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[NEJM在线发表]:RELIEF研究显示,围手术期限制性输液策略不能改善腹部大手术患者预后
2018年05月16日 时讯速递, 进展交流 暂无评论

Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery

Myles PS, Bellomo R, Corcoran T, et al

N Engl J Med published on May 10, 2018

DOI: 10.1056/NEJMoa1801601

BACKGROUND 背景

Guidelines to promote the early recovery of patients undergoing major surgery recommend a restrictive intravenous-fluid strategy for abdominal surgery. However, the supporting evidence is limited, and there is concern about impaired organ perfusion.

旨在促进大手术患者早期康复的指南推荐腹部手术采用限制性静脉输液策略。然而,支持这一推荐意见的证据有限,而且限制性输液策略可能导致器官灌注不足。

METHODS 方法

In a pragmatic, international trial, we randomly assigned 3000 patients who had an increased risk of complications while undergoing major abdominal surgery to receive a restrictive or liberal intravenous-fluid regimen during and up to 24 hours after surgery. The primary outcome was disability-free survival at 1 year. Key secondary outcomes were acute kidney injury at 30 days, renal-replacement therapy at 90 days, and a composite of septic complications, surgical-site infection, or death.

在这项实效性国际临床试验中,我们对有高并发症风险的3000名腹部大手术患者进行随机分组,分为术中及术后24小时内限制性或自由性静脉输液策略。主要预后指标为1年时无残疾生存率。关键的次要预后指标为30天时急性肾损伤,90天内肾脏替代治疗,以及包括全身性感染并发症、手术部位感染或死亡的复合指标。

RESULTS 结果

During and up to 24 hours after surgery, 1490 patients in the restrictive fluid group had a median intravenous-fluid intake of 3.7 liters (interquartile range, 2.9 to 4.9), as compared with 6.1 liters (interquartile range, 5.0 to 7.4) in 1493 patients in the liberal fluid group (P<0.001). The rate of disability-free survival at 1 year was 81.9% in the restrictive fluid group and 82.3% in the liberal fluid group (hazard ratio for death or disability, 1.05; 95% confidence interval, 0.88 to 1.24; P = 0.61). The rate of acute kidney injury was 8.6% in the restrictive fluid group and 5.0% in the liberal fluid group (P<0.001). The rate of septic complications or death was 21.8% in the restrictive fluid group and 19.8% in the liberal fluid group (P = 0.19); rates of surgical-site infection (16.5% vs. 13.6%, P = 0.02) and renal-replacement therapy (0.9% vs. 0.3%, P = 0.048) were higher in the restrictive fluid group, but the between-group difference was not significant after adjustment for multiple testing.

在手术期间及术后24小时内,限制性输液组1490名患者静脉液体入量中位数3.7 L(四分位区间,2.9 to 4.9),自由输液组1493名患者静脉液体入量中位数为6.1 L(四分位区间,5.0 to 7.4)(P<0.001)。限制性输液组和自由输液组患者1年后无残疾生存率分别为81.9% 和 82.3%(死亡或残疾风险比,1.05;95%可信限,0.88 to 1.24;P = 0.61)。限制输液组急性肾损伤发生率为8.6%,自由输液组为5.0% (P<0.001)。限制输液组和自由输液组感染性并发症或死亡发生率分别为21.8%和19.8% (P = 0.19);限制输液组手术部位感染率(16.5% vs. 13.6%, P = 0.02)及肾脏替代治疗比例(0.9% vs. 0.3%, P = 0.048)高于自由输液组,但对多次测定结果进行校正后没有组间差异。

CONCLUSIONS 结论

Among patients at increased risk for complications during major abdominal surgery, a restrictive fluid regimen was not associated with a higher rate of disability-free survival than a liberal fluid regimen and was associated with a higher rate of acute kidney injury. (Funded by the Australian National Health and Medical Research Council and others; RELIEF ClinicalTrials.gov number, NCT01424150.)

对于高并发症风险的腹部大手术患者,与自由输液策略相比,限制输液策略并不伴随无残疾生存率改善,且急性肾损伤比例升高。

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