2005～2009年上海市中医医院中成药不良反应分析

Analysis of Adverse Drug Reactions Induced by Traditional Chinese Patent Medicines Reported in Shanghai Traditional Chinese Medical Hospital from 2005 to 2009

目的:分析近4年上海市中医医院中成药不良反应报告,促进中成药的合理应用。方法:对我院2005年5月～2009年5月中成药的药品不良反应(ADR)的临床表现及相关因素进行分析,并查阅了发生ADR的28种中成药说明书,将其ADR临床表现与说明书的描述进行分析对比。结果:69例有效ADR报告涉及中成药28种;ADR累及多个器官和系统,其中最为常见的是皮肤及附件的损害(84.05%),其次为消化系统、神经系统等的损害;转归较好,其中治愈41例(59.42%),好转27例(39.13%),仅1例留下后遗症。28种中成药的说明书仅有11种(39.29%)较明确地标注了ADR情况,5种(17.86%)标注"尚不明确",12种(42.85%)无不良反应项。结论:中成药的不良反应不可忽视。中成药说明书的书写不够规范。中成药ADR的监测和对药品生产、使用的规范化管理,对减少不良反应的发生、控制药物滥用、促进中成药安全合理地应用具有重要意义。

OBJECTIVE： To analyze the adverse drug reactions （ADRs） of traditional Chinese patent medicines （CPM） reported by Shanghai Traditional Chinese Medical Hospital from 2005 to 2009 so as to promote clinical rational use of CPM. METHODS： The clinical manifestations and the associated factors of ADR induced by traditional CPM reported in our hospital from May 2005 to May 2009 were analyzed,meanwhile,the clincial presentations wereompared with those stated in package inserts of 28 kinds of drugs that induced ADRs. RESULTS： 28 kinds of CMP were involved in a total of 69 ADR cases. The ADRs involved multiple organs and systems,with 84. 05% presented as lesions of skin and appendix,followed by lesions of digestive system and nervous system. The ADRs showed a favorable turn,41 （59. 42% ） were cured,27（39. 13% ） took a favarable turn,and 1 presented with sequela. Of the total 28 drug package inserts,11 （39. 29% ） had definite labelling of ADRs,5 （17. 86% ） had indefinite labelling of ADRs,and 12 （42. 85% ） had unlabelling ADRs. CONCLUSION： The ADR of CPM shouldn′t be neglated. The writing of the package inserts of CPM is not standard. Tigtening monitoring on CPM-induced ADR monitoring and stardardized management on the production and utilization of CMP is of utmost importance for the reduction of ADR incidence and drug abuse and promotion of safe and rational use of CPM.