43313例兰索拉唑用药患者的安全性自动监测研究

Safety evaluation of lansoprazole based on automatic surveillance system

目的通过大样本自动监测研究,了解兰索拉唑真实世界中不良反应的发生情况。方法借助"医疗机构ADE主动监测与智能评估警示系统"调取2016年1月-2017年12月间解放军总医院43 313例使用过注射用兰索拉唑(规格:30 mg)的所有住院患者相关信息,回顾性研究兰索拉唑相关的不良反应。结果兰索拉唑致血小板减少、白细胞减少、中性粒细胞减少、贫血(血红蛋白减少)、肝损害、急性肾损伤和皮肤损害的发生率分别为0.10%(n=32 986)、0.14%(n=31 727)、0.11%(n=31 727)、0.11%(n=26 840)、1.00%(n=27 040)、0.02%(n=35 152)、0.07%(n=40 577);合计总发生率为0.96%;用药时长≥6 d为兰索拉唑肝损害的危险因素。结论兰索拉唑安全性较高,但临床仍需警惕其用药风险,用药时长超过5 d时需关注患者肝功能指标变化。

Objective To determine the occurrence of adverse reactions of lansoprazole by automatic surveillance. Methods We retrospectively analyzed blood cell loss and liver or kidney damage induced by lansoprazole with the help of the active surveillance and assessment system of adverse drug events(ADE-ASAS). Results The incidence of thrombocytopenia, leukopenia, neutropenia, anemia, hepatic damage, acute kidney injury, and skin lesion induced by lansoprazole was 0.10%(n = 32 986), 0.14%(n = 31 727), 0.11%(n = 31 727), 0.11%(n = 26 840), 1.00%(n = 27 040), 0.02%(n = 35 152), and 0.07%(n = 40 577), respectively, and the total incidence was 0.96%. Drug administration longer than 6 days was a risk factor for liver damage by lansoprazole. Conclusion Lansoprazole is relatively safe. The changes in liver function should be vigilant when the medication use is longer than 5 days.