The Clinic And Experimental Research Of "Homogeny Of Clear Fluid And Blood" For Treatment Of Primary Sjogren’s Syndrome

Sjogren’s syndrome (Sjogren’s syndrome, SS) is a chronic autoimmune disease, which mainly destroys systemic exocrine gland, especially salivary and lacrimal gland. It also affects respiratory, digestive, nephritic, neural and hemal system, Its etiology and pathogenesis is still not fully clarified. There is no ideal therapy now, substitutive therapy and heteropathy are mostly used, but clinical therapeutic effects and safety of drugs should be verified further. With the theory of "homogeny of clear fluid and blood" and treatment based on syndrome differentiation, we used Shengjinyangxue granule to treat SS of blood cells decrease in clinic. Comparing with control group which treated by hydroxychloroquine, we tried to evaluate therapeutic effect and safety of Shengjinyangxue granule.Objective: Comparing with control group which treated by hydroxychloroquine,we objectively evaluate the efficacy and safety of Shengjinyangxue granule, which afford the theories and methods for treatment in SS blood cells decrease by Chinese traditional medicine. Synchronously, we studied the effect of Shengjinyangxue granule in the treatment of SS mice, in order to seeking effects and relevant mechanisms of Shengjinyangxue granule.Method: Based on the principles of randomization, non-blind, antitheses, we selected 36 patients with the diagnosis of primary Sjogren’s syndrome and blood cells decrease and TCM in line with the standard syndrome of blood deficiency and depleted fluid. The observation of patients are completed. Thirty six patients were randomly divided into two groups, one group of 18 patients in treatment of Shengjinyangxue granule and control group of 18 patients in treatment of hydroxychloroquine. The period of treatment is three months. We used mice submandibular gland to make ICR of SS mice immuned as the model in animal experiment, while providing Shengjinyangxue granule. In four weeks of the experiment, we measured the quantity of drinking and saliva weekly, executed the mice in the last remedy, and took away submandibular gland, thymus and spleen, lastly calculated their exponential. In addition we took partial submandibular gland to examine the anti-CD4, CD8 by flow cytometry (FCM), and did pathological examination.Results: Shengjinyangxue granules have the significant effect in improving the clinical symptoms and body signs of patient (p<0.01), increasing the quantity of saliva (p<0.01) and blood cells (p<0.05), and have a nicer comprehensive effect than the control group (p<0.05).The two groups both have good security in the clinical study. The animal experiment confirms that Shengjinyangxue granule have significant effects which can reduce water drinking, promote glandular secrete, reduce the ratio of CD4/CD8 and CD4, prevent the immune organs atrophy and reduce pathological changes.Conclusion: The clinical study confirms that Shengjinyangxue granule granules can improve the clinical symptoms and body signs of patient, increase the quantity of saliva and blood cells, and have the nice security. The animal experiment confirms that Shengjinyangxue granule can promote glandular secrete, prevent the immune organs atrophy and reduce pathological changes.