noted: Perineal urticaria was reported in three interviews and isolated,mild fever in two.These were minor self-limited adverse events with a subacute onset and no hospital admittance was necessary.Ninety-six point two percent of the parents would prefer future VUS examinations with use of SH.CONCLUSION No severe adverse events were observed and indications of self-limited minor allergic reactions related to intravesical administration of SH were reported in less than 1%.展开更多
<strong><em>Background</em></strong><span style="font-family:Verdana;"><strong>:</strong></span><span style="font-family:;" "="">...<strong><em>Background</em></strong><span style="font-family:Verdana;"><strong>:</strong></span><span style="font-family:;" "=""><span style="font-family:Verdana;"> Despite of different adverse events, streptokinase (SK) is widely used to treat patients presented with acute ST segment elevation myocardial infarction. </span><b><i><span style="font-family:Verdana;">Objective</span></i><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"> The purpose of the present study was to observe different adverse events in patients of acute ST segment elevation myocardial infarction receiving SK infusion. </span><b><i><span style="font-family:Verdana;">Methodology</span></i><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"> This cross-sectional type of analytic observational study was carried out in the inpatient department of Cardiology at National Institute of Cardiovascular Diseases, Dhaka, Bangladesh from December 23</span><sup><span style="font-size:12px;font-family:Verdana;">rd</span></sup></span><span style="font-family:Verdana;"> </span><span style="font-family:;" "=""><span style="font-family:Verdana;">2019 to February 22</span><sup><span style="font-size:12px;font-family:Verdana;">nd</span></sup><span style="font-family:Verdana;"> 2020 for a period of two (2) months. All patients diagnosed as acute ST segment elevation myocardial infarction receiving SK were included in the present study. Adverse events were documented through completing a questionnaire by reviewing the records in the medical file as well as interviewing with the patients. </span><b><i><span style="font-family:Verdana;">Result</span></i><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"> In this study, 43 (26.2%) patients developed different types of adverse events and 121 (73.8%) had no complications following SK infusion. The most common adverse event was hypotension </span><i><span style="font-family:Verdana;">i.e.</span></i><span style="font-family:Verdana;"> 26 (60.4%) and other adverse events were bleeding 8 (4.8%) and allergic reaction 7 (4.2%). Statistically significant higher rate of adverse events occurred in diabetic, hypertensive and dyslipidemia group which was 26 (56.5%) Vs. 17 (14.4%), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.000, 37 (36.6%) Vs. 06 (09.5%), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.000 and 18 (54.5%) Vs. 25 (19.1%), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.000 respectively. The independent factors for the development of adverse events were smoking {OR: 5.1</span></span><span style="font-family:Verdana;"> </span><span style="font-family:;" "=""><span style="font-family:Verdana;">with 95% CI (1.7 to 15.1), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.003}, diabetes {OR: 14.9 with 95% CI (5.0 to 44.8), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.000}, hypertension {OR: 5.1with 95% CI (1.7 to 15.1), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.003} and dyslipidemia {OR: 4.6 with 95% CI (1.5 to 13.7), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.007}. </span><b><i><span style="font-family:Verdana;">Conclusion</span></i><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"> Streptokinase infusion was associated with different adverse events. Among them the commonest one was hypotension and other less common events were minor bleeding and minor allergic reaction. The adverse events were more frequently documented in patients who were smoker, diabetic, hypertensive and dyslipidemic.</span></span>展开更多
