热毒宁注射液不良反应325例分析  

Analysis of 325 cases of adverse drug reaction of Reduning injection

作　　者：江莹 张锦文[2] 何艳 漆建军 柳莹 何凯霞 姜淑君 JIANG Ying;ZHANG Jinwen;HE Yan;QI Jianjun;LIU Ying;HE Kaixia;JIANG Shujun(Center for ADR monitoring of Wuhan City,Wuhan,Hubei 430030,China;Department of Pharmacy,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430030,China;Department of Integrated Traditional Chinese and Western Medicine,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430030,China)

机构地区：[1]武汉市药品不良反应监测中心,湖北武汉430030 [2]华中科技大学同济医学院附属同济医院药学部,湖北武汉430030 [3]华中科技大学同济医学院附属同济医院中西医结合科,湖北武汉430030

出　　处：《安徽医药》2025年第1期205-209,共5页Anhui Medical and Pharmaceutical Journal

摘　　要：目的探讨热毒宁注射液不良反应发生的规律及特点,为临床合理用药提供依据。方法对2012年1月至2022年12月武汉市药品不良反应监测中心数据库中收集的325例热毒宁注射液药物不良反应(ADR)报告进行统计分析。结果325例热毒宁注射液ADR报告中,6岁以下儿童发生ADR居多,多数为联合用药(52.62%);不合理用药导致ADR的影响因素为用药剂量不合理(14.77%)、超适应证用药(1.54%)、溶媒不合理(1.54%);ADR主要发生在用药30 min内,累及系统-器官与临床表现主要为皮肤及其附件损害(52.71%),全身性损害次之(21.26%)。结论临床上需加强儿童病人(尤其是6岁以下)使用热毒宁注射液的ADR风险管理,应尽量避免循证医学证据不足的超剂量用药、超适应证及联合用药等不合理使用,避免增加ADR发生风险,保障热毒宁注射液的安全有效使用。Objective To investigate the rules and characteristics of adverse drug reactions(ADR)of Reduning injection,so as to provide evidence for clinical rational drug use.Methods Three hundred and twenty-five cases of ADR related to Reduening injection which were collected from January 2012 to December 2022 based on database of Center for ADR Monitoring of Wuhan city were analyzed statistically.Results In 325 cases of Reduning injection ADR,the majority of ADR occurred in children under 6 years old,most of which were combined medication(52.62%).The influencing factors of irrational drug use leading to ADR were unreasonable dose(14.77%),off-label drug use(1.54%)and unreasonable solvent(1.54%).ADR mainly occurred within 30 min of medication,and the main systematic-organ and clinical manifestations were skin and accessory damage(52.71%),followed by systemic damage(21.26%).Conclusion In clinical practice,it is necessary to strengthen ADR risk management of Reduning injection in children(especially under 6 years old),and avoid unreasonable use of excessive dosage,off-label and combined drug use with insufficient evidence of evidence-based medicine,so as to avoid increasing the risk of ADR and ensure the safe and effective use of Reduning injection.

关 键 词：药物相关性副作用和不良反应 抗病毒药 中草药 热毒宁注射液 安全用药 分析 

分 类 号：R285.6[医药卫生—中药学]