糖肾宁颗粒治疗糖尿病肾病多中心随机双盲对照临床试验

发布时间：2018-06-25 21:55

本文选题：糖肾宁颗粒 + 临床研究　；参考：《中华中医药杂志》2017年11期

【摘要】：目的:客观评价糖肾宁颗粒治疗糖尿病肾病(DKD)临床疗效,并对其作用机制进行初步探讨。方法:采用多中心、随机、双盲、阳性药物平衡对照的试验设计方法,将符合诊断标准的早期DKD患者250例,随机分为治疗组和对照组,对照组在饮食控制、控制血糖基础上,口服氯沙坦,1片/d;治疗组在此基础上予口服糖肾宁颗粒8g,2次/d,疗程为12周。重点观察两组患者的中医临床症状、24h白蛋白排泄率(24h UAER)、估算肾小球滤过率(e GFR)、超氧化物歧化酶(SOD)、超敏C反应蛋白(hs-CRP)等指标治疗前后变化。结果:治疗组总有效率为86.0%,对照组总有效率为58.8%,治疗组的疗效明显优于对照组(P0.05);治疗组在降低患者的24h UAER和改善中医临床症状方面明显优于对照组(P0.01)。治疗组患者血清SOD水平明显高于对照组(P0.05),血清MDA、hs-CRP水平明显低于对照组(P0.05);试验过程中未出现任何不良反应。结论:糖肾宁颗粒是治疗早期DKD安全有效的药物,其作用机制可能与改善机体微炎性反应状态及氧化应激状态有关。
[Abstract]:Objective: to evaluate the clinical efficacy of Tangshenning granule in the treatment of diabetic nephropathy (DKD) and to explore its mechanism. Methods: 250 early DKD patients who met the diagnostic criteria were randomly divided into treatment group and control group by a multicenter, randomized, double-blind, positive drug balance control method. The control group was based on diet control and blood glucose control. On this basis, the treatment group was given 8 g / d Tangshenning granule for 12 weeks. The changes of 24 hours albumin excretion rate (UAER), glomerular filtration rate (eGFR), superoxide dismutase (SOD) and hypersensitive C-reactive protein (hs-CRP) were observed. Results: the total effective rate of the treatment group was 86.0 and the total effective rate of the control group was 58.8, the curative effect of the treatment group was significantly better than that of the control group (P0.05), and the treatment group was obviously superior to the control group in reducing the 24h UAER of patients and improving the clinical symptoms of TCM (P0.01). The level of serum SOD in the treatment group was significantly higher than that in the control group (P0.05), and the level of serum MDAHs-CRP was significantly lower than that in the control group (P0.05). Conclusion: Tangshenning granule is a safe and effective drug in the treatment of early DKD, and its mechanism may be related to improving the state of microinflammatory reaction and oxidative stress.
【作者单位】：首都医科大学中医药学院;中医络病研究北京市重点实验室;首都医科大学附属北京中医医院;北京中医药大学东方医院;北京大学首钢医院;清华大学玉泉医院;北京市宣武中医医院;
【基金】：国家重点基础研究发展计划(973计划)项目(No.2012CB518602)~~
【分类号】：R259

【相似文献】