Aim: Investigating the incidence of non-renal acute adverse events (AAEs) in patients undergoing unenhanced or enhanced computed tomography (CT) or magnetic resonance (MR) (four groups) using the ac- tive interview-me...Aim: Investigating the incidence of non-renal acute adverse events (AAEs) in patients undergoing unenhanced or enhanced computed tomography (CT) or magnetic resonance (MR) (four groups) using the ac- tive interview-method. Methods: The imaging procedure followed the standards of the department. Furthermore, the iodine-based (nonionic monomer) and gadolinium-based (cyclic) contrast agent was the same as used for all other examinations in the department. All patients were interviewed for 72 hours after the MR or CT examination regarding occurrence of AAEs using a structured questionnaire. Results: A total of 1358 patients (259 with enhanced MR, 434 with unenhanced MR, 450 with enhanced CT and 215 with unenhanced CT) were enrolled. AAEs were significantly higher (P unenhanced MR [39 (9.0%)] and CT [5 (2.3%)] groups. Dizziness was significantly [19 (7.3%), (P frequent in the enhanced MR. The same AAEs were reported in both contrast groups and control groups. Conclusion: AAEs which are mainly considered to be caused by the contrast medium are also experienced by patients undergoing CT or MR without contrast. Enhanced MR is correlated with more reactions than unenhanced MR and enhanced CT. Dizziness was reported more frequently after MR than CT, both with and without contrast;more patients were CNS examined with MR and with CT.展开更多
BACKGROUND Since February 2021,vaccination against coronavirus disease 2019(COVID-19)caused by severe acute respiratory syndrome coronavirus 2 has started in Korea.AIM To perform a questionnaire survey about the preve...BACKGROUND Since February 2021,vaccination against coronavirus disease 2019(COVID-19)caused by severe acute respiratory syndrome coronavirus 2 has started in Korea.AIM To perform a questionnaire survey about the prevention and management of adverse events of COVID-19 vaccination among public health doctors of Korean Medicine(PHKMDs).METHODS An online questionnaire was developed,comprising categories about adverse events of vaccination(AEVs)and perception of using Korean medicine(KM)in managing vaccine adverse events(AEs)among PHKMDs.PHKMDs’experience of AEVs,usage of Korean medicine for AEVs,and perception and attitude in using KM for AEVs were surveyed.The survey web-link was emailed to the association of PHKMDs.Online links were sent through Survey Monkey to all PHKMDs in Korea.RESULTS A total of 143 participants were recruited for this study;65%of participants were vaccinated at the same of the survey(n=93).Although most participants did not take any medication for prevention of the adverse events,62%(n=58)of participants had taken herbal medicine to treat the adverse events(n=52).Approximately 35%of participants(n=33)said that they would recommend taking herbal medicine to prevent any AEVs.From various KM interventions,the participants strongly recommended taking an herbal medicine(n=69,74.19%)to treat AEs,and the second-highest was acupuncture treatment(n=19,20.43%).CONCLUSION Overall,this research demonstrated a high prevalence of KM usage by the PHKMDs.Hence,this study’s results may serve as fundamental evidence for health professionals to consider using KM treatments when treating or preventing AEVs in the near future.展开更多
