使用疾病修饰治疗的多发性硬化症患者的相对感染风险:观察性研究的系统性审查
M W Y Leung1, E M W Van de Garde1, B M J Uitdehaag2
1Division Pharmacoepidemiology & Clinical Pharmacology, Department of Pharmaceutical Sciences, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.
概括
对多发性硬化症 (MS) 治疗的观察性研究显示,感染风险数据稀少. 现实世界的数据为使用疾病修饰疗法 (DMT) 研究多发性硬化患者的感染提供了机会.
科学领域:
- 神经学 神经学
- 传染性疾病 传染性疾病
- 药物监督 药物监督 药物监督
背景情况:
- 多发性硬化症 (MS) 的疾病修饰治疗 (DMT) 可以增加感染风险.
- 对于MS DMTs,临床试验和现实世界观察研究之间的感染风险比较尚未得到充分证实.
研究的目的:
- 评估使用DMT的MS患者感染风险的观察研究现状.
- 确定在现实世界MS群体中研究特定的DMT和感染类型的差距.
主要方法:
- 在PubMed和Embase的系统文献搜索中查找到2023年4月为止的观察性研究.
- 对研究的DMT对比,感染类型和频率的分析.
- 对最受研究的DMT的观察结果与超分析中现有的临床试验数据的比较.
主要成果:
- 确定了22项观察性研究,只有5项报告了相对风险 (RR).
- 纳塔利祖马布是研究最多的DMT,与其他DMT或没有DMT相比报告了12次RR.
- 在观察数据中观察到的感染风险 (呼吸道,尿道) 与临床试验结果相比较.
结论:
- 目前,有关MS DMTs相关的感染风险的现实数据有限.
- 有一个重要的机会,利用日益增长的现实世界数据,进行强有力的感染风险评估在MS.
- 进一步的研究至关重要,特别是对于临床试验中代表性不足的人群.
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