中药注射剂临床安全性评价方法比较与分析

Comparison and analysis of clinical safety evaluation methods for parenterally administered Chinese medicine

中药注射剂在临床上广为应用,尤其在治疗心脑血管疾病、急性感染性疾病、恶性肿瘤等疾病中发挥着不可替代的重要作用。随着中药注射剂临床应用范围的扩大,相关不良事件的报道也日趋增多,中药注射剂安全性问题已经引起管理部门、医护人员和公众的重视。截止到2012年年底国家药品不良反应监测数据库累计收集药品不良反应/事件报告已达500余万份。其中中药注射液不良反应占据了中药不良反应的一大半,如何利用各类流行病学方法分析中药注射剂不良反应数据,为中药注射剂临床使用提供参考是摆在学者面前的重要任务,笔者拟对中药注射剂安全性监测常用的个案评价、集中监测、病例对照等设计进行比较,分析各种方法的优势和不足,为中药注射剂安全性评价分析提供借鉴和思路。

Parenterally administered Chinese medicine is widely applied in clinic. It particularly plays an important role in the treatment of cardiovascular and cerebrovascular disease, acute infectious diseases and malignant tumors. With the expansion of the scope of the clinical application of parenterally administered Chinese medicine adverse event reports also increase day by day. Thus, parenterally administered Chinese medicine has come to the attention of management departments, medical staff and the public. By the end of 2012, the national adverse drug reaction monitoring database has collected more than 5 million adverse drug reactions/events re- ports. Parenterally administered Chinese medicine accounted for more than half of the total number of adverse reactions to Chinese med- icine. Therefore, it is essential that epidemiological methods are used to analyze the national database for all references to parenterally administered Chinese medicine. Our research aims to analyze the advantages and disadvantages of various safety monitoring methods for parenterally administered Chinese medicine and offer guidance in safety evaluation analysis.