BACKGROUND Conventional endoscopic papillectomy(EP)is safe and effective for the treatment of small papilla adenoma to even large laterally spreading tumors of duodenum lesions.As reported by some existing studies,tem...BACKGROUND Conventional endoscopic papillectomy(EP)is safe and effective for the treatment of small papilla adenoma to even large laterally spreading tumors of duodenum lesions.As reported by some existing studies,temporarily placing a prophylactic stent in the pancreatic and bile duct can lower the risk of this perioperative complication.AIM To evaluate the usefulness,convenience,safety,and short-term results of a novel autorelease bile duct supporter after EP procedure,especially the effectiveness in preventing EP.METHODS A single-center comparison study was conducted to verify the feasibility of the novel method.After EP,a metallic endoclip and human fibrin sealant kit were applied for protection.The autorelease bile duct supporter fell into the duct segment and the intestinal segment.Specifically,the intestinal segment was extended by nearly 5 cm as a bent coil.The bile was isolated from the pancreatic juice using an autorelease bile duct supporter,which protected the wound surface.The autorelease bile duct supporter fell off naturally and arrived in colon nearly 10 d after the operation.RESULTS En bloc endoscopic resection was performed in 6/8 patients(75%),and piecemeal resection was performed in 2/8 of patients(25%).None of the above patients were positive for neoplastic lymph nodes or distant metastasis.No cases of mortality,hemorrhage,delayed perforation,pancreatitis,cholangitis or duct stenosis with the conventional medical treatment were reported.The autorelease bile duct supporter in 7 of 8 patients fell off naturally and arrived in colon 10 d after the operation.One autorelease bile duct supporter was successfully removed using forceps or snare under endoscopy.No recurrence was identified during the 8-mo(ranging from 6-9 mo)follow-up period.CONCLUSION In brief,it was found that the autorelease bile duct supporter could decrease the frequency of procedure-associated complications without second endoscopic retraction.Secure closure of the resection wound with clips and fibrin glue were indicated to be promising and important for the use of autorelease bile duct supporters.Well-designed larger-scale comparative studies are required to confirm the findings of this study.展开更多
BACKGROUND Immune checkpoint inhibitors(ICIs)are novel therapeutic agents used for various types of cancer.ICIs have revolutionized cancer treatment and improved clinical outcomes among cancer patients.However,immune-...BACKGROUND Immune checkpoint inhibitors(ICIs)are novel therapeutic agents used for various types of cancer.ICIs have revolutionized cancer treatment and improved clinical outcomes among cancer patients.However,immune-related adverse effects of ICI therapy are common.Cardiovascular immune-related adverse events(irAEs)are rare but potentially life-threatening complications.AIM To estimate the incidence of cardiovascular irAEs among patients undergoing ICI therapy for various malignancies.METHODS We conducted this systematic review and meta-analysis by searching PubMed,Cochrane CENTRAL,Web of Science,and SCOPUS databases for relevant interventional trials reporting cardiovascular irAEs.We performed a single-arm meta-analysis using OpenMeta[Analyst]software of the following outcomes:Myocarditis,pericardial effusion,heart failure,cardiomyopathy,atrial fibrillation,myocardial infarction,and cardiac arrest.We assessed the heterogeneity using the I2 test and managed to solve it with Cochrane’s leave-one-out method.The risk of bias was performed with the Cochrane’s risk of bias tool.RESULTS A total of 26 studies were included.The incidence of irAEs follows:Myocarditis:0.5%[95%confidence interval(CI):0.1%-0.9%];Pericardial effusion:0.5%(95%CI:0.1%-1.0%);Heart failure:0.3%(95%CI:0.0%-0.5%);Cardiomyopathy:0.3%(95%CI:-0.1%-0.6%);atrial fibrillation:4.6%(95%CI:1.0%-14.1%);Myocardial infarction:0.4%(95%CI:0.0%-0.7%);and Cardiac arrest:0.4%(95%CI:0.1%-0.8%).CONCLUSION The most common cardiovascular irAEs were atrial fibrillation,myocarditis,and pericardial effusion.Although rare,data from post market surveillance will provide estimates of the long-term prevalence and prognosis in patients with ICIassociated cardiovascular complications.展开更多
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.
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.
