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宽松与严格输血阈值对重症患者死亡率的影响:一项采用序贯试验分析的随机对照试验系统评价与荟萃分析

Mortality in Critically Ill Patients with Liberal Versus Restrictive Transfusion Thresholds: A Systematic Review and Meta-Analysis of Randomized Controlled Trials with Trial Sequential Analysis.

作者信息

Jiménez Franco Daniel Arturo, Pérez Velásquez Camilo Andrés, Rodríguez Lima David Rene

机构信息

Escuela de Medicina y Ciencias de la Salud, Universidad del Rosario, Bogotá 111221, Colombia.

Critical and Intensive Care Medicine, Hospital Universitario Mayor-Mederi, Bogotá 111411, Colombia.

出版信息

J Clin Med. 2025 Mar 18;14(6):2049. doi: 10.3390/jcm14062049.

DOI:10.3390/jcm14062049
PMID:40142858
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11943106/
Abstract

: Anemia is common in critically ill patients, yet red blood cell (RBC) transfusion without active bleeding does not consistently improve outcomes and carries risks such as pulmonary injury, fluid overload, and increased costs. Optimal transfusion thresholds remain debated, with some guidelines recommending a restrictive target of 7 g/dL instead of a more liberal target of 9 g/dL. : We conducted a systematic review and meta-analysis following PRISMA guidelines, searching PubMed, EMBASE, and LILACS from January 1995 to October 2024. Thirteen randomized controlled trials involving 13,705 critically ill adults were included, with 6855 assigned to liberal and 6850 to restrictive transfusion strategies. The risk of bias was assessed using the Cochrane Risk of Bias Tool 2, and the pooled effect sizes were estimated with a random-effects model. We registered the protocol in PROSPERO International Prospective Register of Systematic Reviews (CDR42024589225). : No statistically significant difference was observed in 30-day mortality between restrictive and liberal strategies (odds ratio [OR] 1.02; 95% confidence interval [CI], 0.83-1.25; I = 49%). Similarly, no significant differences emerged for the 90-day or 180-day mortality, hospital or intensive care unit (ICU) length of stay, dialysis requirement, or incidence of acute respiratory distress syndrome (ARDS). However, patients in the restrictive group received significantly fewer RBC units. The trial sequential analysis (TSA) indicated that the evidence accrued was insufficient to definitively confirm or exclude an effect on the 30-day mortality, as the required sample size was not reached. : In conclusion, while our meta-analysis found no statistically significant difference in the short-term mortality between restrictive and liberal transfusion strategies, larger trials are needed to fully determine whether any clinically meaningful difference exists in critically ill populations.

摘要

贫血在重症患者中很常见,然而在无活动性出血情况下输注红细胞(RBC)并不能持续改善预后,且存在诸如肺损伤、液体超负荷和成本增加等风险。最佳输血阈值仍存在争议,一些指南推荐的限制性目标为7 g/dL,而非更为宽松的9 g/dL目标。

我们按照PRISMA指南进行了一项系统评价和荟萃分析,检索了1995年1月至2024年10月期间的PubMed、EMBASE和LILACS。纳入了13项涉及13705名成年重症患者的随机对照试验,其中6855名被分配至宽松输血策略组,6850名被分配至限制性输血策略组。使用Cochrane偏倚风险工具2评估偏倚风险,并采用随机效应模型估计合并效应量。我们已将该方案注册到国际前瞻性系统评价注册库PROSPERO(注册号CDR42024589225)。

在限制性和宽松输血策略组之间,30天死亡率未观察到统计学显著差异(优势比[OR] 1.02;95%置信区间[CI],0.83 - 1.25;I² = 49%)。同样,90天或180天死亡率、住院或重症监护病房(ICU)住院时间、透析需求或急性呼吸窘迫综合征(ARDS)发生率也未出现显著差异。然而,限制性输血组患者接受的RBC单位显著更少。试验序贯分析(TSA)表明,由于未达到所需样本量,积累的证据不足以明确证实或排除对30天死亡率的影响。

总之,虽然我们的荟萃分析发现限制性和宽松输血策略在短期死亡率方面无统计学显著差异,但仍需要更大规模的试验来全面确定重症患者群体中是否存在任何具有临床意义的差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfd6/11943106/372fa923a0ad/jcm-14-02049-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfd6/11943106/90fcd7c51270/jcm-14-02049-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfd6/11943106/529fa8b711a9/jcm-14-02049-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfd6/11943106/b317c4b97ae3/jcm-14-02049-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfd6/11943106/372fa923a0ad/jcm-14-02049-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfd6/11943106/90fcd7c51270/jcm-14-02049-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfd6/11943106/529fa8b711a9/jcm-14-02049-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfd6/11943106/b317c4b97ae3/jcm-14-02049-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfd6/11943106/372fa923a0ad/jcm-14-02049-g004.jpg

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本文引用的文献

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JAMA. 2024 Nov 19;332(19):1623-1633. doi: 10.1001/jama.2024.20424.
2
Liberal versus restrictive transfusion strategies in acute myocardial infarction: a systematic review and comparative frequentist and Bayesian meta-analysis of randomized controlled trials.急性心肌梗死中自由输血策略与限制性输血策略:一项随机对照试验的系统评价以及频率论和贝叶斯比较荟萃分析
Ann Intensive Care. 2024 Sep 28;14(1):150. doi: 10.1186/s13613-024-01376-1.
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Major mistakes or errors in the use of trial sequential analysis in systematic reviews or meta-analyses - the METSA systematic review.
系统评价或荟萃分析中序贯分析使用的主要错误或失误 - METSA 系统评价。
BMC Med Res Methodol. 2024 Sep 9;24(1):196. doi: 10.1186/s12874-024-02318-y.
4
A Contemporary Review of Blood Transfusion in Critically Ill Patients.危重症患者输血的当代研究综述。
Medicina (Kaunas). 2024 Jul 31;60(8):1247. doi: 10.3390/medicina60081247.
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Haemoglobin values, transfusion practices, and long-term outcomes in critically ill patients with traumatic brain injury: a secondary analysis of CENTER-TBI.创伤性脑损伤重症患者的血红蛋白值、输血实践和长期结局:CENTER-TBI 的二次分析。
Crit Care. 2024 Jun 14;28(1):199. doi: 10.1186/s13054-024-04980-6.
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