中药注射剂不良反应现状及风险控制措施浅析

Discussion on Adverse Drug Reactions of the Traditional Chinese Medicine Injections and Risk Control Measures

目的针对中药注射剂的高风险性,分析其引起不良反应的风险因素,并提出相应的风险控制措施,以促进其临床合理用药。方法根据相关文献和报道,对中药注射剂不良反应特别是过敏反应的现状、发生原因和防治措施进行归纳分析。结果中药注射剂的风险因素包括药物、临床使用和用药者三方面。结论改进制剂工艺,规范临床使用,重视患者个体差异,加强安全性相关的基础研究和上市后的安全性再评价工作,以降低中药注射剂的用药风险。

Objective To analyze the causes of adverse drug reaction （ADR） induced by traditional Chinese medicine injections （TCMI） and propose the corresponding risk control measures specifically to the high risk of TCMI, and to promote the clinical rational use. Methods On the basis of the relevant literature and reports, the status, causes and countermeasures of the ADR, especially the allergic reaction induced by TCMI were reviewed. Results The risk factors of ADR induced by TCMI included drugs, clinical use and patients. Conclusion It was suggested that the risks of TCMI could be reduced by improving the preparation technique, regulating clinical use, paying attention to individual differences of patients, and enhancing the basic research as well as the re-evaluation study on the safety of TCMI.