根据国家食品药品监督管理总局发布的2011—2014年《国家药品不良反应监测报告》中关于中药注射剂不良反应/事件的监测数据,分析了中药注射剂发生药品不良反应/事件的现状,并从患者个体因素、中药注射剂自身因素、临床使用因素等方面探讨了中药注射剂不良反应/事件的成因,提出了建立优质中药材种植基地,保障原料供应;采用先进生产工艺,规范操作规程;加强基础研究,完善质量标准;辨证论治,规范用法用量等措施,以降低中药注射剂不良反应/事件发生率。

According to "National Adverse Drug Reaction Monitoring Report" on traditional Chinese medicine injections adverse reactions/events monitoring data released by the China Food and Drug Administration from 2011 to 2014, the current situation of traditional Chinese medicine injections adverse drug reactions/events were analyzed. And the causes of traditional Chinese medicine injections adverse reactions/events were discussed from the individual patient factors, traditional Chinese medicine injection own factors, and clinical factors. And the establishment of high quality planting base to ensure supply of raw materials, using of advanced production technology and standard operating procedures, strengthening basic research and improving the quality standards, syndrome differentiation, regulating usage and dosage, and other measures were proposed to reduce the adverse reaction/event rates of traditional Chinese medicine injections.