目的 分析奧美沙坦的不良事件（ADE）報(bào)告，為臨床安全用藥提供參考。方法 利用OpenVigil 2.1平臺(tái)獲取美國(guó)食品藥品管理局（FDA）不良事件報(bào)告系統(tǒng)（FAERS）中2004年1月1日—2023年9月30日奧美沙坦相關(guān)的ADE報(bào)告，采用報(bào)告比值比法（ROR）、比例報(bào)告比值法（PRR）和貝葉斯置信區(qū)間遞進(jìn)神經(jīng)網(wǎng)絡(luò)法（BCPNN）對(duì)ADE報(bào)告進(jìn)行數(shù)據(jù)挖掘與分析。結(jié)果 共獲得與奧美沙坦相關(guān)的ADE報(bào)告120 264份，在已知性別、年齡或地區(qū)的ADE報(bào)告中，女性占比略高于男性，61～80歲和來(lái)自北美洲的ADE報(bào)告數(shù)占比最大。奧美沙坦的ADE報(bào)告涉及25個(gè)系統(tǒng)器官分類(lèi)（SOC），4 288個(gè)首選術(shù)語(yǔ)（PT），共檢測(cè)到陽(yáng)性SOC信號(hào)7個(gè)，包括胃腸系統(tǒng)疾病、腎臟及泌尿系統(tǒng)疾病、代謝及營(yíng)養(yǎng)類(lèi)疾病等，在PT層級(jí)檢測(cè)到819個(gè)陽(yáng)性信號(hào)，主要包括口炎性腹瀉樣腸病、體質(zhì)量降低、腹瀉、腎損傷、頭暈等。結(jié)論 分析檢測(cè)到的ADE信號(hào)與說(shuō)明書(shū)基本一致，同時(shí)還發(fā)現(xiàn)了一些新的潛在ADE信號(hào)，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(guān)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(shù)創(chuàng)新與應(yīng)用發(fā)展專(zhuān)項(xiàng)重點(diǎn)項(xiàng)目（CSTC2021jscx-gksb-N0013）；重慶市臨床藥學(xué)重點(diǎn)專(zhuān)科建設(shè)項(xiàng)目（渝衛(wèi)辦發(fā)〔2020〕68號(hào)）