Objective:To analyze the clinical characteristics of serious immune-related adverse events(irAEs)such as Stevens-Johnson syndrome(SJS)and toxic epidermal necrolysis(TEN)occurring in patients caused by tislelizumab(BGB-A317),and provide reference for the safe and rational use of BGB-A317.Methods:The case reports and literature related to SJS/TEN caused by BGB-A317 as of November 2022 were searched from domestic and foreign databases such as Embase,PubMed,CNKI,SinoMed using"tislelizumab","Stevens-Johnson syndrome","toxic epidermal necrolysis","adverse drug reaction","immune-related adverse events"and"case report"as the search terms,to analyze the clinical characteristics of SJS/TEN caused by BGB-A317.Results:Five high-quality case reports were searched from relevant databases,involving 5 medical cases,including 4 TEN cases and 1 SJS case;5 patients(3 males and 2 females)were aged from 55 to 93 years,and the dosage and administration of BGB-A317 was"200 mg,q3w".The period from the first use of BGB-A317 to the onset of SJS/TEN was 54 to 127 days(median:63 days).Among the 5 patients,the skin toxic reactions of SJS/TEN caused by BGB-A317 were manifested as mucosal involvement(all oral mucosa)and prodromal rash;among them,patients who developed SJS had mucosal involvement and prodromal rash;while 1 of the 4 patients who developed TEN had no skin toxic reaction and 3 of them developed prodromal rash,but only 1 patient had mucosal involvement.All of the 5 patients who developed SJS/TEN improved or recovered after symptomatic treatment.Conclusion:The irAEs such as SJS/TEN occurring in cancer patients during treatment with BGB-A317 shall be highly concerned;once manifestations such as mucosal involvement or prodromal rash have occurred,clinical investigation and diagnosis shall be performed actively to ensure the medication safety of patients.
Objective:To analyze and evaluate the clinical medication risks of zileuton based on the US FDA adverse event reporting system(FAERS),and provide reference for the clinical medication safety of zileuton.Methods:With the OpenVigil tool,adverse events related to zileuton reported from January 1,2004 to September 30,2022 were retrieved from the Open-FDA database of FAERS,and the characteristics and risks of adverse events related to zileuton were analyzed using the reporting odds ratio method and Beyesian confidence propagation neural network method.Results:A total of 215 adverse event reports related to zileuton were discovered in the Open-FDA database,of which 158 were females(73.49%),including a total of 58 cases(26.98%)of serious adverse events such as hospitalization or severe hospitalization and disability of patients;215 reports involved a total of 26 signals,mapped to 8 SOC,with the main SOC of"respiratory,thoracic,and mediastinal diseases"(87 cases,40.66%),"skin and subcutaneous tissue diseases"(43 cases,20.00%),and"abnormal laboratory indicators"(46 cases,21.40%,all related to liver function damage);the signal intensity detection showed that there were 13 strong warning signals(including 5 related to liver function damage and 4 related to respiratory function abnormalities),and 11 moderate warning signals.Conclusion:Based on FAERS data,the main risks of zileuton are liver function damage and respiratory system abnormalities.Monitoring should be strengthened during clinical treatment to ensure the medication safety of patients.
目的:分析医院碳青霉烯耐药的肠杆菌科细菌(carbapenem-resistant Enterobacteriaceae,CRE)的感染特征及其耐药情况,为临床CRE感染患者的抗感染治疗提供参考.方法:选取 2019 年 5 月—2022 年 10 月临川区人民医院收治的 88 例CRE感染患者作为研究对象,采集患者的科室分布、标本类型和微生物检查结果等信息,分析CRE的感染特征及其耐药情况.结果:88 株CRE中主要菌株为肺炎克雷伯菌(41 株,占 46.59%)、大肠埃希菌(24 株,占 27.27%)、阴沟肠杆菌(13 株,占 14.77%);88 株CRE主要来自于痰液(56 株,占 63.64%),其次为尿液(15 株,占 17.05%)和胆汁(9 株,占 10.23%);88 株CRE主要来自ICU(54 株,占 61.36%),其次为神经外科(14 株,占 15.91%)和呼吸内科(11 株,占 12.50%);药敏结果显示,肺炎克雷伯菌、大肠埃希菌和阴沟肠杆菌对氨苄西林、头孢唑林、头孢呋辛、亚胺培南、氨苄西林-舒巴坦钠、厄他培南、头孢曲松的耐药率较高(＞75.00%),对替加环素、头孢替坦、妥布霉素的耐药率较低(＜15.00%).结论:医院CRE感染的主要致病菌为肺炎克雷伯菌,主要分布于ICU,多在痰液中检出,且对多种常用抗菌药物存在较高的耐药率,对少数抗菌药物如美罗培南、妥布霉素的耐药率较低,临床医师用药前应参考病原菌分布与药敏试验结果,合理选用疗效好的药物进行治疗.
