[Efficay Observation of Xinfeng Capsule for Treating 58 Cases of Sjogren's Syndrome].

Objective To observe the clinical effect of Xinfeng Capsule (XFC) in treating Sjögren's syndrome (SS) and its effect on coagulation parameters, peripheral blood cytokines, and NF- kappa B signaling pathway protein. Methods Totally 58 SS patients were assigned to the treatment group and the control group according to random digit table, 29 cases in each group. Patients in the treat- ment group took XFC, 3 pills each time, 3 times per day. Those in the control group took Hydroxychloro- quine ( HCQ) Sulfate, 0. 1 g per tablet, 2 tablets each time, twice per day. Three months consisted of one therapeutic course and one course for all. Another 20 healthy subjects were recruited as a normal control group. Coagulation parameters (APTT, PT, FIB,TT, D-D) were detected using automatic coagulation an- alyzer in the two groups before and after treatment as well as in the healthy control group. The expres- sions of peripheral blood cytokines (IL-1β, TNF-α, IL-10) and NF-κB signaling pathway proteins (P65, P50, IκBα) were detected before and after treatment using ELISA. Erythrocyte sedimentation rate (ESR) was determined using Westergren method before and after treatment. High sensitivity C-reactive protein (hs-CRP) level was determined using automatic biochemical analyzer before and after treatment. Results Totally 44 SS patients had abnormal coagulation parameters, accounting for 75. 9% of the total. Com- pared with the healthy control group, the levels of D-D, FIB, IL-1 , TNF-α,P50, P65, IκBα, hs-CRP, and ESR increased (P <0.05, P <0. 01), and the IL-10 level decreased in SS patient groups (P <0.01). Spearman correlation analysis showed that coagulation parameters were significantly correlated with cy- tokines, NF-κB signal transduction pathway, and inflammation indices (P <0. 01 , P <0. 05). After drug in- tervention blood coagulation parameters and laboratory indices were partially improved in the two groups. The effective rate and the total effective rate were 59% and 86% in the treatment group, obviously higher than those of the control group with statistical difference (38% and 72%; P <0. 05). Besides, the treat- ment group was superior to the control group in reducing the levels of FIB, D-D, P50, P65, ESR, and hs- CRP, down-regulating levels of TNF-α and IL-1 β, as well as up-regulating the expression of IL-10 (P < 0. 05, P <0. 01). Conclusions There is a hypercoagulable state in SS patients, which is related to abnor- mal activation of cytokines/NF-kappa B signaling pathway. XFC could effectively improve the hypercoagulative state of SS patients. Its mechanism might be related to inhibiting cytokines/NF-κB signaling pathway.