益肾汤口服联合活肾散外敷治疗糖尿病肾病的临床研究

Clinical Observation on Therapeutic Effects of Combination of "yishentang" and "huoshensan" in Treating Diabetic Nephropathy

目的:探讨益肾汤口服联合活肾散外敷治疗糖尿病肾病的临床疗效。方法:将经过4周调整阶段治疗后符合临床试验要求的92例辨证为脾肾气(阳)虚、瘀血阻络的糖尿病肾病患者随机分为治疗组(45例)和对照组(47例),治疗组在基础治疗的同时给予益肾汤口服合并肾俞穴外敷活肾散,对照组在基础治疗的基础上加用洛汀新10mg每日1次治疗,两组均观察2个疗程(8周)。观察临床症状体征的变化,并对肾功能、血脂、血液流变学、尿白蛋白排泄率或24h尿蛋白定量等指标进行观察。结果:89例进入统计分析,治疗组44例,对照组45例,治疗组治疗后主要症状、中医证候疗效及综合总疗效均明显优于对照组(P<0.01或P<0.05);治疗组有更好的降低尿蛋白、调整血脂(HDL-C、LDL-C)及血液流变学各指标的作用(P<0.01或P<0.05);治疗组经治疗后,胱抑素较治疗前有所下降(P<0.05),治疗组无不良反应发生。结论:益肾汤口服联合活肾散外敷治疗糖尿病肾病是有效且安全的。

Objective：To observe the effct of Combination of ＂yishentang＂ and ＂huoshensan＂ in Treating the third or forth stage of Diabetic Nephropathy.Methods：Ninty-two patients with DN （the syndrome of ＂spleen and kidney qi-yang deficiency,blood stasis＂ ） who met the criteria were selected and randomly divided into the treatment group（45 cases） of ＂yishentang＂ and ＂huoshensan＂ with basic treating and the control group （47 cases）of Novartis with basic treating.The observation last 8 weeks after adjusting 4 weeks.The observing indices were clinical symptom,blood fat,BUN,Scr,Cysc,blood rheology,UAER,UPRO.Results：The therapeutic in Traditional Chinese Medicine,clinical symptoms,blood fat,blood rheology,UAER,UPRO,Cysc were improved in treatment group after treatment （P〈0.01 or P〈0.05）,and the treatment group was better than the contrast group in improvement （P〈0.01 or P〈0.05）.Besides,no obvious adverse effect was showed during the treatment.Conclusion：The research indicates that it is safe and effective of Combination of ＂yishentang＂ and ＂huoshensan＂ in treating diabetic nephropathy.