复方夏天无联合甲氨喋呤治疗类风湿关节炎的临床研究

作者	单位
左川	四川大学华西医院风湿科
陈永涛	四川大学华西医院风湿科
王忠明	四川大学华西医院风湿科
杨南萍	四川大学华西医院风湿科

摘要点击次数: 1457

全文下载次数: 3

中文摘要:

目的观察复方夏天无联合甲氨喋呤治疗类风湿关节炎(RA)的临床疗效和安全性。方法76例患者随机分为两组:联合治疗组37例,应用复方夏天无联合甲氨喋呤治疗;甲氨喋呤组39例,仅口服甲氨喋呤治疗,疗程均为12周。疗效评价以美国风湿病学会(ACR)疗效评价指标为标准,以ACR20为主要疗效指标,以ACR50、ACR70以及关节肿胀指数、关节压痛指数、握力、晨僵时间、休息痛和血沉,C反应蛋白等临床指标及健康状况问卷(HAQ)为次要疗效指标,比较两组疗效,同时观察记录不良反应。结果治疗4、8、12周时,联合治疗组的ACR20改善率分别为35·14%、59·46%、70·27%,高于甲氨喋呤组(分别为17·95%、35·90%、46·15%),8周和12周时组间疗效比较,差异有统计学意义(P<0·05);各时间点联合治疗组ACR50和ACR70改善率均有提高,12周时ACR50两组比较差异有统计学意义(43·24%vs20·51%,P<0·05)。联合治疗组在关节肿胀指数、关节压痛指数、握力、晨僵时间、休息痛和血沉、C反应蛋白等临床指标及HAQ评分改善比甲氨喋呤组更为显著(P<0·05)。联合治疗组不良反应事件发生率明显低于甲氨喋呤组(32·43%vs56·41%,P<0·05),尤其在肝损害方面不良反应明显降低(0vs10·26%,P<0·05)。结论复方夏天无联合甲氨喋呤治疗RA的疗效明显优于单用甲氨喋呤,疗效稳定,不良反应较少。

英文摘要:

Objective To observe the clinical efficacy and safety of Corydalis composite (CDC) combined with methotrexate (MTX) in treating rheumatoid arthritis (RA).Methods Seventy-six RA patients were randomly assigned to 2 groups,37 in the treated group received the combined therapy,and the 39 received MTX treatment alone,all were treated for 12 weeks.Efficacy of treatment was evaluated adopting the standard of American College of Rheumatology (ACR),taking ACR20 as the chief criterion;ACR50,ACR70 as well as the clinical indexes and items in Health Account Questionnaire (HAQ) as the auxiliary criteria,including joint swelling index,joint tenderness index,holding power,morning stiffness time,resting pain,erythrocyte sedimentation rate (ESR),C-reactive protein.And the adverse reaction was recorded at the same time.Results After being treated for 4,8 and 12 weeks,the ACR20 response rate reached 35.14%,59.46% and 70.27% respectively in patients of the treated group,while that in the control group was 17.95%,35.90% and 46.15% respectively,significant difference between groups was shown in the outcome of week 8 and 12 (P<0.05).ACR50 and ACR70 improving rate at all the time points of observation were increased in the treated group,with the ACR50 improving rate at week 12 higher than that in the control group (43.24% vs 20.51%,P<0.05).As compared with the control group,the improvements in all the auxiliary criteria were more significant in the treated group (P<0.05).The incidence of adverse reaction was less in the treated group than in the control group (32.43% vs 56.41%,P<0.05),particularly in term of the damage on liver (0 vs 10.26%,P<0.05).Conclusion CDC combined with MTX is more effective than MTX alone in treating active RA with less adverse reaction.

关闭