Clinical Research On Early And Clinical Periods Of Diabetic Nephropathy Treated With Differentiation And Treatment Of TCM

BackgroundThe study is a part of the research that making a synthesis Plant for Chinese medicine in whole range treatment of patients with diabetic nephro-pathy (DN).The research is supported by Science and Technology program for the "11th Five Years" Plan. As a research subcenter, we observed the clinical effect on zhixiaotongmaining series granule in the treatment of DN, follow the experiment program. We wish to scientifically evaluate the effect of Chinese medicine in whole range treatment of patients with DN and finally to provide the evidence for making a TCM characteristics plant for preventing and curing DN.The exemplary diabetic microvascular complication is DN.In the early of DN, the condition can be reversed thought right treatment. But, as the development of the disease, when UAER increased, the condition would continually exacerbate to CKD v, and the Clinical manifes-tation is proteinuria, edema and so on. The grouting cost of DN has be the great economic burden of familiy and society. So, the early diagnosis and treatment for diabetic nephropathy is more important. Presently, the effect therapie of DN that has be proved by evidence-based medicine is symptomatic treatment, thatcontain hypoglycemia, hypotension, limiting protein, correcting dyslipidemia, anti-oxidation and so on. There is not some prevention and cure methods that can effectively delay the process of DN.DN is the one of "the dispersion-thirst disease", secondary "niaozhuo" "shuizhong" and "guange". Pro. LV Ren-he proposals the histology hypothesis of "mini-abdominal mass".In the long time of diabetic, yin and qi were damaged by the dispersion-thirst disease.It caused the deficient of both Yin and Yang that the deficient yin affected yang. As Chronic Diseases Transforming to Collaterals, "mini-abdominal mass" was formed by phlegm, heat pathogen, blood stasis, and qi stagnations interpenetrating.So the kidney was damages and llosed its function. Conception of nephron caused endogenous damp pathogen and toxin, and grow into guange. On the base of studying diabetic microvascular complication, professor. LV researched zhixiaotongmaining series granule that fits every step of DN, and get noticeable effect. Chinese medicine has great prospect and potential in prevention and cure methods of diabetic. The research that about the effect of preventing and delaying the process of DN has important clinical and scientific significance.ObjectivesThrough literature research of DN, to comprehend the current treatment of DN in the status of western and TCM, and the clinical and experimental research of Zhixiaotongmaining ect. To comprehend the quantity and trends of literatures about clinical controlled trials of Traditional Chinese Medicine from 1995 to 2010. The clinical reach was random, contrast, single-blind and prospective.It observes the different of TCM symptom change, UAER,24hrUprV and renal functiong in the patients of early and clinical periods of diabetic nephropathy. Then,it evaluates the quality of life and safety, and comprehensively evaluate the clinical effect of zhixiao tongmaining series granule in the treatment of DN, in order to provide the evidence for making a TCM characteristics plant for preventing and curing DN.Methods1 literature researchReviewed the literature of Diabetic nephropathy and Zhixiaotongmai-ning;Searched VIP(1995 to 2010.12) by computer search and manual search. Search the quantity of clinical controlled trials of Diabetic nephropathy of Traditional Chinese Medicine published every year, and then try to analyse it quantitatively.2 clinical research2.1 32 cases of DN were randomly divided into two groups. Those patients were early and clinical periods of diabetic nephropathy.2.2 In the basic treatment of diet therapy, hypoglycemia, hypotension and correcting dyslipidemia, the treatment group were treated by Zhixiao tongmaining, zhixiao wenshenning or zhixiao baoshenning,1 packet bid po; the control group were treated by Irbesartan, 1grain qd po. They were followed up every 3 months, and still 9 months.2.3 Their therapeutic effects include TCM symptoms, UAER,24hrUprV, SCr, GFR, FBG, PBG, HbAlc, blood lipids. Those were be evaluated;The safety effects include Blood routine, urine routine test, stool for routine, Liver function and ECG.2.4 After inputing and audit the data into database, all data was statistically analysied by SPSS18.0.Result1 Quantitative analysis