中成药说明书安全性信息及不良反应监测数据分析

目的 分析中成药说明书安全性信息,结合不良反应监测数据,为临床合理使用中成药提供依据。方法 通过实地收集获取410个中成药品种的说明书,对安全性信息进行统计和分析;检索浙江省的不良反应监测数据,选取重点品种对比说明书与监测数据之间的差异。结果 共收集中成药说明书410份,302个品种[不良反应]项为尚不明确（占73.66%）;262个品种[禁忌]项为尚不明确（占63.90%）;仅3个品种[特殊人群]项有相关规定。重点品种的不良反应监测数据显示中成药的不良反应并不少见,可累及全身多个系统和器官。结论 中成药的安全监测成果还没有彻底落实在说明书安全性信息的修订与完善中。药品生产企业应充分发挥药品安全主体责任,主动补充更新说明书安全性信息。

Analysis of Leaflets' Safety Informations and Adverse Reaction Monitoring Data of Chinese Patent Drugs

OBJECTIVE To analyze the specification safety information of Chinese patent drugs combined with the adverse drug reactions monitoring data and provide basis for rational use of Chinese patent drugs in clinic. METHODS Making statistics and analysis of safety information by collecting 410 varieties of Chinese patent drugs leaflets in the field. Then selecting the key varieties and comparing the differences between the leaflets and monitoring data by searching Zhejiang sub-database of China adverse drug reaction database. RESULTS A total of 410 leaflets for Chinese patent drugs were collected. The "adverse reactions" item of 302 leaflets were "unclear"(73.66%). The "contraindications" item of 262 leaflets were "unclear"(63.90%). Only three leaflets had relevant regulations under the "use in specific populations" item. The adverse reaction monitoring data of key varieties showed that the adverse reactions of Chinese patent drugs were not uncommon, and involved multiple systems and organs. CONCLUSION The safety monitoring results of Chinese patent drugs have not been fully implemented in the revision and improvement of safety information. Manufactures should take full responsibility for drug safety, and update the safety informations actively.