保肾通络方治疗糖尿病肾脏病（G3期）的前瞻性非随机对照研究＊

目的 采用非随机对照研究评价保肾通络方治疗糖尿病肾脏病（DKD）患者（G3期）的安全性与有效性。方法 选取规律口服双倍剂量肾素血管紧张素系统阻断剂（RASI）符合纳入标准的115例DKD（G3期）患者,其中对照组57例予基础治疗,试验组58例加服保肾通络方;观察12个月,主要比较治疗前及治疗6、12个月后两组24h尿蛋白定量（24-h UP）、血肌酐（SCr）、肾小球滤过率估算值（eGFR）、血清白蛋白（ALB）、血清总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、甘油三酯（TG）、血尿酸（UA）及中医证候积分的变化。结果 两组患者24-h UP、SCr各时间点的差异有统计学意义（P < 0.05）,TC、TG各时间点的差异有显著统计学意义（P < 0.01）,试验组优于对照组（P < 0.01）。试验组经治疗中医证候积分明显下降（P < 0.01）;对照组无明显变化（P > 0.05）。结论 保肾通络方能够延缓DKD（G3期）患者肾脏病进展,降低蛋白尿,降低血脂水平,减轻临床症状,且安全稳定。

Prospective, Clinical, Non-randomized Controlled Trial of Baoshen-Tongluo Recipe in the Treatment of Diabetic Kidney Disease (G3 stage)

Objective The evaluation of the safety and efficacy of Baoshen-Tongluo Recipe is taken adventage of in the course of the treatment of patients with diabetic kidney disease (G3 stage) with the method, non-randomized, controlled trial.Methods A total of 115 patients with DKD (G3 stage) are compliance with the inclusion criteria who received regular oral double-dose renin angiotensin system blocker were enrolled. Among them, 57 patients in the control group were treated with Western medicine, and 58 patients in the experimental group were treated with Baoshen-Tongluo Recipe. Observed for 12 months, mainly compare the two groups before treatment and after 6 and 12 months of treatment, 24-hour urine protein, serum creatinine, estimated glomerular filtration rate, serum albumin, serum kalium, serum uric acid, serum total cholesterol, low-density lipoprotein cholesterol, changes in triglycerides, serum albumin and TCM syndrome scores.Results The differences in 24-h UP, SCr at different time points of different groups were statistically significant (P < 0.05), and the differences in time points of TC and TG were statistically significant (P < 0.01), the test group is better than the control group (P < 0.01). some TCM syndrome scores before and after treatment in the experimental group were statistically different (P <0.01), and there was no significant change in the control group (P > 0.05).Conclusion Baoshen-Tongluo Recipe can delay the progression of kidney disease in patients with DKD (G3 stage), reduce proteinuria, lower blood lipid levels, reduce clinical symptoms, and is safe and stable.