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目的系统评价《国家基本药物目录》(2002年版)中药注射剂类药品及相关同品种不同剂型的临床研究文献,了解和分析其不良反应发生情况。方法系统性评价方法。结果72个药品中有5个药品未检索到文献,17个药品无临床治疗性文献,34个药品报告不良事件/不良反应4156例,其中注射剂4146例,占99.76%;同品种其他剂型10例,占0.24%。结论报告的不良事件/不良反应绝大多数为中药注射剂品种,而同品种其他剂型(如口服液、颗粒剂、胶囊剂、片剂等)则大多未出现或很少出现不良事件/不良反应。不良反应报告不规范,未进行不良反应因果关系判断,且无前瞻性研究,无法获得不良反应发生率。当前中药安全性研究工作重点是加强对中药注射剂的安全性进行监测、评价和研究。
Objective To systematically evaluate the clinical research literature of the National Essential Drug Directory (2002 edition) for traditional Chinese medicine injections and different dosage forms of the same variety, and to understand and analyze the occurrence of adverse reactions. Methods Systematic evaluation methods. Results Of the 72 drugs, 5 drugs did not retrieve the literature, 17 drugs had no clinical therapeutic literature, 34 drugs reported 4156 adverse events/adverse reactions, 4146 of which were injections, accounting for 99.76%; 10 doses of other formulations of the same variety. , accounting for 0.24%. Conclusion The majority of reported adverse events/adverse reactions were TCM injections, while most of the other formulations of the same variety (such as oral liquids, granules, capsules, tablets, etc.) did not show or rarely had adverse events/adverse reactions. The adverse reaction report was not standardized, no causality judgments were made for adverse reactions, and there was no prospective study, and the incidence of adverse reactions could not be obtained. The focus of current research on the safety of Chinese medicine is to strengthen the monitoring, evaluation, and research of the safety of Chinese medicine injections.