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全面系统综述摘要:多发性硬化症成人疾病修正治疗:美国神经病学学会指南制定、传播和实施小组委员会的报告。

Comprehensive systematic review summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.

机构信息

From the Department of Neurology (A.R.-G.), Cleveland Clinic, OH; Department of Neurology (G.S.D.), Charles F. and Joanne Knight Alzheimer Disease Research Center, Washington University in St. Louis, MO; Department of Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Neurology (A.R.), Mayo Clinic, Rochester, MN; UCSF Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), University of California, San Francisco; Department of Neurology (G.S.G.), Kansas University Medical Center, Kansas City; Department of Neurology, School of Medicine (M.H.), University of Louisville, KY; Consortium of Multiple Sclerosis Centers (J.H.), Hackensack, NJ; Department of Neuroscience (J.P.H.), St. Luke's University Health Network, Bethlehem, PA; Department of Neurology (D.E.J.), University of Virginia, Charlottesville; Consortium of Multiple Sclerosis Centers (R.L.), Hackensack, NJ; Department of Neurology, School of Medicine (R.L.), Wayne State University, Detroit, MI; Department of Neurology, Keck School of Medicine (D.P.), University of Southern California, Los Angeles; Neurology Department (S.P.), Southern California Permanente Medical Group, Kaiser, Los Angeles; National Multiple Sclerosis Society (C.S.), Arlington, VA; National Multiple Sclerosis Society (R.S.), New York, NY; Santa Fe (J.S.), NM; Heart Rhythm Society (T.S.D.G.), Washington, DC; American Academy of Neurology (S.A.M.), Minneapolis, MN; and Department of Clinical Neurosciences, Psychiatry, Pediatrics and Community Health Sciences, Cumming School of Medicine (T.P.), University of Calgary, Alberta, Canada.

出版信息

Neurology. 2018 Apr 24;90(17):789-800. doi: 10.1212/WNL.0000000000005345.

Abstract

OBJECTIVE

To review evidence on starting, switching, and stopping disease-modifying therapies (DMTs) for multiple sclerosis (MS) in clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and progressive MS forms.

METHODS

Relevant, peer-reviewed research articles, systematic reviews, and abstracts were identified (MEDLINE, CENTRAL, EMBASE searched from inception to November 2016). Studies were rated using the therapeutic classification scheme. Prior published Cochrane reviews were also used.

RESULTS

Twenty Cochrane reviews and an additional 73 full-text articles were selected for data extraction through an updated systematic review (completed November 2016). For people with RRMS, many DMTs are superior to placebo (annualized relapses rates [ARRs], new disease activity [new MRI T2 lesion burden], and in-study disease progression) (see summary and full text publications). For people with RRMS who experienced a relapse on interferon-β (IFN-β) or glatiramer acetate, alemtuzumab is more effective than IFN-β-1a 44 μg subcutaneous 3 times per week in reducing the ARR. For people with primary progressive MS, ocrelizumab is probably more effective than placebo (in-study disease progression). DMTs for MS have varying adverse effects. In people with CIS, glatiramer acetate and IFN-β-1a subcutaneous 3 times per week are more effective than placebo in decreasing risk of conversion to MS. Cladribine, immunoglobulins, IFN-β-1a 30 μg intramuscular weekly, IFN-β-1b subcutaneous alternate day, and teriflunomide are probably more effective than placebo in decreasing risk of conversion to MS. Suggestions for future research include studies considering comparative effectiveness, usefulness of high-efficacy treatment vs stepped-care protocols, and research into predictive biomarkers.

摘要

目的

综述临床孤立综合征(CIS)、复发缓解型多发性硬化症(RRMS)和进展型多发性硬化症患者开始、转换和停止疾病修正治疗(DMT)的证据。

方法

检索了 MEDLINE、CENTRAL、EMBASE 等数据库中从建库至 2016 年 11 月的相关同行评议研究文章、系统评价和摘要。使用治疗分类方案对研究进行评估,并参考了之前发表的 Cochrane 评价。

结果

通过更新的系统评价(2016 年 11 月完成),共选择了 20 篇 Cochrane 评价和另外 73 篇全文文章进行数据提取。对于 RRMS 患者,许多 DMT 优于安慰剂(年复发率[ARR]、新疾病活动[新 MRI T2 病变负担]和研究内疾病进展)(见总结和全文出版物)。对于 RRMS 患者在接受干扰素-β(IFN-β)或那他珠单抗治疗后复发的患者,阿仑单抗比 IFN-β-1a 44 μg 皮下每周 3 次更有效降低 ARR。对于原发性进展型多发性硬化症患者,奥瑞珠单抗可能比安慰剂更有效(研究内疾病进展)。DMT 治疗多发性硬化症有不同的不良反应。在 CIS 患者中,那他珠单抗和 IFN-β-1a 皮下每周 3 次较安慰剂更有效降低 MS 转化率。克拉屈滨、免疫球蛋白、IFN-β-1a 30 μg 肌内每周、IFN-β-1b 皮下隔日和特立氟胺较安慰剂更有效降低 MS 转化率。未来研究的建议包括考虑比较有效性的研究、高效治疗与阶梯治疗方案的实用性研究以及预测生物标志物的研究。

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