行湿颗粒联合伤科黄水对湿热毒盛型糖尿病足溃疡创面愈合情况的临床观察

Clinical Observation on Wound Healing of Diabetic Foot Ulcer with Damp-Heat and Toxicity Accumulation Type Treated by Oral Use of Xingshi Granules Combined with External Application of Shangke Huangshui Medicated Gauze

【目的】观察行湿颗粒联合伤科黄水治疗湿热毒盛型糖尿病足的临床疗效及对血清炎症因子的影响。【方法】将60例湿热毒盛型糖尿病足溃疡患者随机分为试验组和对照组,每组各30例。对照组给予西医基础治疗联合伤科黄水纱外敷局部创面治疗,试验组在对照组的基础上加用行湿颗粒口服治疗,疗程为4周。观察2组患者治疗前后中医证候积分和血清炎症因子[肿瘤坏死因子α(TNF-α)、白细胞介素6(IL-6)]水平的变化情况,比较2组患者的溃疡创面红肿开始消退时间,评价2组患者的的临床疗效和安全性。【结果】(1)治疗4周后,试验组的总有效率为96.7%(29/30),对照组为83.3%(25/30),试验组的疗效明显优于对照组(P<0.01)。(2)试验组患者的溃疡创面红肿开始消退时间为(3.34±1.67)d,较对照组的(6.29±2.38)d明显缩短(P<0.01)。(3)治疗后,2组患者的中医证候积分均较治疗前明显降低(P<0.01),且试验组对中医证候积分的降低作用明显优于对照组(P<0.05)。(4)治疗后,2组患者的血清TNF-α、IL-6水平均较治疗前明显降低(P<0.01),且试验组对血清TNF-α、IL-6水平的降低作用均明显优于对照组(P<0.05)。(5)治疗过程中,2组患者均无明显不良反应发生,且患者的血、尿常规和肝肾功能等均无明显异常。【结论】行湿颗粒联合伤科黄水治疗湿热毒盛型糖尿病足溃疡患者疗效确切,不仅可以有效促进溃疡创面的愈合,还可以明显缩短局部肿胀消除时间,这可能与其下调炎症因子水平有关。

Objective To observe the clinical efficacy of oral use of Xingshi Granules combined with external application of Shangke Huangshui medicated gauze for the treatment of damp-heat and toxicity accumulation type of diabetic foot ulcer,and to explore their effect on the serum inflammatory cytokines.Methods Sixty patients of damp-heat and toxicity accumulation type of diabetic foot ulcer were randomized into trial group and control group,30 cases in each group.The control group was given basic western medicine treatment combined with external application of Shangke Huangshui medicated gauze on the wound surface,and the trial group was given oral use of Xingshi Granules based on the treatment for the control group.The treatment for the two groups lasted 4 weeks.Before and after treatment,the scores of traditional Chinese medicine(TCM)syndromes and the serum inflammatory cytokines levels of tumor necrosis factor alpha(TNF-α),interleukin 6(IL-6)in the two groups were observed.The time for the ulcer wound swelling starting to subside in the two groups was compared,and the clinical efficacy and safety in the two groups after treatment were compared.Results(1)After treatment for 4 weeks,the total effective rate of the trial group was 96.7%(29/30)and that of the control group was 83.3%(25/30).The intergroup comparison showed that the trial group had stronger clinical efficacy than the control group,and the difference was statistically significant(P<0.01).(2)The time for the ulcer wound swelling starting to subside in the trial group was(3.34±1.67)days,obviously shorter than that in the control group(6.29±2.38 days),and the difference was statistically significant(P<0.01).(3)After treatment,the scores of TCM syndromes in the two groups were obviously decreased in comparison with those before treatment(P<0.01),and the decrease in the trial group was superior to that in the control group(P<0.05).(4)After treatment,serum inflammatory factors of TNF-αand IL-6 in the two groups were obviously decreased in comparison with those before treatment(P<0.01),and the trial group had stronger effect on decreasing serum TNF-αand IL-6 levels than the control group(P<0.05).(5)During the trial,no obvious adverse reaction occurred in the two groups,or no abnormal changes in the routine test for the blood and urine and in the examination of hepatic and renal function were found in the two groups either.Conclusion Oral use of Xingshi Granules combined with external application of Shangke Huangshui medicated gauze is effective for the treatment of damp-heat and toxicity accumulation type of diabetic foot ulcer.The combined therapy can not only effectively promote the healing of ulcer wound,but also can significantly shorten the time for local swelling subsiding,and the therapeutic mechanism is probably related to the downregulation of inflammatory cytokines.