中国药物警戒 ›› 2016, Vol. 13 ›› Issue (5): 266-268.

• 基础与临床研究 • 上一篇    下一篇

依那西普联合甲氨蝶呤治疗类风湿关节炎的临床观察

朱帅,黄煜鹏,贺勇,聂鑫,王伟青,都向阳,郭英,李贵星   

  1. 四川大学华西医院实验医学科，四川 成都 610041
  • 收稿日期:2016-04-05 修回日期:2016-06-30 出版日期:2016-05-20 发布日期:2016-06-30
  • 通讯作者: 李贵星，男，硕士，教授·硕导，肝肾疾病的发病机制研究。E-mail：liguixing27@163.com
  • 作者简介:朱帅，男，在读硕士，检验师，临床检验诊断学。

Clinical Observation of Etanercept Combined with Methotrexate in Treatment of Patients with Rheumatoid Arthritis

ZHU Shuai, HUANG Yu-peng, HE Yong, NIE Xin, WANG Wei-qing, DU Xiang-yang, GUO Ying, LI Gui-xing   

  1. West China Hospital of Sichuan University, Sichuan Chengdu 610041, China
  • Received:2016-04-05 Revised:2016-06-30 Online:2016-05-20 Published:2016-06-30

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摘要： 目的 探讨依那西普（重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白，rhTNFR: Fc）联合甲氨喋呤治疗类风湿关节炎（RA）的有效性和安全性。方法 选取2015年9月至2016年1月期间就诊的RA患者54例进行开放性观察研究。对照组30例口服甲氨喋呤10 mg/次，每周1次；观察组24例皮下注射依那西普25 mg/次，每周1次，同时口服甲氨喋呤（剂量同对照组）。给药后4、8、12周观察压痛关节数、肿胀关节数、患者对疾病总体状况的视觉模拟（VAS）评分、医师对疾病总体状况VAS评分、患者对关节疼痛的VAS评分、患者健康状况问卷（HAQ）和红细胞沉降率（ESR）,并采用美国风湿病学会（ACR）疗效评定标准评价疗效。结果 观察组在治疗第4周时关节压痛数、关节肿胀数和ESR较基线有显著改善，第8周时各观察指标较基线均有显著改善，第12周时各观察指标较基线及对照组均有显著改善。从治疗缓解率来看，第8周时观察组较对照组ACR20缓解率有显著改善，第12周时观察组较对照组ACR20、ACR50、ACR70缓解率均有显著改善。以上差异均有统计学意义（P<0.05或P<0.01）。治疗过程中未发生严重不良事件，两组不良事件发生率无显著差异（P＞0.05）。结论 甲氨蝶呤加用依那西普较单用起效快，缓解率更高。

关键词: 依那西普, 甲氨蝶呤, 类风湿关节炎, 有效性, 安全性

Abstract: Objective To explore the efficacy and safety of etanercept combined with methotrexate in treatment of patients with rheumatoid arthritis. Methods 54 outpatient patients with rheumatoid arthritis (RA) from September 2015 to January 2016 were recruited to the open observational study. The control group included 30 patients who received methotrexate (10 mg, po, qw), and the treatment group included 24 patients who received etanercept (25 mg, sc, qw) and methotrexate (10 mg, po, qw). We observed the tender and swollen joint counts, patient visual analogue score (VAS) on disease condition, physician VAS on disease condition, patient VAS on joint pain, patient health questionnaire (HAQ) and erythrocyte sedimentation rate (ESR) at 4, 8 and 12 weeks of follow-up.Therapeutic efficacy was evaluated by the American College of Rheumatism (ACR) efficacy evaluation criteria. Results At 4th week, tender and swollen joint counts and ESR had been significantly improved compared with baseline. All the observation indexes were significantly improved compared with baseline at 8th week, and were significantly improved compared with baseline and the control group at 12nd week. The remission rates of ACR20 at 8th week and ACR20, ACR50, ACR70 at 12nd week of the treatment group were higher than that of the control group in the same period, and the differences were statistically significant (P<0.05 or P<0.01). No serious adverse events were noted during the observation. There was no significant difference in incidence of adverse events between the treatment group and the control group (P>0.05). Conclusion Etanercept combined with methotrexate has better efficacy and higher remission rate than methotrexate used only in treatment of rheumatoid arthritis.

Key words: etanercept, methotrexate, rheumatoid arthritis, efficacy, safety

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