消渴丸上市后临床不良反应文献专家判读

Study on clinical literature of Xiaoke pill's adverse reaction based on experts' evaluation

目的:明确消渴丸与患者发生不良反应之间是否存在因果关系以及对不良反应的预防方法及措施。方法:通过个案不良反应判读表,采用盲法判读的方式,咨询专家意见。结果:81.48%的消渴丸不良反应报告描述的过程是清晰的,68.52%的消渴丸不良反应报告对不良反应发生的过程提供了足够的信息,77.78%的不良反应与消渴丸的应用相关,93.33%所述不良反应可以预防。结论:大部分不良反应都与服用消渴丸存在因果关系,可通过加强合理用药知识宣教、严格掌握其适应症、慎重调整用药剂量、注意合并用药情况等措施,来预防和规避消渴丸相关不良反应发生。

Objective： To study whether there is a causal relationship between the Xiaoke pill and patients＇adverse reactions （ADs）, and to understand the prevention methods for the ADs. Method： ADs were evaluated blindly through consulting experts＇ advice. Result： 81.48% process descriptions on ADs of Xiaoke Pill were clear, 68.52% reports provided enough information on process of ADs, 77.78% of ADs were related with Xiaoke Pill, and 93.33% ADs can be prevented. Conclusion： Most of ADs are related with Xiaoke pill, and can be prevented through strengthening education on drug use knowledge, strictly indications for taking Xiaoke Pill, adjusting dosage carefully, and controlling drugs combination