Title中药辨证组方对慢性肾脏病3期的肾保护作用--315例多中心,前瞻性,双盲,随机对照试验
Other TitlesClinical Research of Traditional Chinese Medicine Combined with Renal Protective Effects of Traditional Chinese Medicine Formula for Patients with Chronic Kidney Disease Stage 3:A Multi-center, Prospective, Double-blinded, Randomized Controlled Trials of
Authors王永钧
何立群
孙伟
鲁盈
王小琴
张佩青
魏连波
曹式丽
杨霓芝
马红珍
高菁
李平
陶筱娟
袁发焕
李靖
姚晨
刘旭生
Affiliation浙江中医药大学广兴医院 杭州市中医院,杭州,310007
上海中医药大学曙光医院,上海,200021
江苏省中医院,南京,210029
湖北省中医院,武汉,430061
黑龙江省中医研究院,哈尔滨,150036
南方医科大学珠江医院,广州,510280
天津中医药大学第一医院,天津,300193
广东省中医院,广州,510120
浙江省中医院,杭州,310006
北京中医药大学东直门医院,北京,100700
北京中日友好医院,北京,100029
杭州市红十字会医院,杭州,310003
第三军医大学新桥医院,重庆,400037
北京大学第一医院统计室,北京,100034
Keywords慢性肾脏病
肾功能
中药辨证组方
Chronic kidney disease
Kidney function
Chinese medical formula by symptom differentiation
Issue Date2013
Publisher世界中医药
Citation世界中医药.2013,(9),1001-1005,1009.
Abstract目的:观察中药辨证组方对慢性肾小球肾炎CKD3期患者的肾保护作用及安全性。方法:对入组人群采用前瞻、双盲、随机对照的研究方法,将符合方案集(Per-protocol.PP)的315例患者分成中药辨证组(158例)和西药苯那普利组(157例)。中药组按肾气阴两虚、肾络瘀痹、风湿扰肾、湿热内蕴四证予中药辨证组方+苯那普利模拟剂+基础治疗;西药组予西药苯那普利10 mg/d+中药组方模拟剂+基础治疗,观察24 h尿蛋白定量(u-pr/24 h)、尿白蛋白/肌酐比值(U-Alb/Cr)、血肌酐(Scr)、尿素氮(Bun)、尿酸(UA)、钾(K+)、估测肾小球滤过率(eGFR· MDRD公式)、CKD分期、中医证候与症状积分值、综合疗效分析及安全性。疗程24周。结果:中药组治后Scr下降,eGFR升高(P<0.05~0.01),不良反应少,但尿蛋白却较基线有所增高。西药组治后尿蛋白有减少(P>0.05),但Scr增高(P<0.01),其中31例(19.7%)增幅>30%,8例(5.10%)增幅>50%,eGFR降低,有27例(17.2%)由CKD3期进展至CKD4期。结论:中药辨证组方对慢性肾脏病具有不依赖于减少尿蛋白的肾保护作用,且安全性好。
Objective:To investigate the efficacy and safety of Chinese medical formula by symptom differentiation and signs on patients with chronic Stage 3 kidney disease.Methods:This is a prospective, double blinded, randomized, controlled trial enrolling a total of 315 patients in per-protocol data set assigned to traditional Chinese medicine group ( TCM group, 158 cases ) or western medicine (benazepril) group (WM group, 157 cases).TCM group received general therapy , benazepril placebo and Chinese medical formula ac-cording to the four Chinese medicine patterns including qi yin /xue deficiency patterns , blood stasis in the kidney patterns , wind-damp-ness interfering in the kidney patterns , endoretention of damp heat patterns .WM group received 10 mg/d of benazepril , placebo of Chi-nese medicine formula and general therapy .Finally, 24 h proteinuria, ratio of urinary albumin versus creatinine , serum creatinine, urea nitrogen, uric acid, potassium, evaluated glomerular filtration rate (eGFR), stage of chronic kidney disease , score of Chinese patterns and syndromes, evaluation of composite effects and safety were assessed .Patients were followed up for 24 weeks.Results: In TCM group, serum creatinine was decreased while eGFR was increased at week 24 as compared with baseline (P<0.05-0.01) with little side effects, whereas proteinuria was increased a bit compared with baseline .In WM group, proteinuria was decreased (P>0.05), whereas serum creatinine was increased ( P<0.01) as compared with baseline .Of the WM group, serum creatinine in 31 cases (19.7%) in-creased >30%, 8 cases (5.10%) increased >50%.eGFR was decreased with 27 (17.2%) cases developed CKD Stage 4 from Stage 3.Conclusion:Chinese medicine formula by differentiation of symptoms and signs had renal protective effects independent of re -ducing proteinuria with safety .
URIhttp://hdl.handle.net/20.500.11897/236049
ISSN1673-7202
DOI10.3969/j.issn.1673-7202.2013.09.004
Indexed中国科技核心期刊(ISTIC)
Appears in Collections:第一医院

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