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BACKGROUND Endoscopic retrograde cholangiopancreatography(ERCP)is a valuable therapeutic technique for pancreatobiliary diseases,and its application in the elderly is no longer limited.However,a higher incidence of procedure difficulty and periprocedural adverse events might be expected in elderly patients due to the presence of other medical disorders and the poor general condition of this population.AIM To evaluate the incidence,causes,and management of difficult biliary cannulation during ERCP in elderly patients and the role of difficult cannulation as a risk factor for adverse events.METHODS A total of 614 patients who underwent ERCP during the study period were prospectively studied and divided into two groups based on their age.One hundred and forty-six patients were aged 80 years or older and 468 patients were aged less than 80 years.The primary outcome measurements were cannulation difficulty,cannulation success rate,ERCP procedure time,and related adverse events.RESULTS There was no difference in the incidence of difficult cannulation among the two groups(32.9%vs 34.4%,P=0.765),as well as in the cannulation success rate(96.6%vs 96.8%,P=0.54).The cannulation techniques were shown to be safe and efficient in achieving successful cannulation.Logistic regression analysis showed that patients aged 80 years or older were not associated with increased adverse events;however,difficult cannulation cases[adjusted odds ratio(AOR)=3.478;95%confidence interval(CI):1.877-6.442;P<0.001]and patients with Charlson Comorbidity Index≥2(AOR=1.824;95%CI:0.993-3.349;P=0.045)were more likely to develop adverse events.In contrast,other factors including age≤65(AOR=3.460;95%CI:1.511-7.922;P=0.003),female gender(AOR=2.362;95%CI=1.089-5.124;P=0.030),difficult cannulation(AOR=4.527;95%CI:2.078-9.860;P<0.001),and patients with cholangitis(AOR=3.261;95%CI:1.204-8.832;P=0.020)were strongly associated with a higher rate of post-ERCP pancreatitis.CONCLUSION Advanced age has not been proved to be a risk factor for difficult cannulation,and secondary cannulation techniques can be safely and efficaciously utilized in this group.Patients with a Charlson Comorbidity Index≥2 and difficult cannulation are associated with an increased overall adverse events rate,while age≥80 years is not.
文摘AIM: To evaluate the medical quality of ophthalmologic perioperative period during 2010-2012 in our hospital.·METHODS: The relevant data of perioperative period were collected in our hospital during 2010-2012, and the medical quality of perioperative period was evaluated by using the traditional evaluation indexes and adverse events. Whereby, the traditional indicators include vision changes, improving of intraocular pressure, diagnostic accordance rate before and after operation, cure improvement rate, successful rescue rate, and incidence of surgical complications, etc. Adverse events are associated with ophthalmologic perioperative events including pressure sores, postoperative wound infection,drug adverse events, and equipment related adverse events.·RESULTS: There were 1483, 1662 and 1931 ophthalmic operations in our hospital in the year 2010, 2011 and2012, respectively. From traditional index analysis, the proportions of vision improvement for each year were96.43%, 96.76% and 97.32%, respectively; the rates of intraocular pressure improvement were 87.50%, 85.72%and 90.17%, respectively(P <0.05); the diagnostic accordance rates before and after operation were 99.86%,99.94% and 99.90%, respectively; cure improvement rates were 99.73%, 99.93% and 99.84%, respectively; the successful rescue rates were 82.98%, 81.46% and76.66%, respectively; the complications incidence rates were 18.44%, 17.52% and 17.97%, respectively. The negative factor analysis results showed that: among all the patients of ophthalmic surgeries in our hospitalduring 2010 and 2012, only one case of postoperative wound infection was found in 2011, and also only one case of tumbling in 2010. The adverse drug events for each year were 1 case(0.07%), 2 cases(0.12%), and 4cases(0.21%), respectively; the medical device adverse events for each year were 3 cases(0.20%), 5 cases(0.30%), and 6 cases(0.31%), respectively. Noticeably,only one case with postoperative infection of endophthalmitis was found in 2011. Moreover, no pulmonary infection or pulmonary embolism occurred during the three years. The perioperative adverse event rates for each year were 0.34%(5/1483), 0.48%(8/1662)and 0.52%(10/1931), respectively. Though incidence was rising during the three years, no statistical significance was observed(P >0.05). It is the same case with drugs and medical devices adverse events(P >0.05).·CONCLUSION: Traditional indicators reflect an excellent operation of the perioperative ophthalmologic quality, whereas adverse events analysis indicates some underlying problems. Compared with the traditional indexes for medical quality evaluation, the index of adverse events is more reasonable and easier to make an objective evaluation for medical quality of ophthalmologic perioperation, facilitating further refine analysis. Reasonable application of the adverse events indicators helps hospital to make the detailed quality control measures.
