双黄连注射剂不良反应回顾性研究

Case Retrospective Study of Adverse Drug Reaction of Shuanghuanglian Injection

目的 :了解双黄连注射剂不良反应类型及其发生率 ,探索药物流行病学方法在药品安全性评价中的应用。方法 :采用病历回顾性研究法 ,对北京等 6省市 16家医院 4 382份使用双黄连注射剂的完整住院病历进行调查 ,用SPSS11.5进行统计分析。结果 :双黄连注射剂主要不良反应为变态反应 (发生率 2 .2 4 % ) ,其中以皮疹(1.6 9% )最为常见 ;胃肠道反应 (1.5 1% )以恶心、呕吐、腹痛、腹泻为常见 ;其他不良反应包括发热 (0 .6 4 % )、心脑血管反应 (0 .4 3% )、胸闷心悸 (0 .32 % )。结论 :病历回顾性研究方法适用于药品的安全性研究。双黄连注射剂的常见不良反应应引起临床医生的重视。有必要修改其药品说明书 。

Objective: To investigate the adverse reaction types and their incidence rates of shuanghuanglian injection, and explore the application of pharmacoepidemiology methods to drug safety reevaluation.Method: By means of case retrospective study, we have investigated 4382 integrated cases used shuanghuanglian injection in 16 hospitals respectively located in six provinces and cities, such as Beijing city, and so on. The results were statistically analyzed by SPSS (version )11.5)).Result: the main ADRs of shuanghuanglian injection respectively were allergic reactions (incidence )2.24%)), with rash )1.69%), and then gastrointestinal reactions )1.51%), including nausea, vomit, bellyache and diarrhea. The incidence rate of fever was )0.64%), and cardio-cerebrovascular reactions )0.43%), with chest distress and palpitation symptoms )0.32%).Conclusion: Case retrospective study is suitable for drug reevaluation. More attention should be paid to the common ADRs of shuanghuanglian injection by doctors. The drug labeling should be modified, and the ADRs of shuanghuanglian injection should be studied deeply.