基于层次分析法的中药注射剂安全性评价

Safety evaluation of traditional Chinese medicine injections based on analytical hierarchy process

目的用层次分析法对中药注射剂进行安全性评价,并对其进行分类,为临床安全使用中药注射剂提供参考。方法对常用且批准文号为中药类的25种注射剂,通过检索中国期刊全文数据库(1994—2010年)和中国生物医学文献数据库(1994-2010年)间中药注射剂不良反应的报道文献,对文献数据利用Matlab及SPSS进行层次分析,对各中药注射剂作出安全性评价并分类。结果 25种中药注射剂分为4类,安全类8种、较安全类11种、较危险类3种、危险类3种。结论 25种中药注射剂76%属于安全或较安全种类,较危险及危险类中药注射剂在临床使用中应当严格按照说明书及辨证论治使用,同时密切关注不良反应的发生,并做好积极处理的准备工作。

Objective To evaluate and classify the safety of 25 kinds of traditional Chinese medicine injections（TCMi）by commonly used analytic hierarchy process in order to provide the reference to the safe use of TCMi in clinic.Methods With 25 kinds of TCMi as the research objects,TCMi adverse reaction data were obtained by retrieval of the CNKI（1994-2010）and Cbmdisc（1994-2010）and analyzed by analytic hierarchy process with Matlab 7.1 and SPSS 15.0. Results The 25 kinds of TCMi were divided into four categories,8 kinds of safe TCMi class,11 kinds of safer TCMi class,3 kinds of unsafe TCMi class and 3 kinds of dangerous TCMi class. Conclusion 76%of researched TCMi belong to safe or safer class,the use of unsafe and dangerous class injections should strictly be in accordance with the drug instruction and its principle.The unsafe and dangerous class injections adverse drug reaction should be monitored,and positive treatment should be prepared before use.