北京中医药2026，Vol.45Issue(5)：581-588,8.DOI:10.16025/j.1674-1307.2026.05.003
基于多准则决策分析通脉降糖胶囊治疗糖尿病慢性并发症的临床证据与价值
Clinical evidence and value evaluation of Tongmai Jiangtang Capsule in treating chronic complications of diabetes based on multi-criteria decision analysis
摘要
Abstract
Objective To evaluate the clinical evidence and value of Tongmai Jiangtang Capsule(TJC)in the treatment of chronic diabetic complications based on multi-criteria decision analysis(MCDA).Methods BBased on the MCDA model,quantitative and qualitative analysis methods,including evidence-based medicine and health technology assessment,were applied to evaluate the multidimensional clinical evidence and value of TJC in the treatment of diabetic peripheral neuropathy(DPN)and diabetic kidney disease(DKD),including safety,efficacy,and other aspects.Results Toxicological studies,spontaneous reporting system(SRS)monitoring by the National Adverse Drug Reaction Monitoring Center,and pharmaceutical quality evaluations of TJC showed that its known risks were controllable,with relatively clear safety conclusions,and the safety evaluation grade was B.Systematic reviews and meta-analyses of TJC in the treatment of DKD showed that TJC combined with conventional Western medicine was superior to the control group in improving glomerular filtration rate(GFR),serum creatinine(SCr),and 24-h urinary microalbumin(UMA)levels in patients with DKD.Systematic reviews and meta-analyses of TJC in the treatment of DPN showed that TJC could significantly accelerate nerve conduction velocity measured by electromyography in DPN patients and increase the overall response rate,with an efficacy evaluation grade of B.Budget impact analysis showed that inclusion of TJC in the medical insurance reimbursement scope could reduce the pressure of medical insurance expenditure,increase the number of patients using TJC,and reduce patients'economic burden.TJC has a lower price than similar drugs and possesses a price advantage,with an economic evaluation grade of C.TJC is a formula developed based on traditional Chinese medicine(TCM)theories and the medication experience of renowned physicians,demonstrating good clinical innovation,with an innovation evaluation grade of C.TJC can basically meet the medication needs of clinicians and patients,with good suitability and a suitability evaluation grade of B.TJC has good affordability,is marketed in multiple medical institutions nationwide,and is supported by abundant medicinal resource availability,with an accessibility evaluation grade of A.TJC has prominent TCM characteristics and a history of more than 100 years of human use experience,with a TCM characteristic evaluation grade of B.The legally registered information of TJC as a Chinese patent medicine complies with national standards.Based on the evaluation results of the six dimensions of TJC in the treatment of DPN and DKD,TJC was classified as a category B product.Conclusion TJC has good clinical value in the treatment of DPN and DKD.Therefore,it is recommended that TJC be conditionally transformed into relevant basic clinical medication management policies according to established procedures.关键词
通脉降糖胶囊/糖尿病慢性并发症/循证证据/价值评估/多准则决策分析Key words
Tongmai Jiangtang Capsule/chronic complications of diabetes/evidence-based evidence/value evaluation/multi-criteria decision analysis引用本文复制引用
付常宽,胡聿尔,陈明,王可,谢雁鸣,黎元元..基于多准则决策分析通脉降糖胶囊治疗糖尿病慢性并发症的临床证据与价值[J].北京中医药,2026,45(5):581-588,8.基金项目
中国中医科学院科技创新工程重大攻关项目(CI2021A00702) （CI2021A00702）
国家重点研发计划项目(2018YFC1707400) （2018YFC1707400）
中国中医科学院科技创新工程中医临床基础学科创新团队项目(CI2021B003) （CI2021B003）
中央级公益性科研院所基本科研业务费专项资金资助项目(ZB2025045) （ZB2025045）
