培元通络方对脾肾气阴两虚兼毒瘀互结型糖尿病肾病临床疗效及氧化应激的影响

摘要

目的:观察培元通络方对糖尿病肾病早中期临床疗效及氧化应激的影响,探讨培元通络方治疗DKD的作用机制.方法:选取2014年10月至2017年10月重庆市中医院肾病科门诊及住院收治的DKD早期患者106例.采用SAS软件随机程序,将符合诊断标准的DKD早中期患者106例患者,随机分为观察组(培元通络方组)和对照组(尿毒清颗粒组),每组53例,实际完成98例,观察组和对照组各49例. 2组患者除基础治疗外,观察组予培元通络方颗粒,20 g,3次/d,对照组予尿毒清颗粒,10 g,3次／d,疗程均为8周.观察2组患者中医临床症状积分、24 h尿蛋白排泄率(24 h UAER)、血肌酐(SCr)、估算肾小球滤过率(eGFR)、超氧化物歧化酶(SOD)、活性氧(ROS)、丙二醛(MDA)、晚期糖基化终产物(AGEs)的变化情况,并进行统计分析.结果:观察组总有效81.63%%(26／49),对照组总有效53.06%(26／49),观察组疗效明显优于对照组,差异有统计学意义(P＜0.05). 2组治疗后中医临床症状积分、24 h UAER均下降,且观察组低于对照组,差异有统计学意义(P＜0.01). 2组治疗后血清SOD活性显著升高,血清ROS、MDA、AGEs水平均明显降低,差异有统计学意义(P＜0.05,P＜0.01),但观察组血清氧化应激指标改善优于对照组,差异有统计学意义(P＜0.05).试验过程中2组患者均未出现明显不良反应情况.结论:培元通络方是治疗早中期DKD患者的安全有效药物,其机制可能与改善机体的氧化应激有关.%Objective:To observe the effects of Peiyuan Tongluo Recipe (PTR) on clinical efficacy and oxidative stress for patients in early and middle stage of diabetic kidney disease ( DKD),and investigate the mechanism of PTR in treatment of DKD.Meth－ods:A SAS software random program was performed in our study.A total of 106 patients,who had been diagnosed with early stage of DKD,were randomly divided into 2 groups:the normal control group ( treated by Niaoduqing Granule ) and the treatment group (treated by PTR),with 53 cases in each group.The study was completed actually in 98 patients,and 49 in each group.All patients received basic treatment.Moreover,the patients of control group were treated with Niaoduqing Granule (10 g,tid),and the patients of treatment group were treated with PTR (20 g,tid).The treatment was lasted for 8 weeks.The Traditional Chinese Medicine (TCM) patterns efficacy and changes of 24 hours urine albumin excretion rate (24 h UAER),serum creatinine (SCr),estimated glomerular filtration rate (eGFR),superoxide dismutase (SOD),reactive oxygen species (ROS),malonaldehyde (MDA) and ad－vanced glycation end－products (AGEs) were observed and analyzed statistically in 2 groups.Results:The total effective rate of treatment group was 81.63%%(26/49),and the control group was 53.06%(26/49) ( P＜0.05).Compared with the control group,the treatment group significantly relieved the clinical signs of DKD patients and effectively decreased the UAER ( P ＜0.01).Compared with the control group ,the level of serum SOD was significantly increased and the level of ROS ,MDA,AGEs was significantly decreased in the treatment group (P＜0.05,P＜0.01),which were superior to those in control group at the same term (P＜0.05).No adverse reactions and side effects were observed during the trail.Conclusion:PTR is a safe and effective drug for the treatment of early and middle DKD ,and its mechanism might be related to the improvement of oxidative stress.