2005至2011年重庆市中成药不良反应监测及安全性再评价

Reevaluation on adverse reaction monitoring and safety of proprietary Chinese medicines of Chongqing from 2005 to 2011

目的:系统梳理中成药不良反应监测情况,为临床安全用药提供参考。方法:利用Excel及SPSS 17.0全面汇总分析中成药ADR监测情况,并与非中成药对比评价。结果与结论:中成药与非中成药ADR不同状态报告数据存在显著性差异(P<0.05),中成药严重ADR与非中成药相比安全风险比例为1.057(95%CI:0.915,1.221),中成药安全性并不比非中成药高;清开灵、血塞通、香丹等品种ADR及严重ADR排名多年一直位居前5,药监卫生体系应采取更为有效的控制措施,加强合理用药监控;中成药严重ADR临床表现以过敏性休克所占比例最大,目前皮试等手段不能有效预测和监控,应该加强临床用药前的风险效益评估。

Objective： To systematically summarize the monitoring over adverse reactions of proprietary Chinese medicines, in order to provide reference for safe clinical medication. Method： By using Excel and SPSS 17. 0 were adopted for summarizing ADR monitoring over Chinese patent medicines and comparatively evaluating the non-proprietary Chinese medicines. Result and Conclusion： There were significant differences in data of different state reports of proprietary Chinese medicines and non-proprietary Chinese medicines （ P 〈 0. 05 ）. The ratio between the serious ADR of proprietary Chinese medicines and the safety risk of non-proprietary Chinese medicines was 1. 057 （95% CI：0. 915, 1. 221 ）, suggesting that the safety of proprietary Chinese medicines was not higher than the non-proprietary Chinese; as such medicines as Ql_＇ngkailing, Xuesaitong and Xiangdan have ranked top five for years in terms of ADR and serious ADR, the drug administration and hygiene system shall take more effective control measures for strengthening the monitoring over rational use of drugs ; clinical manifestations of severe ADR of proprietary Chinese medicines were dominated by allergic shock, which could not be effectively prevented and monitored by such means as skin test, therefore, pre-clinical treatment risk-benefit evaluation shall be improved.