摘要
目的评价真实世界中老年患者应用痰热清注射液的安全性。方法采用多中心、大样本、双向队列、注册登记临床监测方法,在全国83家二级以上医院纳入2014年1月-2015年5月连续处方使用痰热清注射液的13 061例年龄≥60岁的住院、急诊老年患者。主要评价指标为不良反应/事件的发生率。此外,对不良反应/事件的临床表现、严重程度以及转归进行描述。对不良反应可能的危险因素进行单因素回归分析。结果老年患者痰热清注射液药品不良事件发生率为21.06‰(275例,包含严重不良事件192例)。不良反应发生率为2.45‰(32例),其中一般不良反应19例、新的不良反应12例。除1例严重过敏反应外,不良反应的程度均以轻中度为主,以皮肤及其附件损害最常见。75.00%(24例)的不良反应在用药后0.5~24 h内出现。转归均为痊愈或好转。有药物过敏史、采用非规范的输注速度、合并使用抗菌药物、未使用糖或盐作为间隔液的同组输注患者,其痰热清注射液不良反应发生率显著增加(P<0.05)。结论偶见老年患者使用痰热清注射液时发生药品不良反应。识别高危人群,并对给药方法进行规范,或能够保障痰热情注射液的用药安全。
Objective To evaluate the safety of Tanreqing Injection among the elderly.MethodsA multicenter,large sample,ambispective cohort study was established,with registration-type clinical safety monitoring.A total of 13 061 inpatients and patients from emergency units using Tanreqing Injection and aged≥60 years were recruited from January 2014 to May 2015 in 83 secondary and tertiary hospitals in China.The main outcome was the incidence of adverse drug reaction/adverse drug event(ADR/ADE)of Tanreqing Injection.In addition,the clinical feature,severity and prognosis of ADR/ADE were described.A univariate analysis was conducted to explore the risk factors of ADR.Results The incidence of ADE was 21.06‰(275 cases,including 192 serious ones).The incidence of ADR was 2.45‰(32 cases),including 19 cases of general ADR and 12 cases of new ADR.All the ADR cases were mild or moderate,except for 1 case of serious ADR,with damages in skin and appendages.Most of ADR cases happened in 0.5-24 hours after applying Tanreqing Injection,fortunately all the cases got improved or cured.Having histories of allergies to drugs and non-normalized infusion speed,being combined with antibacterial agents,and without glucose or saline between dosing interval increased the incidence of ADR(P<0.05).ConclusionsTanreqing Injection has an occasional incidence of ADR in the elder.Identifying high-risk patients and improve administration management may further increase the safety of Tanreqing Injection.
作者
李潇潇
卓琳
杨毅恒
詹思延
翟所迪
LI Xiao-xiao;ZHUO Lin;YANG Yi-heng;ZHAN Si-yan;ZHAI Suo-di(Department of Pharmacy,Peking University Third Hospital,Beijing,100191;School of Pharmaceutical Sciences,Peking University,Beijing,100191;School of Public Health,Peking University,Beijing,100191)
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2019年第8期954-959,共6页
Chinese Journal of Integrated Traditional and Western Medicine
基金
国家中医药管理局2013年度科技项目(No.国中医药科2013ZX04)
