| Primary Sjogren’s Syndrome (pSS) is a systemic autoimmune disease whose etiology and pathogenesis is still undefined up to date. In most cases scholars regard its etiology of close concern with virus infection, inheritance, estrogen abnomity and autoimmune reaction etc. Recent study on its mechanism abroad mainly focuses on the development of inflamationary factors, and it has been generally accepted by foreign scholars that ESSPRI (EULR Sjogren’s Syndrome Patient Reported Index) is safe and sound raised by EULAR. Domestic research on this disease is mostly the analysis of immune markers of salivas and application of imaging diagnosis such as ECT(Emission Computed Tomograph) on saliva glands. Latest reports on the oral cavity treatment of pSS still stager on clinical stage three and further development is seldom reported; Further, there is a study shows that rituximab-kind of biological agent is effective in the treatment of pSS.In Traditional Chines medical system, pSS can be classified into "Zao Bi"-kind of arthromyodynia caused by dryness, which is further divided into "external dryness" and "internal dryness"(the former derives from one of the six external pathogenical factors that invades human body, and the latter results from either yin humour deficiency or body fluids transportation disorders), damaging the process of transformation of Qi, Blood and Body fluids-whose name is first raised by Pro. Lu Zhizheng. In Pro.Lu’s view, the main and most common pathogenesis of pSS is the deficiency of both vital energy and yin humor. As qi acts as the commander of blood, when vital energy is insufficient, blood lacks enough driving force to move through blood vessels. Deficiency of yin humor truly worsens the situation, and, the ultimate sequela is clear that dryness and blood stasis combine to obstruct blood vessels. As a result, Pro.Lu puts forward to "tonifying vital energy and nourishing yin humor" as the foundamental law in the treatment of pSS and believes this law must accompany its beginning to end. Modern TCM scholars resemble Pro.Lu on his analysis of pathogenesis and etiology of pSS but also share different characteristics on the diffentiation of it most of which worth learning. Latest study of large samples on its TCM symptoms, in addition, indicates that Yin deficiency is the most common symptom, while other symptoms such as Qi difficiency. Blood stasis or toxic dryness can be intermingled with. However, unified standard on the TCM diffenciation of pSS is still absent to all, and large sampls study of which can be a guidance to refer to.Up to now, study of TCM regimens such as Chinese Qigong and food therapy on pSS is inadequate while other TCM external treatments like acupuncture, moxibustion, TCM fuming,acupoint injection and massage are reported marked curative effects.Objective:To study and contrast therapeutic effect and security of hydroxychloroquine sulfate and "Pro.Lu’s decoction to moisten dryness" on dry mouth of Primary Sjogren’s Syndrome.Method:A single blind design is made to randomly divide116pSS cases differenciated by "difficiency in both vital energy and Yin humor" and "blood stasis" into treatment group and control group. Patients in treatment group are differenciated by their syndroms and treated by Chinese herbs according to their differenciation with "Pro.Lu’s decoction to moisten dryness" being the basic prescription while patients in control group are given hydroxychloroquine sulfate. To observe changes of visual analogue scoring(VAS) for dry mouth, TCM symptoms scoring chart, laboratory indexing and safety index every month for six continuous months. Total judgement of therapeutic effect of this subject mainly relies on TCM syndrom differenciation scoring chart, with reference to the guidelines of clinical research on new TCM herbs(version.2002) and Nimpdipine method evaluating the scores. Judgment of therapeutic effect of pSS dry mouth also combines VAS, and other methods.Result:After treatment of six continuous months, it’s found that total therapeutic effective rate of patients in treatment group and control group is82.76%and60.34%respectively, manifestationg great advantage contrasting control group. What’s more, statistical significance of treatment group is notoble in both VAS on pSS dry mouth and TCM syndrom diffenrenciation scoring system comparing with either statistics prior treatment or with control group(p<0.05). As for laboratory indexing, it is only the level of IgG shows marked statistical significance contrasting prior treatment(p<0.05), no significant difference is found in other indices including safty index(p>0.05).Conclusion:It has been proven that dry mouth symptom in pSS patients can be notably improved by "Pro.Lu’s decoction to moisten dryness", and in addition to it immune system indices such as the level of IgG are decreased during the course of treatment, demonstrating that such decoction can truly improve patients’physical conditions and delay whole progress of the disease. In sum, it’s testified that safty and reliability of this method is guaranted and it is thus worth promoting in modern clinics. |
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