18种中药注射剂不良反应/不良事件文献分析

目的:调查18种中药注射剂的不良反应/不良事件文献分析报道。了解其基本情况和文献研究趋势,为中药注射剂合理使用、安全警戒以及风险管理工作提供参考依据。方法:对国内文献检索到的18种中药注射液不良反应/不良事件文献分析报道进行分类调查。结果:18种中药注射剂涉及不良反应病例5816例。其中,刺五加注射液、参麦注射液、茵栀黄注射液不良反应最多,均超过900例(共占74.95%);双黄连、刺五加、鱼腥草和茵栀黄4种中药注射剂部分生产企业叫停,其ADR/ADE文献发表量与监管作用相辅相成。ADR/ADE多发生于>40岁年龄组,出现时间多发生于用药后的30分钟。不良反应主要表现为过敏反应(74.15%),死亡率0.17%(10例)。结论:临床应重视中药注射剂的不良反应/不良事件。加强上市后安全性再评价和合理用药应是当前中药注射剂研究工作的重点。

Investigation on the Adverse Drug Reactions and Adverse Events of 18 Traditional Chinese Medical Injections by Data Analysis

Objective： To investigate the adverse drug reactions （ADR） and adverse events （ADE） of 18 traditional Chinese medical injections （TCM） by data analysis. To retrieve basic ADR information and research trends related to TCM and to provide evidence for the rational use of TCM, pharmacovigilance and risk management. Methods： To analize the retrieved ADR/ADE of 18 TCMs in Chinese Journals. Results： Among 5 816 cases of ADR/ADE involved in the 18 TCMs, most ADRs/ADEs were related to Ciwujia, Shenmai, Yinzhihuang injections （each of the three injections has more than 900 ADRs, accounting for 74.95% of the tota1）. The Ministry of Health and the State Food and Drug Administration （SFDA） have taken measures for the supervision. The four kinds of TCMs （Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections） which were the top 4 reported ADRs/ADEs in literatures were removed from market or suspended for production by part of manufacturers. 5 816 cases of ADRs/ADEs were mostly occur in the age groups of over 40. They usually occurred in the first 30 minutes after taking the drug. The main ADRs reflected as allergic reactions （74.15%）. The mortality rate is 0.17%. Conclusion： It is necessary to pay more attention to the ADR, and enforce safety reevaluation of TCM and to promote the clinical rational use.