再论中药注射剂的合理性——基于红花注射液和喜炎平注射液召回事件的思考

Further Discussion on the Rationality of TCM Injection:Thinking Based on the Recall of Safflower Injection and Xiyanping Injection

目的:探讨中药注射剂的合理性,为优化中药注射剂发展提供参考。方法:通过文献研究,系统回顾中药注射剂的起源与发展,深入剖析其存在的安全性问题及原因,并结合中药注射剂自身属性和历史经验探讨其存在的合理性,由此提出针对性的中药注射剂发展建议。结果:中药注射剂由于自身技术性问题、流通与存储环节不规范、临床使用不合理、患者个体差异性、监测与管理机制匮乏等原因依然存在安全性问题,但是从产品技术、临床疗效、临床需求量及中药发展等角度分析,其存在是合理且必要的。结论:建议从研发生产、上市流通、临床使用以及监测与管理等角度强化中药注射剂全生命周期内的合理开发与使用;全面开展中药注射剂技术评估,促进其优胜劣汰、健康发展;建立健全中药注射剂产品人身损害的救助机制,保障患者权益。

OBJECTIVE:To explore the rationality of TCM injection,and to provide reference for optimizing the development of TCM injection.METHODS:Through literature research,the origin and development of TCM injections were systematically reviewed;the security problems of TCM injections and their causes were deeply analyzed;based on the characteristics and historical experience of TCM injections,their rationality was explored,so as to put forward specific suggestions.RESULTS:TCM injections still had safety problems due to their own technical problems,irregular circulation and storage links,unreasonable clinical use,individual differences among patients,lack of monitoring and management mechanisms.But from the perspectives of product technology,clinical efficacy,clinical demand and the development of TCM,the existence of TCM injections was reasonable and necessary.CONCLUSIONS:The rational development and use of TCM injections throughout the life cycle are strengthened from the perspectives of R&D and production,marketing,clinical use,and monitoring management.Meanwhile,technical assessment of TCM injections is carried out comprehensively to promote their survival of the fittest and healthy development.It is suggested to establish and improve the rescue mechanism for personal injury of TCM injections,and protect patients’rights.