基金Supported by National Key R and D Program of China,No. 2016YFC1303601。
文摘BACKGROUND Pancreatic adenoma can potentially transform into adenocarcinoma, so it is recommended to be resected surgically or endoscopically. Endoscopic papillectomy is one of the main treatments for papillary adenoma, and bleeding, perforation, and pancreatitis are the most frequent and critical adverse events that restrict its wider use. There is no standard procedure for endoscopic papillectomy yet. The procedure is relevant to postoperative adverse events.AIM To reduce the postoperative adverse event rates and improve patients' postoperative condition, we developed a standard novel procedure for endoscopic papillectomy.METHODS The novel endoscopic papillectomy had two main modifications based on the conventional method: The isolation of bile from pancreatic juice with a bile duct stent and wound surface protection with metal clips and fibrin glue. We performed a single-center retrospective comparison study on the novel and conventional methods to examine the feasibility of the novel method for reducing postoperative adverse events.RESULTS A total of 76 patients, of whom 23 underwent the novel procedure and 53 underwent the conventional procedure, were retrospectively evaluated in this study. The postoperative bleeding and pancreatitis rates of the novel method were significantly lower than those of the conventional method(0 vs 20.75%, P = 0.028, and 17.4% vs 41.5%, P = 0.042, respectively). After applying the novel method, the most critical adverse event, perforation, was entirely prevented, compared to a prevalence of 5.66% with the conventional method. Several postoperative symptoms, including fever, rapid pulse, and decrease in hemoglobin level, were significantly less frequent in the novel group(P = 0.042, 0.049, and 0.014, respectively). Overall, the total adverse event rate of the novel method was lower(0 vs 24.5%, P = 0.007) than that of the conventional method.CONCLUSION Patients who underwent the novel procedure had lower postoperative adverse event rates. This study demonstrates the potential efficacy and safety of the novel endoscopic papillectomy in reducing postoperative adverse events.
文摘Immune checkpoint inhibitors(ICIs) targeting cytotoxic T-lymphocyte antigen 4 and programmed cell death protein 1 receptor/ligand have revolutionized cancer treatment, achieving unprecedented efficacy in numerous malignancies. Despite the excellent therapeutic effects of ICIs, medications, such as pembrolizumab, ipilimumab, nivolumab, atezolizumab, avelumab, and durvalumab, typically cause a broad spectrum of toxicity events termed as immune-related adverse events(ir AEs). Out of all ir AEs, ophthalmic adverse events occur infrequently and are not comprehensively recognized. The current understanding of ophthalmic ir AEs is mainly derived from case reports and case series. In this review, based on relevant articles in the literature and current evidence, we summarize the incidences, manifestations, diagnoses, underlying mechanisms, treatments, and outcomes of ophthalmic ir AEs and discuss possible management strategies. A better understanding of these features is critical for managing patients with ICI-associated ophthalmic adverse events.
文摘BACKGROUND Immune checkpoint inhibitors(ICPi)cause various immune-related adverse events(irAE)with thyroid dysfunction as a commonly reported abnormality.There is increasing evidence showing positive association with development of irAE and survival.However,prior trials with ICPi had underrepresentation of minorities with<5%African Americans.AIM To evaluate the association between development of irAE and survival outcomes among a racially diverse patient population.METHODS Data on patients with stage IV solid malignancies treated with programmed cell death-protein 1/programmed death ligand 1 blockers between January 2013 and December 2018 across MedStar Georgetown Cancer Institute facilities were retrospectively reviewed.Patients treated with cytotoxic T-lymphocyte-associated protein 4 inhibitors were excluded.Progression free survival(PFS)and overall survival(OS)were primary endpoints and were calculated using Kaplan-Meier methods and Wilcoxon rank sum test for comparison.RESULTS Out of 293 patients who met eligibility criteria,91 pts(31%)had any grade irAE;most common AE were endocrine(40.7%)specifically TSH elevation,dermatological(23.1%)and rheumatologic(18.7%).Proportion of irAE was significantly higher in Caucasians vs African Americans(60.4%vs 30.8%),in patients with low programmed death ligand 1,lower LDH,older age,and those who had more treatment cycles with ICPi.Rate of progression was lower in patients with irAE(30.8%vs 46.0%,P=0.0140).Median PFS(5.8 vs 3.0 mo,P=0.0204)and OS(17.1 vs 7.2 mo,P<0.0001)were higher with irAE.Statistically significant difference in OS(17.1 vs 8.6 mo,P=0.0002)but not in PFS(5.8 vs 3.3 mo,P=0.0545)was noted with endocrine irAE.No differences in survival were observed among other commonly reported irAE.Differences in survival among subgroups of patients with irAE are described.CONCLUSION Development of irAE positively correlated with improved PFS and OS as reported in previous studies.To our knowledge,this is the first study observing differences in OS favoring endocrine AE and Caucasian race.These factors may be potential surrogate markers of prognosis pending replication of these results in large-scale studies.
