目的：探讨黄芪注射液不良反应发生状况及原因。方法：广泛收集2009年4月以前发表的黄芪注射液不良反应病例报告。应用Microsoft Excel建立信息提取表，分析数据。结果：发表于1995～2008年的83篇报道黄芪注射液不良反应的文献纳入分析，涉及出现各类型不良反应患者190例。82例患者原发病不详，其余108例患者的原发病涉及循环、消化、泌尿、呼吸、神经系统，只有6例患者有相应的中医诊断。137例患者过敏史未予报道。118例注明黄芪注射液用量的病例中按说明书使用的仅为60例，174例未提及注射液的滴速。各类不良反应中过敏反应占105例，以皮肤过敏反应居多，所有病例经立即停药，对症处理后均好转，无死亡及严重后遗症。分析不良反应发生的原因主要涉及药物的生产、临床适应症的选择及用药的方式方法等方面。结论：应进一步加强注射液生产全过程的质量控制，辨证施药，规范临床使用，用药过程中加强监测，从而减少或避免不良反应的发生。

Objective: To investigate the incidence and the causes of the adverse reactions of Huangqi Injection. Methods: To collect the case reports on adverse reaction of Huangqi Injection published before April, 2009. To educe the information from the above data and set up extraction form used the Microsoft Excel and analysis of the data. Results: Eighty-three case reports on adverse reaction of Huangqi Injection published from 1995 to 2008 were analyzed. One hundred and ninety patients with various types of adverse reactions were involved. The primary diseases of 82 cases were unknown and the remaining 108 cases with the primary diseases of circulation, digestive, urinary, respiratory, and nervous systems. However, there were only six of the cases with the relative diagnosis of traditional Chinese medicine（TCM）. The history of allergy was not mentioned in 137 cases. Only 60 of the 118 cases used the injection according to the specification on the dose. One hundred and seventy four cases did not mention the iv drip speed. Among various types of adverse reactions the skin reactions were very common. All the cases were recovery after immediate cessation of medication and corresponding treatment. There were no deaths and serious sequelae. The causes of adverse reactions mainly related to the production of the drugs, the choice of the clinical indication, and the ways of administration. Conclusion: The quality control of drug production should be improved. Also the drug application should be based on the theory of TCM. The monitoring of the injection application need to be further improved, which will reduce or avoid the occurrence of the adverse reactions.

国家科技重大专项课题（2008ZX09312）