益气养阴解毒通络法治疗早期糖尿病肾病的临床研究

目的]初步评价具有益气养阴解毒通络功效的糖肾Ⅰ号治疗早期糖尿病肾病(DN)的有效性和安全性.方法]采用随机对照方法,将120例中医辨证为气阴两虚肾虚血瘀的早期DN患者随机分为治疗组和对照组各60例,在基础治疗的同时分别给予糖肾Ⅰ号和氯沙坦治疗12周,观察指标为证候积分、尿白蛋白排泄率(UAER)、内生肌酐清除率(Ccr)及安全性指标,治疗期间监测血糖、血脂、血压.结果]治疗组总有效率为83.9%,优于对照组的66.0%(P<0.05).糖肾Ⅰ号可明显改善DN患者临床症状,降低UAER,改善早期DN的肾小球高滤过,从而保护肾功能、延缓DN的进展恶化.治疗期间未发现明显的不良反应.结论]糖肾Ⅰ号是治疗早期DN安全有效的方药.

Clinical research of replenishing Qi,nourishing Yin,detoxication and dredging collateral in treating early diabetic nephropathy

Objective] To observe the clinical efficiency and safety of TangShen YiHao (Diabetic Nephropathy No.1,TSYH) having replenish-ing Qi,nourishing Yin,detoxication and dredging collaterals on early diabetic nephropathy (DN). Methods] A random control study design was used in this study. One hundred and twenty cases from early DN with Qi-Yin deficiency,kidney deficiency and blood stasis syndrome were randomly divided into two groups:treatment group and control group. Patients in both groups were treated with TSYH or Losartan for 12 weeks besides basic treatment. Clinical symptom integral,urinary albumin excretion rate (UAER),endogenous creatinine clearance rate (Ccr) and side-effects were observed before and after treatment in two groups. Plasma glucose,blood lipid,blood pressure were monitored during the treatment period also. Results] The total efficiency of treatment group was 83.9%,which was higher than that of control group(P<0.05). TSYH could significantly improve the clinical symptoms,reduce UAER,and ameliorate renal hyperfil-tration and therefore protected renal functions. No obvious adverse reaction and side effect were observed. Conclusion] TSYH was an effective and safe medicine for the treatment of early DN.