温脾汤治疗慢性肾脏病3、4期临床研究

Efficacy and safety of Wen-Pi-Tang for chronic kidney disease(stage 3～4)

目的:评价温脾汤对慢性肾脏病(CKD)3、4期-脾肾阳虚瘀浊互结证疾病的有效性及安全性。方法:41名CKD3、4期患者(年龄18～65岁)随机分配至对照组(20名)接受常规治疗或试验组(21名)在常规治疗基础上接受温脾汤治疗。观察8周。期间观测血BUN、SCr、24h尿蛋白、Hb、Alb、中医证候变化及药物不良反应。结果:治疗8周后,与对照组相比,试验组患者血BUN、SCr下降,Hb显著上升,中医症候明显改善,同时不良反应轻微,两组间比较,差异有统计学意义(P<0.05)。结论:温脾汤对CKD3、4期-脾肾阳虚瘀浊互结证疾病有良好的降低血清尿毒素、改善贫血、改善中医症候的作用,而不良反应轻微,安全性高。

Objective To investigate the efficacy and safety of Wen-Pi-Tang（a preparation of traditional Chinese medicine） for chronic kidney disease（CKD） stage 3 ～ 4 which were diagnosed as syndrome of yang deficiency of spleen and kidney and turbid phlegm and blood stasis in TCM.Method A total of 41 patients（aged 18 ～ 65 years） with CKD stage 3 ～ 4 were randomly assigned to receive conventional treatment（the control group,n = 20） or Wen-Pi-Tang and conventional treatment（the experimental group,n = 21） for 8 weeks.For 24 h albuminuria and blood urea nitrogen（BUN）,serum creatinine（Scr）,serum albumin（Alb）,hemoglobin（Hb）,and the efficacy（changes of traditional Chinese medical syndrome） and side effects were assessed at the very beginning of the trials and 8 weeks later respectively.Results Compared with the control group,BUN and Scr decreased,while Hb increased markedly and TCM symptom improved significantly with merely side effects in Wen-Pi-Tang group.There was significant difference between the two groups after 8 weeks＇ course of treatment（P 0.05）.Conclusion Wen-Pi-Tang can significantly decrease the urine toxin in serum,improve anemia and TCM symptom of CKD 3 ～ 4 stages,with advantages of light side effects and highly safety.