| Sj?gren's syndrome (SS) is an autoimmune disease that is characterized by infiltration of exocrine tissues especially salivary glands and lacrimal glands., resulting in xerostomia(dry mouth) and keratoconjunctivitis sicca (dry eyes). Dry mouth, dry eyes, recurrent enlargement of parotid glands and arthralgia is the main clinical symptoms of the patient.The degree of clinical condition is different. Primary Sj?gren's syndrome (PSS) is the simple Sj?gren's syndrome without another connective tissue disease which is definitely diagnosed. Research shows that PSS is the result of integrated effect with environment, inheritance, immunity and infected factors ect. Its main morphological change is chronic progressive lymphocytic infiltration of exocrine glands, hyperplasia, destruction, atrophy and substituted by hyperplasia fibrous tissue of the epithelium of gland, and external gland vasculitis which is caused by Cryoglobulinemia, hyperglobulinemia or/and deposit of immunity complex mainly with the middle and small vasculopathy. Endarteritis obliterans can be induced by long-term vasculitis. The western medical treatment has its side effect, therefore, develop the effective Chinese patent medicine is the urgent mission. Jinjuqingrun capsule is a pure Chinese drugs pharmaceutics, developed by Pro. Wu Yi-ling under the directions of Traditional Chinese medicine (TCM) Meridian Theory, and obtained manifest therapeutic effect on the clinical and experimental study till now.Objective:Discuss the Primary Sj?gren's syndrome's Chinese medicine path mechanism and treatment by the way of TCM Meridian Theory; Establish composing prescriptions of Jinjuqingrun capsule in treating PSS under the Direction of TCM Meridian Theory. Preliminarily clarify the clinical effect of Jinjuqingrun capsule, Futher investigate its mechanism from immunological Theory through Observing the improvement of clinical symptoms ,TCM syndromes, immunological functions, morphology and functions to the exocrine glands by treating with Jinjuqingrun capsule's.Methods:1 Basing on the collection and sorting all discussions of PSS in the past dynasties and advancement of PSS with modern medicine, we discuss the Chinese pathological mechanisms of PSS under the theory of TCM Meridian Theory2 According to the hospitalization date and the random-double blind-control principle, the PSS patients was randomly divided into 2 groups, the curing group and the control group,50 cases per group. Patients of curing group were treated with Jinjuqingrun capsule and placebo, Patients of control group were treated with prednisone tablet and placebo. Patients of both groups were treated with the artificial tears. Course of treatment is 90 days. Compare the changes on the index of the pre- and post-treatment clinical curative effect scores, TCM syndrome scores, detect the salivary flow rate, tear flow rate, parotid sialography, pathology of labial salibary gland, Autoimmumn antibody, Serumγ-globulins and T lymphocyte subsets ,serum BAFF level ect.Results:1 According to the clinical manifestation of PSS, it should belongs to dyness syndrome category of Traditional Chinese Medicine."deficiency of qi and yin"is its pathogenesis basis of TCM,"body fluids consumed by dryness-heat, phlegm and blood stasis"is its main main pathogenesis."collaterals rest product form"is its pathologic changes designed. the treatment method of supplementing qi and nourishing Yin , clearing heat and moisturizing dryness, dredging collaterals and eliminate product as well as created Jinjuqingrun capsule and its composing prescription.2 Clinical research shows: the clinical effect score statistic result shows that the marked effect rate of curing is 55.10%,and the total effective ratio of curing group is 95.92%, and that of the control group is 28.26% and 80.43%, manifest difference exit between these two groups, p<0.05; the change of Chinese medical symptom score statistic result shows that the the marked effect rate of curing is 75.51%,and the total effective ratio of curing group is 97.96%, and that of the control group is 30.43% and 78.26%, manifest difference exist between these two groups, p<0.01. In this study, the patients in the control group appeared side-effects such as slight hepatic dysfunction, increasing fasting serum glucose, femoral head necrosis and central obesity. On the contrary, Jinjuqingrun capsule has exact curing effect without any side-effect, these shows that Jinjuqingrun capsule is better than prednisone tablet.3 Study on the morphology and functions to the exocrine glands shows: Treating with Jinjuqingrun capsule can not only increase the salivary flow rate and tear flow rate markedly, but also improve the shap of the main and branch dilated catheter of parotid gland and reduce focal lymphocytic infiltration,which indicate that treating with Jinjuqingrun capsule can rehabilitate destruct exocrine tissues.4 The study on the immunity shows that : Treating with Jinjuqingrun capsule can obviously decrease Serum immu-globulins, Serumγ-globulins, anti-SSA, anti-SSB, anti-ANA et.which indicate that treating with Jinjuqingrun capsule can restrain abnormal humoral immunity; through increasing the percentage of CD8+T cell, decreasing the ratio of CD4+T/ CD8+T, so as to inhibition Th cell proliferation, promote Ts cell activation and result in redistribution of T lymphocyte subsets .All these show that it can rectify abnormal immune response, induce balancing autoimmune .5 Influence on cytokines:Through reducing the excretion of BAFF, Jinjuqingrun capsule can suppresse B cell producing auto-antibodies mainly as molecular HLA-DR and anti-SSB by inhibiting cell proliferation, Which reflects in one aspect that it resolves blood-stasis and meanwhile regulates humoral and cellular immune as to exert immunological effect ,reach the effective therapy through regulating cytokine network.Conclusions:1 It's the first time using Chinese medicine (TCM) Meridian Theory to investigate TCM pathogenesis and therapy of PSS in this study. Suggest that PSS is based on long-time"deficiency of qi and yin", resulted in body fluids consumed by dryness-heat, phlegm and blood stasis, ended to collaterals rest product form. designed the treatment method of supplementing qi and nourishing Yin , clearing heat and moisturizing dryness, dredging collaterals and eliminate product as well as created JinJuQingRun capsules and Composing Prescription. have the certain theories innovation.2 From the study of clinical effect and TCM syndrome, it shows: Jinjuqingrun capsule can significantly improve clinical symptom and TCM syndrome.3 Investigating the changes of the function and morphology to the exocrine glands through testing the salivary flow rate ,tear flow rate , parotid sialography and pathology of labial salibary gland shows: Jinjuqingrun capsule has efficacy not only relieving the clinical symptoms but also repairing injured gland tissues. 4 The study on the immunity shows that : Through reducing the excretion of BAFF, Jinjuqingrun capsule can restrain abnormal humoral immunity, by increasing the percentage of CD8+T cell, decreasing the ratio of CD4+T/ CD8+T, so as to inhibition Th cell proliferation, promote Ts cell activation and result in redistribution of T lymphocyte subsets .All these show that it can rectify abnormal immune response, induce balancing autoimmune .
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