目的 分析奧美沙坦的不良事件（ADE）報告，為臨床安全用藥提供參考。方法 利用OpenVigil 2.1平臺獲取美國食品藥品管理局（FDA）不良事件報告系統(tǒng)（FAERS）中2004年1月1日—2023年9月30日奧美沙坦相關的ADE報告，采用報告比值比法（ROR）、比例報告比值法（PRR）和貝葉斯置信區(qū)間遞進神經網(wǎng)絡法（BCPNN）對ADE報告進行數(shù)據(jù)挖掘與分析。結果 共獲得與奧美沙坦相關的ADE報告120 264份，在已知性別、年齡或地區(qū)的ADE報告中，女性占比略高于男性，61～80歲和來自北美洲的ADE報告數(shù)占比最大。奧美沙坦的ADE報告涉及25個系統(tǒng)器官分類（SOC），4 288個首選術語（PT），共檢測到陽性SOC信號7個，包括胃腸系統(tǒng)疾病、腎臟及泌尿系統(tǒng)疾病、代謝及營養(yǎng)類疾病等，在PT層級檢測到819個陽性信號，主要包括口炎性腹瀉樣腸病、體質量降低、腹瀉、腎損傷、頭暈等。結論 分析檢測到的ADE信號與說明書基本一致，同時還發(fā)現(xiàn)了一些新的潛在ADE信號，如胃食管反流病、痔瘡、便秘、出血性甲狀腺囊腫、腸息肉等，值得臨床關注。

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

重慶市技術創(chuàng)新與應用發(fā)展專項重點項目（CSTC2021jscx-gksb-N0013）；重慶市臨床藥學重點專科建設項目（渝衛(wèi)辦發(fā)〔2020〕68號）