艾拉莫德阶段性联合甲泼尼龙和甲氨蝶呤治疗类风湿关节炎伴白细胞减少的临床观察

Clinical observation of iguratimod periodically combined with methylprednisolone and methotrexate in the treatment of rheumatoid arthritis with leucopenia

目的探讨艾拉莫德阶段性联合甲泼尼龙和甲氨蝶呤治疗类风湿关节炎(RA)伴白细胞减少的临床疗效及安全性。方法选择20例伴白细胞减少的RA患者进行自身对照研究,20例患者在发病初期予艾拉莫德(每2日1次25 mg)联合甲泼尼龙(每日1次8 mg)治疗;中期在艾拉莫德基础上加用甲氨蝶呤(每周1次7.5 mg),结合甲泼尼龙撤减;后期以艾拉莫德联合甲氨蝶呤长期维持治疗,疗程12周。治疗前后分别记录20例患者的ESR、CRP、疾病活动指数28(DAS28)评分、美国风湿病学会RA 20%、50%、70%(ACR20、ACR50、ACR70)缓解率、血常规、肝肾功能等指标,评价艾拉莫德阶段性联合甲泼尼龙和甲氨蝶呤治疗RA及升高白细胞的疗效及安全性。结果治疗12周后,20例RA患者的ESR、CRP、DAS28评分、白细胞计数均比治疗前改善(P均<0.05)。ACR20缓解率为85%,ACR50缓解率为45%。白细胞升高的总有效率为95%。治疗期间患者对治疗方案的耐受性良好,仅1例出现轻度肝损害,未停药情况下给予护肝治疗后肝功能恢复正常,后未再出现肝损害。结论艾拉莫德阶段性联合甲泼尼龙和甲氨蝶呤治疗伴白细胞减少的RA患者疗效良好,安全性好。

Objective To evaluate the clinical efficacy and safety of iguratimod combined with methylprednisolone and methotrexate during different phases in treating rheumatoid arthritis（ RA） complicated with leucopenia. Methods Twenty RA patients complicated with leucopenia were recruited in this self-control clinical trial. During the early onset,all patients were administered with iguratimod at a dose of 25 mg once every2 days in combination with methylprednisolone at a dose of 8 mg once daily. During the middle stage,iguratimod combined with methotrexate at a dose of 7. 5 mg was delivered once every week and methylprednisolone at a decreased dose. In the advanced stage,iguratimod combined with methotrexate was implemented for 12 weeks. The erythrocyte sedimentation rate（ ESR）,C-reactive protein（ CRP）,disease activity score（ DAS）28,American College of Rheumatology 20% improvement criteria（ ACR20）,ACR50 and ACR70,blood routine test,liver and kidney function were performed to evaluate the clinical efficacy and safety of iguratimod combined with methylprednisolone and methotrexate in treating RA complicated with leucopenia. Results After 12-week treatment,ESR,CRP,DAS28 and white blood cell（ WBC） count were significantly improved（ all P〈0. 05）. The ACR20 was 85% and 45% for ACR50. The overall effective rate of WBC count elevation was95%. A majority of RA patients were well tolerated throughout the treatment. Only one patient developed mild liver damage and continuously received the combined therapy,which was effectively healed after routine liver protection therapy. Conclusion Iguratimod combined with methylprednisolone and methotrexate in different stages is an efficacious and safe treatment of RA complicated with leucopenia.