柴胡地芍汤联合艾拉莫德治疗原发性干燥综合征的临床研究

Clinical study on chaihu dishao tang combined with iguratimod in the treatment of primary sjo‥gren's syndrome

目的:探讨柴胡地芍汤联合艾拉莫德治疗原发性干燥综合征的临床疗效及对免疫球蛋白和细胞因子的影响。方法:选取2021年1月—2021年12月收治的原发性干燥综合征患者88例,按照随机数字表法分为对照组和观察组,每组44例。对照组予以口服艾拉莫德片治疗,观察组在对照组的基础上加用柴胡地芍汤,两组疗程均为12周。观察两组患者治疗前后的临床表现、欧洲抗风湿病联盟(EULAR)干燥综合征患者自我报告指数评分(ESSPRI)、EULAR干燥综合征疾病活动指数评分(ESSDAI)和免疫球蛋白G(IgG)、免疫球蛋白M(IgM)、免疫球蛋白A(IgA)、白细胞介素-1β(IL-1β)、肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)等水平及泪液分泌(Schirmer)试验、唾液流率,同时观察两组患者出现的不良反应。结果:经过12周治疗后,观察组总有效率(77.27%)高于对照组(52.27%),差异有统计学意义(P<0.05)。治疗后两组患者的ESSPRI评分、ESSDAI评分以及IgG,IgM,IgA,IL-1β,TNF-α,IL-6水平均低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05)。两组患者治疗后的Schirmer试验、唾液流率高于治疗前,且观察组高于对照组,差异有统计学意义(P<0.05)。两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论:柴胡地芍汤联合艾拉莫德治疗原发性干燥综合征,可降低患者ESSPRI及ESSDAI评分,改善外分泌腺功能,降低免疫球蛋白及细胞因子水平,临床疗效确切,安全性高。

Objective:To investigate the clinical efficacy of chaihu dishao tang combined with iguratimod in the treatment of primary Sjo‥gren's syndrome and its effect on immunoglobulins and cytokines.Methods:A total of 88 patients with primary Sjo‥gren's syndrome who were admitted to our department from January 2021 to December 2021 were selected and divided into two groups according to the random number table method,namely the control group and the experimental group,with 44 cases in each group.The control group was treated with oral iguratimod tablets,and the experimental group was treated with additional chaihu dishao tang on top of the control group.The course of treatment in both groups was 12 weeks.The clinical manifestations,European League against rheumatism(EULAR)Sjo‥gren's syndrome patient self-report index score(ESSPRI),the EULAR Sjo‥gren's syndrome disease activity index score(ESSDAI),and immunoglobulin G(IgG),immunoglobulin M(IgM),immunoglobulin a(IgA),Il1b(il-1β),tumor necrosis factor(TNF-α),and IL6(IL-6),tear secretion(Schirmer)test and salivary flow rate of the two groups were compared,and the adverse reactions that occurred in the two groups were observed at the same time.Results:After 12 weeks of treatment,the total effective rate in the experimental group(77.27%)was higher than that in the control group(52.27%),and there was a statistical difference between the groups(P<0.05).After treatments,the ESSPRI and ESSDAI scores of the two groups of patients were both decreased,and the ESSPRI and ESSDAI scores of the experimental group were significantly lower than those of the control group,the differences were statistically significant(P<0.05).The levels of IgG,IgM,IgA,IL-1β,TNF-α,and IL-6 were all decreased after treatments(P<0.05),and the levels of the experimental group were significantly lower than those of the control group,the differences were statistically significant(P<0.05).Two groups of patients showed an increase in Schirmer test and saliva flow after treatments(P<0.05),and the levels of the experimental group were significantly higher than those of the control group,the differences were statistically significant(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:Chaihu dishao tang combined with iguratimod in treating primary Sjo‥gren's syndrome can reduce patients'ESSPRI and ESSDAI scores,improve the function of exocrine glands,reduce the levels of immunoglobulins and cytokines,and has definite clinical efficacy and high safety.