目的 分析熊去氧胆酸在0～17岁儿童真实世界临床应用药物不良事件（adverse event，AE）的发生情况。方法 收集WHO全球个例安全性病理报告（VigiBase）数据库、美国食品和药物管理局药品不良事件自发呈报系统（FAERS）数据库及欧洲药物管理局药物警戒（Eudra Vigilance）数据库中0～17岁儿童有关熊去氧胆酸的AE报告数据。运用描述分析和比例报告比值比（proportional reporting ratio，PRR）数据挖掘算法检测药物安全信号。结果 熊去氧胆酸在3～11岁儿童的AE报告占比较高（1.8%～6.3%），女性稍高于男性，VigiBase数据库中熊去氧胆酸致胃肠系统疾病、皮肤及皮下组织类疾病和血液及淋巴系统疾病的AE报告较多。FAERS数据挖掘显示，熊去氧胆酸对0～2岁儿童AE风险信号“并指”的PRR值高达1 111.15，需引起关注；3～17岁儿童需关注再生障碍性贫血。结论 儿科临床应用熊去氧胆酸时需关注胃肠系统、皮肤及皮下组织类、血液及淋巴系统、肝胆系统方面的AE，熊去氧胆酸可能会增加新生儿AE的发生风险，妊娠、哺乳期女性使用需谨慎。

Objective To analyze the incidence of adverse events (AEs) of clinical drug use of ursodeoxycholic acid in children aged 0 to 17 years in the real world. Methods The AE report data of ursodeoxycholic acid among 0 to 17 years old children in WHO VigiBase database, FDA FAERS database and Eudra Vigilance database were collected. Descriptive analysis and proportional reporting ratio (PRR) data mining algorithms were used to detect drug safety signals. Results Ursodeoxycholic acid had a higher AE report proportion (1.8%—6.3%) in children aged 3 to 11 years, and women were slightly higher than men. In VigiBase databases, gastrointestinal diseases, skin and subcutaneous tissue diseases, and blood and lymphatic system diseases induced by ursodeoxycholic acid had more AE reports. FAERS data mining showed that the PRR value of syndactyly in 0 to 2 year old children was as high as 1 111.15, which needed attention. The aplastic anemia in children aged 3 to 17 should pay more attention. Conclusions The clinical application of ursodeoxycholic acid in pediatrics should pay attention to the AE of gastrointestinal diseases, skin and subcutaneous tissue diseases, blood and lymphatic system diseases and hepatobiliary system diseases. Urodeoxycholic acid may increase the risk of AE in newborn, and the use of ursodeoxycholic acid in pregnant and lactating women should be cautious.

R285.63

湖北省药品（医疗器械）不良反应监测中心研究项目（20210817）；湖北省武汉市卫生健康科研基金资助面上项目（WZ21A07）