我院祛瘀及清热类中药致新的和严重的不良反应298例分析

Analysis of 298 Cases of New and Severe ADR Induced by TCM for Removing Blood Stasis and Clearing Heat in Our Hospital

目的:了解我院祛瘀及清热类中药致新的和严重的不良反应(ADR)发生的特点和规律,为中药临床安全用药提供参考。方法:收集我院2006年1月-2016年12月上报国家ADR监测中心的ADR报告中的祛瘀及清热类中药致新的和严重的ADR,对患者性别、年龄、过敏史、给药途径、涉及药品种类及剂型、发生时间、累及系统/器官及临床表现、转归等信息进行回顾性分析。结果:298例报告中,女性发生率(70.13%)高于男性(29.87%),尤以50~59岁患者最多(21.48%);既往有ADR史77例(25.84%);引发ADR的给药途径以口服给药为主(57.37%),剂型以注射剂为主(25.50%),主要涉及药品种类为中成药(53.53%);且多发生于用药后>1 d(48.32%);ADR累及系统/器官以皮肤及其附件损害、全身系统损害及胃肠损害为主,主要临床表现为皮疹、接触性皮炎、瘙痒、输液反应、寒战、发热、恶心、呕吐、腹泻等。经停药或对症治疗后有97.99%的患者好转和治愈,未有患者死亡。结论:祛瘀及清热类中药致新的和严重的ADR较多,临床用药时需加强监测,以减少ADR的发生。

OBJECTIVE:To investigate the characteristics and rules of new and severe ADR induced by TCM for removing blood stasis and clearing heat in our hospital,and to provide reference for safe drug use in clinic.METHODS:New and severe ADR induced by TCM for removing blood stasis and clearing heat reported to national ADR monitoring center were collected from our hospital during Jan.2006-Dec.2016.Those ADR cases were analyzed retrospectively in respects of gender,age,allergic history,route of administration,drug type and dosage form,occurrence time,organs/systems involved and clinical manifestations,outcome.RESULTS:Among 298 reports,the incidence of ADR in female(70.13%)was higher male(29.87%),especially in patients aged 50-59(21.48%);there were 77 allergic cases(25.84%).Route of administration was mainly oral administration(57.37%),and dosage form was mainly injection(25.50%).Main ADR-inducing drug was Chinese patent medicine(53.53%).ADR mostly occurred over 1 d after medication(48.32%).Systems/organs involved in ADR were mainly lesion of skin and its appendants,systemic damage and gastrointestinal damage.Main clinical manifestations were rash,contact dermatitis,pruritus,infusion reaction,chills,fever,nausea,vomiting,diarrhea,etc.After drug withdrawal or symptomatic treatment,97.99%patients were revered and cured.There was no death case.CONCLUSIONS:TCM for removing blood stasis and clearing heat causes most new and severe ADR.Clinical drug use should be monitored closely to reduce the occurrence of ADR.