黄芪知母参七汤联合西药治疗糖尿病肾病Ⅳ期(气阴两虚)随机平行对照研究

Treatment of Diabetic Nephropathy Stage Ⅳ(Qiyin Liangxu/气阴两虚) with Huangqi Zhimu Shenqi Decoction(黄芪知母参七汤) and Western Medicine Randomized Parallel Ccontrolled Study

[目的]观察黄芪知母参七汤联合西药治疗糖尿病肾病Ⅳ期(气阴两虚)疗效。[方法]使用随机平行对照方法,将45例门诊患者按就诊顺序号抽签随机分为两组,糖尿病肾脏疾病健康知识宣传,畅情志,适量运动,预防感冒;低盐低脂糖尿病饮食,保证每日总热量摄入,均衡饮食营养;积极给予抗感染、抗氧化及改善微循环等对症处理,禁输注白蛋白。对照组23例精蛋白生物合成人胰岛素注射液,1支/次,1次/d,皮下注射;卡托普利,12.5mg/次,2～3次/d;辛伐他汀,10mg/次,1次/d;以上药物均根据患者实际情况调整剂量。治疗组22例芪知母参七汤(黄芪30g,知母15g,地黄熟、构祀、黄柏、泽泻各12g,肉从蓉、三七、赤芍、丹参各10g),半袋/次,热开250mL冲服,2次/d;西药治疗同对照组。连续治疗4周为1疗程。观测临床表现、中医证候、空腹血糖(GLU)、糖化血红蛋白(GHb)、尿微量白蛋白(ALB)、血清肌酐、血清尿素氮、血清胱抑素(Cys-c)、血清视黄醇结合蛋白(RBP)、尿β2微球蛋白(尿β2-MG)、尿α1微球蛋白(尿α1-MG)、肾脏体积、不良反应。治疗1疗程(4周),判定疗效。[结果]治疗组显效15例,有效5例,无效3例,总有效率86.96%;对照组显效7例,有效4例,无效11例,总有效率50.00%;治疗组疗效优于对照组(P<0.05)。中医证候疗效治疗组显效16例,有效5例,无效2例,总有效率91.30%;对照组显效6例,有效7例,无效9例,总有效率59.09%;治疗组疗效优于对照组(P<0.05)。GLU、GHb、ALB、尿微量白蛋白/尿肌酐、Cys-c、RBP、尿β2-MG、尿α1-MG、RI两组均有改善(P<0.01),治疗组改善优于对照组(P<0.05,P<0.01),肾脏体积治疗前后两组均无显著变化(P>0.05)。[结论]黄芪知母参七汤联合西药治疗糖尿病肾病Ⅳ期(气阴两虚),疗效满意,无严重不良反应,值得推广。

[Objective]To observe the curative effect of Huangqi Zhimu Shenqi decoction combined with western medicine on stage IV diabetic nephropathy(Qiyin Liangxu).[Method]45 outpatients were randomly divided into two groups by drawing lots according to the order of visiting.They were given diabetic kidney disease health knowledge propaganda,good mood,proper exercise,cold prevention,low-salt and low-fat diabetic diet to ensure daily total calorie intake and balanced diet and nutrition,and were given symptomatic treatment such as anti-infection,anti-oxidation and improving microcirculation actively,and no transfusion was allowed.Albumin.In the control group,23 cases of protamine biosynthetic human insulin injection were injected subcutaneously,once a day,once a day;captopril,12.5 mg/time,2~3 times/d;simvastatin,10 mg a time,once a day;the above drugs were adjusted according to the actual situation of patients.The treatment group consisted of 22 cases of Huangqi Zhimu Shenqi decoction(Huangqi 30 g,Zhimu 15 g,Shudihuang,Gouqi,Huangbai,Zexie each 12 g,Roucongrong,Sanqi,Chishao,Danshen 10 g),half bag/time,hot 250 mL,twice a day;Western medicine treatment was the same as the control group.Continuous treatment for 4 weeks is a course of treatment.Clinical manifestations,TCM syndromes,fasting blood sugar(GLU),glycosylated hemoglobin(GHb),urinary microalbumin(ALB),serum creatinine,serum urea nitrogen,serum cystatin(Cys-c),serum retinol binding protein(RBP),urinary beta-2 microglobulin(urine beta-2-MG),urinary alpha-1 microglobulin(urine alpha-1-MG),renal volume and adverse reactions were observed.One course of treatment(4 weeks)was used to determine the curative effect.[Result]In the treatment group,15 cases were markedly effective,5 cases were effective,3 cases were ineffective,and the total effective rate was86.96%.In the control group,7 cases were markedly effective,4 cases were effective and 11 cases were ineffective,the total effective rate was 50.00%.The curative effect of the treatment group was better than that of the control group(P<0.05).The total effective rate was 91.30%in the treatment group and 59.09%in the control group.The total effective rate in the treatment group was better than that in the control group(P<0.05).GLU,GHb,ALB,urinary microalbumin/creatinine,Cys-c,RBP,urinary beta-2-MG,urinary alpha-1-MG and RI were improved in both groups(P<0.01).The improvement in treatment group was better than that in control group(P<0.05,P<0.01).There was no significant change in renal volume before and after treatment in both groups(P>0.05).[Conclusion]Huangqi Zhimu Shenqi decoction combined with western medicine in the treatment of stage IV diabetic nephropathy(deficiency of both Qi and Yin)has satisfactory curative effect and no serious adverse reactions,which is worthy of promotion.