| Background:Type 2 diabetes mellitus (T2DM) is an endocrine disease with the feature of high plasma glucose which course by both of genetic factors and environmental factors, it often occurrences serious complications in ketoacidosis, hypoglycemia, great vessels, microvascular, and peripheral neuropathy, as a main reason of death, disability and increased medical costs. Now widely recognized that insulin resistance (IR) andβcell dysfunction are important aspects in the course of T2DM. The diabetes prevention strategy that intensive blood glucose control and comprehensive treatment of cardiovascular risk factors are baese on the results of DCCT and UKPDS studies, and it has been effectively delay diabetes and its complications. But there are still many shortcomings in the prevention and treatment of T2DM. Such as intensive blood glucose control greatly increases the risk of hypoglycemia; Using single Sulfonylurea mostly invalid after 5 years, it is mostly because ofβ-cell's defects, which causes insulin secretion progressively decreased. In order to obtain good glycemic control, patient often need to use different oral hypoglycemic drugs or combine with insulin; IR is the common risk factor for many cardiovascular events, who is throughout the disease, but current drugs have limited role in improving the IR. And current drugs also have disadvantages in instability efficacy, liver and kidney damage, high cost etc. So its use is subject to certain restriction.Type 2 diabetes mellitus belong to Xiaoke disease in Traditional Chinese Medicine. People generally believed that polydipsia, polyuria, diuresis and emaciation are its main clinical festations, Yin Asthenia and Dryness Heat are its main pathogenesis. But in clinical practice, my tutor Professor Lin Mian found, that the incipient type 2 diabetic mellitus patients in addition to have the typical symptoms of the above, the majority accompanied by symptoms of Qi-Yin Deficiency, such as lassitude, shortness of breath, disinclination to talk, thirst, greasy fur, etc. The symptoms are always existing throughout the disease, while the symptoms of polydipsia, polyuria, diuresis and emaciation had improved after treating with hypoglycemic medicine. So that the Qi-Yin Deficiency is an important pathologic basis of T2DM, which is rerult of Splenic Asthenia and Phlegm. Therefore, he proposed that T2DM should be treated by invigorating the spleen and eliminating phlegm, supplementing Qi and nourishing Yin, using Li's Qing Shu Yi Qi Decoction. This study observed the clinical efficacy of Li's Qing Shu Yi Qi Decoction in patients with T2DM who are Splenic Asthenia and Phlegm, Qi-Yin Deficiency, and investigates its effect in IR andβcell function.Purpose:To observe the clinical efficacy of Li's Qing Shu Yi Qi Decoction in patients with T2DM who are Splenic Asthenia and Phlegm, Qi-Yin Deficiency, and to preliminary investigate its effect in IR andβcell function, to provide clinical basis for the treatment of T2DM in Tradictional Chinese Medicine.Patients and Method:The prospective trial is performed in Zhongshan Hospital of TCM, between Aug 2009 and Apr 2010,60 hospital or clinic patients with newly diagnosed T2DM were enrolled. Both groups have 30 patients. All patients received diabetes education, a unified program of diet and exercise therapy. Project for Western Group:treating with Sulfonylurea+ Metformin; Project for TCM Group:the treatment of western medicine is the same as Western Group, combined with Lee Ching Shu Qi Decoction. Observed 60 days, evaluated the efficacy and security before and after treatment. The observational points included TCM integration, fasting and postprandial 2 hour plasma glucose, glycated hemoglobin, lipids, Homa insulin resistance index, Homa insulin secretion index.Results:Li's Qing Shu Yi Qi Decoction can significantly improve the clinical symptoms, decrease the symptom score. Compare with the control group, there is significant difference (P<0.05);Fasting plasma glucose, postprandial 2 hour plasma glucose, glycosylated hemoglobin, lipid level decreased than that before treatment,while Homa insulin resistance index was significantly lower, Homa insulin secretion index was significantly increased. The treatment group had a better integrated effect of the disease than the control group, showed significant difference (P＜0.05).Conclusions:For patients with T2DM of Splenic Asthenia and Phlegm, Qi-Yin Deficiency, Li's Qing Shu Yi Qi Decoction has good effect in improving clinical symptoms and IR, protecting theβ-cell function. |
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