机构地区:[1]华中科技大学同济医学院附属同济医院药学部,武汉430030
出 处:《临床药物治疗杂志》2024年第3期68-72,共5页Clinical Medication Journal
基 金:湖北省卫生健康委员会科研项目(WJ2023F004)。
摘 要:目的探索构建钠-葡萄糖协同转运蛋白2(SGLT-2)抑制剂治疗2型糖尿病(T2DM)的临床综合评价体系,为临床合理用药提供方法学参考。方法基于文献分析法建立初步指标池,结合运用两轮德尔菲专家咨询法和层次分析法(AHP)明确最终的指标体系及权重。结果经专家咨询论证,最终确定6个一级指标和32个二级指标的SGLT-2抑制剂综合评价体系。一级指标权重排序为有效性(25.42%)、安全性(23.50%)、经济性(15.87%)、适宜性(12.21%)、创新性(11.79%)和可及性(11.21%)。二级指标组合权重为1.43%~5.52%,经济性指标成本-效用分析(5.52%)、年均治疗费用(5.42%)排名前二;其次为有效性指标糖化血红蛋白(HbA1c)水平降低(5.41%)、HbA1c达标率(5.41%)及全因死亡风险降低(5.27%)等;安全性指标中与不良反应相关指标的权重占比较高;适宜性和可及性指标中患者用药依从性和药品可获得性居首位。结论基于德尔菲法和AHP构建SGLT-2抑制剂治疗T2DM的临床综合评价体系具有较高的权威性、科学性和可靠性,鉴于不同药品属性、疾病特性及用药人群的差异,有必要基于三者开展符合当下用药需求的临床综合评价。Objective To construct a clinical comprehensive evaluation index system for sodium-glucose cotransporter 2(SGLT-2)inhibitors in the clinical management of type 2 diabetes mellitus(T2DM),to provide methodological references for the rational use of drugs in clinical practice.Methods Preliminary indicators were established based on literature research and expert consultations,and the final index system and weightings were determined through two rounds of the Delphi method and analytic hierarchy process.Results After expert consultations and discussions,the final clinical evaluation index system for SGLT-2 inhibitors in the treatment of T2DM was determined,which included 6 first-level indicators and 32 second-level indicators.The weights of the first-level indicators were as follows:efficacy(25.42%),safety(23.50%),economy(15.87%),suitability(12.21%),innovation(11.79%),and accessibility(11.21%).The combined weights of the second-level indicators ranged from 1.43% to 5.52%,cost-utility analysis(5.52%)and average annual treatment cost(5.42%)ranked the top two,followed by the second-level indicators of efficacy,such as the rate of HbA1c compliance(5.41%),the reduction of HbA1c level(5.41%)and the reduced risk of all-cause mortality(5.27%).The weight of the safety indicators related to adverse reactions was relatively large and medication adherence and availability were the top second-level indicators of suitability and accessibility.Conclusion SGLT-2 inhibitor clinical comprehensive evaluation index system in the treatment of T2DM has been constructed based on the Delphi method and analytic hierarchy process in this study,which possesses high authority,scientific and reliability,and provides methodological references for comprehensive analysis decision-making.Because of the differences in the properties of different medicines,disease characteristics,and populations,it is necessary to carry out a comprehensive clinical evaluation that is more in line with the current drug needs based on this.
关 键 词:德尔菲法 层次分析法 钠-葡萄糖协同转运蛋白2抑制剂 临床综合评价
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