消渴丸治疗2型糖尿病的有效性与经济学评价

Xiaoke Pills for Type 2 Diabetes Mellitus:Efficacy and Pharmacoeconomic Evaluation

目的:评价消渴丸控制2型糖尿病患者血糖的经济学效果。方法:采用国家药品不良反应监测中心制定的药品上市后再评价方案和《中药新药治疗消渴病的临床研究指导原则》,分析服用消渴丸控制血糖的成本-效果比。对调查中纳入病例按用药情况分为消渴丸组与非消渴丸组(使用其他抗糖尿病药)进行观察比较,观察周期为2个月。采用《消渴丸及其他降糖药临床应用登记表》,记录患者性别、年龄、生活习惯、体征及身体状况等基本情况,采用《用药情况记录》,记录患者观察期间用药情况和分段收集患者测量血糖情况,采用卡方检验法分析消渴丸服药前后血糖控制情况。服药2个月后复查空腹血糖、餐后2 h血糖。以《新药(中药)治疗消渴病(糖尿病)临床研究指导原则》制定的标准判断疗效。结果:消渴丸组与非消渴丸组在降低空腹血糖和改善生存质量方面均存在显著性差异。消渴丸组成本-效果比较低,即消渴丸组与非消渴丸组获得相同效果时,消渴丸组所需费用较低。结论:消渴丸治疗2型糖尿病有药物经济学的优势。

To evaluate the cost-effectiveness of Xiaoke Pills in controlling blood glucose in patientswith type 2 diabetes mellitus. METHODS：The cost-effectiveness ratio of Xiaoke Pills for controlling blood glucose was analyzed using the postmarketing reevaluation plan established by national monitoring center on adverse drug reactions. The included cases were divided into Xiaoke Pills group and non-Xiaoke Pills group （ other hypoglycemic drugs） and the two groups were followed for two months and compared. Patients＇ basic conditions including gender, age, living habits, physical signs and physical conditions were recorded by using clinical application registration form of Xiaoke Pills and other hypoglycemic drug;patients＇ medication condition and blood glucose level fractionally collected were recorded using medication record, and the control of blood glucose before and after taking Xiaoke Pills was analyzed using chi- square analysis. The fasting blood glucose level and postprandial blood glucose level （2 hours after dining） were re- tested 2 months oral administration with Xiaoke Pills. The curative efficacy was evaluated according to the criteria stated in the Guiding principles for clinical research on new drugs of traditional Chinese medicine for treatment of diabetes. RESULTS：There were significant differences between the Xiaoke Pill group and the non-Xiaoke Pill group in reduction of fasting blood glucose level and improvement of quality of life. The cost-effectiveness ratio was lower in Xiaoke Pills group than in non-Xiaoke Pill group, i. e. , to achieve the same effectiveness, less cost was needed in Xiaoke Pills group than in non-Xiaoke Pills group. CONCLUSION：Xiaoke Pills are superior to non-Xiaoke Pills in pharmacoeconomics in the treatment of type 2 diabetes mellitus.