低剂量甲氨蝶呤和霉酚酸酯在非感染性葡萄膜炎中的应用：一线抗代谢药物作为类固醇节约疗法（FAST）试验的亚分析。
Reduced Dose Methotrexate and Mycophenolate Mofetil in Noninfectious Uveitis: A Sub-Analysis from the First-Line Antimetabolites as Steroid Sparing Therapy (FAST) Trial.
机构信息
Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.
Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA.
出版信息
Ocul Immunol Inflamm. 2024 Aug;32(6):955-960. doi: 10.1080/09273948.2023.2165949. Epub 2023 Jan 26.
PURPOSE
Some patients taking methotrexate (MTX) or mycophenolate mofetil (MMF) experience intolerable side effects at full doses. We evaluated whether dose reduction affected treatment outcomes in uveitis patients.
METHODS
Subanalysis of the First-line Antimetabolites as Steroid-sparing Treatment (FAST) uveitis trial. Patients were randomized to receive MTX (25 mg weekly) or MMF (3 g daily). A pre-specified dose reduction protocol could be employed for intolerable side effects. Primary analysis was performed at 6 months.
RESULTS
43/194 patients (22%) required dose reduction. 88/151 patients (58%) on maximum doses and 32/43 patients (74%) on reduced doses were deemed treatment successes at 6 months. The odds ratio point estimate (1.60, 95% CI 0.72-3.74) favored dose-reduction but this was not significant. Following reduction, adverse events improved at the subsequent study visit (79 events reduced to 63 events).
CONCLUSION
Dose reduction of antimetabolites was not associated with worse outcomes in this subanalysis of a uveitis trial.
目的
一些接受甲氨蝶呤（MTX）或吗替麦考酚酯（MMF）治疗的患者在全剂量治疗时会出现无法耐受的副作用。我们评估了剂量减少是否会影响葡萄膜炎患者的治疗结果。
方法
一线抗代谢物作为类固醇保留治疗（FAST）葡萄膜炎试验的亚组分析。患者被随机分配接受 MTX（每周 25mg）或 MMF（每天 3g）治疗。对于无法耐受的副作用，可以采用预先指定的剂量减少方案。主要分析在 6 个月时进行。
结果
43/194 名患者（22%）需要减少剂量。在最大剂量下的 88/151 名患者（58%）和在减少剂量下的 32/43 名患者（74%）在 6 个月时被认为是治疗成功的。剂量减少的优势比点估计值（1.60，95%CI 0.72-3.74）有利于剂量减少，但这并不显著。减少剂量后，后续研究访视时不良事件有所改善（79 次减少至 63 次）。
结论
在这项葡萄膜炎试验的亚组分析中，抗代谢物的剂量减少与治疗结果无显著相关性。
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