基于药物警戒视角的河南省中药不良反应实证分析

Empirical analysis of adverse drug reaction of traditional Chinese medicine in Henan province based on pharmacovigilance

目的了解河南省中药不良反应的现状及其影响因素,为提升河南省药物警戒水平提供相关建议。方法运用描述性分析、χ^(2)检验、z检验和二元logistic回归分析对河南省中药不良反应监测数据进行实证分析。结果组织机构方面,中药不良反应报告以医疗机构为主要报告单位,生产经营企业报告较少,其中不同报告主体对药物不良反应的评价差异有统计学意义;风险管理方面,既往史(β=1.10,P=0.04)与注射途径给药(β=2.22,P<0.01)是严重不良反应发生的危险因子。结论提升河南省中药药物警戒水平应从组织机构与风险管理两方面着手,建议加强药物警戒相关宣传培训以提升药品全产业链相关人员的药物警戒意识与能力、关注报告主体的专业性,同时重点关注患者既往史与给药途径等方面以进行风险管理,实现患者既往史等信息的互联互通。

Objective To understand the current situation and influencing factors of adverse reactions of traditional Chinese medicine(TCM)in Henan Province,and provide relevant suggestions for improving the level of pharmacovigilance.Methods Descriptive analysis,Chi-square test,z test and Binary Logistic regression analysis were used to empirically analyze the monitoring data of Adverse Drug Reaction(ADR)of TCM in Henan Province.Results In terms of organizational institution,ADR of TCM were mainly reported by medical institutions with few reported by production and operation enterprises,and there was statistically significant differences in the evaluation of adverse drug reactions by different reporting entities.As regards risk management,it was noteworthy that both of patients’history(β=1.10,P=0.04)and administration by injection route(β=2.22,P<0.01)were risk factors for severe ADR.Conclusion To improve the pharmacovigilance level of traditional Chinese medicine in Henan Province,two aspects should be focused on:organizational institution and risk management.It was recommended to strengthen the publicity and training related to pharmacovigilance to improve the pharmacovigilance awareness and ability of related personnel in the entire pharmaceutical industry chain,especially the professionalism of reporters.In terms of risk management,attention should be paid to reporters’specialty,patients’history and administration routes,and to realize the interconnection of patients’history and related information.