文摘AIM To evaluate the risk profile of sulfur hexafluoride in voiding urosonography(VUS) based on a large cohort of children.METHODS Since 2011 sulfur hexafluoride(SH,SonoV ue?,Bracco,Italy) is the only ultrasound contrast available in the European Union and its use in children has not been approved.Within a 4-year-period,531 children with suspected or proven vesicoureteral reflux(f/m = 478/53; mean age 4.9 years; 1 mo-25.2 years) following parental informed consent underwent VUS with administration of 2.6 ± 1.2 mL SH in a two-center study.A standardizedtelephone survey on adverse events was conducted three days later.RESULTS No acute adverse reactions were observed.The survey revealed subacute,mostly self-limited adverse events in 4.1%(22/531).The majority of observed adverse events(17/22) was not suspected to be caused by an allergic reaction: Five were related to catheter placement,three to reactivated urinary tract infections,five were associated with perineal disinfection before voiding urosonography or perineal dermatitis and four with a common cold.In five patients(0.9%) hints to a potential allergic cause were noted: Perineal urticaria was reported in three interviews and isolated,mild fever in two.These were minor self-limited adverse events with a subacute onset and no hospital admittance was necessary.Ninety-six point two percent of the parents would prefer future VUS examinations with use of SH.CONCLUSION No severe adverse events were observed and indications of self-limited minor allergic reactions related to intravesical administration of SH were reported in less than 1%.
文摘<strong><em>Background</em></strong><span style="font-family:Verdana;"><strong>:</strong></span><span style="font-family:;" "=""><span style="font-family:Verdana;"> Despite of different adverse events, streptokinase (SK) is widely used to treat patients presented with acute ST segment elevation myocardial infarction. </span><b><i><span style="font-family:Verdana;">Objective</span></i><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"> The purpose of the present study was to observe different adverse events in patients of acute ST segment elevation myocardial infarction receiving SK infusion. </span><b><i><span style="font-family:Verdana;">Methodology</span></i><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"> This cross-sectional type of analytic observational study was carried out in the inpatient department of Cardiology at National Institute of Cardiovascular Diseases, Dhaka, Bangladesh from December 23</span><sup><span style="font-size:12px;font-family:Verdana;">rd</span></sup></span><span style="font-family:Verdana;"> </span><span style="font-family:;" "=""><span style="font-family:Verdana;">2019 to February 22</span><sup><span style="font-size:12px;font-family:Verdana;">nd</span></sup><span style="font-family:Verdana;"> 2020 for a period of two (2) months. All patients diagnosed as acute ST segment elevation myocardial infarction receiving SK were included in the present study. Adverse events were documented through completing a questionnaire by reviewing the records in the medical file as well as interviewing with the patients. </span><b><i><span style="font-family:Verdana;">Result</span></i><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"> In this study, 43 (26.2%) patients developed different types of adverse events and 121 (73.8%) had no complications following SK infusion. The most common adverse event was hypotension </span><i><span style="font-family:Verdana;">i.e.