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输血策略对心肌梗死合并贫血患者生活质量的影响:MINT随机临床试验的二次分析

Transfusion Strategy Effect on Quality of Life in Patients With Myocardial Infarction and Anemia: A Secondary Analysis of the MINT Randomized Clinical Trial.

作者信息

Prochaska Micah T, Portela Gerard T, Brooks Maria Mori, Fergusson Dean A, Hébert Paul C, Polonsky Tamar S, Caixeta Adriano, Cooper Howard A, Crozier Ian, Daneault Benoit, Kim Sarang, Bainey Kevin R, de Barros E Silva Pedro, Goldfarb Michael, Gupta Rajesh, Rao Sunil V, Fonteles Ritt Luiz Eduardo, Simon Tabassome, Carson Jeffrey L

机构信息

Department of Medicine, University of Chicago, Chicago, Illinois.

Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania.

出版信息

JAMA Intern Med. 2025 Jun 3. doi: 10.1001/jamainternmed.2025.0654.

DOI:10.1001/jamainternmed.2025.0654
PMID:40459491
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12135017/
Abstract

IMPORTANCE

Both myocardial infarction (MI) and anemia have deleterious effects on health-related quality of life (QOL). Red blood cell (RBC) transfusion may improve QOL after MI by relieving symptoms and/or increasing functional capacity.

OBJECTIVE

To evaluate whether a liberal transfusion strategy compared with a more restrictive transfusion strategy affects QOL in patients with MI and anemia.

DESIGN, SETTING, AND PARTICIPANTS: This analysis of QOL as a prespecified secondary outcome of the Myocardial Ischemia and Transfusion (MINT) trial, a randomized clinical trial comparing a liberal vs restrictive RBC transfusion strategy, included participants from 144 sites across 6 countries. Hospitalized adults with acute MI and anemia (hemoglobin [Hb] less than 10 g/dL). The MINT trial randomized 3504 patients, and this analysis included those who had QOL data collected and those who died before the 30-day follow-up period. Data were collected from April 2017 to April 2023, and data were analyzed from February 2024 to January 2025.

INTERVENTIONS

The MINT trial randomized patients to a restrictive (Hb of 7 to 8 g/dL) or a liberal (Hb of less than 10 g/dL) RBC transfusion strategy.

MAIN OUTCOMES AND MEASURES

QOL was measured using the EQ-5D-5L 30 days after randomization.

RESULTS

Of 2844 included patients, 1551 (54.5%) were male, and the mean (SD) age was 71.9 (11.5) years. A total of 2525 (88.8%; 1254 [49.7%] in the restrictive group and 1271 [50.3%] in the liberal group) had QOL data, and 319 (11.2%) died before 30-day follow-up. Overall, there were no differences in mean or median scores for any EQ-5D-5L QOL outcome between assigned transfusion strategies at 30 days postrandomization. Although a higher percentage of patients in the liberal compared with the restrictive transfusion group reported no problems compared with any problem in usual activities (506 of 1268 [39.9%] vs 473 of 1247 [37.9%]), mobility (474 of 1270 [37.3%] vs 460 of 1254 [36.7%]), and self-care (858 of 1271 [67.5%] vs 803 of 1254 [64.0%]) domains, none of these differences were statistically significant. Adjusted mixed-effects linear regressions showed no association between assigned transfusion strategy and mean differences in any QOL outcome. Adjusted regressions in several prespecified subgroups showed an association between a liberal transfusion strategy and better QOL scores in domains related to functional capacity, but the effects were only statistically significant in patients with a history of heart failure (Health Today rating: β, 2.06 [95% CI, -0.23 to 4.35] vs -1.44 [95% CI, -3.81 to 0.92]; P = .04).

CONCLUSIONS AND RELEVANCE

This secondary analysis of the MINT trial found that in patients with MI and anemia, a liberal transfusion strategy compared with a restrictive transfusion strategy did not affect QOL outcomes 30 days after randomization. This suggests that higher Hb levels maintained with RBC transfusion may not offer significant benefits to QOL overall in patients with MI and anemia. Additional studies may be useful for further examining and validating transfusion's effect on QOL in patients with MI and heart failure.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02981407.

