抗磷脂抗体谱随时间的稳定性：来自 APS ACTION 临床数据库和存储库的前瞻性结果。
Antiphospholipid Antibody Profile Stability Over Time: Prospective Results From the APS ACTION Clinical Database and Repository.
机构信息
E. Gkrouzman, MD, MS, Hospital for Special Surgery, New York, New York, USA;
E. Sevim, MD, Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, New York, USA.
出版信息
J Rheumatol. 2021 Apr;48(4):541-547. doi: 10.3899/jrheum.200513. Epub 2020 Sep 1.
OBJECTIVE
The APS ACTION Registry studies long-term outcomes in persistently antiphospholipid antibody (aPL)-positive patients. Our primary objective was to determine whether clinically meaningful aPL profiles at baseline remain stable over time. Our secondary objectives were to determine (1) whether baseline characteristics differ between patients with stable and unstable aPL profiles, and (2) predictors of unstable aPL profiles over time.
METHODS
A clinically meaningful aPL profile was defined as positive lupus anticoagulant (LAC) test and/or anticardiolipin (aCL)/anti-β glycoprotein-I (anti-β-GPI) IgG/M ≥ 40 U. Stable aPL profile was defined as a clinically meaningful aPL profile in at least two-thirds of follow-up measurements. Generalized linear mixed models with logit link were used for primary objective analysis.
RESULTS
Of 472 patients with clinically meaningful aPL profile at baseline (median follow-up 5.1 yrs), 366/472 (78%) patients had stable aPL profiles over time, 54 (11%) unstable, and 52 (11%) inconclusive. Time did not significantly affect odds of maintaining a clinically meaningful aPL profile at follow-up in univariate ( = 0.906) and multivariable analysis ( = 0.790). Baseline triple aPL positivity decreased (OR 0.25, 95% CI 0.10-0.64, = 0.004) and isolated LAC test positivity increased (OR 3.3, 95% CI 1.53-7.13, = 0.002) the odds of an unstable aPL profile over time.
CONCLUSION
Approximately 80% of our international cohort patients with clinically meaningful aPL profiles at baseline remain stable at a median follow-up of 5 years; triple aPL-positivity increase the odds of a stable aPL profile. These results will guide future validation studies of stored blood samples through APS ACTION Core Laboratories.
目的
APS ACTION 登记研究持续抗磷脂抗体（aPL）阳性患者的长期结局。我们的主要目标是确定基线时具有临床意义的 aPL 谱是否随时间稳定。我们的次要目标是确定（1）基线特征在稳定和不稳定 aPL 谱患者之间是否存在差异，以及（2）随时间推移不稳定 aPL 谱的预测因素。
方法
临床上有意义的 aPL 谱定义为阳性狼疮抗凝剂（LAC）试验和/或抗心磷脂（aCL）/抗-β糖蛋白-I（抗-β-GPI）IgG/M≥40 U。稳定的 aPL 谱定义为至少三分之二随访测量中有临床上有意义的 aPL 谱。使用逻辑回归的广义线性混合模型进行主要目标分析。
结果
在基线时有临床意义的 aPL 谱的 472 名患者中（中位随访时间为 5.1 年），366/472（78%）名患者在随访期间保持稳定的 aPL 谱，54 名（11%）不稳定，52 名（11%）不确定。时间在单变量（=0.906）和多变量分析（=0.790）中均未显著影响在随访时保持临床上有意义的 aPL 谱的可能性。基线时三联 aPL 阳性率降低（OR 0.25，95%CI 0.10-0.64，=0.004），孤立的 LAC 试验阳性率升高（OR 3.3，95%CI 1.53-7.13，=0.002），随时间推移不稳定 aPL 谱的可能性增加。
结论
我们的国际队列中，大约 80%的基线时具有临床意义的 aPL 谱的患者在中位随访 5 年后保持稳定；三联 aPL 阳性增加了 aPL 谱稳定的可能性。这些结果将指导通过 APS ACTION 核心实验室对储存的血液样本进行未来的验证研究。
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