中药注射剂药品不良反应安全性评价体系构建的探究——以喜炎平与利巴韦林在儿科的对比研究为例

Adverse reactions and safety evaluation system of traditional Chinese medicine injection——an example of a comparative study on Xiyanping and ribavirin for pediatric

目的:本文通过对喜炎平和利巴韦林在儿科注射用药中发生的不良反应(ADR)进行系统分级与综合评价,旨在探索构建中药注射剂不良反应安全性评价体系,以指导临床合理用药,并为中药注射剂的使用与监督管理提供建议。方法:系统检索1999年至2018年期刊文献,根据相关ADR报告,采用儿童患者的年龄和ADR严重程度作为评价指标,运用统计学检验方法,进行量化评价。结果:在6-14岁,利巴韦林的ADR平均严重程度低于喜炎平。结论:在儿科用药中,利巴韦林的ADR严重程度高于喜炎平。

Objective: This article systematically classifies and comprehensively evaluates the adverse reactions(ADR) of Xiyanping and ribavirin in pediatric injections, aiming to construct a safety evaluation system for the adverse reactions of traditional Chinese medicine injections to guide the rational clinical use of drugs, and provide advices on the use and supervision of Chinese medicine injections. Method: The periodical literature from 1999 to 2018 was systematically searched. According to the relevant ADR reports, the age of children and the severity of ADR were used as evaluation indicators, and statistical method was applied in quantitative evaluation. Result: At the age of 6-14, the average severity of ADR in ribavirin was lower than that of Xiyanping. Conclusion: In pediatric medications, ribavirin has a higher ADR severity than Xiyanping.