摘要

重要性

心肌梗死(MI)和贫血均对健康相关生活质量(QOL)有不良影响。红细胞(RBC)输注可能通过缓解症状和/或增加功能能力来改善心肌梗死后的生活质量。

目的

评估与更严格的输血策略相比,宽松输血策略是否会影响心肌梗死合并贫血患者的生活质量。

设计、设置和参与者:本分析将生活质量作为心肌缺血与输血(MINT)试验预先设定的次要结局,该试验是一项比较宽松与严格红细胞输血策略的随机临床试验,纳入了来自6个国家144个地点的参与者。急性心肌梗死合并贫血(血红蛋白[Hb]低于10 g/dL)的住院成年人。MINT试验将3504例患者随机分组,本分析纳入了收集了生活质量数据的患者以及在30天随访期前死亡的患者。数据收集时间为2017年4月至2023年4月,数据分析时间为2024年2月至2025年1月。

干预措施

MINT试验将患者随机分为严格(Hb为7至8 g/dL)或宽松(Hb低于10 g/dL)红细胞输血策略组。

主要结局和测量指标

随机分组30天后使用EQ-5D-5L测量生活质量。

结果

在纳入的2844例患者中,1551例(54.5%)为男性,平均(标准差)年龄为71.9(11.5)岁。共有2525例(88.8%;严格组1254例[49.7%],宽松组1271例[50.3%])有生活质量数据,319例(11.2%)在30天随访前死亡。总体而言,随机分组后30天,指定输血策略之间的任何EQ-5D-5L生活质量结局的平均或中位数得分均无差异。尽管与严格输血组相比,宽松输血组中报告在日常活动(1268例中的506例[39.9%]对1247例中的473例[37.9%])、活动能力(1270例中的474例[37.3%]对1254例中的460例[36.7%])和自我护理(1271例中的858例[67.5%]对1254例中的803例[64.0%])方面无任何问题的患者百分比更高,但这些差异均无统计学意义。调整后的混合效应线性回归显示,指定输血策略与任何生活质量结局的平均差异之间无关联。在几个预先设定的亚组中的调整回归显示,宽松输血策略与功能能力相关领域的更好生活质量得分之间存在关联,但仅在有心力衰竭病史的患者中效应具有统计学意义(今日健康评分:β,2.06[95%CI,-0.23至4.35]对-1.44[95%CI,-3.81至0.92];P = 0.04)。

结论和相关性

MINT试验的这项次要分析发现,在心肌梗死合并贫血患者中,与严格输血策略相比,宽松输血策略在随机分组30天后并未影响生活质量结局。这表明通过红细胞输注维持较高的Hb水平可能不会给心肌梗死合并贫血患者的总体生活质量带来显著益处。进一步的研究可能有助于进一步研究和验证输血对心肌梗死合并心力衰竭患者生活质量的影响。

试验注册

ClinicalTrials.gov标识符:NCT02981407。

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本文引用的文献

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JAMA Netw Open. 2024 Nov 4;7(11):e2442361. doi: 10.1001/jamanetworkopen.2024.42361.
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Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia.心肌梗死合并贫血的限制性输血或宽松性输血策略。
N Engl J Med. 2023 Dec 28;389(26):2446-2456. doi: 10.1056/NEJMoa2307983. Epub 2023 Nov 11.
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Pharmacoeconomics. 2023 Apr;41(4):427-438. doi: 10.1007/s40273-023-01243-0. Epub 2023 Jan 31.
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Rationale and design for the myocardial ischemia and transfusion (MINT) randomized clinical trial.心肌缺血与输血(MINT)随机临床试验的原理与设计。
Am Heart J. 2023 Mar;257:120-129. doi: 10.1016/j.ahj.2022.11.015. Epub 2022 Nov 20.
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Health-related quality of life after restrictive versus liberal RBC transfusion for cardiac surgery: Sub-study from a randomized clinical trial.心脏手术后限制与自由输血对红细胞相关生活质量的影响:一项随机临床试验的亚组研究。
Transfusion. 2022 Oct;62(10):1973-1983. doi: 10.1111/trf.17084. Epub 2022 Sep 6.
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EQ-5D-5L Health-State Values for the Mexican Population.墨西哥人群 EQ-5D-5L 健康状态值。
Appl Health Econ Health Policy. 2021 Nov;19(6):905-914. doi: 10.1007/s40258-021-00658-0. Epub 2021 Jun 26.
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Red cell transfusion in outpatients with myelodysplastic syndromes: a feasibility and exploratory randomised trial.骨髓增生异常综合征门诊患者的红细胞输注:一项可行性和探索性随机试验。
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A new tool for creating personal and social EQ-5D-5L value sets, including valuing 'dead'.一种用于创建个人和社会 EQ-5D-5L 值集的新工具,包括对“死亡”的赋值。
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