中药内服、外用治疗糖尿病足早期的临床研究

Clinical research of early stage of diabetic feet with TCM internal and external

目的:观察内服健脾清化颗粒与外用温通散对糖尿病足早期的临床疗效。方法:随机、双盲、安慰剂对照临床研究,中药组20例予健脾清化颗粒口服及温通散熏洗足部,对照组20例予安慰剂,用法同前,共治疗16周,观察两组临床总疗效、糖代谢指标、足部感觉异常(VAS评分)、踝/肱比指数(ABI)及神经电生理检测的变化。结果:中药组临床总有效率(89.47%)明显高于对照组(36.84%),差异有显著性意义(P<0.01)。中药组FPG、PPG均升高,对照相组FPG稍增加,两组HbA1C均有所下降,但差异均无统计学意义(P<0.05)。中药组在改善肢端麻木感、疼痛感、冷感、感觉减退诸症和踝肱比指数等方面明显优于对照组(P<0.01),同时各条神经传导速度及诱发电位波幅均有所提高,对照组仅部分神经传导速度及诱发电位波幅有所改善,组间比较,仅腓肠神经传导速度改善有显著性差异(P<0.05)。结论:健脾清化颗粒、温通散内外合治对糖尿病足早期患者疗效佳,是比较规范、有效的糖尿病足早期中医综合防治方案,值得临床推广。

Objective： To observe the clinical efficacy of Jianpiqinghua Particles and Wentong Powder on early stage of diabetic feet adding to basal treatment, and to establish a standardized clinical diabetic foot prevention program of integrated traditional Chinese medicine. Methods： Take a randomized blind placebo-controlled add-on trial： The treatment group of 20 was given with Jianpiqinghua Particle （oral）, Wentong Powder （foot washing）, the control group of 20 was given placebo by same methods. The course in both groups was16 weeks. The change of total effect body and foot feeling （ VAS scale ） , electroneurophysiological examination and ankle/brachial ratio were evaluated. Results： The TCM group was superior to the control group in improving the body and feet clinical symptoms, nerve conduction velocity, evoked potential amplitude and the ABI index （ P〈0.01 ） . The clinical total effective rate （89.47%） in TCM group was significantly higher than that in control group （36.84%）, which had a significant difference （P〈0.01）. Conclusion： Internal and external TCM treatment with Jianpiqinghua Particles and Wentong Powder had good efficacy on patients with early stage of diabetic foot, which was worthy to be clinical popularized.