现在的位置: 首页时讯速递, 进展交流>正文
[Lancet Respir Med在线发表]:感染性休克患者机械通气时的高氧及使用高张盐水复苏
2017年02月17日 时讯速递, 进展交流 暂无评论

Articles

Hyperoxia and hypertonic saline in patients with septic shock (HYPERS2S): a two-by-two factorial, multicentre, randomised, clinical trial

 

Pierre Asfar, Frédérique Schortgen, Julie Boisramé-Helms, et al.

Lancet Respir Med 2017

http://dx.doi.org/10.1016/S2213-2600(17)30046-2

Summary

Background 背景

There is insufficient research into the use of mechanical ventilation with increased inspiratory oxygen concentration (FiO2) and fluid resuscitation with hypertonic saline solution in patients with septic shock. We tested whether these interventions are associated with reduced mortality.

对于感染性休克患者,使用机械通气时提高吸入氧浓度(FiO2)并用高张盐水溶液进行液体复苏尚缺乏充分的研究。我们验证了上述治疗是否伴随病死率降低。

Methods 方法

This two-by-two factorial, multicentre, randomised, clinical trial (HYPERS2S) recruited patients aged 18 years and older with septic shock who were on mechanical ventilation from 22 centres in France. Patients were randomly assigned 1:1:1:1 to four groups by a computer generated randomisation list stratified by site and presence or absence of acute respiratory distress syndrome by use of permuted blocks of random sizes. Patients received, in an open-labelled manner, mechanical ventilation either with FiO2 at 1·0 (hyperoxia) or FiO2 set to target an arterial haemoglobin oxygen saturation of 88–95% (normoxia) during the first 24 h; patients also received, in a double-blind manner, either 280 mL boluses of 3·0% (hypertonic) saline or 0·9% (isotonic) saline for fluid resuscitation during the first 72 h. The primary endpoint was mortality at day 28 after randomisation in the intention-to-treat population. This study was registered with ClinicalTrials.gov, number NCT01722422.

这是一项多中心,随机,2x2析因临床研究(HYPERS2S),在法国22个中心入选了接受机械通气且年龄超过18岁的感染性休克患者。根据计算机产生的随机序列,并根据中心及是否合并ARDS,采用随机大小的置换区组,将患者按照1:1:1:1的比例被随机分为4个组。在最初24小时内(开放),患者接受FiO2 1.0(高氧)或设置FiO2使动脉血氧饱和度88-95%(正常氧);患者还在最初72小时内接受(双盲)280 mL的3.0%盐水(高张)或0.9%盐水(等张)快速输注进行液体复苏。主要预后终点为随机分组后意向治疗人群28天病死率。此研究在ClinicalTrials.gov注册,注册号NCT01722422。

Findings 结果

Between Nov 3, 2012, and June 13, 2014, 442 patients were recruited and assigned to a treatment group (normoxia [n=223] or hyperoxia [n=219]; isotonic [n=224] or hypertonic [n=218]). The trial was stopped prematurely for safety reasons. 28 day mortality was recorded for 434 patients; 93 (43%) of 217 patients had died in the hyperoxia group versus 77 (35%) of 217 patients in the normoxia group (hazard ratio [HR] 1·27, 95% CI 0·94–1·72; p=0·12). 89 (42%) of 214 patients had died in the hypertonic group versus 81 (37%) of 220 patients in the isotonic group (HR 1·19, 0·88–1·61; p=0·25). We found a significant difference in the overall incidence of serious adverse events between the hyperoxia (185 [85%]) and normoxia groups (165 [76%]; p=0·02), with a clinically relevant doubling in the hyperoxia group of the number of patients with intensive care unit-acquired weakness (24 [11%] vs 13 [6%]; p=0·06) and atelectasis (26 [12%] vs 13 [6%]; p=0·04) compared with the normoxia group. We found no statistical difference for serious adverse events between the two saline groups (p=0·23).

在2012年11月3日至2014年6月13日期间,共入选442名患者,随机分为治疗组(正常氧[n = 223]或高氧[n = 219];等张[n = 224]或高张[n = 218])。由于安全性原因试验提前结束。434名患者记录了28天病死率;高氧组217名患者中93名(43%)死亡,正常氧组217名患者中77名(35%)死亡(风险比 [HR] 1·27, 95% CI 0·94–1·72; p=0·12)。高张组214名患者中89名(42%)死亡,等张组220名患者中81名(37%)死亡 (HR 1·19, 0·88–1·61; p=0·25)。我们发现,高氧组 (185 [85%])与低氧组 (165 [76%]; p=0·02)严重不良事件的总发生率存在显著差异,高氧组患者发生ICU获得性无力(24 [11%] vs 13 [6%]; p=0·06) 及肺不张 (26 [12%] vs 13 [6%]; p=0·04) 的比例为低氧组的2倍。我们在两种盐水治疗组之间并未发现严重不良事件存在统计学差异。

Interpretation 结论

In patients with septic shock, setting FiO2 to 1·0 to induce arterial hyperoxia might increase the risk of mortality. Hypertonic (3%) saline did not improve survival.

对于感染性休克患者,将FiO2设置为1.0以达到动脉高氧可能增加病死率风险。高张(3%)盐水不能改善生存率。

Funding

The French Ministry of Health.

 

给我留言

您必须 [ 登录 ] 才能发表留言!

×
腾讯微博