葛根素注射剂不良反应影响因素Logistic回归分析

Logistic regression analysis on influential factors of ADR caused by puerarin injection

目的:探讨临床使用葛根素注射剂发生不良反应的可疑影响因素。方法:通过检索2003—2012年某省不良反应中心葛根素注射剂所致不良反应报告1 016例,对患者使用葛根素注射剂的临床特点及葛根素注射剂的不良反应相关因素进行统计分析,采用SPSS13.0软件对葛根素注射剂不良反应的影响因素进行Logistic回归分析。结果:葛根素注射剂不良反应的主要影响因素有:患者性别、年龄、过敏史、剂型、剂量、用药天数。其不良反应主要为皮肤系统,其次为消化系统。结论:在葛根素注射剂使用过程中,应做到用药前仔细询问患者既往过敏史和用药史,根据患者体质,辨证个体化谨慎用药,同时对患者进行用药教育,加强用药监护,从而减少其不良反应的发生。

OBJECTIVE To explore the risk factors of adverse drug reactions（ADRs）due to puerarin. METHODS Collecting puerarin ADR reports 1016 from database of ADR spontaneous reporting system from 2003 to 2012 and using logistic regression model to analysis the impact of risk factors. RESULTS The main impact factors were： gender, age, allergies, dosage form, dosage and the number of drug-used days. Adverse reactions mainly occurred in skin system, followed by the digestive system. CONCLUSION Careful inquiry about previous history of allergy and medication should be done before puerarin injection treatment and aecording to the patient＇s constitution, individualized treatment dialectically, medication education and strengthened medication monitoring should be done to reduce adverse reactions.