Zivadinov Robert, Zorzon Marino, De Masi Roberto, Nasuelli Davide, Cazzato Giuseppe
Department of Clinical Medicine and Neurology, University of Trieste, Trieste, Italy.
J Neurol Sci. 2008 Apr 15;267(1-2):28-35. doi: 10.1016/j.jns.2007.09.025. Epub 2007 Oct 18.
The aim of the present study was to evaluate whether intravenous methylprednisolone (IVMP) pulses affect the confluence and enlargement of T2 lesions in the long term in patients with relapsing-remitting (RR) multiple sclerosis (MS). Of 88 RR MS patients, randomly assigned to regular pulses of IVMP (1 g/day for 5 days with an oral prednisone taper) or IVMP on the same dose schedule only for relapses, and followed up without other disease-modifying drug therapy for 5 years, 81 patients completed the trial as planned. Pulsed IVMP was given every 4 months for 3 years, and then every 6 months for the subsequent 2 years. Calculations were performed for number, size and lesion volume (LV) of T2- and confluent T2-lesions. At study entry, the number, size and LV of T2- and confluent T2-lesions were well matched in the two study arms. At the end of the study, patients who received IVMP pulses every 4-6 months for 5 years had significantly fewer confluent T2 lesions (105 vs. 270, p<0.0001), lower confluent T2-LV (5.4 ml vs. 17.4 ml, p<0.00001), fewer large T2 lesions (>10 mm) (165 vs. 541, p<0.00001), and lower T2-LV/N degrees T2 lesion index (0.52 vs. 1.1, p=0.007) when compared to patients who received IVMP only for relapses. There were more small T2 lesions (1082 vs. 288, p<0.000001) in the IVMP pulsed arm. Patients who received higher total doses of IVMP showed the smallest changes in confluent T2-LV during the study. This study suggests that treatment with pulses of IVMP may prevent the confluence of T2 lesions, which may in turn contribute to slower progression of disability in the long term. However, pulsed IVMP treatment did not significantly slow down accumulation of overall T2-LV and there were more smaller T2 lesions in the IVMP pulsed arm at the end of the study.
本研究的目的是评估静脉注射甲基强的松龙(IVMP)脉冲疗法对复发缓解型(RR)多发性硬化症(MS)患者T2病变的融合和扩大是否具有长期影响。88例RR MS患者被随机分为两组,一组接受IVMP常规脉冲治疗(1 g/天,共5天,随后口服泼尼松逐渐减量),另一组仅在复发时按相同剂量方案接受IVMP治疗,且在不使用其他疾病修饰药物治疗的情况下随访5年,81例患者按计划完成试验。脉冲IVMP每4个月给药1次,共3年,随后2年每6个月给药1次。对T2和融合T2病变的数量、大小和病变体积(LV)进行了计算。研究开始时,两个研究组中T2和融合T2病变的数量、大小和LV匹配良好。研究结束时,接受每4 - 6个月1次IVMP脉冲治疗5年的患者,其融合T2病变显著减少(105个对270个,p<0.0001),融合T2 - LV较低(5.4 ml对17.4 ml,p<0.00001),大T2病变(>10 mm)较少(165个对541个,p<0.00001),且T2 - LV/N°T2病变指数较低(0.52对1.1,p = 0.007),而仅在复发时接受IVMP治疗的患者情况则相反。接受IVMP脉冲治疗的组中小T2病变更多(1082个对288个,p<0.000001)。在研究期间接受IVMP总剂量较高的患者,其融合T2 - LV的变化最小。本研究表明,IVMP脉冲治疗可能会预防T2病变的融合,这反过来可能有助于长期减缓残疾进展。然而,脉冲IVMP治疗并未显著减缓总体T2 - LV的积累,且在研究结束时,接受IVMP脉冲治疗的组中小T2病变更多。