</span></i><span style="font-family:Verdana;"> 26 (60.4%) and other adverse events were bleeding 8 (4.8%) and allergic reaction 7 (4.2%). Statistically significant higher rate of adverse events occurred in diabetic, hypertensive and dyslipidemia group which was 26 (56.5%) Vs. 17 (14.4%), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.000, 37 (36.6%) Vs. 06 (09.5%), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.000 and 18 (54.5%) Vs. 25 (19.1%), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.000 respectively. The independent factors for the development of adverse events were smoking {OR: 5.1</span></span><span style="font-family:Verdana;"> </span><span style="font-family:;" "=""><span style="font-family:Verdana;">with 95% CI (1.7 to 15.1), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.003}, diabetes {OR: 14.9 with 95% CI (5.0 to 44.8), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.000}, hypertension {OR: 5.1with 95% CI (1.7 to 15.1), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.003} and dyslipidemia {OR: 4.6 with 95% CI (1.5 to 13.7), </span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> = 0.007}. </span><b><i><span style="font-family:Verdana;">Conclusion</span></i><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"> Streptokinase infusion was associated with different adverse events. Among them the commonest one was hypotension and other less common events were minor bleeding and minor allergic reaction. The adverse events were more frequently documented in patients who were smoker, diabetic, hypertensive and dyslipidemic.</span></span>
基金Johannes Fogs Fond Aase og Ejnar Danielsens Fond
文摘Aim: Investigating the incidence of non-renal acute adverse events (AAEs) in patients undergoing unenhanced or enhanced computed tomography (CT) or magnetic resonance (MR) (four groups) using the ac- tive interview-method. Methods: The imaging procedure followed the standards of the department. Furthermore, the iodine-based (nonionic monomer) and gadolinium-based (cyclic) contrast agent was the same as used for all other examinations in the department. All patients were interviewed for 72 hours after the MR or CT examination regarding occurrence of AAEs using a structured questionnaire. Results: A total of 1358 patients (259 with enhanced MR, 434 with unenhanced MR, 450 with enhanced CT and 215 with unenhanced CT) were enrolled. AAEs were significantly higher (P unenhanced MR [39 (9.0%)] and CT [5 (2.3%)] groups. Dizziness was significantly [19 (7.3%), (P frequent in the enhanced MR. The same AAEs were reported in both contrast groups and control groups. Conclusion: AAEs which are mainly considered to be caused by the contrast medium are also experienced by patients undergoing CT or MR without contrast. Enhanced MR is correlated with more reactions than unenhanced MR and enhanced CT. Dizziness was reported more frequently after MR than CT, both with and without contrast;more patients were CNS examined with MR and with CT.
基金Supported by National Research Foundation of Korea grant funded by the Korea,No.2022R1C1C200873811。
文摘BACKGROUND Since February 2021,vaccination against coronavirus disease 2019(COVID-19)caused by severe acute respiratory syndrome coronavirus 2 has started in Korea.AIM To perform a questionnaire survey about the prevention and management of adverse events of COVID-19 vaccination among public health doctors of Korean Medicine(PHKMDs).METHODS An online questionnaire was developed,comprising categories about adverse events of vaccination(AEVs)and perception of using Korean medicine(KM)in managing vaccine adverse events(AEs)among PHKMDs.PHKMDs’experience of AEVs,usage of Korean medicine for AEVs,and perception and attitude in using KM for AEVs were surveyed.The survey web-link was emailed to the association of PHKMDs.Online links were sent through Survey Monkey to all PHKMDs in Korea.RESULTS A total of 143 participants were recruited for this study;65%of participants were vaccinated at the same of the survey(n=93).Although most participants did not take any medication for prevention of the adverse events,62%(n=58)of participants had taken herbal medicine to treat the adverse events(n=52).Approximately 35%of participants(n=33)said that they would recommend taking herbal medicine to prevent any AEVs.From various KM interventions,the participants strongly recommended taking an herbal medicine(n=69,74.19%)to treat AEs,and the second-highest was acupuncture treatment(n=19,20.43%).CONCLUSION Overall,this research demonstrated a high prevalence of KM usage by the PHKMDs.Hence,this study’s results may serve as fundamental evidence for health professionals to consider using KM treatments when treating or preventing AEVs in the near future.
