艾司奥美拉唑不良反应418例报告分析

目的：了解艾司奥美拉唑发生药品不良反应（adverse drug reaction，ADR）的特点及相关因素，探讨其安全性，为临床合理用药提供参考。方法：调取江苏省药品不良反应监测中心数据库收集的2013-2016年379 801例报告，提取其中418例艾司奥美拉唑ADR报告进行描述性统计分析。结果：418份ADR报表中，类型为一般的有378例，其中新的有262例，严重的40例；注射剂29例，胶囊片剂389例；不良反应发生较多的是中老年人（83.47%）；ADR可累及多个器官或系统，主要为消化系统（37.80%）、皮肤系统（11.00%）和神经系统（10.53%）。临床症状范围较广。只有124例（29.67%）因果关系为肯定，可能，很可能或可能无关，294例（70.33%）是待评价和无法评价。合并用药有188例（44.97%）。结论：虽然严重的艾司奥美拉唑不良反应不多，但新的不良反应依然很多，临床上应重视其所致的ADR，并加强合理用药，确保用药安全。

Analysis of 418 case of adverse drug reaction induced by esomeprazole

OBJECTIVE To analyze the characteristics and related factors of adverse drug reactions (ADR) induced by esomeprazole in Jiangsu Province to improve the rational drug use in clinical practice.METHODS Retrospective analysis was performed to 418 adverse drug reactions.RESULTS There were 378 ADR reports and 40 serious ADR reports, including 262 new cases. There were 29 injections and 389 capsules & tablets resulting in 418 esomeprazole ADRs. ADRs induced by esomeprazole were mostly seen in middle-aged and old people, accounting for 83.47%. ADRs involved multiple organs or systems, mainly digestive system (37.80%), skin system (11.00%) and nervous system (10.53%). There was a wide range of clinical symptoms. In the correlation judgment, only 124 cases (29.67%) of causal relationships were definitely, probably or possibly unrelated. Reports of 294 cases (70.33%) were to be evaluated or could not be evaluated. There were 188 cases (44.97%) using combined drugs.CONCLUSION There are not many serious adverse effects induced by esomeprazole, but still many new adverse reactions. Clinical monitoring should be applied to these ADRs and the rational drug use should be enhanced to ensure drug safety.