Objective:This subject study the efficacy and safety of treatment for type 2 diabetes (syndrome of spleen qi deficiency clip dampness) by Zhupisanjing therapy, adopting randomized and contrast methods. The mechanism is also explored, to provide the basis for the application.Methods:Through systematic review of Traditional Chinese and Western medicine studies of type 2 diabetes and combined with the experience of my supervisor, the thesis indicates the spleen qi deficiency, dampness block and essence errors as the importance of disease pathogenesis of type 2 diabetes (syndrome of spleen qi deficiency clip dampness),establishing Zhupisanjing as the key method of remedy and using the Shenqisanjing Decoction to treat. The 86 patients which meet the diagnostic criteria and inclusion criteria, are randomly divided into 2 groups, i.e. the treatment group of 43 patients and the control group of 43 patients. The treatment group is treated with Shenqisanjing Decoction, Metformin hydrochloride tablets and the basic treatment, while the control group doesn't use the Chinese medicine. Both groups are observed for 8 weeks. The changement before and after treatment, and the changement of the indexes such as clinical symptoms, FPG,2hPG, HbA1c, TC, TG, BMI are observed. The obtained data are taking statistical analysis by SPSS13.0 statistical software.Results:(1)Shenqisanjing Decoction improves the languid, abdominal swelling and other clinical symptoms in patients which suffered by type 2 diabetes (syndrome of spleen qi deficiency clip dampness) than the control group (P<0.05).The clinical efficacy cases in treatment group are7 (17.1%), effective cases are 26 (63.4%),invalid cases are 8 (19.5%), the total effective rate was 80.5%. The contrast group has 2 clinical efficacy cases (5.1%), effective cases are 22 (56.4%), and the ineffective cases are 15 cases (38.5%), the total effective rate was 61.5%. The treatment group gets ahead of the contrast group (P<0.01).(2) After treatment, the FPG,2hPG, HbA1c were significantly lower than before (P<0.01), but the comparison between groups shows that the treated group is better than the contrast group(P<0.01 or P<0.05). TC, TG are reduced in both groups, but after treatment TC has no significant difference between the groups (P>0.05); the treated group has the better treatment of TG than the contrast group (P<0.01);(3) After treatment, BMI decreased in both groups compared with the situation before treatment (P<0.05), but there is no statistical significance between the comparison between the groups (P>0.05). (4) The gastro-intestinal tract adverse events,the treatment group has 2 cases (5.0%), the control group 6 cases (14.0%), no other side effects in both groups.Conclusions:(1) Zhupisanjing method of treatment for type 2 diabetes (syndrome of spleen qi deficiency clip dampness) can effectively improve the clinical symptoms, lowering blood glucose, blood lipids and improve the control of body weight; (2)The treated group had low incidence of gastrointestinal reactions and the patients have more tolerance to ensure the adherence of the treatment, which has a better prospects.
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