Williams H J, Willkens R F, Samuelson C O, Alarcón G S, Guttadauria M, Yarboro C, Polisson R P, Weiner S R, Luggen M E, Billingsley L M
Arthritis Rheum. 1985 Jul;28(7):721-30. doi: 10.1002/art.1780280702.
One hundred eighty-nine patients with rheumatoid arthritis were entered into a prospective, controlled, double-blind multicenter trial comparing placebo and methotrexate (MTX). One hundred ten patients completed 18 weeks of therapy. No remissions were seen, but patients able to tolerate low-dose pulse MTX therapy were significantly improved, compared with patients receiving placebo therapy, for all clinical variables measured, including joint pain/tenderness and swelling counts, rheumatoid nodules, and patient and physician assessment of disease activity. MTX treatment demonstrated statistically significant improvement over placebo in patients with anemia, elevated erythrocyte sedimentation rate, and rheumatoid factor. However, nearly one-third of the patients receiving MTX were withdrawn for adverse drug reactions, of which elevated levels of liver enzymes was the most common. Pancytopenia occurred in 2 patients taking MTX. All adverse drug effects resolved without sequelae. MTX appears to be effective in the treatment of active rheumatoid arthritis but requires close monitoring for toxicity.
189例类风湿关节炎患者参与了一项前瞻性、对照、双盲多中心试验，比较安慰剂和甲氨蝶呤（MTX）的疗效。110例患者完成了18周的治疗。未观察到缓解情况，但与接受安慰剂治疗的患者相比，能够耐受低剂量脉冲MTX治疗的患者在所有测量的临床变量上均有显著改善，包括关节疼痛/压痛和肿胀计数、类风湿结节以及患者和医生对疾病活动的评估。在贫血、红细胞沉降率升高和类风湿因子阳性的患者中，MTX治疗显示出比安慰剂有统计学意义的改善。然而，近三分之一接受MTX治疗的患者因药物不良反应而退出，其中肝酶水平升高是最常见的。2例服用MTX的患者出现全血细胞减少。所有药物不良反应均未留下后遗症而得以缓解。MTX似乎对治疗活动性类风湿关节炎有效，但需要密切监测毒性。
