艾拉莫德治疗原发性干燥综合征疗效观察

Clinical observation on treatment of primary Sjogren's syndrome by Iguratimod

目的 观察艾拉莫德治疗原发性干燥综合征（pSS）的疗效及安全性.方法 将50例pSS患者随机分成治疗组和对照组各25例,治疗组用艾拉莫德25mg每天2次,强的松5～10mg每天1次,羟氯喹200mg每天2次,溴乙新16mg每天3次,口服,疗程12周;对照组用强的松5～10mg每天1次,羟氯喹200mg每天2次,溴乙新16mg每天3次,口服,疗程12周;定期对患者的ESSPRI评分、ESSDAI评分、免疫球蛋白、血小板、Schirmer Ⅰ试验和药物不良反应进行评价.结果 治疗组患者有效率（72％）明显高于对照组（52％）,组间差异有显著性（P＜0.05）;治疗组患者全部观察指标均有改善,而对照组患者对其中两项（PLT和双眼Schirmer试验）观察指标的变化没有统计学差异（P＞0.05）.从改善指标的效率和变化程度上看,治疗组均明显优于对照组（P＜0.05）,且治疗组中疗效显著的患者占32％,对照组仅为16％;两组患者不良反应发生率无明显差异（P＞0.05）.结论 在干燥综合征的治疗中,艾拉莫德联合低剂量激素、羟氯喹和溴乙新的治疗方案较单独使用上述联合药物的效果好.

Objective To investigate the efficacy and safety of Iguratimod on primary Sjogren＇s syndrome.Methods 50 patients with pSS were randomly assigned into 2 groups：the experimental group treated with Iguratimod 25mg twice a day,prednisone 5mg to 10mg once a day,hydroxychloroquine 200mg twice a day and bromineethyl 16mg three times a day for 12 weeks and the control group treated with prednisone 5mg to 10mg once a day,hydroxychloroquine 200mg twice a day and bromineethyl 16mg three times a day for 12 weeks.ESSPRI score,ESSDAI score,immunoglobulin,platelets,Schirmer I test and the adverse reaction were collected and analyzed.Results The efficacy of experimental group （72%） was much higher than that of control group （52%）.All the observation indices in experimental group improved and the change of two indicators in control group had no statistical difference.From the perspective of extension and efficiency of indices,the experimental group was much better than the control group.Patients＇ work speed in the experimental group is 32%,while 16% in control group.For the adverse reactions,it has no statistic difference between two groups.Conclusion In the treatment of Sjogren＇s syndrome,Iguratimod combined with standard therapy is superior over standard therapy alone.