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蛛网膜下腔出血后超早期氨甲环酸作为标准治疗补充用药的成本效益(ULTRA试验)

Cost-Effectiveness of Ultra-Early Tranexamic Acid as Add-On to Standard Care After Subarachnoid Hemorrhage (ULTRA Trial).

作者信息

Denneman Nadine, Post René, van Eekelen Rik, Tjerkstra Maud A, Kempeneers Marinus A, Labib Homeyra, Germans Menno R, Vergouwen Mervyn D I, Jellema Korne, Koot Radboud W, Kruyt Nyika D, Wolfs Jasper F C, Nanda Dharmin, Van Der Pol Bram, Roks Gerwin, De Beer Frank, Reichman Loes J A, Brouwers Paul J A M, Vincent H Kwa, Bienfait Henri P, Boogaarts Hieronymus D, Klijn Catharina J M, van den Berg René, Coert Bert A, Horn Janneke, Majoie Charles B L M, Rinkel Gabriël J E, Roos Yvo B W E M, Vandertop W Peter, Verbaan Dagmar

机构信息

Amsterdam UMC Location University of Amsterdam, Neurosurgical Center Amsterdam, Amsterdam, the Netherlands.

Amsterdam Neuroscience, Neurovascular Disorders, Amsterdam, the Netherlands.

出版信息

Eur J Neurol. 2025 Aug;32(8):e70208. doi: 10.1111/ene.70208.

DOI:10.1111/ene.70208
PMID:40843772
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12371436/
Abstract

OBJECTIVE

To evaluate the cost-effectiveness and cost-utility of adding ultra-early and short-term administration of tranexamic acid (TXA) to standard care in patients with subarachnoid hemorrhage (SAH).

MATERIALS AND METHODS

An economic evaluation was performed alongside the ultra-early tranexamic acid after subarachnoid hemorrhage (ULTRA) trial. The main outcomes were the incremental cost-effectiveness ratio (ICER), expressed as costs per one-point increase in modified Rankin scale (mRS) score, and the incremental cost-utility ratio (ICUR), expressed as costs per quality-adjusted life-year (QALY). Cost-effectiveness acceptability curves (CEACs) were visualized with varying ICER cut-offs. Bootstrapping techniques and sensitivity analyses were performed to account for uncertainty.

RESULTS

The ULTRA trial included 955 patients, with 480 assigned to the TXA group and 475 to the control group. The mean mRS score was 3.4 (95% CI: 3.2-3.5) in the TXA group and 3.2 (95% CI: 3.0-3.4) in the control group. The mean QALY was 0.26 (95% CI: 0.24-0.28) in the TXA group and 0.28 (95% CI: 0.26-0.30) in the control group. Mean costs were €62,180 (95% CI: 57,589-66,913) in the TXA group and €58,624 (95% CI: 53,693-63,955) in the control group. The probability of treatment with TXA being cost-effective ranged from 4% to 16% for mRS and from 8% to 16% for QALYs.

CONCLUSIONS

Ultra-early and short-term administration of TXA to patients with SAH is not cost-effective. Therefore, we recommend against using TXA for this patient group.

TRIAL REGISTRATION

Netherlands Trial Register: NTR3272.

CLINICALTRIALS

gov identifier: NCT02684812.

摘要

目的

评估在蛛网膜下腔出血(SAH)患者的标准治疗中加用超早期和短期氨甲环酸(TXA)治疗的成本效益和成本效用。

材料与方法

在蛛网膜下腔出血后超早期使用氨甲环酸(ULTRA)试验的同时进行了一项经济学评估。主要结局指标为增量成本效益比(ICER),以改良Rankin量表(mRS)评分每增加1分的成本表示;以及增量成本效用比(ICUR),以每质量调整生命年(QALY)的成本表示。通过不同的ICER阈值绘制成本效益可接受性曲线(CEAC)。采用自抽样技术和敏感性分析来考虑不确定性。

结果

ULTRA试验纳入了955例患者,其中480例分配至TXA组,475例分配至对照组。TXA组的平均mRS评分为3.4(95%CI:3.2 - 3.5),对照组为3.2(95%CI:3.0 - 3.4)。TXA组的平均QALY为0.26(95%CI:0.24 - 0.28),对照组为0.28(95%CI:0.26 - 0.30)。TXA组的平均成本为62,180欧元(95%CI:57,589 - 66,913),对照组为58,624欧元(95%CI:53,693 - 63,955)。对于mRS,TXA治疗具有成本效益的概率为4%至16%;对于QALY,概率为8%至16%。

结论

对SAH患者进行超早期和短期TXA治疗不具有成本效益。因此,我们不建议对该患者群体使用TXA。

试验注册

荷兰试验注册库:NTR3272。

临床试验

gov标识符:NCT02684812。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bb1/12371436/ce9a6e76f768/ENE-32-e70208-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bb1/12371436/9f6c4589e9fa/ENE-32-e70208-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bb1/12371436/ce9a6e76f768/ENE-32-e70208-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bb1/12371436/9f6c4589e9fa/ENE-32-e70208-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bb1/12371436/ce9a6e76f768/ENE-32-e70208-g005.jpg

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本文引用的文献

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Neurology. 2024 Jun 25;102(12):e209169. doi: 10.1212/WNL.0000000000209169. Epub 2024 May 24.
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Tranexamic Acid After Aneurysmal Subarachnoid Hemorrhage: Post Hoc Analysis of the ULTRA Trial.氨甲环酸治疗颅内动脉瘤性蛛网膜下腔出血:ULTRA 试验的事后分析。
Neurology. 2022 Dec 5;99(23):e2605-e2614. doi: 10.1212/WNL.0000000000201160.
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A cost-utility analysis comparing endovascular coiling to neurosurgical clipping in the treatment of aneurysmal subarachnoid haemorrhage.
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