复方丹参注射液不良反应的文献回顾性分析及其机制的探讨

目的:探讨复方丹参注射液所致不良反应的一般规律及特点,为临床合理用药提供参考。方法:对1994年1月～2009年12月间国内公开发行的医药期刊上有关复方丹参注射液所致不良反应病例进行统计,对病例所涉及的患者情况、用药情况、不良反应发生情况等进行分类、统计与分析。结果:查阅文献45篇,不良反应病例数共计116例,其不良反应主要为变态反应,共64例,占55.18%。结论:应加强复方丹参注射液的应用监测,生产企业要完善各项质量标准,国家应尽快制订统一的工艺标准,规范和完善复方丹参注射液的药品说明书,以促进药品的合理应用。

Objective： To explore the general rule and the characteristics of adverse drug reaction （ADR） induced by Salvia miltiorrhiza Compound Injection and to provide some references for clinical medicine and rational use of drug.Methed We： 1994 to December,2009 from China Hospital Knowledge Database and CNKI. We collected and statistically analyzed ADR reports, involved in the situation of patients,drug use,the occurrence of adverse reactions and so on. Result：The total cases of Salvia miltiorrhiza Compound Injection Adverse Drug Reactions are 116 cases. The main ADR were allergic reactions about 64 cases （55.18%）. Conclusion： We should take more monitoring in the application of Salvia milfforrhiza Compound Injection to reduce the occurrence of serious ADR. Manufacturer should improve the quality standard and the preparation process of Salvia miltiorrhiza Compound Injection. Our states should make a unified technology standards as soon as possible, standardize and improve the drug manual, strengthening the monitoring of adverse drug reactions.