Tugwell P, Bennett K, Gent M
Ann Intern Med. 1987 Sep;107(3):358-66. doi: 10.7326/0003-4819-107-2-358.
Evidence on the safety and efficacy of methotrexate as a second- or third-line agent for treating patients with rheumatoid arthritis is reviewed. Four placebo-controlled clinical trials have documented short-term benefit from methotrexate; although true remission is rare, patients receiving methotrexate showed a 26% (95% confidence interval [CI], 17% to 35%) greater improvement in their inflamed joint count and a 39% (95% CI, 26% to 51.5%) greater improvement in pain than did controls receiving nonsteroidal anti-inflammatory agents with or without prednisone. With respect to long-term benefit, improvement usually occurs within 1 month, reaching a maximum at 6 and then leveling off for the duration of treatment; in some patients, the benefit may wane after an initial satisfactory response in the first 4 to 6 months. In one third of those given methotrexate, treatment had to be discontinued because of adverse effects, less than 1% of which were life threatening. Careful baseline and follow-up monitoring is recommended until more data on the safety of methotrexate are available.
对甲氨蝶呤作为类风湿性关节炎患者二线或三线治疗药物的安全性和有效性证据进行了综述。四项安慰剂对照临床试验记录了甲氨蝶呤的短期疗效；虽然真正的缓解很少见，但接受甲氨蝶呤治疗的患者与接受非甾体抗炎药（无论是否联合泼尼松）的对照组相比，其炎症关节计数改善幅度高26%（95%置信区间[CI]，17%至35%），疼痛改善幅度高39%（95%CI，26%至51.5%）。关于长期疗效，改善通常在1个月内出现，在6个月时达到最大，然后在治疗期间趋于平稳；在一些患者中，最初4至6个月出现满意反应后，疗效可能会减弱。在接受甲氨蝶呤治疗的患者中，有三分之一因不良反应而不得不停药，其中危及生命的不到1%。在获得更多关于甲氨蝶呤安全性的数据之前，建议进行仔细的基线和随访监测。
