中医药膳治疗重症糖尿病足坏疽合并重度低蛋白血症的临床研究

Clinical study on TCM medicated diet treatment of severe diabetic foot gangrene complicated with severe hypoproteinemia

目的观察中医药膳黄芪猪蹄汤治疗重症糖尿病足坏疽合并重度低蛋白血症的临床疗效。方法将87例重症糖尿病足坏疽合并重度低蛋白血症患者随机分为治疗组(44例)和对照组(43例)。两组均给予常规治疗并配合糖尿病饮食,在此基础上,治疗组口服中医药膳黄芪猪蹄汤,对照组口服复方氨基酸胶囊,两组疗程均为8周。观察临床疗效及创面愈合情况,比较血清营养学指标、常量与微量元素水平、创周皮温、经皮氧分压,以及神经传导速度(CV)、振幅(Amp)的变化情况,并进行安全性评价。结果(1)试验过程中,治疗组脱落2例,对照组脱落1例,最终完成试验者84例,治疗组、对照组各42例。(2)治疗组、对照组总有效率分别为90.48%、71.43%;两组临床疗效比较,治疗组优于对照组(P<0.05)。(3)治疗前后组内比较,两组创面面积缩小(P<0.05);组间治疗后比较,治疗组创面面积小于对照组(P<0.05)。(4)随着治疗时间的延长,两组血清营养学指标(白蛋白、前白蛋白、血红蛋白水平)均有不同程度的改善(P<0.01,P<0.05),且治疗组的改善情况优于对照组(P<0.01,P<0.05)。(5)试验过程中,对照组Ca、Mg、Zn、Fe元素水平无明显变化(P>0.05)。治疗4周时与治疗前组内比较,治疗组Mg、Fe元素水平升高(P<0.05);治疗前后组内比较,治疗组Mg、Zn、Fe元素水平升高(P<0.01);治疗后与治疗4周时组内比较,治疗组Mg、Zn、Fe元素水平升高(P<0.01)。治疗4周时组间比较,两组Ca、Mg、Zn、Fe元素水平差异无统计学意义(P>0.05);治疗后组间比较,治疗组Mg、Zn、Fe元素水平高于对照组(P<0.01)。(6)试验过程中,两组创周皮温、经皮氧分压均无明显变化(P>0.05);各观察时点组间比较,创周皮温、经皮氧分压差异无统计学意义(P>0.05)。(7)试验过程中,对照组CV、Amp值无明显变化(P>0.05);随着治疗时间的延长,治疗组CV、Amp值逐渐升高(P<0.01,P<0.05)。治疗后组间比较,治疗组CV、Amp值高于对照组(P<0.01)。(8)两组患者均未发生明显不良反应。结论中医药膳黄芪猪蹄汤治疗重症糖尿病足坏疽合并重度低蛋白血症的疗效满意,可明显改善患者的营养状况及神经功能,提高常量、微量元素水平,促进创面愈合,且无明显不良反应。

Objective To investigate the clinical efficacy of traditional Chinese medicine(TCM)medicated diet Huangqi Zhuti Decoction(Astragalus pork trotter soup)on severe diabetic foot gangrene complicated with severe hypoproteinemia.Methods Eighty-seven patients with severe diabetic foot gangrene complicated with severe hypoproteinemia were randomly divided into a treatment group(n=44)and a control group(n=43).Both groups were given the conventional treatment and a diabetes diet.The treatment group was additionally administered with Huangqi Zhuti Decoction,while the control group was given compound amino acid capsules.The treatment lasted 8 weeks.The clinical efficacy and wound healing were observed,and the changes of serum nutritional indexes,the levels of major and minor elements,peri-wound skin temperature,transcutaneous oxygen tension(TcPO2),nerve conduction velocity(CV)and amplitude(Amp)were compared,and the safety evaluation was conducted.Results(1)During the trial,there were 2 drop-out cases in the treatment group and 1 drop-out case in the control group.Finally,84 cases completed the experiment,with 42 cases in each group.(2)The total effective rate of the treatment group was 90.48%and that of the control group was 71.43%.The treatment group had better clinical efficacy than the control group(P<0.05).(3)According to the intra-group comparison before and after treatment,the wound area of the two groups decreased after treatment(P<0.05);After treatment,the wound area of the treatment group was smaller than that of the control group(P<0.05).(4)With the prolongation of treatment time,the serum levels of nutritional indexes(albumin,prealbumin and hemoglobin)of the two groups were improved in different degrees(P<0.01,P<0.05),and the treatment group had better improvement than the control group(P<0.01,P<0.05).(5)During the trail,the contents of Ca,Mg,Zn and Fe in serum of control group had no significant change(P>0.05).In the treatment group,compared with those before treatment,the contents of Mg and Fe in serum increased after 4 weeks of treatment(P<0.05)and the contents of Mg,Zn and Fe in serum increased significantly after 8 weeks of treatment(P<0.01);the serum contents of Mg,Zn and Fe in the treatment group after 8 weeks of treatment were higher than those after 4 weeks of treatment(P<0.01).There was no significant difference in serum contents of Ca,Mg,Zn and Fe between the two groups after 4 weeks of treatment(P>0.05);After8 weeks of treatment,the serum contents of Mg,Zn and Fe in the treatment group were higher than those in the control group(P<0.01).(6)During the trial,there was no significant change in peri-wound skin temperature and transcutaneous oxygen tension in both groups(P>0.05);According to the inter-group comparisons at each observation point-in-time,there was no significant difference in peri-wound skin temperature and transcutaneous oxygen tension between the two groups(P>0.05).(7)During the trail,the values of CV and Amp in the control group did not change significantly(P>0.05);With the prolongation of treatment time,the values of CV and Amp in the treatment group increased gradually(P<0.01,P<0.05).After 8weeks of treatment,the values of CV and Amp in the treatment group were higher than those in the control group(P<0.01).(8)There was no obvious adverse reaction in cases of the two groups.Conclusion TCM medicated diet Huangqi Zhuti Decoction has achieved satisfactory therapeutic effect on severe diabetic foot gangrene complicated with severe hypoproteinemia,which can significantly improve the nutritional status and neurological function of patients,increase the levels of major and minor elements,and promote wound healing without significant adverse reactions.