Results of a 1-year randomised double-blind placebo-controlled trial with methotrexate 25 mg/week in recently diagnosed polymyalgia rheumatica.

Previous randomised controlled trials (RCTs) have reported conflicting results but used low doses of methotrexate (7.5-10 mg/wk).

之前的随机对照试验（RCTs）报告了相互矛盾的结果，但使用的是低剂量的甲氨蝶呤（每周7.5-10 mg）。

More evidence on higher doses (25 mg/wk) is needed.

需要更多证据来证明更高剂量（每周25毫克）的效果。

Methods

In this 52-week blinded, placebo-controlledRCT, patients with recently diagnosed PMR (per 2012 European League Against Rheumatism/American College of Rheumatology criteria) and <8 weeks of GC use were randomised 1:1 to methotrexate 25 mg/wk or placebo, alongside a 24-week GC-tapering protocol.

在这项为期52周的双盲、安慰剂对照的随机对照试验中，新近诊断为多发性肌炎（根据2012年欧洲抗风湿病联盟/美国风湿病学会标准）且糖皮质激素使用时间不超过8周的患者，按照1:1的比例随机分配到每周25毫克甲氨蝶呤组或安慰剂组，并接受为期24周的糖皮质激素减量方案。

The primary outcome was GC-free remission (Polymyalgia Rheumatica-Activity Score <10 and no GC use) at week 52, tested with a 1-sided Cochran-Mantel-Haenszel test stratified by sex and inflammatory markers.

主要结果是第52周时的无胃癌缓解（多发性肌炎活动评分<10且未使用糖皮质激素），使用性别和炎症标志物分层的单侧Cochran-Mantel-Haenszel检验进行测试。

Results

Sixty-four patients were recruited, of whom 58 were included in the final analysis.

共招募了64名患者，其中58名被纳入最终分析。

GC-free remission at 52 weeks was achieved in 80% of patients in the methotrexate group vs 46% in the placebo group (risk difference 34%, 1-sided 95% CI: 14%, 1-sided P = .0042).

在甲氨蝶呤组中，52周时有80%的患者实现了无糖皮质激素(GC)缓解，而在安慰剂组中这一比例为46%（风险差异34%，单侧95%置信区间：14%，单侧P = .0042）。

Conclusions

This small but high-quality RCT demonstrated that methotrexate 25 mg/wk significantly increases the likelihood of achieving GC-free remission at 52 weeks in newly diagnosed PMR.

这项小型但高质量的随机对照试验(RCT)证明，每周25毫克的甲氨蝶呤显著增加了新诊断的多发性肌炎(PMR)患者在52周时实现无糖皮质激素(GC)缓解的可能性。

These findings show a benefit of early introduction of methotrexate in PMR.

这些发现表明，在多发性肌炎/皮肌炎（PMR）中早期引入甲氨蝶呤是有益的。

Further research is needed to determine the optimal timing of methotrexate initiation.

需要进一步研究以确定甲氨蝶呤的最佳开始时机。