Boh L E, Schuna A A, Pitterle M E, Adams E M, Sundstrom W R
Clin Pharm. 1986 Jun;5(6):503-8.
The efficacy and toxicity of low-dose, weekly oral methotrexate (MTX) therapy for inflammatory arthritis was evaluated. Fifty-nine patients with a diagnosis of inflammatory arthritis who had failed to respond to or developed toxicity to gold, penicillamine, or hydroxychloroquine therapy were treated with MTX 10-20 mg administered orally or intravenously once a week in divided doses. Various tests to assess arthritis were performed upon each patient's entrance into the study and at specified intervals throughout the 24-month study period. The mean duration of methotrexate therapy was 15.5 months. Patients showed significant improvement in number of swollen joints, duration of morning stiffness, amount of pain, and amount of activity during the study period. Of the 35 patients who had had roentgenographic studies of their hands performed initially and after one year of MTX therapy, 23 had no evidence of new joint erosions after one year. Biopsies of hepatic tissue from 20 patients showed no progressive changes when compared with pretreatment biopsies. Gastrointestinal symptoms, mucocutaneous lesions, or small increases in liver enzyme concentrations were observed in 31 patients; three patients developed pulmonary toxicity and had to be withdrawn from the study. MTX is an effective agent for the treatment of inflammatory arthritis in patients who do not respond to therapy with nonsteroidal anti-inflammatory drugs or slow-acting antirheumatic drugs. Short-term weekly oral MTX therapy does not appear to result in clinically important liver disease.
评估了低剂量、每周口服甲氨蝶呤(MTX)治疗炎性关节炎的疗效和毒性。59例诊断为炎性关节炎且对金制剂、青霉胺或羟氯喹治疗无反应或出现毒性反应的患者,接受每周10 - 20mg口服或静脉注射甲氨蝶呤治疗,分剂量给药。在每位患者进入研究时以及在整个24个月的研究期间按特定间隔进行了各种评估关节炎的测试。甲氨蝶呤治疗的平均持续时间为15.5个月。在研究期间,患者的关节肿胀数、晨僵持续时间、疼痛程度和活动量均有显著改善。在最初和接受甲氨蝶呤治疗一年后对手部进行X线检查的35例患者中,23例在一年后没有新的关节侵蚀迹象。与治疗前活检相比,20例患者的肝组织活检未显示进行性变化。31例患者出现胃肠道症状、皮肤黏膜病变或肝酶浓度略有升高;3例患者出现肺部毒性,不得不退出研究。对于对非甾体抗炎药或慢作用抗风湿药治疗无反应的患者,甲氨蝶呤是治疗炎性关节炎的有效药物。短期每周口服甲氨蝶呤治疗似乎不会导致具有临床意义的肝脏疾病。