Study On Quality Of Life Of Diabetic Nephropathy Based On Traditional Chinese Medicine Intervention Program

Objectives:1. The main aim of this study is to evaluate the treatment effects and impact on quality of life of patients with diabetic nephropathy through a clinical trial intervened by Chinese medicine, in order to provide evidence for determining effective interferance of DN by TCM.2. To study the relationship between QOL and other clinical outcomes such as TCM syndromes in order to provide evidence for determining effective evaluation system of DN treatment by TCM.3. analyzing the influencing factors of QOL of patients with diabetic nephropathy.Methods:First study:Study on the effect of the program of combined therapy of TCM on quality of life of diabetic nephropathy. With the support from "llth five-year" National Key Technology Research and Development Program-the Study on the Comprehensive Protocol of Whole-course TCM Intervention for the Development of DN(project number:2006BAIO4AO3-2), the cases were enrolled from6institutions (Dongzhimen Hospital of Beijing, etc). Select161cases which have completion clinical data of all eight observed courses for the study, to analyse its data such as quality of life scores, symptom scores and laboratory indicators.Second study:Study on the correlation of dynamic changes between TCM Syndrome and QOL of diabetic nephropathy. With the support from subproject of major scientific and technological projects on technical platform of new drugs clinical evaluation(project number:2011ZX09302-006-01), the cases were enrolled from4institutions (Dongzhimen Hospital of Beijing, etc). Select57cases which have completion clinical data of all five observed courses for the study, to analyse the data by statistical methods, such as generalized estimating equations and regression analysis.Results:First study:1Compared with control group, experiment group is better at improving WHOQOL-BREF psychological dimension scores and the total scores, experiment group improve quality of life of each dimension in WHOQOL-BREF better than control group; the same outcomes was found in DOQL.2There is an obvious correlation between the WHOQOL-BREF and DQOL; and there are different degrees of correlation between changes in all dimensions of quality of life in WHOQOL-BREF and DQOL after treatment. There is an obvious correlation between QOL and syndromes, and changes butween quality of life scores and the syndrome scores is closely related too. Glycemic, urine protein and individual dimensions of quality of life score has some relevance, there is no correlation bttween serum creatinine and QOL. 3Patients with different syndromes are different in quality of life, patients with both yin and yang deficiency syndrome have more severe damage to the quality of life compared to patients with yin deficiency and yang deficiency, patients with yin deficiency have poorer responsiveness to treatment than patients with the other two types. Patients in clinical stages are in quality of life, patient in4th stage is more serious and poorer responsiveness to treatment than in3rd stage. Patients with longer course of disease have poorer quality of life and responsiveness to treatment. The older ones also have poorer quality of life and responsiveness to treatment. Some differences in quality of life between men and women, but there was no statistically significant, and responsiveness to treatment of women is more sensitive than men.Second study:1Two treatments are available to improve patient symptom scores and quality of life score, and the longer the treatment, the better the effect. Compared with control group, experiment group is better at improving QOL and syndrome.2Trends between changes of syndrome and changes of WHOQOL-BREF physical domain dimension, WHOQOL-BREF psychological field dimension, WHOQOL-BREF quality of life and DQOL physiological functions dimension, DQOL psychological spiritual dimension, DQOL quality of life are identical in experiment group. Trends between changes of syndrome and changes of WHOQOL-BREF social relations dimension, DQOL social relations dimension, DQOL treatment response dimension are similar. Trends between changes of syndrome and changes of WHOQOL-BREF environmental field dimension are different.3Correlations between changes of syndrome scores and changes of scores in WHOQOL-BREF social relations dimension, WHOQOL-BREF environmental field dimension, DQOL social relations dimension, DQOL treatment response dimension are not significant. While Correlations between changes of syndrome scores and changes of scores in WHOQOL-BREF physical dimension, WHOQOL-BREF psychological dimension, WHOQOL-BREF total scores, DQOL physical dimension, DQOL psychological dimension, DQOL total scores reached a significant level.Conclusion:1Based on diet control and basic treatment such as reduce blood pressure, reduce blood glucose, reduce lipid and so on, combined traditional Chinese medicine cuold not only improve health closely related to the physiological function of the body, but also improve mental and psychological health. Compared with Irbesartan, TCM program is better at improving QOL and syndrome. To analyse repeated measurement data of QOL and syndrome by generalized estimating equations, we found that both treatment program can improve QOL and syndrome of patients of diabetic nephropathy, and the longer the better treatment efficacy. 2Syndrome of diabetic nephropathy is closely related to quality of life. There are linear correlations between changes of syndrome scores and changes of scores in WHOQOL-BREF physical dimension, WHOQOL-BREF psychological dimension, WHOQOL-BREF total scores, DQOL physical dimension, DQOL psychological dimension, DQOL total scores. To use syndrome scores of diabetic nephropathy as a standard of treatment effect is trusted and feasible, for there is a consistency between the assessment of syndrome and assessment of QOL.3The QOL influencing factors include different Syndromes, different clinical stages, course of disease, age, sex. Patients with Yin deficiency who have poorer responsiveness to treatment should receive long-term treatment. Patients in4th stage, have long disease course, old, show poor QOL and low responsiveness to treatment, hence these patients should be the focus of future diabetic nephropathy research.4Different values and social structure from different cultural backgrounds, there are some differences in content of quality of life between western and our coutry. So assessment tools which just a simple translation comes from abroad can not fully meet the needs of our country, especially in the field of TCM.