降低剂量与标准剂量的梅尔法兰作为多发性骨髓瘤自动HSCT中的单剂调节方案:系统性审查和元分析
Rowel David D Yap1, Deonne Thaddeus Gauiran1
1Division of Hematology, Department of Medicine, University of the Philippines - Philippine General Hospital, Manila, Philippines.
Blood cell therapy
|December 10, 2025
概括
标准剂量梅尔法兰 (SDM) 与减少剂量梅尔法兰 (RDM) 相比,在接受自身造血干细胞移植 (AHSCT) 的多发性骨髓瘤患者中没有显著改善生存结果. 临床决策应考虑患者特定的因素,而不仅仅是生存效益.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 在多发性骨髓瘤中,针对自身造血干细胞移植 (AHSCT) 进行梅尔法兰的最佳调节剂量仍在争论中.
- 关于标准剂量梅尔法兰 (SDM) 与减少剂量梅尔法兰 (RDM) 的生存优势,存在相互矛盾的证据.
研究的目的:
- 评估SDM与RDM相比,在总生存 (OS) 和无进展生存 (PFS) 中是否提供显著的好处.
- 评估二次结果,包括非复发性死亡率 (NRM),移植相关死亡率 (TRM) 和移植时间 (ET).
主要方法:
- 六项涉及3721名患者的研究的系统审查和元分析.
- 危险比率 (HRs) 和95%置信区间 (CI) 用于主要结果 (OS和PFS).
- 采用固定效应模型,对主要结果观察到的异质性较低.
主要成果:
- 对于OS (p=0.119) 或PFS (p=0.353) 的SDM和RDM之间没有发现统计学上显著的差异.
- 对于OS (0.0962) 和PFS (0.0337) 的效应大小很小,这表明临床相关性有限.
- 在二次结果 (NRM,TRM,ET) 中没有发现显著差异.
结论:
- 在多发性骨髓瘤的AHSCT中,SDM与RDM相比,在统计学上没有显著的生存益处.
- 关于梅尔法兰剂量的临床决定应纳入患者特定的因素,如耐受性和副作用的风险.
- 根据效果大小分析,观察到有利于SDM的生存趋势在临床上没有意义.
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