of the literatureClinical controlled trials of DN treated by TCM from the beginning of a gradual increase in 1995, of which the number of randomized controlled trials from the beginning of 1999 was a significant upward trend in non-randomized clinical randomized controlled trials from 1999 the number increased, but increased the speed of the slowdown since 2000, and in 2000 less on randomized controlled trials. Articles published from year to year than to look at composition, clinical randomized controlled trials was also the proportion of the gradual upward trend. Clinical controlled trials of Chinese medicine in the random and the ratio of non-random in 1995-1998 from close to 0, to increase in 2010 is much larger than 4.2 clinical research2.1 Baseline:no significant(P>0.05)between two groups in sex, marriage, culture, occupation, age, weight, disease classification, syndromes classification of TCM and allergies, as well as main outcome measures, secondary outcome measures and quality of life evaluation were found. And no significant (P>0.05)were found in main outcome measures between patients in stage III, IV of two groups.2.2 Intention-to-treat of clinical efficacy:treatment after 3,6,9 months, there was no significant (P>0.05) between two groups in main outcome measures, secondary outcome measures and quality of life evaluation after treatment 3 months.The general Change Trend of main outcome measures of two groups was found stable(P>0.05), there was interaction between glomerular filtration rate and grouping, and the rising trends of treatment group was found more obvious than the control group (P<0.05). 2.3 Per-Protocll population of clinical efficacy:treatment for 3 months, There were no significant (P>0.05) in main outcome measures, secondary outcome measures and quality of life evaluation of two groups;treatment for 6 months, the serum creatinine and glomerular filtration rate of the treatment group were better than that in the control group(P<0.05);9 months after treatment, the main outcome measures, secondary outcome measures of treatment group compared with the control group, the difference was not significant(P> 0.05);Change Trend of main outcome measures of two groups in different periods of time were stable (P>0.05); treatment for 3 months, serum creatinine, scores of TCM symptoms, glomerular filtration rate were improved significantly (P <0.05) compared with before treatment;the downward trend of treatment group in serum creatinine, scores of TCM symptoms were more obvious than in the control group(P<0.05);compared the glomerular filtration rate in treatment for 6 months with in treatment for 3months, the treatment group rised more obviously than the control group(P<0.05).2.4 Efficacy score of TCM symptoms:treatment for 3,6,9 months, there was no significant(P>0.05)in the composition of clinical efficacy between the treatment group and the control group.2.5 The safety was evaluated as 1 level;adverse events occurred in 1 case which was regarded "unlikely related" to the study drugs.Conclusion1 These years, we have made grate progress on the research of DN by the treatment of TCM;Over the past 15 years, the quantity of randomized controlled trials of Traditional Chinese Medicine in terms of both absolute number or proportion of the rising trend year by year.2 Comprehensive Treatment project of TCM differentiation and Treatment have Positive clinical effects and good safety in treatment for early and clinical periods of diabetic nephropathy.There was the same general efficacy betweenTCM differential treatment group and control group at 3 months,6 months and 9 months;the degree of improvement on the glomerular filtration rate, serum creatinine, in the periods of 3-month and 6-month better than irbesartan.3 The therapeutic effects of series prescriptions as Zhixiaotongmaining in the early and the clinical periods of diabetic nephropathy further confirmed the pathogenesis rule what is Diabetes injured the qi and yin,also injure the yin and yang, and lead to the deficiency of qi and yin, as well as yin and yang, Chronic Diseases Transforming to Collaterals, the interaction of turbid phlegm, pathogenic heat, Blood Stasis, Qi depression lead to the formation of mini-abdominal mass, damage to the renal, then Renal dysfunction in the course of time.4 Comprehensive Treatment project of TCM differentiation and Treatment in the subject can't improve obviously the TCM symptoms and quality of life in early and clinical periods, and the reason was needed to further discussion.