摘要
目的探讨中成药不良反应(ADR)的发生特征并提出干预措施,为临床安全用药提供依据。方法回顾性分析玉林市中医医院2022-2024年收集的102例中成药ADR报告,按发生科室、药物品种、给药途径、临床表现及报告类型等进行统计,并提出可能原因与相应干预措施。结果ADR主要集中于风湿科/风湿病科、肝病科、心病科一区、儿科/儿童康复科及脑病科相关科室。药物方面,刺五加注射液发生例数最多(24例,23.53%),其后依次为注射用血塞通(含冻干)(7.84%)、热毒宁注射液(6.86%)、心脉隆注射液(6.86%)与痰热清注射液(5.88%)。给药途径以静脉滴注为主(87/102,85.29%),口服占9.80%,外用为3例(2.94%),局部注射占1.96%。累及系统/器官以皮肤及其附件为主(95次),常见表现为瘙痒、皮疹及皮肤(潮)红;其次为全身性损害(35次,寒战、发热、出汗、畏寒、乏力)和呼吸系统(29次,胸闷、呼吸困难、咳嗽、气促、气喘)。报告类型以一般ADR为主(71.57%),新的一般ADR占23.53%,严重ADR占4.90%。结论我院中成药ADR以静脉给药的注射剂为主要风险来源,临床表现以皮肤过敏样反应最常见;应加强医护培训与处方审核,严格适应证与滴速管理,重视高风险人群评估与首剂监护,健全ADR监测-反馈-改进闭环,以降低ADR发生风险。
Objective To investigate the characteristics of adverse drug reactions(ADRs)associated with Chinese patent medicines and propose intervention measures to support safer clinical medication practices.Methods A retrospective analysis was conducted on 102 ADR reports related to Chinese patent medicines collected at Yulin Hospital of Traditional Chinese Medicine between 2022 and 2024.The data were analyzed in terms of departments involved,drug types,administration routes,clinical manifestations,and report categories.Potential causes were explored,and corresponding intervention strategies were proposed.Results ADRs primarily occurred in departments related to rheumatology,hepatology,cardiology,pediatrics/children’s rehabilitation,and neurology.The most frequently implicated drug was Acanthopanax senticosus injection(24 cases,23.53%),followed by Xuesaitong for injection(7.84%),Reduning injection(6.86%),Xinmailong injection(6.86%),and Tanreqing injection(5.88%).Intravenous infusion was the predominant administration route(87/102,85.29%),followed by oral administration(9.80%),topical application(2.94%),and local injection(1.96%).Affected systems/organs were mainly the skin and its appendages(95 instances),with common symptoms including pruritus,rash,and flushing.Systemic reactions(35 instances;chills,fever,sweating,chills,fatigue)and respiratory symptoms(29 instances;chest tightness,dyspnea,cough,shortness of breath)were also observed.Most reports were general ADRs(71.57%),followed by newly identified general ADRs(23.53%)and severe ADRs(4.90%).Conclusion Intravenous Chinese patent medicine injections are the primary risk source of ADRs in our hospital,with allergic-like skin reactions being the most common clinical manifestation.To reduce the incidence of ADRs,it is essential to enhance medical staff training and prescription review,strictly control indications and infusion rates,conduct risk assessments for high-risk patients,ensure first-dose monitoring,and establish a closed-loop system for ADR monitoring,feedback,and improvement.
作者
易文深
罗赞君
Yi Wenshen;Luo Zanjun(Yulin Hospital of Traditional Chinese Medicine,Yulin,Guangxi 537000,China)
出处
《首都食品与医药》
2026年第1期63-66,共4页
Capital Food Medicine
关键词
中成药
不良反应
中药注射剂
临床分析
干预措施
Chinese patent medicine
adverse drug reaction
Chinese medicine injection
clinical analysis
intervention strategies
