Burton Jodie M, O'Connor Paul W, Hohol Marika, Beyene Joseph
Department of Clinical Neurosciences, University of Calgary, Calgary, Canada.
Cochrane Database Syst Rev. 2012 Dec 12;12:CD006921. doi: 10.1002/14651858.CD006921.pub3.
This is an updated Cochrane review of the previous version published (Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD006921. DOI: 10.1002/14651858.CD006921.pub2).Multiple sclerosis (MS), a chronic inflammatory and neurodegenerative disease of the central nervous system (CNS), is characterized by recurrent relapses of CNS inflammation ranging from mild to severely disabling. Relapses have long been treated with steroids to reduce inflammation and hasten recovery. However, the commonly used intravenous methylprednisolone (IVMP) requires repeated infusions with the added costs of homecare or hospitalization, and may interfere with daily responsibilities. Oral steroids have been used in place of intravenous steroids, with lower direct and indirect costs.
The primary objective was to compare efficacy of oral versus intravenous steroids in promoting disability recovery in MS relapses <= six weeks. Secondary objectives included subsequent relapse rate, disability, ambulation, hospitalization, immunological markers, radiological markers, and quality of life.
A literature search was performed using Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group's Trials Register (January 2012), abstracts from meetings of the American Academy of Neurology (2008-2012), the European Federation of Neurological Sciences (2008-2012), the European Committee for Treatment and Research in Multiple Sclerosis and American Committee for Treatment and Research in Multiple Sclerosis (2008-2012) handsearching. No language restrictions were applied.
Randomized or quasi-randomized trials comparing oral versus intravenous steroids for acute relapses (<= six weeks) in patients with clinically definite MSover age 16 were eligible.
Three review authors (JB, PO and MH) participated in the independent assessment of all published articles as potentially relevant to the review. Any disagreement was resolved by discussion among review authors.We contacted study authors for additional information.Methodological quality was assessed by the same three review authors. Relevant data were extracted, and effect size was reported as mean difference (MD), mean difference (MD), odds ratio (OR) and absolute risk difference (ARD).
With this current update, a total of five eligible studies (215 patients) were identified. Only one outcome, the proportion of patients with Expanded Disability Status Scale (EDSS) improvement at four weeks, was common to three trials, while two trials examined magnetic resonance imaging (MRI) outcomes. The results of this review shows there is no significant difference in relapse recovery at week four (MD -0.22, 95% confidence interval (95% CI), 0.71 to 0.26, P = 0.20) nor differences in magnetic resonance imaging (MRI) gadolinium enhancement activity based on oral versus intravenous steroid treatment. However, only two of the five studies employed more current and rigorous methodological techniques, so these results must be taken with some caution. The Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA) trial and the "Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses" (COPOUSEP) trial, designed to address such limitations, are currently underway.
AUTHORS' CONCLUSIONS: The analysis of the five included trials comparing intravenous versus oral steroid therapy for MS relapses do not demonstrate any significant differences in clinical (benefits and adverse events), radiological or pharmacological outcomes. Based on the evidence, oral steroid therapy may be a practical and effective alternative to intravenous steroid therapy in the treatment of MS relapses.
这是对先前发表版本(《Cochrane系统评价数据库》2009年第3期。文章编号:CD006921。DOI:10.1002/14651858.CD006921.pub2)的Cochrane系统评价更新。多发性硬化症(MS)是一种中枢神经系统(CNS)的慢性炎症性和神经退行性疾病,其特征是中枢神经系统炎症反复复发,程度从轻到重度致残不等。长期以来,复发一直用类固醇治疗以减轻炎症并加速恢复。然而,常用的静脉注射甲基泼尼松龙(IVMP)需要反复输注,增加了家庭护理或住院的费用,并且可能干扰日常事务。口服类固醇已被用于替代静脉类固醇,直接和间接成本较低。
主要目的是比较口服和静脉类固醇在促进病程≤6周的MS复发患者功能障碍恢复方面的疗效。次要目的包括后续复发率、功能障碍、步行能力、住院情况、免疫标志物、放射学标志物和生活质量。
使用Cochrane多发性硬化症和中枢神经系统罕见疾病小组的试验注册库(2012年1月)、美国神经病学学会会议(2008 - 2012年)摘要、欧洲神经科学联合会(2008 - 2012年)摘要、多发性硬化症治疗和研究欧洲委员会以及多发性硬化症治疗和研究美国委员会(2008 - 2012年)的手工检索进行文献检索。不设语言限制。
比较口服和静脉类固醇治疗16岁以上临床确诊MS患者急性复发(病程≤6周)的随机或半随机试验符合要求。
三位综述作者(JB、PO和MH)参与了对所有已发表文章的独立评估,判断其是否可能与本综述相关。任何分歧通过综述作者之间的讨论解决。我们联系研究作者获取更多信息。方法学质量由这三位综述作者评估。提取相关数据,效应量报告为均值差(MD)、均数差(MD)、比值比(OR)和绝对风险差(ARD)。
在本次更新中,共确定了5项符合要求的研究(215例患者)。只有一个结局,即四周时扩展残疾状态量表(EDSS)改善的患者比例,在三项试验中是共同的,而两项试验研究了磁共振成像(MRI)结局。本综述结果显示,四周时复发恢复方面无显著差异(MD -0.22,95%置信区间(95%CI),0.71至0.26,P = 0.20),基于口服与静脉类固醇治疗的磁共振成像(MRI)钆增强活性也无差异。然而,五项研究中只有两项采用了更新且更严格的方法学技术,因此这些结果必须谨慎看待。旨在解决此类局限性的“多发性硬化症急性加重期口服大剂量皮质类固醇治疗(OMEGA)试验”和“口服与静脉注射甲基泼尼松龙治疗多发性硬化症(MS)复发的疗效与安全性(COPOUSEP)试验”目前正在进行中。
对五项纳入试验进行的比较静脉与口服类固醇治疗MS复发的分析表明,在临床(益处和不良事件)、放射学或药理学结局方面无显著差异。基于现有证据,口服类固醇治疗可能是治疗MS复发的一种实用且有效的替代静脉类固醇治疗的方法。