The Preliminary Clinical Exploratory Study Of Qi Zhu Granules In Treatment Of Early Type 2 Diabetic Kidney Disease

Diabetic kidney disease(DKD)is one of the most serious and common microvascular complications of diabetes,with an increasing incidence year by year.If the disease progresses to end-stage renal disease,it will seriously threaten the life and health of patients and cause death.However,at present there is no specific treatment for this disease and the occurrence and development of this disease cannot be effectively controlled by the comprehensive treatment measures such as blood glucose control,blood pressure control and lipid metabolism regulation.It is characterized by microalbuminuria and has a high rate of missed diagnosis.Clinical effects of syndrome differentiation of traditional Chinese medicine on this disease is good.especially in the early stage of active intervention which has important clinical significance.To some extent this method can effectively delay DKD progress.Therefore,this clinical trial depends on the sub-project of the national major science and technology project aiming to explore effective treatment for early type 2 diabetic kidney disease from traditional Chinese medicine.Objective:This trial aims at exploring the effect of Qi Zhu granules on early type 2 diabetic kidney disease with qi and Yin deficiency,dampness turbidity and blood stasis syndrome.The two groups were both given irbesartan as foundation treatment,comparing the change of urinary microalbumin creatinine ratio of treatment group and control group after 24 weeks treatment.Tumor necrosis factor alpha.hypersensitive c-reactive protein,superoxide dismutase.malondialdehyde,transforming growth factor beta were monitored to explore the action mechanism of Qi Zhu granules on early type 2 DKD.Methods:This study is a single-blind,randomized,placebo parallel control trial.Thirty six patients with early type 2 diabetic kidney disease and qi and Yin deficiency,dampness turbidity and blood stasis syndrome were randomly assigned to receive Qi Zhu granules or placebo.Those patients must meet the standards of aging from 18-70 years old,hemoglobinAlc controlling under 8%,blood pressure controlling under 140/90mmHg.They were both given irbesartan as foundation treatment.The treatment group received Qi Zhu granules(Huangqi,Nuzhenzi.Baizhu.Jinyingzi Huangshukuihua,Bixi.Chishao.Huanglian).The control group was treated with placebo.The induction period was 2 weeks and the test cycle was 24 weeks.General indicators such as gender,age,body temperature and blood pressure were recorded before the test.The primary efficacy index is urinary microalbumin creatinine ratio(once every 4 weeks to check).The secondary efficacy indexs include TCM scores(once every 4 weeks to record),tumor necrosis factor alpha,hypersensitive c-reactive protein,superoxide dismutase,malondialdehyde,transforming growth factor beta,hemoglobinAlc,fasting blood sugar,2h postprandial blood glucose,estimated glomerular filtration rate,cholesterol,triglycerides,high-density lipoprotein cholesterol,low-density lipoprotein cholesterol(at baseline,12 weeks follow-up and 24 weeks follow-up to check).After the test,the results are statistically analyzed by SPSS21.0.the measurement data is showed by mean±standard deviation,which uses nonparametric test and t test;The enumberation data is represented by frequency(composition ratio),which uses chi square test.Results:Thirty six participants were recruited from Xi Yuan hospital endocrinology.They were randomly divided into 18 cases of treatment group and 18 cases of control group.Up to now.the treatment group has completed a 24-week course of treatment in 13 cases,and 2 cases of shedding(1 patient did not take medicine regularly as required,and 1 patient did not follow up according to the follow-up time).In the control group,12 patients completed the 24-week course of treatment.2 patients were excluded(2 did not meet the inclusion criteria after the end of the induction period),and 1 patient withdrew voluntarily.1 case(statistical)of treatment group appeared stomachache after taking the drug and got well after changing the time of taking medicine.The control group did not appear harmful response.At present.6 cases are still in the follow-up period(including 3 cases in the treatment group and 3 cases in the control group).1.After treatment,the efficacy of TCM syndromes was compared between the two groups,with an effective rate of 92%in the treatment group and 42%in the control group.There was statistical significance between two groups in effective rate.(P<0.05)2.After treatment,the TCM symptoms of treatment group were significantly relieved than before in hunger,frequent urination,fatigue,shortness of breath,lazy speech,sweats and night sweats,heavy head and body sleepiness,and numbness and pain(P<0.05).In the control group,there were no significant differences in the improvement of all symptoms.Comparison between groups after treatment showed that the treatment group was significantly better than the control group in relieving fatigue(P<0.05).3.After treatment,the total scores of TCM syndromes were both reduced compared with the scores before treatment in two groups(P<0.000,P<0.006)and the reduction of TCM syndrome total scores in the treatment group was more than that in the control group(P<0.05).4.After treatment,in the primary efficacy index-urine micro albumin creatinine ratio,there were no statistically significant differences in both groups compared with before(P>0.05,P>0.05)and there was no statistically significant difference between two groups(P>0.05).5.After treatment in the secondary efficacy indexes,the level of 2h postprandial blood glucose was reduced compared with the level before treatment(P<0.05)and the level of high-density lipoprotein cholesterol was improved compared with the level before treatment(P<0.05)in treatment group.After treatment,the treatment group was better than the control group in reducing 2h postprandial blood glucose(P<0.05).There were no significant differences in the levels of other efficacy indexes in the same groups or between two groups.6.After treatment,there was no significant difference in the occurrence of adverse reactions between two groups(P>0.05).Conclusion:Qi Zhu granules can obviously relieve TCM symptoms in the the early type 2 DKD patients with qi and Yin deficiency,dampness turbidity and blood stasis syndrome.Qi Zhu granules can reduce 2h postprandial blood glucose,adjust blood lipid metabolism,but there were no obvious improvement for the levels of micro albumin urine creatinine ratio,tumor necrosis factor alpha,hypersensitive c-reactive protein,superoxide dismutase,malondialdehyde,transforming growth factor beta.The results probably ascribed to small sample size and 6 cases in the follow-up were not included in the statistic analysis.There were no obvious adverse reactions and side effects in Qi Zhu granules.As a consequence,the efficacy and mechanism of Qi Zhu granules need further exploration.