Department of Neurology-Neuroimmunology, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d'Hebron University Hospital, Barcelona, Spain.
Department of Neurology, Ruhr University, St. Josef-Hospital, Bochum, Germany.
Mult Scler. 2018 Feb;24(2):96-120. doi: 10.1177/1352458517751049. Epub 2018 Jan 20.
Multiple sclerosis (MS) is a complex disease with new drugs becoming available in the past years. There is a need for a reference tool compiling current data to aid professionals in treatment decisions.
To develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS.
This guideline has been developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology and following the updated EAN recommendations. Clinical questions were formulated in Patients-Intervention-Comparator-Outcome (PICO) format and outcomes were prioritized. The quality of evidence was rated into four categories according to the risk of bias. The recommendations with assigned strength (strong and weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panelists was reached by use of the modified nominal group technique.
A total of 10 questions were agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency (EMA) at the time of publication. A total of 21 recommendations were agreed by the guideline working group after three rounds of consensus.
The present guideline will enable homogeneity of treatment decisions across Europe.
多发性硬化症（MS）是一种复杂的疾病，近年来有新的药物问世。因此，需要有一个参考工具来汇编最新数据，以帮助专业人员做出治疗决策。
制定一个基于证据的多发性硬化症药物治疗临床实践指南。
本指南使用推荐评估、制定和评估（GRADE）方法制定，并遵循 EAN 的最新建议。临床问题以患者-干预-比较-结果（PICO）格式提出，并对结果进行了优先排序。根据偏倚风险，将证据质量评为四个等级。根据证据质量和风险效益平衡，制定了具有指定强度（强和弱）的建议。使用改良的名义群体技术达成了小组成员之间的共识。
共达成 10 个问题，涵盖了治疗效果、应答标准、应对应答不佳的策略以及多发性硬化症和妊娠中的安全性问题和治疗策略。该指南考虑了在发布时欧洲药品管理局（EMA）批准的所有疾病修饰药物。在三轮共识后，指南工作组共达成 21 项建议。
本指南将使欧洲的治疗决策趋于同质化。
