一线免疫抑制剂（FAST）治疗中霉酚酸酯与甲氨蝶呤作为激素节省治疗的 CD4 计数比较。
Comparison of CD4 Counts with Mycophenolate Mofetil versus Methotrexate from the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial.
机构信息
F.I. Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.
Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.
出版信息
Ocul Immunol Inflamm. 2022 Jan 2;30(1):198-202. doi: 10.1080/09273948.2020.1774906. Epub 2020 Aug 11.
PURPOSE
Sub-analysis of the FAST Trial comparing change in CD4 (∆CD4) from baseline through 12 months in uveitis patients treated with mycophenolate mofetil (MMF) and methotrexate (MTX).
METHODS
Patients were randomly allocated to 1.5 g twice daily MMF or 25 mg weekly MTX. Individuals with CD4 counts at baseline, 6 months (or treatment failure prior), and 12 months (or treatment failure between 6 and 12 months) were included. The association between treatment and ∆CD4 (cells/μL) was analyzed using multivariable linear regression.
RESULTS
There was no significant difference in ∆CD4 between MMF and MTX at 6 months (-31.7 cells/μL for MMF compared to MTX; 95% CI: -358.2 to 294.8, = .85) and 12 months (-78.3 cells/μL for MMF compared to MTX; 95% CI: -468.0 to 311.3; = .69).
CONCLUSION
There was no significant difference in ∆CD4 between MMF and MTX from baseline to 12 months, suggesting that MMF does not confer additional risk of CD4 lymphopenia in uveitic patients.ClinicalTrials.gov Identifier: NCT01829295.
目的
对 FAST 试验的亚组分析比较了接受吗替麦考酚酯（MMF）和甲氨蝶呤（MTX）治疗的葡萄膜炎患者从基线到 12 个月时 CD4 变化（∆CD4）。
方法
患者被随机分配到 1.5g 每日两次 MMF 或 25mg 每周 MTX。纳入了基线、6 个月（或治疗失败前）和 12 个月（或 6 至 12 个月之间治疗失败）时 CD4 计数的个体。使用多变量线性回归分析治疗与 ∆CD4（细胞/μL）之间的关联。
结果
在 6 个月时，MMF 和 MTX 之间的 ∆CD4 没有显著差异（MMF 与 MTX 相比为-31.7 细胞/μL；95%CI：-358.2 至 294.8， = 0.85）和 12 个月时（MMF 与 MTX 相比为-78.3 细胞/μL；95%CI：-468.0 至 311.3； = 0.69）。
结论
从基线到 12 个月，MMF 和 MTX 之间的 ∆CD4 没有显著差异，这表明 MMF 不会给葡萄膜炎患者带来 CD4 淋巴细胞减少的额外风险。
ClinicalTrials.gov 标识符：NCT01829295。
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