Target ranges of oxygen saturation in extremely preterm infants.
Target ranges of oxygen saturation in extremely preterm infants.
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DOI：
10.1056/nejmoa0911781
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发表时间：
2010-05-27
期刊：
影响因子：
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通讯作者：
Higgins RD
中科院分区：
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作者：
SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network;Carlo WA;Finer NN;Walsh MC;Rich W;Gantz MG;Laptook AR;Yoder BA;Faix RG;Das A;Poole WK;Schibler K;Newman NS;Ambalavanan N;Frantz ID 3rd;Piazza AJ;Sánchez PJ;Morris BH;Laroia N;Phelps DL;Poindexter BB;Cotten CM;Van Meurs KP;Duara S;Narendran V;Sood BG;O'Shea TM;Bell EF;Ehrenkranz RA;Watterberg KL;Higgins RD
先前的研究表明，暴露于低水平氧合的早产儿的视网膜病变发生率低于暴露于高氧合水平的早产儿。然而，目前尚不清楚什么范围的氧饱和度适合在不增加不良后果的情况下将视网膜病变降至最低。我们用2×2析因设计进行了一项随机试验，比较了1316名出生在孕24周0天和27周6天之间的婴儿的血氧饱和度目标范围为85%到89%或91%到95%。主要结果是早产儿的严重视网膜病变(定义为存在阈值视网膜病变、需要外科眼科干预或使用贝伐单抗)、出院前死亡或两者兼而有之。所有婴儿也被随机分配给持续气道正压或插管和肺表面活性物质。低血氧饱和度组和高血氧饱和度组的严重视网膜病变或死亡率差异无统计学意义(分别为28.3%和32.1%；低血氧饱和度组的相对危险度为0.90；95%可信区间[CI]为0.76~1.06；P=0.21)。低氧饱和度组出院前死亡发生率较高(19.9%对16.2%；相对危险度1.27；95%可信区间1.01~1.6；P=0.04)，而存活者严重视网膜病变发生率较低(8.6%对17.9%；相对危险度0.52；95%可信区间0.37~0.73；P<；0.001)。其他不良事件的发生率没有显著差异。较低的氧合目标范围(85%至89%)与较高的氧合范围(91%至95%)相比，并未显著降低严重视网膜病变或死亡的综合结果，但它导致了死亡率的增加和幸存者中严重视网膜病变的大幅减少。死亡率的增加是一个主要的问题，因为越来越多的人主张降低血氧饱和度的目标范围，以预防早产儿的视网膜病变。(ClinicalTrials.gov编号，NCT00233324。)
Previous studies have suggested that the incidence of retinopathy is lower in preterm infants with exposure to reduced levels of oxygenation than in those exposed to higher levels of oxygenation. However, it is unclear what range of oxygen saturation is appropriate to minimize retinopathy without increasing adverse outcomes. We performed a randomized trial with a 2-by-2 factorial design to compare target ranges of oxygen saturation of 85 to 89% or 91 to 95% among 1316 infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. The primary outcome was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before discharge from the hospital, or both. All infants were also randomly assigned to continuous positive airway pressure or intubation and surfactant. The rates of severe retinopathy or death did not differ significantly between the lower-oxygen-saturation group and the higher-oxygen-saturation group (28.3% and 32.1%, respectively; relative risk with lower oxygen saturation, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P = 0.21). Death before discharge occurred more frequently in the lower-oxygen-saturation group (in 19.9% of infants vs. 16.2%; relative risk, 1.27; 95% CI, 1.01 to 1.60; P = 0.04), whereas severe retinopathy among survivors occurred less often in this group (8.6% vs. 17.9%; relative risk, 0.52; 95% CI, 0.37 to 0.73; P<0.001). There were no significant differences in the rates of other adverse events. A lower target range of oxygenation (85 to 89%), as compared with a higher range (91 to 95%), did not significantly decrease the composite outcome of severe retinopathy or death, but it resulted in an increase in mortality and a substantial decrease in severe retinopathy among survivors. The increase in mortality is a major concern, since a lower target range of oxygen saturation is increasingly being advocated to prevent retinopathy of prematurity. (ClinicalTrials.gov number, NCT00233324.)