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。
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 weeks.The urinary albumin excretion rate（UAER）,24 h quantitative examination of urinary protein（UPQ） and fasting plasma glucose were measured respectively before the treatment,4 and 8 weeks after the administration.RESULTS One hundred and ninety-four stageⅢorⅣDN patients participated in the trials.Excluding 10 patients,the per-protocol set was 184 patients.The clinical control rates were 47%, 42%and 18%in the high dose group,low dose group and control group,respectively.The treatment effectiveness of patients with low or high dose Tangjiangshenkang granule was better than those with placebo（P0.05）.There were no significantly differences between the high dose and low dose groups in clinical efficacy （P0.05）.After the treatment,the UAER was（83±157）,（212±612） and（298±783）μg·min^-1, the UPQ was（477±427）,（675±856） and（812±1 318） mg in the high dose group,low dose group and control group,respectively.UAER and UPQ in the high and low dose groups were significantly higher than those in the control group（P0.05）.No serious adverse reaction occurred in all groups.CONCLUSION Tangjiangshenkang granule is effective and safe in the treatment of DN.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2011年第1期16-19,共4页
Chinese Journal of New Drugs and Clinical Remedies
基金
国家"十一五""重大新药创制科技重大专项"课题(2008ZX09101-Z-019)
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
diabetic nephropathy
randomized controlled trials
multicenter studies
Tangjiang-shenkang granule
