中国防痨杂志2026，Vol.48Issue(7)：948-957,10.DOI:10.19982/j.issn.1000-6621.20250455
基于德尔菲法和层次分析法的抗结核药物临床综合评价体系构建
Construction of a clinical comprehensive evaluation system for anti-tuberculosis drugs based on Delphi and analytic hierarchy process
摘要
Abstract
Objective:To establish a multidimensional clinical comprehensive evaluation system for anti-tuberculosis drugs encompassing safety,effectiveness,economy,innovation,suitability,and accessibility,thereby providing a reference for rational drug use,new drug selection,and drug formulary optimization in healthcare institutions.Methods:Based on the indicator framework in the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition),the Delphi method was employed to screen and revise indicators,and to establish an evaluation framework tailored to anti-tuberculosis drugs.The analytic hierarchy process(AHP)was used to assign the weight of each indicator,forming a complete and quantifiable comprehensive evaluation system.An empirical evaluation was conducted on 6 drugs using for the treatment of multidrug-resistant tuberculosis(MDR-TB),including levofloxacin tablets,moxifloxacin hydrochloride tablets,linezolid tablets,clofazimine soft capsules,bedaquiline fumarate tablets and cycloserine capsules.Results:After two rounds of Delphi consultation with 15 experts,a comprehensive clinical evaluation system for anti-tuberculosis drugs was finally established,covering 6 dimensions(effectiveness,safety,economy,suitability,innovation and accessibility),the system comprised 6 first-level indicators,20 second-level indicators and 35 third-level indicators.The questionnaire response rate reached 100.0％,the authority coefficient was 0.824 and the Kendall's W for the final indicator system was 0.266(P＜0.001),indicating a high level of consensus among experts.By integrating the AHP judgment matrices from the 15 experts and passing the consistency test(CR＜0.1),reliable indicator weights were obtained.The empirical evaluation results showed that the scores of levofloxacin tablets,moxifloxacin hydrochloride tablets,linezolid tablets,clofazimine soft capsules,bedaquiline fumarate tablets,and cycloserine capsules were 81.17,67.17,65.57,62.77,60.92,and 57.69,respectively,which were consistent with clinical practice.Conclusion:The anti-tuberculosis drug clinical comprehensive evaluation system constructed in this study aligns highly with the objectives and requirements of drug clinical comprehensive evaluation and demonstrates good scientific validity and practicality.It not only serves as a valuable reference for rational drug use,new drug selection,and drug formulary optimization in medical institutions but also provides a scientific foundation for regional health policy development.关键词
结核/德尔菲技术/药物评价/系统综合/层次分析Key words
Tuberculosis/Delphi technique/Drug evaluation/Systems integration/Analytic hierarchy process分类
医药卫生引用本文复制引用
叶觉鲜,周乾坤,李冬兰,覃雄之,樊爱敏,刘爱梅..基于德尔菲法和层次分析法的抗结核药物临床综合评价体系构建[J].中国防痨杂志,2026,48(7):948-957,10.基金项目
广西科技重大专项(桂科AA22096027) （桂科AA22096027）
广西医疗卫生适宜技术与推广应用项目(S2023050) （S2023050）
广西壮族自治区第二批药品临床综合评价项目(YPPJ020) Guangxi Major Science and Technology Project(GuiKe AA22096027) （YPPJ020）
Guangxi Promotion and Application of Medical and Health Appropriate Technology Project(S2023050) （S2023050）
The Second Batch of Drug Clinical Comprehensive Evaluation Project of Guangxi Zhuang Autonomous Region(YPPJ020) （YPPJ020）
