| 糖降肾康颗粒治疗糖尿病肾病随机双盲安慰剂对照多中心临床试验 |
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| 引用本文： | 马松涛,刘冬恋,牛锐,刘睿斌,吉勤,詹继红,史伟,张磊. 糖降肾康颗粒治疗糖尿病肾病随机双盲安慰剂对照多中心临床试验[J]. 中国新药与临床杂志, 2011, 0(1) |
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| 作者姓名： | 马松涛 刘冬恋 牛锐 刘睿斌 吉勤 詹继红 史伟 张磊 |
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| 作者单位： | 成都医学院药学院;成都尚科药业有限责任公司;重庆科瑞制药有限责任公司;云南中医学院第一附属医院;贵阳中医学院第一附属医院;广西中医学院第一附属医院;四川省人民医院; |
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| 基金项目： | 国家“十一五”“重大新药创制科技重大专项”课题(2008ZX09101-Z-019) |
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| 摘 要： | 目的评价糖降肾康颗粒治疗糖尿病肾病(DN)的临床疗效与安全性。方法采用随机、双盲、双模拟、安慰剂平行对照、多中心临床试验设计。低剂量组:糖降肾康颗粒1袋+糖降肾康颗粒模拟剂1袋,3次·d~(-1),口服。高剂量组:糖降肾康颗粒2袋,2次·d,模拟剂2袋,1次·d~(-1),口服。安慰剂组:模拟剂,2袋,3次·d~(-1),口服。8 wk为一个疗程。所有受试者在试验期间糖尿病基础治疗不变。观察临床疗效,治疗前、治疗4 wk和8 wk末检查尿微量白蛋白排泄率(UAER)、24 h尿蛋白定量和空腹血糖。结果共纳入194例Ⅲ或Ⅳ期DN患者,剔除8例,脱落2例,184例按方案完成试验。高剂量组临床控制率为47%,低剂量组为42%,安慰剂组为18%,高、低剂量组疗效优于安慰剂组(P<0.01),而高、低剂量组间无显著差异(P>0.05)。治疗后,高、低剂量组和安慰剂组UAER分别为(83±157)、(212±612)和(298±783)μg·min~(-1),24 h尿蛋白定量分别为(477±427)、(675±856)和(812±1318)mg,高、低剂量组均低于安慰剂组(P<0.01)。试验过程中未出现严重不良反应。结论糖降肾康颗粒治疗DN具有良好的疗效,且安全性良好。
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| 关 键 词： | 糖尿病肾病 随机对照试验 多中心研究 糖降肾康颗粒 |
Tangjiangshenkang granule in treatment of diabetic nephropathy:a doubleblind,randomized,placebo-controlled multicentre clinical trial |
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| MA Song-tao,LIU Dong-lian,NIU Rui,LIU Rui-bing,JI Qin,ZHAN Ji-hong,SHI Wei,ZHANG Lei (. Tangjiangshenkang granule in treatment of diabetic nephropathy:a doubleblind,randomized,placebo-controlled multicentre clinical trial[J]. Chinese Journal of New Drugs and Clinical Remedies, 2011, 0(1) |
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| Authors: | MA Song-tao LIU Dong-lian NIU Rui LIU Rui-bing JI Qin ZHAN Ji-hong SHI Wei ZHANG Lei ( |
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| Affiliation: | MA Song-tao~1,LIU Dong-lian~1,NIU Rui~2,LIU Rui-bing~3,JI Qin~4,ZHAN Ji-hong~5,SHI Wei~6,ZHANG Lei~7 (1.Department of Pharmacy,Chengdu Medical College,Chengdu SICHUAN 610083,China,2.Chengdu Shangke Pharmaceutical Co.,Ltd,Chengdu SICHUAN 610000,3.Chongqing Kerui Pharmaceutical Co.,CHONGQING 400060,4.The First Affiliated Hospital of Yunnan College of Traditional Chinese Medicine,Kunming YUNNAN 650051,5.The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine,Guiy... |
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| Abstract: | AIM To evaluate the safety and efficacy of Tangjiangshenkang granule in the treatment of diabetic nephropathy(DN).METHODS This study was a multicentre,double-blind,double-dummy, randomized and parallel placebo controlled clinical trial.Based on basic treatment,eligible patients were administered orally with low dose(one pack of Tangjiangshenkang granule and one pack of placebo,tid),high dose(two packs of Tangjiangshenkang granule,bid,and two packs of placebo,qd) and placebo(two packs of placebo,tid) for 8 w... |
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| Keywords: | diabetic nephropathy randomized controlled trials multicenter studies Tangjiang-shenkang granule |
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