中成药辨证论治慢性肾脏病3-4期的多中心前瞻性临床研究  

Prospective multicenter study on syndrome differentiation-based treatment with traditional Chinese medicine for Chronic Kidney Disease(CKD3-4)

作　　者：孟元[1] 张胜容[1] 刘宝利[1] 李靖[2] 赵轶雯[3] 王雨[1] 赵静[1] 赵文景[1] 葛楠[1] 杨彦芳[4] 刘洋[5] 任建伟[6] 程虹[7] 刘建平[8] 

机构地区：[1]首都医科大学附属北京中医医院,北京市100010 [2]北京中医药大学东直门医院,北京市100700 [3]首都医科大学附属天坛医院,北京市100050 [4]中日友好医院,北京市100029 [5]解放军总医院,北京市100853 [6]航空总医院,北京市100012 [7]首都医科大学附属安贞医院,北京市100029 [8]北京中医药大学循证医学中心,北京市100029

出　　处：《实用医学杂志》2014年第16期2658-2662,共5页The Journal of Practical Medicine

基　　金：首都医学科技发展基金资助课题(编号:SF-2009-I-06)

摘　　要：目的:研究中成药辨证论治对CKD3-4期患者的临床疗效。方法:采用前瞻性多中心随机对照研究的方法,将符合方案的339例患者,分为规范组167例、对照组172例,规范组按辨证论治方案予中成药单方或组方口服;对照组予经验中成药单方口服;观察24周后两组的临床疗效。结果:CKD3期规范组治疗后血肌酐、肾小球滤过率估算值、24 h尿蛋白定量均有统计学意义(P<0.05);对照组无明显变化(P>0.05),规范组优于对照组;CKD4期规范组与治疗组,组内、组间比较均无统计学差异(P>0.05)。CKD3-4期规范组治疗后的中医证候积分均较基线时明显改善(P<0.05),而对照组无统计学意义(P>0.05),规范组较对照组中医证候积分下降更明显(P<0.05)。结论:中成药辨证论治对CKD3-4期患者在保护肾功能、减少尿蛋白、降低证候积分方面优于经验用药治疗。Objective To study the clinical curative effect of syndrome differentiation-based treatment with traditional Chinese medicine on patient with Chronic Kidney Disease （CKD3-4）. Method According to prospective multicenter randomized controlled study which was applied to the patients with CKD3-4 , the total of 339 patients were divided into two groups. To one group as standard including 167 patients ,the other including 172 patients. Chinese Traditional Patent Medicine single or combined-prescription oral treatment according to syndrome differentiation-based treatment was employed. To the other group as reference , Chinese Traditional Patent Medicine oral treatment according to experienced rule was applied. The clinical curative effect results were obtained after a 24 weeks-treatment. Result The Scr ,eGFR and UTP with CKD3 in standard group illustrate statistics significance （P〈0.05）. On the opposite, those of the reference group remain insignificance （P 〉 0.05）. The clinical curative effect result of patient in standard group was better than that of reference group. About the clinical curative effect of CKD4, no statistics significance difference （P 〉 0.05） could be found between groups or between patients in one group. The TCM score of patient with CKD3-4 in standard group have improved （P 〈 0.05） according to baseline. However, that of reference group did not show any statistics significance （P 〉 0.05）. Conclusion Syndrome differentiation-based treatment with traditional Chinese medicine illustrated a better result in protection of renal function, reduction in urinary protein and decline in TCM score than the treatment according to experienced rule.

关 键 词：慢性肾脏病 3-4期 中成药 辨证论治 

分 类 号：R277.5[医药卫生—中医学]