根據(jù)國家食品藥品監(jiān)督管理總局發(fā)布的2011—2014年《國家藥品不良反應(yīng)監(jiān)測報告》中關(guān)于中藥注射劑不良反應(yīng)/事件的監(jiān)測數(shù)據(jù),分析了中藥注射劑發(fā)生藥品不良反應(yīng)/事件的現(xiàn)狀,并從患者個體因素、中藥注射劑自身因素、臨床使用因素等方面探討了中藥注射劑不良反應(yīng)/事件的成因,提出了建立優(yōu)質(zhì)中藥材種植基地,保障原料供應(yīng);采用先進(jìn)生產(chǎn)工藝,規(guī)范操作規(guī)程;加強(qiáng)基礎(chǔ)研究,完善質(zhì)量標(biāo)準(zhǔn);辨證論治,規(guī)范用法用量等措施,以降低中藥注射劑不良反應(yīng)/事件發(fā)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.