菝葜八味汤加减治疗糖尿病足湿热毒盛证的临床疗效

Therapeutic Effect of Modified Baqia Baweitang on Diabetic Foot Due to Dampness-heat Toxicity

目的:观察菝葜八味汤加减治疗糖尿病足湿热毒盛证的临床疗效。方法:104例患者随机分为对照组和观察组,每组52例。对照组给予依帕司他联合复方黄柏液,观察组在对照组基础上口服菝葜八味汤加减。治疗前后分别观察比较两组患者静息疼、间歇性跛行、足冷感觉、中医证候评分,病足溃疡面积,溃疡面pH,溃疡深度和经皮氧分压。检查患者糖脂指标[空腹血糖(FPG)、餐后2 h血糖(2 h PG)、甘油三酯(TG)、总胆固醇(TC)],足背动脉血液流变学指标(血流峰值、血流量、血管内径和搏动指数),运动和感觉神经传导速度,血清和皮损组织中炎性因子[肿瘤坏死因子-α(TNF-α)、白细胞介素(IL)-6、IL-13、C反应蛋白(CRP)]的水平。比较观察两组患者的临床疗效和安全性。结果:观察组患者总有效率为96.2%(50/52),对照组患者总有效率为80.8%(42/52),观察组患者总有效率明显高于对照组,差异具有统计学意义(χ^(2)=6.029,P<0.05)。与本组治疗前比较,治疗后,两组患者静息疼、间歇性跛行、足冷感觉、中医证候积分、溃疡面积、溃疡面pH和溃疡深度均明显降低(P<0.05),经皮氧分压明显升高(P<0.05)。FPG、2h PG、TG、TC、血流峰值、TNF-α、IL-6、IL-18和CRP明显降低(P<0.05),血流量、血管内径和搏动指数明显升高(P<0.05),运动和感觉神经传导速度明显加快(P<0.05)。与对照组治疗后比较,观察组患者上述指标改善更优,差异具有统计学意义(P<0.05)。治疗期间,对照组不良反应发生率为21.2%(11/52),观察组为23.1%(12/52),两组间比较差异无统计学意义。结论:菝葜八味汤加减可促进DF湿热毒盛证患者的病足创面愈合,改善患者足背动脉血液流变学,加快神经传导,降低炎性反应。

Objective:To observe the clinical effect of modified Baqia Baweitang on diabetic foot due to dampness-heat toxicity.Method:One hundred and four patients were randomized into control and observation groups(52 cases).The control group was treated with epalrestat combined with Compound Huangbai Liquid,and the observation group with modified Baqia Baweitang on the basis of the therapy in the control group.The resting pain,intermittent claudication,foot cold feeling,traditional Chinese medicine(TCM)symptoms,ulcer area,ulcer surface pH,ulcer depth,and percutaneous oxygen partial pressure were measured before and after treatment.The blood glucose and lipid levels[fasting blood glucose(FPG),2 h postprandial blood glucose(2 h PG),triglyceride(TG),and total cholesterol(TC)],hemorheological indexes(peak blood flow,blood flow,vascular diameter,and pulse index),motor and sensory nerve conduction velocity,and inflammatory cytokines[tumor necrosis factor-α(TNF-α),interleukin(IL)-6,IL-13,and C-reactive protein(CRP)]in the serum and skin lesions were determined.The clinical efficacy and safety were compared between the two groups.Result:The total response rate in the observation group was 96.2%(50/52),which was higher than that(80.8%,42/52)in the control group(χ^(2)=6.029,P<0.05).The treatment in both groups decreased the resting pain,intermittent claudication,foot cold feeling,TCM symptom scores,ulcer area,ulcer surface pH,and ulcer depth(P<0.05)and increased the percutaneous oxygen partial pressure(P<0.05).Furthermore,the treatment lowered the levels of FPG,2 h PG,TG,TC,blood flow peak,TNF-α,IL-6,IL-18,and CRP(P<0.05)and increased the blood flow,vascular diameter,pulse index,and the motor and sensory nerve conduction velocity(P<0.05).Moreover,the changes in the above indexes were more significant in the observation group than in the control group(P<0.05).The incidence of adverse reactions was 21.2%(11/52)in the control group and 23.1%(12/52)in the observation group,with no statistical significance.Conclusion:Modified Baqia Baweitang can promote wound healing,improve the dorsal artery hemorheology of feet,accelerate nerve conduction,and reduce inflammation in the patients with diabetic foot due to dampnessheat toxicity.