| ObjectiveTo investigate the pathogenisis and the patterns in Traditional Chinese Medicine (TCM) on primary Sjogren’s Syndrome (pSS) by literature theoretically, and to observe the clinical efficacy and safety of Zenyehuolu decoction refined from the experience of treating pSS by professor WANG Yue.MethodTheoretically, by retrieving relevant records at all times and in China and abroad about pSS, analyzing its pathogenesis based on the research progress in modern medicine, and uniting it with the classical philosophy by analogizing approach in TCM, to provide a simplified differentiation procedure in TCM for the therapy of pSS.Clinically, applying one-to-one parallel control principle to establish the treatment group and the control group from 60 cases of patients corresponding to the clinical diagnosis of pSS,30 cases in each group and 12 weeks for the course. The TCM decoction of Zenyehuolu was administrated orally and once daily for the treatment group while conventional oral medicine was given for the control group, including tablets of hydroxychloroquine sulfate (0.1g, bid) and capsule of total glucosides of paeony (0.6 g, bid). The symptoms, TCM syndromes, tear flows, salivary flow rate, laboratory examination, and safety indexes were observed before and after the treatment to compare and analyze the data statistically.ResultTheoretically, we consider that the pathogenesis of pSS includes yin deficiency with fluid depletion, internal fire damaging fluid, abnormal Qi of pushing fluid, phlegm-dampness stasis, and internal harassment of dryness toxin for a total of 5 nodes on fluid transportation, and any abnormality on each node will cause the dryness symptom happened on the terminal end such as the poor water storage in relevant Zangs, the over-depleting rate of fluid, the problems of Qi in charge of pushing fluid, the obstruction along the fluid passage, and the deterioration of fluid quality.Clinically, before the treatment, no significant difference on each selected observation item between the treatment and control groups (P>0.05) suggested the comparability of the baseline of this study. The efficacy of TCM symptoms in the treatment group was 90.00%, better than (P<0.05) that of 63.33% in the control group. The curative efficacy in the treatment group was 86.67%, better than (P<0.05) that of 60.00% in the control group. The tear and salivary flow in both groups were improved (P<0.05), with a better improvement in the treatment group than (P<0.05) that in control one. The indexes of relevant tests of liver and kidney function showed no abnormality, with no obvious side effect or other incident was observed.ConclusionTheoretically, the differentiational procedure of pSS based on acquiring the information of disease by defining the characteristic of the disease before examining the location of disease, and choose the ingredients to form a formula according to the information is a new mindset for the clinical syndrome differentiation in TCM on this disease. The plain and simple theory can be attributed to assist the understanding of the medical approach for local patients and the solution of communication for expanding the TCM treatment of pSS internationally.Clinically, Zenyehuolu decoction combines methods of nourishing yin and moistening dryness, activating blood to free the collateral vessels, and heat-clearing and detoxifying, has distinct advantage for treating pSS over conventional medicine, can reduce the dryness symptoms on eyes and mouth of patients, increase the flow rate of tear and saliva, improve the indexes of TCM symptoms and quality of life, and never reduce the safety in clinical observation, with a worthy of further study and clinical promotion. |
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