摘要
目的：应用随机对照临床试验（ｒａｎｄｏｍｉｚｅｄｃｏｎｔｒｏｌｅｄｔｒｉａｌ，ＲＣＴ）方法比较在非甾类抗炎镇痛药基础上用和不用甲氨蝶呤（ＭＴＸ）对成年人活动性类风关病人临床疗效的影响。方法：１３２例病人采用区组随机化方法以２∶１比例分为ＭＴＸ和对照组，后者服用与ＭＴＸ外形、颜色、味道相同的安慰剂。两组病人每周服用３粒～６粒研究药物，共１２周。结果：ＭＴＸ组有效率８８％，对照组６５％，两者有显著差别（Ｐ＝０００）。除晨僵外，ＭＴＸ组在其他各项临床指标的改善值和改善百分率上均高于对照组（Ｐ＜００５）。ＭＴＸ组副反应发生率为３０％，以轻微不良反应发生占绝大多数（８０％）。结论：小剂量ＭＴＸ治疗成年人活动性类风关病人３个月，在临床症状改善上优于对照组，且副反应轻微。
Objective:To assess clinical effectiveness in rheumatoid arthritis(RA)patients with 3 month methotrexate (MTX) plus NSAIDs (nonsteroidal anti inflammatory drugs) therapy,compared with NSAIDs alone.Methods:One hundred thirty two consecutive patients,who suffered from active rheumatoid arthritis,were randomly allocated into MTX treatment and controlled groups.Patients in the latter group had received an identical placebo which was similar to MTX in shape,color and taste.Patients received 3～6 tablets of MTX or an identical placebo each week.All the patients were followed up 3 months.Results:The overall response rates were 85% and 65% for MTX and placebo respectively,there was significant difference between the two groups.The patients receiving methotrexate had a great improvement than the controlled patients and the median index of improvement in joint tenderness count/score,joint swelling count/score,ESR,CRP,RHF and the grip strength respectively was statistically significant between the two groups.The occurrence rate of adverse effect was 39% in the MTX therapy group and 80% of the total adverse effect events was slight.Conclusion:Methotrexate therapy is effective for the patients with active rheumatoid arthritis in the improvement of clinical symptom and has slight adverse effect events.
出处
《中华风湿病学杂志》
CAS
CSCD
1998年第4期204-207,共4页
Chinese Journal of Rheumatology
基金
INCLEN资助项目
关键词
类风湿性关节炎
治疗
甲氨蝶呤
副反应
疗效
arthritis,rheumatoid randomized controlled trial methotrexate adverse effects
