The Clinical Research Of The Effect On T Lymphocytes Immune Function Of Type 2 Diabetes Mellitus With The Treatment Of Warming Viscera, Reinforce The Healthy Qi And Eliminate The Pathogenic Factors

Background:In recent years,Chinese medicine has gradually reflected a unique advantage in the treatment of type 2 diabetes mellitus(T2DM) and its complications.The role of multi-targets owned by TCM can regulate the body immune function so as to achieve the goal of 'reinforce the healthy qi to eliminate the pathogenic factors,eliminate the pathogenic factors without the healthy qi damage'.With the improvement of living standards and lifestyle changes,the incidence rate of Type 2 diabetes is getting higher and higher. It has become the third disease which result in death following after the tumor and cardiovascular diseases.For the treatment of this disease,most Chinese medicine doctors use the combination method of syndrome differentiation and disease differentiation.The common therapeutic methods include inriching yin and clearing heat,tonifying qi and inriching yin,clearing heat and engendering fluid,fortifying the spleen and resolving dampness,activating blood and resolving stasis,etc.The mechanisms are related to improving insulin resistance,adjusting the disorders of blood glucose and lipid, reducing inflammation etc.The research mentioned above deepened our knowledge of TCM treatment on T2DM.Nevertheless,there are still a lot of problems that need to be settled urgently in this field.Many factors such as constitution, environment and living habit are related to T2DM occurrence.Different treatments work at different stages of this disease.How to embody the 'syndorme differentiation' of the treatment demands further studied.Objective:The characteristic of healthy qi and yang qi deficiency is found in clinical on T2DM patients.From the six-meridian syndrome differentiation point of view T2DM occurs based on san-yin disease which complicated by lesser yang disease and controlled by greater disease.Based on the treatment of 'warming viscera,reinforce healthy qi and eliminate the pathogenic factors' a decoction named WenZangFuZhengquxie(WZFZ) was produced.This research is to observe the effect of WZFZ in the T2DM clinical,the improving symptoms of TCM,the improving insulin resistance,the adjusting blood blucose and lipid,the regulation of T lymphocytes immune function and primarily probe its mechanism.Methods:1.The present status of TCM study on T2DM is reviewed in literature research.At present,yin deficiency with internal heat and deficiency of qi and yin are the most two common mechanisms of T2DM in TCM point.Under these theories influence clinical doctors get used to the treatment methods like inriching yin and clearing heat,tonifying qi and inriching yin,fortifying the spleen and activiting blood,etc.But it is rarely in the study based on Treatise on Cold Damage Diseases and six-meridian syndrome differentiation.2.73 T2DM patients who were diagnosed with deficiency cold syndrome blongs to san-yin disease were randomly divided in to two groups:treating group(n=38) and control group(n=35).All those patients were selected from the endocrinology clinic of the First affiliated hospital of Guangzhou university of Chinese Medicine during March 2007 to March 2009.2 groups were giver the same basal treatment including education course for diabetes,diabetic diet and moderate exercise.Patients in the control group attended to metformin hydrochloride(0.50g,po,bid,after meals) and gliclazide(80mg,po,bid, before meals).And to those in the treating group,WZFZ therapy was given additionally,one dose taken in twice a day.After 1 month' s treatment,the curative effect and Chinese medical syndromes were observed.Moreover,fasting blood glucose(FBG),post-prandial 2-hour blood glucose(P₂hBG),blood lipid, fasting insulin(FINS),insulin resistance index(IRI),insulin sensitivity index(ISI),CD4+,CD8+ and CD4+/CD8+ were measured and compared before and after treatment. Results:1.The difference among sex,age,TCM syndromes,FBG,P₂Hbg,blood lipid and T lymphocytes immune function were not signification between treating group and control group(P＞0.05).2.Based on controlling the blood glucose availability,the total ratio of effective of treating group was 84.3%,control group was 65.7%.Compared with two groups,treating group was obviously excel to control group(P＜0.05).In the total effective ratio of TCM syndrome,the treating group achieved 100.0%significantly higher than the control group 74.3%(P＜0.05). Both groups had a obviously decrease in the syndrome scores(P＜0.05),while in the comparison of difference treating group was superiorer to control group (P＜0.05).FBG and P₂hBG lowered in both groups(P＜0.01),but no difference was found between the treating group and control group(P＞0.05).Both groups can decrease the FINS and IRI as well as increase the ISI(P＜0.05).Also, no difference was found between groups(P＞0.05).Both groups worked good in blood lipid regulation with a significant difference compared with before treatment(P＜0.05).Compared with two groups,treating group was superior to control group in decreasing TC,TG,and LDL-C(P＜0.05),but not significant in increasing HDL-C(P＞0.05).In the aspect of adjusting T lymphocytes immune function,compared with their levels before treatment separately,treating group made a better effect in increasing the levels of CD4+,CD8+ and CD4+/CD8+ (P＜0.05),however,the control group not(P＞0.05).3.There are no toxicity and side-effect in tow groups.Conclusions:1.Yang qi of human body is deficient easy,and the deficiency of yang qi can also incur to diabetes.The same situation occurs when the healthy qi is deficient.The yang qi deficiency of san-yin disease complicated by the lesser yang disease is the main mechanism of T2DM.All the pathogenic factors include cold,dampness,phlegm and static blood are produced on this basis. According to this characteristic,a treatment method named 'warming viscera, reinforce healthy qi and eliminate the pathogenic factors' is established. And this method is used to warm the viscera of san-yin,reinforce the healthy qi,harmonize lesser yang and eliminate the pathogenic factors.2.The WZFZ can increase the clinical efficacy of T2DM,decrease the TCM syndromes,lower FBG and P₂hBG,improve insulin resistance and injust the disorders of blood lipid.3.Diabetic patients have a significant lower T-lymphocyte function which closely related with the healthy qi of body than normal person.WZFZ can increase the levels of CD4+,CD8+ and CD4+/CD8+ to improve the T lymphocyte function of diabetic patients and enhance the immunological function of body. The therapeutic mechanism for T2DM is not depend on the controlling blood glucose availability,but is probably pathway of relating to regulate the immunological function.It can regulate organism all round through neuro-endocrinc-immunomodulation network of the whole body.