目的：探討黃芪注射液不良反應(yīng)發(fā)生狀況及原因。方法：廣泛收集2009年4月以前發(fā)表的黃芪注射液不良反應(yīng)病例報(bào)告。應(yīng)用Microsoft Excel建立信息提取表，分析數(shù)據(jù)。結(jié)果：發(fā)表于1995～2008年的83篇報(bào)道黃芪注射液不良反應(yīng)的文獻(xiàn)納入分析，涉及出現(xiàn)各類型不良反應(yīng)患者190例。82例患者原發(fā)病不詳，其余108例患者的原發(fā)病涉及循環(huán)、消化、泌尿、呼吸、神經(jīng)系統(tǒng)，只有6例患者有相應(yīng)的中醫(yī)診斷。137例患者過敏史未予報(bào)道。118例注明黃芪注射液用量的病例中按說明書使用的僅為60例，174例未提及注射液的滴速。各類不良反應(yīng)中過敏反應(yīng)占105例，以皮膚過敏反應(yīng)居多，所有病例經(jīng)立即停藥，對(duì)癥處理后均好轉(zhuǎn)，無死亡及嚴(yán)重后遺癥。分析不良反應(yīng)發(fā)生的原因主要涉及藥物的生產(chǎn)、臨床適應(yīng)癥的選擇及用藥的方式方法等方面。結(jié)論：應(yīng)進(jìn)一步加強(qiáng)注射液生產(chǎn)全過程的質(zhì)量控制，辨證施藥，規(guī)范臨床使用，用藥過程中加強(qiáng)監(jiān)測(cè)，從而減少或避免不良反應(yīng)的發(fā)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.

國家科技重大專項(xiàng)課題（2008ZX09312）