基金Supported by National Key R&D Program of China,No. 2016YFC1303600
文摘BACKGROUND Conventional endoscopic papillectomy(EP)is safe and effective for the treatment of small papilla adenoma to even large laterally spreading tumors of duodenum lesions.As reported by some existing studies,temporarily placing a prophylactic stent in the pancreatic and bile duct can lower the risk of this perioperative complication.AIM To evaluate the usefulness,convenience,safety,and short-term results of a novel autorelease bile duct supporter after EP procedure,especially the effectiveness in preventing EP.METHODS A single-center comparison study was conducted to verify the feasibility of the novel method.After EP,a metallic endoclip and human fibrin sealant kit were applied for protection.The autorelease bile duct supporter fell into the duct segment and the intestinal segment.Specifically,the intestinal segment was extended by nearly 5 cm as a bent coil.The bile was isolated from the pancreatic juice using an autorelease bile duct supporter,which protected the wound surface.The autorelease bile duct supporter fell off naturally and arrived in colon nearly 10 d after the operation.RESULTS En bloc endoscopic resection was performed in 6/8 patients(75%),and piecemeal resection was performed in 2/8 of patients(25%).None of the above patients were positive for neoplastic lymph nodes or distant metastasis.No cases of mortality,hemorrhage,delayed perforation,pancreatitis,cholangitis or duct stenosis with the conventional medical treatment were reported.The autorelease bile duct supporter in 7 of 8 patients fell off naturally and arrived in colon 10 d after the operation.One autorelease bile duct supporter was successfully removed using forceps or snare under endoscopy.No recurrence was identified during the 8-mo(ranging from 6-9 mo)follow-up period.CONCLUSION In brief,it was found that the autorelease bile duct supporter could decrease the frequency of procedure-associated complications without second endoscopic retraction.Secure closure of the resection wound with clips and fibrin glue were indicated to be promising and important for the use of autorelease bile duct supporters.Well-designed larger-scale comparative studies are required to confirm the findings of this study.
文摘BACKGROUND Immune checkpoint inhibitors(ICIs)are novel therapeutic agents used for various types of cancer.ICIs have revolutionized cancer treatment and improved clinical outcomes among cancer patients.However,immune-related adverse effects of ICI therapy are common.Cardiovascular immune-related adverse events(irAEs)are rare but potentially life-threatening complications.AIM To estimate the incidence of cardiovascular irAEs among patients undergoing ICI therapy for various malignancies.METHODS We conducted this systematic review and meta-analysis by searching PubMed,Cochrane CENTRAL,Web of Science,and SCOPUS databases for relevant interventional trials reporting cardiovascular irAEs.We performed a single-arm meta-analysis using OpenMeta[Analyst]software of the following outcomes:Myocarditis,pericardial effusion,heart failure,cardiomyopathy,atrial fibrillation,myocardial infarction,and cardiac arrest.We assessed the heterogeneity using the I2 test and managed to solve it with Cochrane’s leave-one-out method.The risk of bias was performed with the Cochrane’s risk of bias tool.RESULTS A total of 26 studies were included.The incidence of irAEs follows:Myocarditis:0.5%[95%confidence interval(CI):0.1%-0.9%];Pericardial effusion:0.5%(95%CI:0.1%-1.0%);Heart failure:0.3%(95%CI:0.0%-0.5%);Cardiomyopathy:0.3%(95%CI:-0.1%-0.6%);atrial fibrillation:4.6%(95%CI:1.0%-14.1%);Myocardial infarction:0.4%(95%CI:0.0%-0.7%);and Cardiac arrest:0.4%(95%CI:0.1%-0.8%).CONCLUSION The most common cardiovascular irAEs were atrial fibrillation,myocarditis,and pericardial effusion.Although rare,data from post market surveillance will provide estimates of the long-term prevalence and prognosis in patients with ICIassociated cardiovascular complications.
