Long-term tolerability of methotrexate at doses exceeding 15 mg per week in rheumatoid arthritis
Long-term tolerability of methotrexate at doses exceeding 15 mg per week in rheumatoid arthritis
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DOI：
10.1007/bf00290521
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发表时间：
1996-01-01
影响因子：
4
通讯作者：
Gross, WL
中科院分区：
文献类型：
--
作者：
Schnabel, A;Herlyn, K;Gross, WL
这项研究的目的是在一项开放标签的前瞻性研究中，纵向检查每周超过15 mg剂量的甲氨蝶呤(MTX)治疗的耐受性。185例类风湿关节炎患者被随机分为每周服用15 mg和25 mg甲氨蝶呤，并进行了30个月以上的随访。随后根据疗效和耐受性进行的剂量调整导致平均剂量稳定在每周18毫克，最初的治疗组被合并进行一项纵向研究，比较1-12个月和13-30个月的毒性事件。1-12个月和13-30个月分别为17%和4%；因副作用而减少的剂量分别为9%和7%。胃肠道反应的年发生率从26%上升到39%(P=0.05)，肝酶升高的发生率从43%下降到10%(P
The objective of this study was to examie longitudinally the tolerability of methotrexate (MTX) treatment at doses exceeding 15 mg/week in an open-label, prospective study. One hundred and eighty-five patients with rheumatoid arthritis were randomized to receive 15 mg or 25 mg MTX per week initially, and were followed over 30 months. Subsequent dose adjustments according to efficacy and tolerability resulted in levelling off of the mean dose at 18 mg/week, and the original treatment groups were combined for a longitudinal study comparing toxic events during months 1-12 and months 13-30. With drawals due to side-effects amounted to 17% during months 1-12 and 4% during months 13-30; dose reductions due to side-effects were 9% and 7%, respectively. The annual incidence of gastrointestinal side-effects increased from 26% to 39% (P=0.05), that of liver enzyme elevation dropped from 43% to 10% (P