目的 分析奥美沙坦的不良事件（ADE）报告，为临床安全用药提供参考。方法 利用OpenVigil 2.1平台获取美国食品药品管理局（FDA）不良事件报告系统（FAERS）中2004年1月1日—2023年9月30日奥美沙坦相关的ADE报告，采用报告比值比法（ROR）、比例报告比值法（PRR）和贝叶斯置信区间递进神经网络法（BCPNN）对ADE报告进行数据挖掘与分析。结果 共获得与奥美沙坦相关的ADE报告120 264份，在已知性别、年龄或地区的ADE报告中，女性占比略高于男性，61～80岁和来自北美洲的ADE报告数占比最大。奥美沙坦的ADE报告涉及25个系统器官分类（SOC），4 288个首选术语（PT），共检测到阳性SOC信号7个，包括胃肠系统疾病、肾脏及泌尿系统疾病、代谢及营养类疾病等，在PT层级检测到819个阳性信号，主要包括口炎性腹泻样肠病、体质量降低、腹泻、肾损伤、头晕等。结论 分析检测到的ADE信号与说明书基本一致，同时还发现了一些新的潜在ADE信号，如胃食管反流病、痔疮、便秘、出血性甲状腺囊肿、肠息肉等，值得临床关注。

Objective To analyze the ADE reports of olmesartan to provide reference for safe medication in clinic. Methods Using the OpenVigil2.1 platform to obtain olmesartan-related ADE reports from FAERS from the January 1, 2004 to September 30, 2023, and the reporting odds ratio (ROR), proportional reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) methods were used for data mining and analysis of ADE reports. Results A total of 120 264 ADE reports related to olmesartan were obtained, with slightly more women than men among ADE reports of known gender, age or region, with the largest proportion of ADE reports being 61 — 80 years of age and from North America. The ADE report of olmesartan involved 25 SOCs and 4 288 PTs, and seven positive SOC were detected, including gastrointestinal disorders, renal and urinary disorders, metabolism and nutrition disorders, etc., and 819 positive signals were detected at the PT level. It mainly includes sprue-like enteropathy, weight decreased, diarrhoea, kidney injury, dizziness, etc. Conclusion The ADE signals detected in this study were generally consistent with the instructions, and some new potential ADE signals were also found, such as gastroesophageal reflux disease, haemorrhoids, constipation, haemorrhagic thyroid cyst, intestinal polyp, and so on, which are worthy of clinical attention.

R972

重庆市技术创新与应用发展专项重点项目（CSTC2021jscx-gksb-N0013）；重庆市临床药学重点专科建设项目（渝卫办发〔2020〕68号）