时珍国医国药2026，Vol.37Issue(4)：691-697,7.DOI:10.70976/j.1008-0805.SZGYGY-2026-0412
糖足方治疗Wagner0级糖尿病足的80例随机对照试验
A randomized controlled trial of Tangzu Formula(糖足方)for Wagner grade 0 diabetic foot in 80 cases
摘要
Abstract
Objective To evaluate the clinical efficacy and safety of Tangzu Formula(糖足方,TZF)in the treatment of high-risk dia-betic foot with Wagner grade 0.Methods A total of 172 patients with high-risk diabetic foot were randomly assigned to the observation group and the control group,with 86 patients in each group.Both groups received standard care and treatment.The control group was treated with mecobalamin tablets combined with enteric-coated aspirin,while the observation group received oral administration and foot bathing with TZF.The treatment duration was 6 months for both groups,followed by a 6-month follow-up period.Clinical efficacy,inci-dence of foot ulceration,traditional Chinese medicine(TCM)symptom scores,lower limb arterial color Doppler ultrasound scores,Toronto Clinical Scoring System(TCSS),Michigan Neuropathy Screening Instrument(MNSI),and nerve conduction velocity(NCV)[including motor nerve conduction velocity(MNCV)and sensory nerve conduction velocity(SNCV)]were compared before and after treatment.Liver and kidney function,as well as adverse events,were also assessed.Results A total of 80 patients in each group com-pleted the study and were included in the final analysis.After 12 months of treatment,the total effective rate in the observation group was 95.00%,significantly higher than that in the control group(85.00%,P<0.05).The incidence of foot ulcers was 5.00%in the observation group and 11.25%in the control group,with no statistically significant difference(P>0.05).Compared with baseline,TCM symptom scores,TCSS,and MNSI scores were significantly reduced in both groups(P<0.05),with a greater reduction observed in the observation group(P<0.05).The arteriosclerosis(AS)score significantly decreased in the observation group after treatment and was lower than that of the control group(P<0.05),while no significant change was observed in the control group(P>0.05).There were no significant differences in intima-media thickness or vascular stenosis scores before and after treatment in either group(P>0.05).No significant adverse reactions occurred during treatment,and liver and kidney function remained stable in both groups.Conclusion TZF demonstrates significant clinical efficacy in treating patients with Wagner grade 0 diabetic foot.It effectively alleviates symptoms,increases nerve conduction velocity,and may help reduce the incidence of foot ulcers,with good safety and clinical applicability.关键词
糖足方/Wagner0级/糖尿病高危足/足溃疡/足浴疗法Key words
Tangzu Formula(糖足方)/Wagner grade 0/High-risk diabetic foot/Foot ulcer/Foot bath therapy分类
医药卫生引用本文复制引用
陈泓,黄仁燕,游洋,柳国斌..糖足方治疗Wagner0级糖尿病足的80例随机对照试验[J].时珍国医国药,2026,37(4):691-697,7.基金项目
国家自然科学基金(82305245 （）
82274528) （）
