消渴方治疗难治性2型糖尿病的多中心临床研究  

Multicenter clinical study of Xiaoke Formula for the treatment of refractory type 2 diabetes mellitus

作　　者：曲笑啸 袁莎莎[2] 张丹[2] 张曾[2] 贺晓立 何燕铭[2] 杨宏杰[2] QU Xiaoxiao;YUAN Shasha;ZHANG Dan;ZHANG Zeng;HE Xiaoli;HE Yanming;YANG Hongjie(Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China)

机构地区：[1]上海中医药大学,上海201203 [2]上海中医药大学附属岳阳中西医结合医院,上海每200437

出　　处：《中华中医药杂志》2025年第3期1508-1512,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家自然科学基金面上项目(No.81973818);国家自然科学基金青年科学基金项目(No.82004263,No.82205009);上海市卫健委临床研究项目(No.20214Y0178);上海中医药大学预算内项目(No.2021LK092);上海市医院中药制剂产业转化协同创新中心项目,《促进市级医院临床技能与临床创新三年行动》研究型医师创新转化能力培训项目(No.SHDC2022CRD009);抗甲方人用经验的研究项目(横向)。

摘　　要：目的:评估消渴方的临床疗效和对中医证候的影响,为中医药辨证施治难治性2型糖尿病(T2DM)提供循证依据。方法:将120例气阴两虚型难治性T2DM患者随机分为对照组和试验组,每组60例。两组皆给予西医常规治疗,对照组加用消渴方安慰剂,试验组患者加用消渴方颗粒。观察两组患者治疗前后糖化血红蛋白(HbAlc)、血糖、C肽、中医症候积分等水平变化。结果:试验组患者HbAlc、FPG、1hGlu、2hGlu较干预前显著降低(P<0.01),C-P、1hC-P、2hC-P、AUC水平较干预前显著升高(P<0.01);与对照组比较,试验组干预后FPG、1hGlu、2hGlu水平显著降低(P<0.01,P<0.05)。治疗至第8、12周末试验组FPG显著低于对照组(P<0.01);与对照组比较,试验组干预后中医症候积分显著降低(P<0.01)。试验组治疗有效率为68.33%(41/60),对照组治疗有效率为33.33%(20/60),试验组较对照组显著改善(P<0.01)。结论:消渴方可显著降低患者HbA1c和血糖水平,改善胰岛β细胞功能,同时减轻患者的中医临床症状,在治疗难治性2型糖尿病方面具有良好的临床疗效。Objective:To evaluate the clinical efficacy of Xiaoke Formula and its effect on traditional Chinese medicine(TCM)syndromes,providing evidence-based basis for TCM syndrome differentiation and treatment of refractory type 2 diabetes mellitus(T2DM).Methods:A total of 120 patients with refractory T2DM and deficiency of both qi and yin were randomly divided into two groups:control group(n=60)and experimental group(n=60).Both groups received routine western medicine treatment,but the control group received Xiaoke formula placebo while the experimental group received Xiaoke Formula granules.Changes in glycosylated hemoglobin,blood glucose,C-peptide,and TCM syndrome scores were observed in both groups before and after treatment.Results:The levels of HbAlc,FPG,1hGlu,2hGlu were significantly lower in the test group compared with the pre-intervention period(P<0.01),and the levels of C-P,1hC-P,2hC-P,AUC were significantly higher compared with the preintervention period(P<0.01).Compared with the control group,FPG,1hGlu,and 2hGlu levels were significantly reduced in the test group after the intervention(P<0.01,P<0.05).Fasting blood glucose of the experimental group was significantly lower than that of the control group at the end of the 8th and 12th week of treatment(P<0.01).Compared with the control group,the TCM symptom score was significantly lower in the test group after the intervention(P<0.01).The treatment effectiveness rate of the experimental group was 68.33%(41/60),and that of the control group was 33.33%(20/60),and the difference of the treatment effectiveness rate between the two groups was statistically significant(P<0.01).Conclusion:Xiaoke Formula can significantly reduce patients'HbAlc and blood glucose levels,improve pancreaticβ-cell function,and at the same time alleviate patients'TCM clinical symptoms,which has good clinical efficacy in the treatment of refractory T2DM.

关 键 词：消渴方 难治性2型糖尿病 糖化血红蛋白 血糖 胰岛功能 中医证候 

分 类 号：R259[医药卫生—中西医结合]