Department of Neurology, Glostrup Hospital, University of Copenhagen, Denmark.
Mult Scler. 2012 Jan;18(1):72-81. doi: 10.1177/1352458511415452. Epub 2011 Sep 15.
In recent years, small-scale clinical trials have indicated that statins or 3-hydroxy-3-methylglutaryl coenzyme A (HMGCoA) reductase inhibitors exert pleiotropic immunomodulatory effects, with potential therapeutic implications in multiple sclerosis (MS).
To investigate whether simvastatin treatment (80 mg daily for 6 months) in patients with optic neuritis (ON) had a beneficial effect on visual outcome and on brain MRI.
Sixty-four patients with acute ON were randomized to simvastatin treatment (n = 32) or placebo (n = 32) for 6 months. None of the patients had been on immunosuppressive therapy for 6 months prior to inclusion or treated with steroids from symptom onset. Contrast sensitivity (Arden plates), visual acuity, colour perception, visual evoked potentials (VEP)--latency and amplitude, Visual Analogue Scale (VAS) score, and gadolinium enhancing and T2 lesions on brain MRI were evaluated at screening visit, day 14 (except brain MRI), day 90 and day 180.
Simvastatin had a beneficial effect on VEP in both latency (p = 0.01) and amplitude (p = 0.01), a borderline effect on the Arden score (p = 0.06) and VAS (p = 0.04), and no effect on brain MRI or on relapse rate between the groups.
This study provides Class I evidence that simvastatin 80 mg daily is well tolerated and possibly effective in patients with acute ON.
近年来，小规模临床试验表明他汀类药物或 3-羟基-3-甲基戊二酰辅酶 A（HMGCoA）还原酶抑制剂具有多效性免疫调节作用，可能对多发性硬化症（MS）具有治疗意义。
研究辛伐他汀（每天 80mg，持续 6 个月）治疗视神经炎（ON）患者是否对视力结果和脑 MRI 有有益影响。
64 例急性 ON 患者随机分为辛伐他汀治疗组（n=32）或安慰剂组（n=32），治疗 6 个月。所有患者在入组前 6 个月内均未接受免疫抑制治疗，也未在症状发作时使用类固醇治疗。在筛查时、第 14 天（MRI 除外）、第 90 天和第 180 天评估对比敏感度（Arden 板）、视力、色觉、视觉诱发电位（VEP）-潜伏期和振幅、视觉模拟量表（VAS）评分以及脑 MRI 的钆增强和 T2 病变。
辛伐他汀对 VEP 的潜伏期（p=0.01）和振幅（p=0.01）有有益影响，对 Arden 评分（p=0.06）和 VAS（p=0.04）有边缘影响，对脑 MRI 或两组之间的复发率无影响。
这项研究提供了 I 类证据，表明每天 80mg 辛伐他汀是耐受良好的，并且可能对急性 ON 患者有效。
