646例牛黄解毒制剂不良反应分析

Analysis of 646 Cases of Adverse Drug Reactions Induced by Niuhuangjiedu Preparation

目的:探究牛黄解毒制剂引起不良反应(ADR)的特点,为安全用药提供参考。方法:对2004~2017年江苏省内上报的646例牛黄解毒制剂ADR报告中的患者年龄、性别、原患疾病、给药方法及剂量、合并用药、ADR发生时间、临床表现等方面进行统计分析。结果:646例ADR报告中关联性评价结果为肯定、很可能及可能的报告数分别为122例,157例,367例;新的ADR 417例;严重的ADR 7例。646例ADR中男性略多于女性,原患疾病以呼吸系统和消化系统疾病为主。牛黄解毒制剂均为口服或含服给药,剂量基本符合说明书规定,合并用药最多的为抗感染药。ADR累及器官-系统以胃肠系统损害最为常见,占60.42%,其次为皮肤及其附件损害。结论:重视牛黄解毒制剂引起的不良反应,完善药品说明书,确保用药安全。

Objective:To investigate the characteristics of adverse reactions(ADR)induced by Niuhuangjiedu preparation,so as to provide a reference for rational use of drugs.Methods:A total of 646 ADR cases of Niuhuangjiedu preparation in Jiangsu Province during 2004-2017 were collected and analyzed on age,gender,disease,method of medication and dosage,drug combination,times of ADR,clinical manifestations etc.Results:The results of the relavence evaluation in the ADR reports were 122 cases confirmed,157 cases probable,367 cases possible respectively.There were 417 new ADR and 7 severe ADR.The male cases were slightly more than the females.The primary diseases were respiratory and digestive disease.Niuhuangjiedu preparation were oral administration,the dosage basically conforms to the specification.The most commonly used combination drugs were anti-infective drugs.System organ classes(SOCs)mainly involved in adverse reactions were gastrointestinal disorders,which accounted for 60.42%,lesions of skin and its appendages followed.Conclusion:The adverse reactions caused by Niuhuangjiedu preparation should be paid attention,and the package inserts should be improved to ensure the safe usage.