化湿润燥方治疗原发性干燥综合征的临床疗效

Effect of Huashi Runzao Prescription on Primary Sj?gren’s Syndrome

目的:观察化湿润燥方治疗原发性干燥综合征(pSS)燥湿互结证患者的疗效和安全性。方法:105例符合纳入标准的pSS燥湿互结证患者,分为观察组65例和对照组40例,分别给予化湿润燥方与硫酸羟氯喹口服治疗,疗程12周。采用视觉模拟评分量表(VAS)对症状进行评估。比较两组患者治疗前后干燥、疲乏、肢体疼痛症状,欧洲风湿病联盟(EULAR)干燥综合征患者报告指数(ESSPRI),EULAR干燥综合征疾病活动度指标(ESSDAI)及免疫炎症指标变化,并观察不良反应。结果:与本组治疗前比较,治疗后观察组患者ESSPRI评分降低(P<0.01);与对照组治疗后比较,观察组评分更低(P<0.05)。与本组治疗前比较,观察组患者口干、眼干、总体干燥、疲乏、肢体疼痛VAS评分较治疗前下降(P<0.01);与对照组治疗后比较,观察组患者口干、总体干燥VAS评分更低(P<0.01)。与本组治疗前比较,两组患者ESSDAI评分均下降(P<0.05,P<0.01),但治疗后组间比较两组患者差异无统计学意义。与本组治疗前比较,观察组患者免疫球蛋白M(IgM)下降(P<0.01)、补体C3上升(P<0.01),对照组患者补体C3下降(P<0.05),但治疗后组间比较两组患者差异无统计学意义。治疗过程中,对照组患者出现1例胃痛,经对症治疗后缓解;观察组无不良反应发生。经卡方检验,两组患者不良反应发生率差异无统计学意义。结论:化湿润燥方能有效改善pSS燥湿互结证患者的干燥、疲乏、肢体疼痛症状,降低疾病活动度,且安全性良好。

Objective:To observe the efficacy and safety of Huashi Runzao prescription for patients with primary Sj?gren’s syndrome(pSS)of combined dryness and dampness pattern.Method:A total of 105eligible patients were randomized into the experimental group(65 cases)and control group(40 cases),and they were respectively treated with Huashi Runzao prescription and hydroxychloroquine for 12 weeks.Visual Analogue Scale(VAS)was employed to assess the symptoms.The symptoms of dryness,fatigue,and pain,European League Against Rheumatism(EULAR)Sj?gren’s Syndrome Patient Reported Index(ESSPRI),EULAR Sj?gren’s syndrome disease activity index(ESSDAI),and immune inflammatory indicators before and after treatment were compared between the two groups,and adverse reactions were observed.Result:After treatment,the ESSPRI score was lower than that before treatment in the experimental groups(P<0.01)and was lower in the experimental group than in the control group(P<0.05).The VAS scores of dry mouth,dry eyes,overall dryness,fatigue,and pain in the experimental group decreased compared with those before treatment(P<0.01),and the experimental group had lower VAS scores of dry mouth and overall dryness than the control group(P<0.01).After treatment,the ESSDAI score of both groups decreased compared with that before treatment(P<0.05,P<0.01),but there was no significant difference between the groups.After treatment,the level of immunoglobulin M(IgM)decreased(P<0.01)and the level of complement C3 increased(P<0.01)in the experimental group,while the level of complement C3 decreased in the control group(P<0.05).There was no significant difference in the laboratory indexes between groups.During the treatment,stomachache occurred to one case in the experimental group,which was alleviated after the treatment,and no adverse reaction was observed in the control group.According to the chi-square test,the occurrence of adverse reactions was insignificantly different between the two groups.Conclusion:Huashi Runzao prescription can alleviate the symptoms of dryness,fatigue,and pain,and reduce disease activity without associated side effects in pSS patients with combined dampness and dryness pattern.