| Primary sjogren’s syndrome is a kind of chronic, inflammatory and autoimmune disease. It invades the exocrine glands, especially the salivary gland and lacrimal gland and shows the typical dry mouth and dry eye. In addition, its characteristic clinical manifestations are repeated swelling of the parotid gland, joint pain, purpura, rampant tooth and so on. When the disease progress seriously, patients may appear multisystem damage, such as renal insufficiency, pulmonary interstitial fibrosis, atrophic gastritis and so on.At present, the pathogenesis of this disease in modern medicine is still in the stage of research. There is still no special cure and drug in the treatment of the disease. Corticosteroids hormones and immunosuppressive drugs are used for clinical application. But, their long-term efficacy is not good and systemic side effect is big. So traditional Chinese medicine treatment of the disease reflect some advantages such as symptoms relieving obviously, small side effect, safe and being able to improve the patients quality of the life.Professor Lu Zhizheng, the master of traditional Chinese medicine is one of the top experts of rheumatology in traditional Chinese medicine. He created the name "Dry Bi" in traditional Chinese medicine, and put primary sjogren’s syndrome in it. Combining with the decades of experience of medical using of himself, Professor Lu Zhizheng created "Reinforcing Qi and Nourishing Yin" as the basic solution of the traditional Chinese treatment of the disease. He create "Moistenning Dryness Formula of Lu" to cure the dryness, joint pain and other symptoms.Obiective:Evaluating the therapeutic effect of the dry eye symptoms of patients with primary sjogren’s syndrome whose pathological type is Qi and Yin deficiency about using moistenning dryness formula of Lu. At the same time, Evaluating the clinical application value of moistenning dryness formula of LuMethod:This study is based on the capital medical fund development project. The research is the study that based on the experience of Professor Lu Zhizheng about Evaluating the therapeutic effect of traditional Chinese medicine treating sjogren’s syndrome. My study includes 64 cases of patients with primary sjogren’s syndrome whose pathological type is Qi and Yin deficiency. This study use open clinical trial and before-after self-contrast method. The patients are taking moistenning dryness formula of Lu for 3 months and followed up at Month 0,l,2and3, the each evaluation point. In follow-up, the patients give score of dry eye symptoms, dry eye visual analogue scale, Chinese medical syndrome, joint pain and nocturnal enuresis. At Month 0 and 3, the patients take the inspection including Schirmer I test, blood routine, urine routine, electrocardiogram, liver function, renal function, anti-SSA antibody, anti-SSB antibody, anti-nuclear antibody, rheumatoid factor, immunoglobulin and erythrocyte sedimentation rate. At last,use the date in the follow-up to evaluate the therapeutic effect and safety of the dry eye symptoms of patients with primary sjogren’s syndrome whose pathological type is Qi and Yin deficiency about using moistenning dryness formula of Lu.Result:Firstly, using moistenning dryness formula of Lu to treat the dry eye symptoms of patients with primary sjogren’s syndrome whose pathological type is Qi and Yin deficiency is working at Month 1 and the therapeutic effect has a growth trend as time going on. At Month 3 when the study is over, the effect is very outstanding. The total effective rate of the score of dry eye symptoms and visual analogue scale are 68.75% and 90.63%.Secondly, the moistenning dryness formula of Lu can improve the Chinese medical syndrome of patients with primary sjogren’s syndrome. Its therapeutic effect has a growth trend as time going on. The total effective rate of the score of Chinese medical syndrome is 90.63%. The moistenning dryness formula of Lu can also improve the level of Schirmer I test, rheumatoid factor and immunoglobulin of the patients.Thirdly, the moistenning dryness formula of Lu can treat joint pain and nocturnal enuresis of the patients.Lastly, in the evaluation of the safety of the moistenning dryness formula of Lu treating the patients with primary sjogren’s syndrome whose pathological type is Qi and Yin deficiency, find that it has no effect on blood routine, urine routine, electrocardiogram and liver function. But it has some effect about creatinine in renal function. The level of the creatinine has a growth trend as time going on. But it is all within the normal range and no adverse events appear.Conclusion:The result of this study accounts for that the therapeutic effect of the dry eye symptoms of patients with primary sjogren’s syndrome whose pathological type is Qi and Yin deficiency about using moistenning dryness formula of Lu is very outstanding. It is safe in short period and no adverse events appear. But we still need a same type study with longer period of time and lager sample to evaluate its long-term efficacy and safety. Moistenning dryness formula of Lu is worth to promotion in clinic. |
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