目的:运用《2019 AGS老年人潜在不当用药Beers标准(更新版)》(以下简称《Beers标准(2019 更新版)》),分析与评价社区老年 2 型糖尿病患者的潜在不适当用药(potentially inappropriate medication,PIM)情况,为社区老年患者的用药安全提供参考.方法:选取 2020 年 10 月—2021 年 12 月社区药学门诊服务的＞60～65 岁老年 2 型糖尿病患者作为研究对象,采集患者的年龄、多病共存、服药状况、药物不良反应(adverse drug reactions,ADRs)等信息,分析患者的PIM情况及其与ADRs的关系.结果:此次符合纳入标准的老年糖尿病患者共 80 例,其平均患病种数为 5 种,平均用药种数为 9 种;调查发现,80 例患者中有 58 例存在PIM的情况,其中与药物相关的PIM 44例、与疾病相关的PIM 6例、与老年患者相关的PIM 6例、与药物相互作用相关的PIM 7例、与肾功能不全相关的PIM 5例和《Beers标准(2019 更新版)》未包括的PIM 25 例;80 例患者中真正发生ADRs的有 25 例,发生率为 31.25%;Spearman相关性分析结果显示,用药数量与ADRs的发生呈正相关(r=0.493,P＜0.05),PIM与ADRs的发生具有显著相关(r=0.715,P＜0.01).结论:社区老年 2 型糖尿病患者确实存在较多的PIM情况,且其与ADRs的发生存在较为密切的关系,临床在为此类老年患者开展诊疗的过程中,应多关注患者的多病共存和服药状况,尽量避免PIM的产生,以确保患者的用药安全.
目的:分析 2021 年周口市上报的新的药物不良反应(adverse drug reactions,ADRs)的流行病学特点,为保障患者用药安全提供参考.方法:调取 2021 年 1 月—12 月周口市属各医疗机构、药品经营企业和个人上报至国家药品不良反应监测中心的ADRs的病例报告相关数据,统计、分析患者的基本信息、新的ADRs上报机构和报告人职业、关联性和患者转归、给药途径、药品类别、累及的器官/系统及其临床表现和怀疑药品.结果:筛选出新的ADRs 报告 2 064 例,占全部ADRs 的 13.93%,其中新的一般的ADRs 有 1 952 例,新的严重的ADRs有 112 例;上报的新的ADRs的上报机构以医疗机构为主占 93.27%,报告人职业以医师为主占 56.40%;新的ADRs 患者中女性(1 115 例)多于男性(948 例),45 岁及以上人群为新的ADRs多发人群占 63.66%;新的ADRs的主要给药途径为口服给药;怀疑药品类别例数排名前 3 位依次为中药制剂(1 071 例,占 51.89%)、抗微生物用药(267 例,占 12.94%)和心脑血管系统用药(240 例,占 11.63%),其中中药制剂排名前 10 位药品以感冒治疗用中成药居多,抗菌药物静脉滴注例数最多;累及器官/系统主要为胃肠系统、皮肤黏膜、中枢与外周神经系统等.结论:临床应加强对中药制剂尤其是感冒治疗用中成药和注射剂尤其是静脉滴注抗菌药物的ADRs监测,以保障患者的临床用药安全.
