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目的 :对我国10年来 (1990年～1999年 )85种医药刊物中有关中药不良反应病例报道进行统计分析。方法 :用文献计量学方法 ,对1176例 (1291例次 )中药诱发ADRs报道进行回顾性调查研究 ,分析讨论诱发药物、症状表现、严重程度以及造成中药ADRs的原因。结果 :男女病例数为1∶1 15 ;诱发ADRs的药物涉及138个品种 ,其中以雷公藤片、双黄连注射液 (粉针 )和茵栀黄注射液为最 ,占27 96 % ;A类反应375例次 ,其中心血管系统损害比例最大 (19 73 % ) ;B类反应916例次 ,其中皮肤粘膜损害比例最大 (41 16 % ) ;造成重度损害者373例次 (28 89 % )。结论 :应加强有关中药安全用药知识的普及 ,规范临床合理应用中药及其制剂 ,实施对中药不良反应的控制、监测
Objectives: To conduct statistical analysis of reports on cases of adverse drug reactions in 85 Chinese medical journals over the past 10 years (1990-1999). METHODS: Using literature metrology methods, 1176 cases (1291 cases) of ADRs induced by traditional Chinese medicines were retrospectively investigated and analyzed to discuss the causes of induction of drugs, symptoms, severity, and causes of ADRs in traditional Chinese medicine. Results: The number of male and female patients was 1:115. The drug that induced ADRs involved 138 species, among which the Tripterygium wilfordii tablet, Shuanghuanglian injection (pink injection) and Yinzhihuang injection were the most common, accounting for 27 96%; The response rate was 375 times, with the largest proportion of central vascular system injury (19 73%); 916 cases of type B reactions, including the largest proportion of skin and mucous membrane damage (41 16%); and 373 cases of severe damage (28 89%). Conclusion : The popularization of knowledge on the safe use of Chinese medicine should be strengthened, and the rational use of traditional Chinese medicine and its preparations should be standardized, and the control and monitoring of adverse reactions to traditional Chinese medicine should be implemented.