中药复方糖耐康结合西医常规疗法治疗2型糖尿病足临床研究

Clinical studies on the treatment of TypeⅡDiabetic Foot Ulcer treated by Traditional Chinese Medicine compound Tangnaikang combined with conventional western medicine treatment

目的评价中药糖耐康颗粒结合西医常规疗法治疗2型糖尿病足的疗效。方法将符合入选标准的2019年8月-2020年11月北京中医药大学附属东方医院、团结湖社区卫生服务中心、青塔社区卫生服务中心、承德市双滦区元宝山社区卫生服务中心的67例2型糖尿病足患者以信封法随机分为对照组30例、治疗组37例。对照组给予降糖、抗感染等常规疗法治疗,治疗组在对照组基础上加服中药复方糖耐康颗粒。2组均连续治疗90 d。分别于治疗前后进行中医证候评分、创面肉芽形态评分、VAS评分、瘙痒评分及生活质量综合评定问卷(Generic Quality of Life Inventory-74,GQOL-74)评分;测量溃疡创面面积,计算上皮组织覆盖率;采用ELISA检测VEGF、表皮生长因子(EGF)、碱性成纤维细胞生长因子(bFGF)水平,以全自动血液流变分析仪检测全血黏度、血浆黏度,微量热沉法测定纤维蛋白原,Wintrobe法测定ESR,葡萄糖氧化酶法检测血糖(包括空腹血糖、2 hPG、HbAlc),ELISA检测胰岛素(包括空腹胰岛素、糖负荷2 h胰岛素、胰岛素抵抗指数);观察并记录治疗期间的不良反应,评价临床疗效及中医证候疗效。结果治疗组临床疗效总有效率为89.2%(33/37)、对照组为70.0%(21/30),2组比较差异有统计学意义(χ^(2)=3.90,P<0.01);治疗组证候疗效总有效率为86.5%(32/37)、对照组为63.3%(19/30),2组比较差异有统计学意义(χ^(2)=4.88,P<0.01)。治疗组治疗后肉芽形态评分、疼痛评分及溃疡面积均低于对照组(t=-27.70、-78.76、-5.80,P值均<0.01),肢体疼痛、跛行、皮肤溃疡、肢体青紫、肢体麻木、肌肉萎缩症状改善情况优于对照组(χ^(2)=4.77、4.21、5.75、3.88、4.75、4.48,P值均<0.01);治疗组治疗后,全血黏度、血浆黏度、纤维蛋白原、ESR均优于对照组(t=-23.38、-8.01、18.10、-18.93,P值均<0.01),上皮覆盖面积[(5.43±1.65)cm^(2)比(4.65±1.14)cm^(2),t=2.20]、上皮组织覆盖率[(59.14±3.37)%比(42.42±3.21)%,t=20.63]高于对照组(P<0.05或P<0.01)。治疗组治疗后血清VEGF、EGF、bFGF水平高于对照组(t=3.19、40.59、28.53,P值均<0.01),空腹血糖、胰岛素抵抗指数均低于对照组(t=-8.55、-21.38,P值均<0.01),口渴喜饮、五心烦热症状改善情况优于对照组(χ^(2)=4.38、4.48,P值均<0.01)。结论中药复方糖耐康颗粒结合西医常规疗法可有效改善糖尿病足患者的临床症状,加快疮面愈合时间,提高疗效。

Objective To observe the clinical effects of Traditional Chinese Medicine(TCM)Tangnaikang granules,supplementing to conventional treatment methods,on type 2 diabetic foot ulcer.Methods A total of 67 patients,from Beijing University of Chinese Medicine subsidiary Dongfang Hospital,Tuanjie Lake Community Health Service Center,Qingta Community Health Service Center between August,2019 and November,2020 were assigned to treatment group(37 patients)and control group(30 patients)using sealed envelope randomization method.The control group underwent conventional treatment methods that manage blood sugar and treat infections.The treatment group received,in addition to the conventional treatment methods administered to the control group,Tangnaikang granules.Both groups were continuously treated for 90 days.The TCM symptom scores,granulation tissue scores,visual analogue scale(VAS),itching scores and Generic Quality of Life Inventory-74(GQOL-74)score,wound area were observed pre-and post-treatment.The ELISA kits were used to detect the Vascular Endothelial Growth Factor(VEGF),Epidermal Growth Factor(EGF),Basic Fibroblast Growth Factor(bFGF),fasting blood glucose level,glycated hemoglobin test(HbA1c),fasting insulin level,postprandial 2 hour insulin level,insulin resistance index.And all possible adverse events were noted.The overall clinical treatment effects and TCM symptom treatment effects were assessed.Results Total effective rate for the treatment group 89.2%(33/37),was significantly different from that of the control group 70.0%(21/30)withχ^(2)=3.90 and P<0.01.The TCM symptom effective rate was 86.5%(32/37)for the treatment group and 63.3%(19/30)for the control group.The difference was statistically different withχ^(2)=4.88 and P<0.01.After treatment,whole blood viscosity,plasma viscosity,fibrinogen and erythrocyte sedimentation rate(ESR)of the treatment group were significantly improved than those of the control group(t=-23.38,-8.01,18.10,-18.93,all Ps<0.01).The ulcer closure area(5.43±1.65 cm^(2) vs.4.65±1.14 cm^(2),t=2.20)and ulcer closure area percentage(59.14%±3.37%vs.42.42%±3.21%,t=20.63)were statistically different of both groups(P<0.05 or P<0.01).The VEGF,EGF,and bFGF at 90 day of the treatment group were significantly higher than those of the control group(t=3.19,40.59,28.53,all Ps<0.01).The post-treatment fasting blood glucose level,insulin resistance index of the treatment group were significantly lower than those of the control group(t=-8.55,-21.38,all Ps<0.01).TCM symptoms of thirsty,feverish sensation in chest,palms and soles in the treatment group were significantly improved than the control group(χ^(2)=4.38,4.48,all Ps<0.01).Conclusion TCM compound Tangnaikang granules can relieve diabetic foot ulcer,reduce wound healing time and improve overall treatment outcome,when it was combined of the conventional treatment.