喜炎平注射液上市前后药品循证证据研究

此文基于文献数据,较为系统地总结了喜炎平注射液非临床安全性研究、药理研究和上市后安全性研究,包括幼年和成年动物的急性毒性试验、长期毒性试验、生殖毒性试验、主动被动过敏试验、疗效机制研究、上市后的有效性临床实验研究、安全性主动监测、被动监测的SRS数据分析、真实世界的HIS数据分析、文献分析等研究,讨论了其研究证据的互补性,以点带面,总结其研究思路,为中药注射剂系统研究方案的制定提供参考。

Literature review on premarketing and postmarketing evidence of Xiyanping injection

This article systematically summarizes the non-clinical safety studies, pharmacological studies and postmarketing safety studies of Xiyanping injection based on literature. These studies include acute toxicity test, long-term toxicity test, reproductive toxicity test, active and passive anaphylaxis test, curative mechanism study, clinical trials of effectiveness, active surveillance, security analysis of passive monitoring data, the real world analysis of hospital information system(HIS) data, literature analysis, etcetera. This article also analysis the relationship of the different evidence, summarizes the strategy of the researches, in order to make it to be a reference for making a systemic research program of traditional Chinese medicine injection.