Rieckmann P, Toyka K V, Bassetti C, Beer K, Beer S, Buettner U, Chofflon M, Götschi-Fuchs M, Hess K, Kappos L, Kesselring J, Goebels N, Ludin H-P, Mattle H, Schluep M, Vaney C, Baumhackl U, Berger T, Deisenhammer F, Fazekas F, Freimüller M, Kollegger H, Kristoferitsch W, Lassmann H, Markut H, Strasser-Fuchs S, Vass K, Altenkirch H, Bamborschke S, Baum K, Benecke R, Brück W, Dommasch D, Elias W G, Gass A, Gehlen W, Haas J, Haferkamp G, Hanefeld F, Hartung H-P, Heesen C, Heidenreich F, Heitmann R, Hemmer B, Hense T, Hohlfeld R, Janzen R W C, Japp G, Jung S, Jügelt E, Koehler J, Kölmel W, König N, Lowitzsch K, Manegold U, Melms A, Mertin J, Oschmann P, Petereit H-F, Pette M, Pöhlau D, Pohl D, Poser S, Sailer M, Schmidt S, Schock G, Schulz M, Schwarz S, Seidel D, Sommer N, Stangel M, Stark E, Steinbrecher A, Tumani H, Voltz R, Weber F, Weinrich W, Weissert R, Wiendl H, Wiethölter H, Wildemann U, Zettl U K, Zipp F, Zschenderlein R, Izquierdo G, Kirjazovas A, Packauskas L, Miller D, Koncan Vracko B, Millers A, Orologas A, Panellus M, Sindic C J M, Bratic M, Svraka A, Vella N R, Stelmasiak Z, Selmaj K, Bartosik-Psujik H, Mitosek-Szewczyk K, Belniak E, Mochecka A, Bayas A, Chan A, Flachenecker P, Gold R, Kallmann B, Leussink V, Mäurer M, Ruprecht K, Stoll G, Weilbach F X
Dept. of Neurology, Josef-Schneider-Str. 11, 97080, Würzburg, Germany.
J Neurol. 2004 Nov;251(11):1329-39. doi: 10.1007/s00415-004-0537-6.
Recent clinical studies in multiple sclerosis (MS) provide new data on the treatment of clinically isolated syndromes, on secondary progression, on direct comparison of immunomodulatory treatments and on dosing issues. All these studies have important implications for the optimized care of MS patients. The multiple sclerosis therapy consensus group (MSTCG) critically evaluated the available data and provides recommendations for the application of immunoprophylactic therapies. Initiation of treatment after the first relapse may be indicated if there is clear evidence on MRI for subclinical dissemination of disease. Recent trials show that the efficacy of interferon beta treatment is more likely if patients in the secondary progressive phase of the disease still have superimposed bouts or other indicators of inflammatory disease activity than without having them. There are now data available, which suggest a possible dose-effect relation for recombinant beta-interferons. These studies have to be interpreted with caution, as some potentially important issues in the design of these studies (e. g. maintenance of blinding in the clinical part of the study) were not adequately addressed. A meta-analysis of selected interferon trials has been published challenging the value of recombinant IFN beta in MS. The pitfalls of that report are discussed in the present review as are other issues relevant to treatment including the new definition of MS, the problem of treatment failure and the impact of cost-effectiveness analyses. The MSTCG panel recommends that the new diagnostic criteria proposed by McDonald et al. should be applied if immunoprophylactic treatment is being considered. The use of standardized clinical documentation is now generally proposed to facilitate the systematic evaluation of individual patients over time and to allow retrospective evaluations in different patient cohorts. This in turn may help in formulating recommendations for the application of innovative products to patients and to health care providers. Moreover, in long-term treated patients, secondary treatment failure should be identified by pre-planned follow-up examinations, and other treatment options should then be considered.
近期针对多发性硬化症(MS)的临床研究提供了有关临床孤立综合征治疗、继发进展、免疫调节治疗直接比较以及给药问题的新数据。所有这些研究对MS患者的优化护理都具有重要意义。多发性硬化症治疗共识小组(MSTCG)对现有数据进行了严格评估,并为免疫预防性治疗的应用提供了建议。如果MRI有明确证据显示疾病存在亚临床播散,则首次复发后可能需要开始治疗。近期试验表明,与没有这些情况的患者相比,处于疾病继发进展期的患者若仍有叠加发作或其他炎症性疾病活动指标,则使用干扰素β治疗更有可能有效。现在有数据表明重组β干扰素可能存在剂量效应关系。这些研究的解读需谨慎,因为这些研究设计中的一些潜在重要问题(例如研究临床部分的盲法维持)未得到充分解决。已发表了一项对选定干扰素试验的荟萃分析,对重组IFNβ在MS中的价值提出了质疑。本综述讨论了该报告的缺陷以及与治疗相关的其他问题,包括MS的新定义、治疗失败问题以及成本效益分析的影响。MSTCG小组建议,如果考虑进行免疫预防性治疗,应采用McDonald等人提出的新诊断标准。现在普遍建议使用标准化临床记录,以便随着时间的推移对个体患者进行系统评估,并允许对不同患者队列进行回顾性评估。这反过来可能有助于为向患者和医疗服务提供者应用创新产品制定建议。此外,对于长期接受治疗的患者,应通过预先计划的随访检查来识别继发治疗失败情况,然后再考虑其他治疗选择。