COMPARISON OF LOW-DOSE ORAL PULSE METHOTREXATE AND PLACEBO IN THE TREATMENT OF RHEUMATOID-ARTHRITIS - A CONTROLLED CLINICAL-TRIAL
COMPARISON OF LOW-DOSE ORAL PULSE METHOTREXATE AND PLACEBO IN THE TREATMENT OF RHEUMATOID-ARTHRITIS - A CONTROLLED CLINICAL-TRIAL
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DOI：
10.1002/art.1780280702
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发表时间：
1985-01-01
影响因子：
--
通讯作者：
WARD, JR
中科院分区：
文献类型：
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作者：
WILLIAMS, HJ;WILLKENS, RF;WARD, JR
189例类风湿性关节炎患者参加了一项前瞻性、对照、双盲、多中心试验，比较安慰剂和甲氨蝶呤（MTX）。患者（110）完成了18周的治疗。未观察到缓解，但与接受安慰剂治疗的患者相比，能够耐受低剂量MTX脉冲治疗的患者的所有临床变量均显著改善，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性的评估。MTX治疗在贫血、红细胞沉降率和类风湿因子升高方面明显优于安慰剂。然而，近1/3接受MTX治疗的患者因药物不良反应而退出，其中肝酶水平升高最常见。2例MTX治疗后出现全血细胞减少。所有药物不良反应均消退，无后遗症。甲氨蝶呤似乎是有效的治疗活动性类风湿关节炎，但需要密切监测毒性。
Patients (189) with rheumatoid arthtis were entered into a prospective, controlled, double-blind multicenter trial comparing placebo and methotrexate (MTX). Patients (110) completed 18 wk 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 statisticall significant improvement over placebo in patients with anemia, elevated erythrocyte sedimentation rate and rheumatoid factor. However, nearly 1/3 of the patients receiving MTX were withdrawn for adverse drug reactions, of which elevated levels of liver enzymes was the most common.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.