The Clinical Research Of Sini Powder Combined With Zhenwu Decoction To Patients With Type 2 Diabetes Mellitus Overlapped Nonalcoholic Fatty Liver Disease(T2DM-NAFLD)

Objective:To prove effectiveness and superiority of Sini powder combined with Zhenwu decoction by observing the role it plays in treating T2DM-NAFLD. And also to provide a basis for clinical application to treat T2DM-NAFLD and to explore possible target of traditional Chinese medicine.Method:Randomized controlled trial(RCT) was used, eligible patients were chosen and randomly divided into three groups, that is treatment group, western medicine control group and Chinese patent medicine control group. The three groups were based on eating, exercise and guidance of diabetes mellitus and on blood glucose reduction, lipid regulation and enzyme declination. Meanwhile, patients of treatment group used traditional Chinese medicine decoction which is based on Sini powder combined with Zhenwu decoction, western medicine control group took orally inositol tablet, and Chinese patent medicine control group took orally Xuezhikang tablet. Each group self-monitored blood glucose at least once a week.Subsequent visit for each two weeks or one month and adjust drug, and observe the patients for total 12 weeks. Then, establish database by SPSS17.0 and make statistical analysis, to compare differences of each index before and after treatment and to assess the effect.Result: Patients with stagnation of phlegm and blood stasis and T2DM-NAFLD are total135 persons, and 45 persons for each group. Age, gender and course of disease and other baseline data of patients before treatment have no significant difference by analysis of statistics. And the three sets of data are comparable, P >0.05.Comparison for curative effect:① Improvement of signs and symptoms. After treatment, symptoms improve obviously.And total effective rate is 86.67% for treatment group, 68.89% for western medicine control group, and 80% for Chinese patent medicine control group. After treatment, clinical symptoms scoring in each group is decreased. But in the comparison group, the difference before and after treatment of treatment group and Chinese patent medicine control group has statistical significance. And the treatment group and Chinese patent medicine control groupafter treatment, the difference is statistically significant. For improvement of signs and symptoms, treatment group is better than control group, P <0.05.② Influence for blood glucose and blood lipid. The research is based on the strict control of blood glucose and blood lipid. The blood glucose of patients in each group is controlled in good range in treatment. FBG and 2hPG of treatment group have difference before and after treatment, P <0.05, while that of control group have not any obvious changes, P >0.05.③ Improvement for pancreatic function. Fins, 2hIns and HOMA-IR of treatment group and control group both have reduction. In the comparison group, the difference before and after treatment of treatment group and Chinese patent medicine control group has statistical significance. HOMA-IR difference of treatment group and Chinese patent medicine control group after treatment has statistical significance, P <0.05.④ Influence on liver function. Liver function of patients in each group is controlled in good range. Each group before and after treatment, the difference has no statistical significance, P >0.05.⑤ Influence on liver imaging. After treatment,the effective rate is 84.44% for treatment group, 66.67% for western medicine control group, and 77.78% for Chinese patent medicine control group. Upon examination, the treatment control group and western medicine control group effective rate has statistical significance, P <0.05; the treatment control group and Chinese patent medicine control group has statistical significance in efficiency, P <0.05.Comparison within the group by the degree of fatty liver, before and after treatment showed significant difference has statistical significance, P <0.05, comparisons between western medicine control group before and after treatment, the difference has no statistical significance, P >0.05, comparisons between Chinese patent medicine control group before and after treatment, the difference has statistical significance, P <0.05.Security index: Security index of patients in each group is all in the normal range.Conclusion: From primary clinical study, Sini powder combined with Zhenwu decoction is able to improve clinical symptoms of patient with T2DM-NAFLD and IR, reduces blood glucose and adjusts blood lipids. It is safe and effective, and has extensive application prospect. We should continue to study in depth.