Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Mult Scler. 2012 Jul;18(7):932-46. doi: 10.1177/1352458511433302. Epub 2012 Jan 16.
Reviews of therapeutic drugs usually focus on the highly selected and closely monitored patient populations from randomized controlled trials. The objective of this study was to review systematically the tolerability and adherence of multiple sclerosis disease-modifying therapies, using data from both randomized controlled trials and observational settings. Relevant literature was identified using predefined search terms, and adverse event and study discontinuation data were extracted and categorized according to study type (randomized controlled trial or observational) and study duration. A total of 151 papers were selected for analysis; 33% were classified as randomized controlled trials and 62% as observational studies. Most of the papers concerned interferon preparations and glatiramer acetate; the limited available information on mitoxantrone and natalizumab precluded extensive examination of these. The most common adverse events were flu-like symptoms (interferon therapies only) and injection-site reactions. Mean discontinuation rates ranged from 16% to 27%. There were no marked differences in tolerability or adherence data from randomized controlled trials and observational studies, but the incidence of adverse events remained high in lengthy studies and discontinuations accumulated with time. The present systematic review of randomized clinical trial and observational data highlights the tolerability and adherence issues associated with commonly used first-line multiple sclerosis treatments.
治疗药物的评价通常集中在随机对照试验中高度选择和密切监测的患者人群。本研究的目的是系统地回顾多发性硬化症的多种疾病修正疗法的耐受性和顺应性，使用来自随机对照试验和观察性研究的数据。使用预先定义的搜索词来确定相关文献，根据研究类型（随机对照试验或观察性研究）和研究持续时间提取和分类不良事件和研究中断数据。共选择了 151 篇论文进行分析；33%被归类为随机对照试验，62%为观察性研究。大多数论文涉及干扰素制剂和醋酸格拉替雷；米托蒽醌和那他珠单抗的有限可用信息排除了对这些药物的广泛检查。最常见的不良事件是流感样症状（仅干扰素治疗）和注射部位反应。平均停药率从 16%到 27%不等。随机对照试验和观察性研究的数据在耐受性和顺应性方面没有明显差异，但在长期研究中不良事件的发生率仍然很高，随着时间的推移停药累积。本系统回顾随机临床试验和观察性数据突出了多发性硬化症常用一线治疗药物相关的耐受性和顺应性问题。
