| ObjectiveThis study aimed to evaluate the efficacy of treatment for warming Shen and invigoration Pi in treating patients of diabetic and its effect on patients'Quality of Life (QOL). To systematically explore the mechanism of traditional Chinese medicine (TCM) on the illness and the mechanism of Modified Zhen Wu Tang on preventing and treatingMethods82 patients of diabetic were enrolled in a randomized, controlled study and divided into treatment group and control group, both groups received conventional therapy. Patients in the treatment group took Modified Zhen Wu Tang on the basis of conventional western treatment, while members of control group were treated with Aspirin enteric-coated tablets and Benazepril tablets. The test cycle was 6 weeks. And than evaluated the comprehensive effect on patients of two groups, In addition, all patients'clinical symptoms and some important indicators, such as Fasting blood glucose (FBG),2-hour postprandial blood glucose (P2hBG), glycosylated hemoglobin (HbAlc), fasting insulin (FINS), insulin resistance index (HOMA-IR), total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), fibrinogen (FIB), C-reactive protein (CRP) were contrasted between two groups as well as in the own control. The patients'QOL was evaluated by DSQL Scale.Results(1) The clinical comprehensive curative rates in the treatment group was 76.9% and in the control group was 55.3%, there were no statistical significant difference between two groups (P>0.05); (2) Compared with pre-treatment, the total scores of symptoms in two groups were significantly decreased after treatment(P<0.05, P<0.01), and the treatment group decreased significantly (P<0.01); The clinical efficacy on symptoms of TCM was 92.3% in the treatment group and 73.7% In the control group, there were statistical significant difference between two groups (P<0.05); Compared with the control group, each symptom score in the treatment group improved inordinately after treatment; (3)The levels of FBG, P2hBG, HbA1c decreased significantly in both groups after treatment(P<0.05, P<0.01), but there were no statistical significant difference between two groups (P>0.05); (4) There were statistical significant difference on FINS and HOMA-IR in the own control of the treatment group (P<0.01), but there were'nt it in the control group(P>0.05), there were statistical significant difference between two groups before and after treatment; (5) The levels of TC,TG,LDL decreased significantly in both groups (P<0.01), but there were no statistical significant difference between two groups(P>0.05); The level of HDL increased significantly in the treatment group after treatment, but there was't it in the control group(P>0.05); (6)The levels of CRP and FIB decreased significantly in both groups after treatment (P<0.05, P<0.01), and there were statistical significant difference between two groups(P<0.05); (7)Renal function in the treatment group was improved more significantly compared to the control group(P<0.01), and other indicators of safety, such as liver function, remained unchanged in both groups during the test; (8)Analysis of QOL during treatment, the score on the treatment dimension in the control group increased significantly(P<0.05), and there were upward trends on the scores of the psychological, social and total dimension, while the physical dimension declined, however, there were no significant difference during treatment(P>0.05); Besides social dimension, the scores on the overall dimensions in the treatment group decreased significantly(P<0.01), and and there were statistical significant difference between two groups(P<0.05).Conclusion(1)Spleen-kidney-yang deficiency is the major mechanism of TCM on the diabetes and its chronic complications; (2)there is an ideal indicator on QOL to evaluate efficacy on the treatment of diabetes and its chronic complications with TCM; (3)With theoretical guidance of warming Shen and invigoration Pi, Modified Zhen Wu Tang can improve clinical symptoms and QOL in persons with diabetes and its chronic complications;(4)Modified Zhen Wu Tang, it can help patients to decrease blood sugar, control blood sugar fluctuations, improve insulin resistance, and increase insulin sensitivity; (5)Modified Zhen Wu Tang has a role in regulating blood lipids, can significantly decrease the level of plasma CRP, thereby reducing vascular inflammation and having the protection of the role of vascular endothelial function; (6) Modified Zhen Wu Tang can significantly decrease the level of plasma FIB, improve microcirculation and prevent the occurrence of thrombotic diseases; (7) Modified Zhen Wu Tang have a certain protective effect on renal function, the drug safe and effective, there is no obvious side effects, and it's worth-popularizing.
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