摘要
目的为临床安全使用阿替利珠单抗和度伐利尤单抗提供参考。方法利用OpenVigil 2.1平台,从美国食品和药物管理局不良事件报告系统(FAERS)中提取2016年1月1日至2023年9月30日有关阿替利珠单抗和度伐利尤单抗的药品不良事件(ADE)报告;采用《监管活动医学词典》(MedDRA 24.0)对首选语进行系统器官分类(SOC)匹配;采用报告比值比(ROR)法和比例报告比值(PRR)法挖掘药品不良反应(ADR)信号。结果共获得ADE报告19835份(涉及患者19835例),其中阿替利珠单抗13420份(13420例),度伐利尤单抗6415份(6415例);ADR信号,阿替利珠单抗814个,度伐利尤单抗315个,其中未在药品说明书中提及的均为49个,分别为自身免疫性心肌炎、暴发性1型糖尿病,放射性食管炎、支气管瘘等。共获得192个重叠ADR信号,其中胃肠系统疾病21个,呼吸系统、胸及纵隔疾病21个,各类检查18个,皮肤及皮下组织类疾病18个;阿替利珠单抗发生周围感觉神经病的信号强度远大于度伐利尤单抗(ROR值相差近5倍),度伐利尤单抗发生放射性肺炎、胆道感染、美国东部肿瘤协作组体能状态下降、浅表血栓性静脉炎的信号强度远大于阿替利珠单抗(ROR值相差5~77倍)。结论临床应加强对阿替利珠单抗和度伐利尤单抗主要ADR及差异ADR的认识,重点关注药品说明书中未提及但信号强且易导致不良后果的ADR,从而促进该类药物的临床安全使用。
Objective To provide a reference for the safe use of atezolizumab and durvalumab in clinical practice.Methods The OpenVigil 2.1 platform was used to extract adverse drug event(ADE)reports associated with atezolizumab and durvalumab from January 1,2016 to September 30,2023 in the FDA Adverse Event Reporting System(FAERS).The preferred term(PT)were matched with system organ classification(SOC)by the Medical Dictionary for Regulatory Activities(MedDRA 24.0).The reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods were used to mine adverse drug reaction(ADR)signals.Results A total of 19835 ADE reports were obtained(19835 cases),including 13420 of atezolizumab(13420 cases)and 6415 of durvalumab(6415 cases),involving 814 ADR signals of atezolizumab and 315 of durvalumab,in which 49 were not mentioned in the corresponding drug instructions,such as autoimmune myocarditis and fulminant type 1 diabetes of atezolizumab,radiation esophagitis and bronchial fistula of durvalumab.A total of 192 overlapping ADR signals were obtained,including 21 of gastrointestinal diseases,21 of respiratory,thoracic and mediastinal diseases,18 of various examinations,18 of skin and subcutaneous tissue diseases and others.The signal of peripheral sensory neuropathy induced by atezolizumab was much stronger than that induced by durvalumab,with a difference of nearly five times in ROR,while the signals of radiation pneumonitis,biliary tract infection,physical decline based on the Eastern Cooperative Oncology Group and superficial thrombophlebitis induced by durvalumab were much stronger than those induced by atezolizumab,with a difference of five to seventy-seven times in ROR.Conclusion We should strengthen the awareness of main and differential ADRs of atezolizumab and durvalumab,focus on the ADRs that are not mentioned in the drug instructions but have strong signals and are likely to lead to adverse outcomes to promote the clinical safe use of these drugs.
作者
胡露
王松
赖翔宇
刘海林
HU Lu;WANG Song;LAI Xiangyu;LIU Hailin(The People's Hospital of Liangjiang New Area,Chongqing,China 401121;The Cancer Hospital Affiliated to Chongqing University,Chongqing,China 400030)
出处
《中国药业》
CAS
2024年第6期114-120,共7页
China Pharmaceuticals
基金
重庆市科卫联合医学科研项目[2021MSXM171]。
