基于巢式病例对照方法的丹红注射液安全性再评价研究

Security revaluation study based on nested case-control method of Danhong injection

目的:探讨丹红注射液安全性再评价,进行ADR/ADE发生的相关影响因素研究。方法:用回顾性巢式病例对照研究设计,选择河南中医学院第一附属医院参与丹红注射液不良反应集中监测的8 452例住院患者的调查资料作为研究队列,发生ADR/ADE的患者资料作为病例组,并按照成组设计的方法和个体匹配的方法按照1∶4配比分别选择对照组(病例组52例和对照组208例),估计与ADR/ADE发生的相关影响因素。结果:单因素分析显示成组设计中OR达显著性水平(P<0.05)的因素有:性别、个人过敏史和用药天数,个体匹配中OR达显著性水平(P<0.05)的因素有:用药天数1项。多因素Logistic回归分析显示,被筛选进入方程的因素有有性别和个人过敏史。结论:丹红注射剂不良反应发生的相关影响因素与用药人群相关性较强,女性用药和有个人过敏史的人群用药临床应给予特别关注。

Objective： To explore security revaluation of Danhong injection and study correlative influencing factor of ADR/ ADE. Method： The retrospective nested case-control study was carried out in hospitalized patients of the first affiliated hospital of Henan university of traditional Chinese medicine （TCM）. The 8 452 cases of participation Danhong injection adverse reaction scentralized monitoring were defined as the study cohort. Adverse reactions occurred in patients with data as the case group, according to choose control group by methods of group design and individual matching in accordance with the ratio of 1 ： 4 （ The case group 52 cases and 208 patients in control group）, to estimate the correlative fluencing factor of ADR/ADE. Result： The univariate analysis indicated that factors which OR value of group design reaching significance level were gender, personal allergichistory and medication days（ P 〈 0. 05 ）, factors of individual matching OR value reaching significance level were just only medication days （P 〈 0. 05 ）. Multivariate logistic regression analysis showed that factors screened into equation were gender and personal allergic history. Conclusion： The correlative in fluencing factor of Danhong injection adverse reactions have more correlation with taking medicine population. We should pay special attention to female and the population which have personal allergic history.