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与多发性硬化症疾病修饰疗法相关的癌症发展风险:对随机和非随机研究进行系统审查和元分析的研究方案
Ferrán Catalá-López1,2,3, Laura Tejedor-Romero4, Jane A Driver5,6,7
1Centre for Human and Social Sciences (CCHS), Institute of Public Goods and Policies (IPP), Spanish National Research Council (CSIC), Madrid, Spain. ferran_catala@outlook.com.
Systematic reviews
|October 18, 2024
概括
这项研究综合了使用疾病修饰疗法 (DMT) 的多发性硬化症患者癌症风险的证据. 它旨在澄清有关DMT和随后癌症发展的相互矛盾的结果.
科学领域:
- 神经学 神经学
- 在瘤学瘤学.
- 证据综合 证据综合
背景情况:
- 多发性硬化症 (MS) 和癌症风险之间的关系是正在进行的调查的主题.
- 之前对多发性硬化和癌症风险的疾病修饰疗法 (DMT) 的研究已经产生了相互矛盾的结果.
- 需要对现有研究进行全面的综合分析,以澄清这种关联.
研究的目的:
- 系统地审查和元分析多发性硬化症成年患者随后癌症的风险,这些患者接受了疾病修饰疗法 (DMT) 治疗.
- 调查可能导致跨研究报告的癌症风险异质性的因素.
主要方法:
- 一个系统审查和元分析协议被设计和注册.
- 包括随机和非随机试验,队列研究和病例控制研究,将DMT与安慰剂,无治疗或其他活性剂进行比较.
- 在PubMed/MEDLINE,EMBASE和CENTRAL的文献搜索;由两名研究人员进行独立选;偏差风险评估;以及两阶段的元分析 (Peto的RCT方法,所有研究的随机效应模型).
主要成果:
- 主要结局是与DMT暴露相关的所有恶性瘤的整体风险.
- 二次结果包括特定地点的癌症风险,如乳腺癌.
- 将计算几率比率和95%置信区间,并通过子组分析探索异质性.
结论:
- 这一系统性审查和元分析将提供与多发性硬化症患者的DMT相关的癌症风险的最新综合.
- 该研究将检查影响不同DMT和患者群体癌症风险变化的因素.
- 结果将在同行评审期刊上发表,以告知临床实践和未来的研究.
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