某三级医院2015–2018年268例谷红注射液不良反应报告分析

目的:分析使用谷红注射液导致不良反应(adverse drug reaction,ADR)的患者临床特征及转归,评价中重度ADR发生的影响因素。方法:采用回顾性研究的方法,收集我院2015–2018年期间发生谷红注射液相关不良反应的患者信息,共计纳入268例研究对象,分析患者一般特征、基础疾病、ADR发生时间、分级与临床转归,采用条件Logistic回归分析中重度不良反应发生的影响因素。结果:268例患者中229例(85.4%)为轻度不良反应,39例(14.6%)为中重度不良反应。ADR累及系统/器官以皮肤及附件最为常见(26.5%),其次为呼吸系统(23.9%)、心血管系统(19.8%)。多因素分析显示高龄、既往药物过敏史是患者发生中重度不良反应的独立危险因素。结论:谷红注射液所致不良反应相对较轻,发病人群以中老年患者为主,但临床需仔细询问患者药物过敏史,加强对老年患者的关注,预防中重度不良反应的发生。

Analysis of 268 cases of adverse drug reactions associated with safflower and aceglutamide injection in a tertiary hospital from 2015 to 2018

Objective:To explore the clinical characteristics and prognosis of patients suffering from adverse drug reaction(ADR)caused by safflower and aceglutamide injection,and analyze the influence factors of moderate to severe ADR.Methods:268 cases suffering from ADR caused by intravenous injection of safflower and aceglutamide in our hospital from 2015 to 2018 were retrospectively enrolled in this study.The general characteristics and basic diseases of patients,occurrence time,gradation and clinical outcome of ADR were analyzed.Conditional logistic regression was used to analyze the influence factors of moderate and severe ADR.Results:Among 268 cases of ADR associated with safflower and aceglutamide injection,229 cases(85.4%)were mild ADR,and 39 cases(14.6%)were moderate-to-severe ADR.The most common organs and systems involved in ADR were skin and accessories(26.5%),followed by the respiratory system(23.9%)and cardiovascular system(19.8%).Results of multivariate conditional logistic regression showed that advanced age and previous history of drug allergy were independent risk factors for moderate to severe ADR.Conclusion:ADR of safflower and aceglutamide injection were relatively mild and mainly occurred in middle-aged and elderly patients.More attentions should be paid on elderly patients and their history of drug allergy in order to avoid severe ADR during using safflower and aceglutamide injection.