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血管和血管内手术中,远程缺血预处理与无远程缺血预处理的比较。

Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures.

机构信息

Department of Cardiovascular Surgery, The First Hospital of Lanzhou University, Lanzhou, China.

Department of Thoracic Surgery, the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.

出版信息

Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

Abstract

BACKGROUND

Despite advances in perioperative care, elective major vascular surgical procedures still carry a significant risk of morbidity and mortality. Remote ischaemic preconditioning (RIPC) is the temporary blocking of blood flow to vascular beds remote from those targeted by surgery. It has the potential to provide local tissue protection from further prolonged periods of ischaemia. However, the efficacy and safety of RIPC in people undergoing major vascular surgery remain unknown. This is an update of a review published in 2011.  OBJECTIVES: To assess the benefits and harms of RIPC versus no RIPC in people undergoing elective major vascular and endovascular surgery.

SEARCH METHODS

The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to 1 April 2022.

SELECTION CRITERIA

We included all randomised controlled trials that evaluated the role of RIPC in reducing perioperative mortality and morbidities in people undergoing elective major vascular or endovascular surgery.

DATA COLLECTION AND ANALYSIS

We collected data on the characteristics of the trial, methodological quality, and the remote ischaemic preconditioning stimulus used. Our primary outcome was perioperative mortality, and secondary outcomes included myocardial infarction, renal impairment, stroke, hospital stay, limb loss, and operating time or total anaesthetic time. We analysed the data using random-effects models. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with a 95% confidence interval (CI) based on an intention-to-treat analysis. In addition, we used GRADE to assess the certainty of the evidence for each outcome.

MAIN RESULTS

We included 14 trials which randomised a total of 1295 participants (age range: 64.5 to 76 years; 84% male; study periods ranged from 2003 to 2019). In general, the included studies were at low to unclear risk of bias for most risk of bias domains. The certainty of evidence of main outcomes was moderate due to imprecision of results, moderate heterogeneity, or possible publication bias. We found that RIPC made no clear difference in perioperative mortality compared with no RIPC (RR 1.41, 95% CI 0.59 to 3.40; I = 0%; 10 studies, 965 participants; moderate-certainty evidence). Similarly, we found no clear difference between the two groups for myocardial infarction (RR 0.82, 95% CI 0.49 to 1.40; I = 7%; 11 studies, 1001 participants; moderate-certainty evidence), renal impairment (RR 1.07, 95% CI 0.62 to 1.86; I = 40%; 12 studies, 1054 participants; moderate-certainty evidence), stroke (RR 0.33, 95% CI 0.04 to 3.15; I = 0%; 4 studies, 392 participants; moderate-certainty evidence), limb loss (RR 0.74, 95% CI 0.05 to 10.61; I = 32%; 3 studies, 322 participants; low-certainty evidence), hospital stay (MD -0.94 day, 95% CI -1.95 to 0.07; I = 17%; 7 studies, 569 participants; moderate-certainty evidence), and operating time or total anaesthetic time (MD 5.76 minutes, 95% CI -3.25 to 14.76; I = 44%; 10 studies, 803 participants; moderate-certainty evidence).  AUTHORS' CONCLUSIONS: Overall, compared with no RIPC, RIPC probably leads to little or no difference in perioperative mortality, myocardial infarction, renal impairment, stroke, hospital stay, and operating time, and may lead to little or no difference in limb loss in people undergoing elective major vascular and endovascular surgery. Adequately powered and designed randomised studies are needed, focusing in particular on the clinical endpoints and patient-centred outcomes.

摘要

背景

尽管围手术期护理取得了进展,但择期大血管外科手术仍存在较高的发病率和死亡率。远程缺血预处理(RIPC)是暂时阻断手术目标以外的血管床的血流。它有潜力为进一步延长的缺血期提供局部组织保护。然而,RIPC 对接受大血管手术的患者的疗效和安全性仍不清楚。这是 2011 年发表的一篇综述的更新。

目的

评估择期大血管和血管内手术中 RIPC 与无 RIPC 的疗效和安全性。

检索方法

Cochrane 血管信息专家检索了 Cochrane 血管特刊登记处、CENTRAL、MEDLINE、Embase 和 CINAHL 数据库以及世界卫生组织国际临床试验注册平台和 ClinicalTrials.gov,检索时间截至 2022 年 4 月 1 日。

选择标准

我们纳入了所有评估 RIPC 对降低择期大血管或血管内手术患者围手术期死亡率和发病率作用的随机对照试验。

数据收集和分析

我们收集了试验特征、方法学质量和使用的远程缺血预处理刺激的信息。我们的主要结局是围手术期死亡率,次要结局包括心肌梗死、肾功能损害、中风、住院时间、肢体丧失和手术时间或总麻醉时间。我们使用随机效应模型分析数据。对于每个结局,我们根据意向治疗分析计算风险比(RR)或均数差(MD),并给出 95%置信区间(CI)。此外,我们使用 GRADE 评估每个结局的证据确定性。

主要结果

我们纳入了 14 项试验,共纳入了 1295 名参与者(年龄范围:64.5 至 76 岁;84%为男性;研究期间为 2003 年至 2019 年)。一般来说,大多数偏倚风险领域的纳入研究存在低至不清楚的偏倚风险。由于结果的不精确性、中度异质性或可能存在发表偏倚,主要结局的证据确定性为中度。我们发现,与无 RIPC 相比,RIPC 对围手术期死亡率没有明显影响(RR 1.41,95%CI 0.59 至 3.40;I = 0%;10 项研究,965 名参与者;中等确定性证据)。同样,两组在心肌梗死(RR 0.82,95%CI 0.49 至 1.40;I = 7%;11 项研究,1001 名参与者;中等确定性证据)、肾功能损害(RR 1.07,95%CI 0.62 至 1.86;I = 40%;12 项研究,1054 名参与者;中等确定性证据)、中风(RR 0.33,95%CI 0.04 至 3.15;I = 0%;4 项研究,392 名参与者;中等确定性证据)、肢体丧失(RR 0.74,95%CI 0.05 至 10.61;I = 32%;3 项研究,322 名参与者;低确定性证据)、住院时间(MD-0.94 天,95%CI-1.95 至 0.07;I = 17%;7 项研究,569 名参与者;中等确定性证据)和手术时间或总麻醉时间(MD 5.76 分钟,95%CI-3.25 至 14.76;I = 44%;10 项研究,803 名参与者;中等确定性证据)方面也没有明显差异。

作者结论

总体而言,与无 RIPC 相比,RIPC 可能对择期大血管和血管内手术患者的围手术期死亡率、心肌梗死、肾功能损害、中风、住院时间和手术时间或总麻醉时间没有显著影响,也可能对肢体丧失没有显著影响。需要进行充分的、设计合理的随机研究,特别关注临床终点和患者为中心的结局。

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