基于巢式病例对照研究的红花注射液不良反应/事件相关影响因素分析

Analysis of influencing factors of adverse drug reactions/events(ADR/ADE)caused by Honghua injection—a nested case control study

目的:探讨使用红花注射液后发生不良反应/事件(ADR/ADE)的相关影响因素,指导其在临床上的安全使用。方法:采用回顾性巢式病例对照研究(NCCS)的方法,选取某院医院信息系统(HIS)中使用红花注射液的9 671例住院患者的数据作为研究队列,以发生ADR/ADE的42例患者作为病例组,分别按照成组设计(model 1)和个体匹配(model 2)的原则按照1∶4的比例选择对照组(168例),筛选导致红花注射液ADR/ADE发生的相关危险因素。结果:单因素Logistic回归分析显示,model 1中OR值达显著性水平(P<0.05)的因素有性别、过敏史和单次用药剂量;model 2中OR值达显著性水平(P<0.05)的因素有过敏史和单次用药剂量。多因素Logistic回归分析显示,model 1中最终进入方程(P<0.05)的影响因素有性别和单次用药剂量,model 2中最终进入方程(P<0.05)的影响因素只有过敏史1项。结论:女性、有过敏史和单次超剂量给药是导致红花注射液ADR/ADE发生的危险因素。该研究结论尚需开展前瞻性研究进一步验证。

OBJECTIVE To investigate the influencing factors of adverse drug reactions/events（ADR/ADE）caused by Honghua injection and to guide the clinical medication safely.METHODS Hospital information system（HIS）data was used to carry out a nested case control design study.Totally 9 671 inpatients received Honghua injection were defined as the study cohort subjects,42 patients with ADR/ADEs as the case group.According to group design（model 1）and individual matching（model 2）,control group（168 cases）was assigned at the ratio of 1∶4,to estimate the related risk factors of ADR/ADEs caused by Honghua injection.RESULTS The univariate logistic regression analysis indicated that factors with significant OR values（P〈0.05）included gender,allergy history and single dose in model 1,allergy history and single dose in model 2.Multivariate logistic regression analysis showed that factors screened into equation（P〈0.05）were gender and single dose in model1,and only allergy history in model 2.CONCLUSION Female,allergy history and overdose are risk factors of ADR/ADEs caused by Honghua injection.Prospective studies are required to verify the above conclusion.