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Neurology:芬戈莫德治疗多发性硬化可以增加黄斑体积

来源:互联网 2013-01-02 19:45

芬戈莫德是一种鞘氨醇-1-磷酸受体调节剂,是首个口服治疗多发性硬化的药物,在2010年获FDA批准用于多发性硬化的治疗,商品名Gilenya,由诺华公司研发。为了研究芬戈莫德能否在总体上带来视网膜组织体积的增加,美国加州大学旧金山分校神经科多发性硬化研究中心的Rachel Nolan学士等人员进行了一项研究,研究结果发表在2012年12月5日的Neurology网络版。研究结果显示:MS患者接受芬戈莫德治疗与中等程度、相对快速的黄斑体积增加相关。

该研究是纵向观察性研究,连续纳入接受芬戈莫德治疗的多发性硬化(MS)患者作为治疗组,匹配从未接受芬戈莫德治疗的MS患者作为对照组,对比两组之间光学相干层析成像光谱域(OCT)上黄斑体积的改变。主要参考队列是基于OCT检查时间间隔进行匹配的,次要参考队列是根据年龄和病程进行匹配。根据配对t检验分析每组内黄斑容量的改变。组间黄斑容量的改变使用多元线性回归进行检验。

研究结果显示:30位接受芬戈莫德治疗并平均随访5个月的MS患者,其黄斑容量平均增加0.025mm3(95% 可信区间 [CI] +0.017到+0.033, p < 0.001)。作为对照组的30位从未接受过芬戈莫德治疗的MS患者平均随访6个月(SD 4),其黄斑容量没有显着改变(平均改变:0.003 mm3, 95% 可信区间为0.009到0.004, p = 0.47)。总体上,芬戈莫德组黄斑体积增加者占74%,而对照组黄斑容积增加者占37%。

该研究显示:MS患者接受芬戈莫德治疗与中等程度、相对快速的黄斑容积增加相关。(生物谷Bioon.com)

Fingolimod treatment in multiple sclerosis leads to increased macular volume

Rachel Nolan, BA*, Jeffrey M. Gelfand, MD* and Ari J. Green, MD, MCR

Objective: To determine whether fingolimod, an oral sphingosine-1-phosphate receptor modulator approved for treatment of multiple sclerosis (MS), generally leads to increased retinal tissue volume. Methods: In this longitudinal observational study, we compared changes in macular volume on spectral-domain optical coherence tomography (OCT) between consecutive patients with MS who initiated fingolimod and a matched reference cohort of patients with MS never exposed to the drug. The primary reference cohort was matched based on time interval between OCT examinations. A secondary reference cohort was matched based on age and disease duration. Change in macular volume within each group was analyzed using the paired t test. Change in macular volume between groups was examined using multiple linear regression. Results: Macular volume increased by a mean of 0.025 mm3 (95% confidence interval [CI] +0.017 to +0.033, p < 0.001) in the 30 patients with MS who initiated fingolimod over a mean follow-up time of 5 months (SD 3). Macular volume did not significantly change over a mean follow-up time of 6 months (SD 4) in a comparison group of 30 patients with MS never treated with fingolimod (mean change of −0.003 mm3, 95% CI −0.009 to +0.004, p = 0.47). Overall, 74% of eyes in the fingolimod-treated group exhibited an increase in macular volume vs 37% of eyes in the comparison group. Conclusion: Initiation of fingolimod in MS is associated with a modest, relatively rapid increase in macular volume.

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