2004-2008年上海市中药注射剂不良反应报告分析

Analysis of reports of adverse drug reactions induced by injection of traditional Chinese medicine from Shanghai 2004 to 2008

目的探讨中药注射剂不良反应发生的特点和规律。方法采用描述性分析方法分析2004-2008年上海市不良反应自发呈报数据库中中药注射剂的不良反应报告。结果共纳入5 660条中药注射剂不良反应报告,占同期报告总数的7.16%。中药注射剂不良反应报告中患者以老年、女性群体多见。严重程度以一般为主,但2006至2008年出现新的一般、新的严重报告数明显增多。出现的频率较高的品种有鱼腥草素注射剂、血塞通注射剂、刺五加注射剂等。结论中药注射剂不良反应呈多发性,累及多系统-器官,近年来发现的新的不良反应(包括新的一般和新的严重)有增多趋向,故中药注射剂在临床使用时应加强不良反应监测。

AIM To study the feature and regularity of adverse drug reactions induced by injection of traditional Chinese medicine.METHODS The adverse drug reaction reports from Shanghai adverse drug reaction spontaneous reporting database from 2004 to 2008 were analyzed by descriptive analysis.RESULTS A total of 5 660 reports on adverse drug reactions induced by injection of traditional Qiinese medicine were concluded in this study consisting of 7.16%of the total reports of the same period.The reports showed the senior and female groups were mostly concerned,and mainly marked as moderately injured,but new reports marked as moderate and severe were significantly increased during the period of 2006 to 2008,and most frequently involved injections were Yu-xin-cao,Xue-sai-tong and Ci-wu-jia.CONCLUSION The adverse drug reactions of injection of traditional Chinese medicine happen in multiple systems and organs, and appear an increasing tendency in recent years（including reports on newly happened moderate and severe cases）, therefore monitoring should be strengthened in the clinical use of injection of traditional Chinese medicine.