中成药药物不良反应的临床特征及发生的相关因素分析

目的 :研究中成药药物不良反应 (ADR)的临床特征及发生的相关因素。方法:以《中国药学文摘》2001年～2002年收载的有关中成药ADR的文摘为线索检索原始文献 ,筛选符合ADR判断标准的病例 ,从性别、年龄、给药途径、ADR发生时间及临床表现等方面探讨中成药ADR发生的规律与特征。结果:638例ADR病例涉及256篇文献76种中成药 ,其中以双黄连注射液的ADR最多 (87例 ) ;ADR临床表现以过敏反应最多,其次为肝、肾功能损害 ;ADR的发生年龄主要集中在60岁以上年龄段;ADR主要发生于用药后30分钟内 ;约92 %的患者预后情况良好。结论:给药途径、药物剂型、药品质量、患者年龄及体质等因素均会影响中成药ADR的发生。

Analysis of the Clinical Characteristics and Related Factors in Occurrence of ADRs of Chinese Prepared Medicines

OBJECTIVE:To analyze the ADRs caused by Chinese prepared medicines.METHODS:638ADRs were colˉlected from medical journals of2001～2002in consideration of sex,age,administration route,the time of the occurrence and clinical manifestations.RESULTS:There were638ADR cases involving76kinds of Chinese prepared medicines reported in256articles.Of them,shuanghuanglian injection was the most common preparation(87cases).The commonest clinical manifestaˉtions were allergic reactions(157cases),followed with the liver and kidney injury.The ages of patients were mostly above60years,the time of the occurrence was mostly within30minutes after administration and about92%of the patients recovered within24hours.CONCLUSION:The occurrence of ADRs of Chinese prepared medicines is related to the route of administraˉtion,dosage form of drug,quality of drug,patient’s age and constitution.