Then Bergh Florian, Kümpfel Tania, Schumann Erina, Held Ulrike, Schwan Michaela, Blazevic Mirjana, Wismüller Axel, Holsboer Florian, Yassouridis Alexander, Uhr Manfred, Weber Frank, Daumer Martin, Trenkwalder Claudia, Auer Dorothee P
Section of Neurology, Max-Planck-Institut für Psychiatrie, München, Germany.
BMC Neurol. 2006 May 23;6:19. doi: 10.1186/1471-2377-6-19.
Intravenous methylprednisolone (IV-MP) is an established treatment for multiple sclerosis (MS) relapses, accompanied by rapid, though transient reduction of gadolinium enhancing (Gd+) lesions on brain MRI. Intermittent IV-MP, alone or with immunomodulators, has been suggested but insufficiently studied as a strategy to prevent relapses.
In an open, single-cross-over study, nine patients with relapsing-remitting MS (RR-MS) underwent cranial Gd-MRI once monthly for twelve months. From month six on, they received a single i.v.-infusion of 500 mg methylprednisolone (and oral tapering for three days) after the MRI. Primary outcome measure was the mean number of Gd+ lesions during treatment vs. baseline periods; T2 lesion volume and monthly plasma concentrations of cortisol, ACTH and prolactin were secondary outcome measures. Safety was assessed clinically, by routine laboratory and bone mineral density measurements. Soluble immune parameters (sTNF-RI, sTNF-RII, IL1-ra and sVCAM-1) and neuroendocrine tests (ACTH test, combined dexamethasone/CRH test) were additionally analyzed.
Comparing treatment to baseline periods, the number of Gd+ lesions/scan was reduced in eight of the nine patients, by a median of 43.8% (p = 0.013, Wilcoxon). In comparison, a pooled dataset of 83 untreated RR-MS patients from several studies, selected by the same clinical and MRI criteria, showed a non-significant decrease by a median of 14% (p = 0.32). T2 lesion volume decreased by 21% during treatment (p = 0.001). Monthly plasma prolactin showed a parallel decline (p = 0.027), with significant cross-correlation with the number of Gd+ lesions. Other hormones and immune system variables were unchanged, as were ACTH test and dexamethasone-CRH test. Treatment was well tolerated; routine laboratory and bone mineral density were unchanged.
Monthly IV-MP reduces inflammatory activity and T2 lesion volume in RR-MS.
静脉注射甲基强的松龙（IV-MP）是治疗多发性硬化症（MS）复发的既定疗法，会使脑部磁共振成像（MRI）上钆增强（Gd+）病灶迅速但短暂减少。有人提出间歇性静脉注射甲基强的松龙，单独使用或与免疫调节剂联合使用，作为预防复发的策略，但研究尚不充分。
在一项开放的单交叉研究中，9例复发缓解型多发性硬化症（RR-MS）患者连续12个月每月进行一次头颅钆增强MRI检查。从第6个月开始，他们在MRI检查后接受一次500毫克甲基强的松龙的静脉输注（并口服三天逐渐减量）。主要观察指标是治疗期间与基线期Gd+病灶的平均数量；次要观察指标是T2病灶体积以及皮质醇、促肾上腺皮质激素（ACTH）和催乳素的每月血浆浓度。通过临床检查、常规实验室检查和骨密度测量评估安全性。还额外分析了可溶性免疫参数（sTNF-RI、sTNF-RII、IL1-ra和sVCAM-1）和神经内分泌测试（ACTH测试、联合地塞米松/促肾上腺皮质激素释放激素（CRH）测试）。
与基线期相比，9例患者中有8例每次扫描的Gd+病灶数量减少，中位数减少43.8%（p = 0.013，Wilcoxon检验）。相比之下，来自多项研究的83例未治疗的RR-MS患者的汇总数据集，根据相同的临床和MRI标准选取，显示中位数减少14%，差异无统计学意义（p = 0.32）。治疗期间T2病灶体积减少21%（p = 0.001）。每月血浆催乳素呈平行下降（p = 0.027），与Gd+病灶数量有显著的交叉相关性。其他激素和免疫系统变量未改变，ACTH测试和地塞米松-CRH测试也未改变。治疗耐受性良好；常规实验室检查和骨密度未改变。
每月静脉注射甲基强的松龙可降低RR-MS的炎症活动和T2病灶体积。
