385例茵栀黄制剂不良反应/事件分析

385 cases of adverse drug reactions/adverse drug events caused by Yinzhihuang preparations

目的通过对茵栀黄制剂导致的药品不良反应(ADR)进行分析,了解茵栀黄制剂ADR发生的特点,为规范临床合理用药提供参考。方法收集2012年1月1日至2018年12月31日湖北省药品(医疗器械)不良反应监测中心数据库中385例茵栀黄制剂ADR/事件(ADE)报告,对报告中患者使用药物剂型、患者年龄、性别、原患疾病、使用剂量、发生时间、累及系统-器官以及临床表现等进行统计分析。结果茵栀黄制剂所致ADR/ADE患者中,男女性别比为1.60∶1.00,多发生于40~59岁人群(42.86%);其中有发生时间记录的报告301例,多在用药30 min内出现ADR/ADE;累及系统-器官主要为皮肤及附件损害,主要临床表现为瘙痒及皮疹等。结论茵栀黄制剂可导致不同程度的ADR/ADE,一般经停药或对症处理后患者好转,临床上应给予足够重视,密切关注患者用药后状况,辨证施药,禁止超功能主治施药。

Objective To analyze adverse drug reactions(ADR)caused by Yinzhihuang preparations in order to grasp the characteristics of ADR of Yinzhihuang preparations and provide reference for rational clinical use.Methods A total of 385 reports of ADR/adverse drug events(ADE)of Yinzhihuang preparations were collected by Hubei Center for ADR Monitoring between January 1,2012 and December 31,2018.Dosage forms that patients used,patients’age and gender,preexisting diseases,dosages,times of occurrence,system-organs involved,and clinical manifestations were recorded and analyzed.Results Among these cases,the ratio of males to females was 1.60∶1.00,and the incidence was higher in patients aged 40 to 59(42.86%).There were 301 reports that documented the time ADR occurred(mainly within 30min).The affected systems-organs were mostly the skin and its accessories while the main clinical manifestations were pruritus and rash.Conclusion Yinzhihuang preparations can cause ADR/ADE of varying degrees,but patients can generally improve after drug withdrawal or symptomatic treatment.Enough attention should be paid to the condition of patients after medication.