Ann Hematol:造血干细胞移植患者的固定剂量给药和药代动力学指导调整白消安剂量具有更高的功效、安全性和成本效益

2022-02-09 MedSci原创 MedSci原创

 本研究旨在评估接受造血干细胞移植患者的固定剂量白消安 (Bu) 给药和药代动力学 (PK) 指导调整 Bu 剂量的疗效、安全性和长期成本效益,研究显示PK指导的方法疗效更高,更安全。

在造血干细胞移植(HSCT)前通常需要进行清髓治疗,而大剂量放疗和化疗的联合使用是一种常见的移植前预处理方案。白消安 (Bu)是一种烷基化剂,静脉注射Bu比口服具有更高的药代动力学(PK)可预测性。根据美国血液和骨髓移植学会实践指南委员会,考虑个性化的Bu给药主要是因为Bu的治疗指数狭窄,而特定的Bu暴露与HSCT患者的重要临床结果相关。

在Bu个体化给药时使用PK信息可以补偿药物处理和代谢的个体间差异。pk引导的给药可以最大限度地增加在大剂量化疗期间接受理想药物暴露的患者数量,从而优化治疗效益,同时最小化治疗相关毒性。在pk引导的条件下,Bu在HSCT预处理中的有效性已被检验,但缺乏关于药物浓度或暴露与临床结果关系的循证数据,而且pk引导的给药是否具有成本效益尚不清楚。此次报道的研究旨在评估接受造血干细胞移植患者的固定剂量白消安 (Bu) 给药和药代动力学 (PK) 指导调整 Bu 剂量的疗效、安全性和长期成本效益。使用系统评价和荟萃分析比较了两种给药策略的有效性和安全性。

图1:马尔可夫模型

图2:研究选择流程图

研究采用马尔可夫模型从卫生系统的角度估计相关成本和卫生结果。关注的主要结果是生命周期成本、获得的质量调整生命年 (QALYs) 和每获得 QALY 美元的增量成本效益比 (ICER)。

图3:a-e森林图的荟萃分析结果组和药物剂量组有效指标(1)allo-HSCT和auto-HSCT亚组,(2)总体生存率AML/MDS和非霍奇金淋巴瘤亚组,(b1)无进展生存率allo-HSCT和auto-HSCT亚组,(b2)无进展生存率AML/MDS和非霍奇金淋巴瘤亚组,(c)复发率,安全指标,(d)VOD和(e)急性/慢性GVHD

结果显示,PK指导组的无进展生存期和总生存期均高于固定剂量组,PK 指导组与低非复发死亡率和复发率相关。与安全性相比,两组急性移植物抗宿主病(GVHD)的发生率相同(P  > 0.05)。

图4:龙卷风图:Pk引导组与fxed剂量组的单向确定性敏感性分析结果

图5:PK引导组与fxed剂量组的增量成本有效散点图

成本效益分析显示,PK指导组的QALY(12.8135 QALYs和$582,475.07)相对于固定剂量组(10.7526 QALYs和$562,833.20)增加了2.0609,ICER为$9530.72/QALY。单因素和概率敏感性分析证实了结果的可靠性。

图6:两种策略的成本效益可接受度曲线

总的来说,当Bu作为HSCT患者清髓准备方案的组成时,pk指导是一个更好的选择。它具有更高的功效和安全性,更具有成本效益

 

原始出处:

Chen, T., Chen, C., He, X. et al. Fixed-dose administration and pharmacokinetically guided adjustment of busulfan dose for patients undergoing hematopoietic stem cell transplantation: a meta-analysis and cost-effectiveness analysis. Ann Hematol 101, 667–679 (2022). https://doi.org/10.1007/s00277-021-04733-3

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    2022-06-15 fengyqf
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    2022-02-11 fengyi812
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    2022-02-11 俅侠

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