金氏肾炎丸治疗糖尿病肾病的随机、对照临床研究

Randomized,controlled clinical study of jinshishenyan pills in the treatment of diabetic nephropathy

目的:观察中药金氏肾炎丸治疗糖尿病肾病Ⅲ、Ⅳ期的临床疗效。方法:本研究为随机对照试验,试验针对糖尿病肾病Ⅲ、Ⅳ期的患者,在对照组治疗基础上加用金氏肾炎丸为治疗组(组成:生地、山药、益母草、生薏仁、石苇、车前草、银花、连翘、炒白术、黄柏等),6g,每日3次,连用12周。治疗组及对照组共计进行12周的观察。主要结局指标:尿微量白蛋白,次要结局指标:糖化血红蛋白、血同型半胱氨酸、视黄醇结合蛋白等及中医证侯积分。结果:显示最终进入统计分析为93例患者,服用金氏肾炎丸12周后,治疗组中医证侯积分6.79±5.37,明显低于对照组12.5±7.65(P<0.01),其治疗后治疗组尿微量白蛋白、血同型半胱氨酸、视黄醇结合蛋白分别为76±33mg/24h、11.13±2.24μmol/L、28.1±9.58mg/L,与治疗后对照组尿微量白蛋白、血同型半胱氨酸、视黄醇结合蛋白分别为214±34mg/24h、15.69±2.27μmol/L、37.8±8.72mg/L相比均有所下降(P<0.05或P<0.01),而糖化血红蛋白治疗组治疗后6.87±0.67%,与对照组治疗后6.9±0.93%比较,无统计学差异。结论:金氏肾炎丸结合基础治疗能够有效改善糖尿病肾病III、IV期患者的临床症状,延缓糖尿病肾病的进展。

Objective： To investigate jinshishenyan pills treated with pill type III,IV stage clinical efficacy. Method： This research for random control test,test for diabetes nephropathy III,and IV period of patients,in control group treatment based Shang plus with jinshishenyan pills for treatment group,6g,daily 3 times,used 12 week. Amounted to a 12-week treatment group and the control group were observed. Main outcome measures： urinary microalbumin and secondary outcome measures： glycosylated hemoglobin and blood homocysteine,retinol-binding protein and TCM points. Results： Show eventually enter the statistical analysis of 93 patients after 12 weeks taking pills Guinness nephritis,Hou integral TCM treatment group 6. 79 ± 5. 37was significantly lower than the control group 12. 5 ± 7. 65,there was significant difference（ P 〈0.01） After treatment,the treatment of urinary albumin,serum homocysteine,retinol binding protein which were 76 ±33mg/24h,11.13 ± 2. 24μmol /L,28. 1 ± 9. 58mg /L and after treatment in the control group 214 ± 34mg /24h,15. 69 ± 2. 27μmol /L,37. 8 ± 8. 72mg /L has declined compared,a significant difference（ P 〈 0. 05 or P 〈 0. 01）. And after treatment,glycated hemoglobin 6. 87 ± 0. 67% after treatment with the control group 6. 9 ± 0. 93% compared with no significant difference（ P 〉 0. 05）. Conclusion： Jinshishenyan pills can effectively improve the clinical symptoms of diabetic nephropathy III,IV patients,delay the progress of diabetic nephropathy.