固精方治疗非肾病综合征原发性局灶节段性肾小球硬化的临床研究

Gujing Decoction for Non Nephrotic Syndrome Primary Focal Segmental Glomerulosclerosis

目的:观察固精方治疗非肾病综合征(NS)原发性局灶节段性肾小球硬化(FSGS)的临床疗效及安全性。方法:前瞻性随机对照研究观察64例非肾病综合征原发性FSGS且中医辨证属脾肾气虚证的患者,随机分为治疗组(固精方每日一剂+缬沙坦80 mg/d)与对照组(缬沙坦80 mg/d),疗程6月。观察临床疗效、安全性指标及中医证候变化,并检测尿Podocalyxin水平。结果:两组具有基线同质性,治疗后,治疗组中医症候改善优于对照组;治疗组尿蛋白定量、定性、尿红细胞计数较对照组下降;治疗组尿Podocalyxin低于对照组。治疗前后,两组肾功能、肝功能、血常规均无明显变化,粪常规、心电图未见异常。结论:固精方联合缬沙坦治疗非NS原发性FSGS,可改善临床症状,减少尿蛋白及红细胞排泄且安全性高,其机制可能与减轻足细胞损伤有关。

Objective： To observe the efficiency and safety of Gujing decoction for non nephrotic syndrome primary Focal Segmental Glomerulosclerosis（ n NS-FSGS）.Methods： 64 patients with n NS-FSGS and Chinese Medicine（ TCM） syndrome of deficiency in spleen and kidney were enrolled in this Prospective randomized controlled trail and divided into the control group（ valsartan80 mg/d） and treatment group（ Gujing decoction plus with valsartan 80 mg/d）.The duration of therapy was 6 months.The effects were evaluated by clinic effect,security index,TCM syndrome score and the Podocalyxin（ PCX） in the urine.Results： The two groups had baseline homogeneity.After six months of treatment,the TCM syndrome response to therapy was better than control group.The proteinuria and hematuria of the treatment group was lower than control group.There were no statistical differences in renal function,blood routine examination and liver function between the two groups.There was nothing abnormal in electrocardiogram and stool routine examination.Conclusion： The treatment of gujing decoction plus with valsartan for n NS-FSGS patients had superiority compared to valsartan in improving the clinical symptoms,reducing the protein and red blood cell of urine.TCM treatment was safe enough and the mechanism may be associated with repairing podocyte injury.