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.Methods: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 advanced 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. |