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[JAMA最新论文]:极早产儿不同氧合目标的前瞻荟萃分析
2018年06月13日 时讯速递, 进展交流 暂无评论

Original Investigation

June 5, 2018

Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration

Lisa M. Askie, Brian A. Darlow, Neil Finer, et al.

JAMA. 2018;319(21):2190-2201. doi:10.1001/jama.2018.5725

Abstract

Importance 背景

There are potential benefits and harms of hyperoxemia and hypoxemia for extremely preterm infants receiving more vs less supplemental oxygen.

对于接受积极与保守氧疗的极早产儿,高氧血症与低氧血症各有利弊。

Objective 目的

To compare the effects of different target ranges for oxygen saturation as measured by pulse oximetry (Spo2) on death or major morbidity.

比较通过脉搏氧饱和度(Spo2)测定的不同氧饱和度目标范围对于死亡或严重并发症的影响。

Design, Setting, and Participants 设计,场景及研究对象

Prospectively planned meta-analysis of individual participant data from 5 randomized clinical trials (conducted from 2005-2014) enrolling infants born before 28 weeks’ gestation.

对于入选不足28孕周婴儿的5项随机临床试验(2005-2014年间进行)的个人资料进行前瞻计划的meta分析。

Exposures 暴露因素

Spo2 target range that was lower (85%-89%) vs higher (91%-95%).

较低(85%-89%) 与较高 (91%-95%)的Spo2 目标范围

Main Outcomes and Measures 主要预后指标

The primary outcome was a composite of death or major disability (bilateral blindness, deafness, cerebral palsy diagnosed as ≥2 level on the Gross Motor Function Classification System, or Bayley-III cognitive or language score <85) at a corrected age of 18 to 24 months. There were 16 secondary outcomes including the components of the primary outcome and other major morbidities.

主要预后终点为校正年龄18-24个月时死亡或严重并发症(双眼失明,失聪,根据粗大运动功能分类系统≥2级诊断的脑瘫,或Bayley-III认知或语言评分< 85)的复合终点。研究设定16个次要终点,包括主要预后终点的各个项目或其他严重并发症。

Results 结果

A total of 4965 infants were randomized (2480 to the lower Spo2 target range and 2485 to the higher Spo2 range) and had a median gestational age of 26 weeks (interquartile range, 25-27 weeks) and a mean birth weight of 832 g (SD, 190 g). The primary outcome occurred in 1191 of 2228 infants (53.5%) in the lower Spo2 target group and 1150 of 2229 infants (51.6%) in the higher Spo2 target group (risk difference, 1.7% [95% CI, −1.3% to 4.6%]; relative risk [RR], 1.04 [95% CI, 0.98 to 1.09], P = .21). Of the 16 secondary outcomes, 11 were null, 2 significantly favored the lower Spo2 target group, and 3 significantly favored the higher Spo2 target group. Death occurred in 484 of 2433 infants (19.9%) in the lower Spo2 target group and 418 of 2440 infants (17.1%) in the higher Spo2 target group (risk difference, 2.8% [95% CI, 0.6% to 5.0%]; RR, 1.17 [95% CI, 1.04 to 1.31], P = .01). Treatment for retinopathy of prematurity was administered to 220 of 2020 infants (10.9%) in the lower Spo2 target group and 308 of 2065 infants (14.9%) in the higher Spo2target group (risk difference, −4.0% [95% CI, −6.1% to −2.0%]; RR, 0.74 [95% CI, 0.63 to 0.86], P < .001). Severe necrotizing enterocolitis occurred in 227 of 2464 infants (9.2%) in the lower Spo2 target group and 170 of 2465 infants (6.9%) in the higher Spo2 target group (risk difference, 2.3% [95% CI, 0.8% to 3.8%]; RR, 1.33 [95% CI, 1.10 to 1.61], P = .003).

共有4965名婴儿接受随机分组(2480名分至低 Spo2 目标范围组,2485名分至高 Spo2 目标范围组),中位孕周为 26 周(四分位区间,25-27 周),平均出生体重 832 g (SD, 190 g)。低Spo2 目标组2228名婴儿中 1191 名 (53.5%) ,高Spo2 目标组2229名婴儿中1150名(51.6%)发生主要预后终点事件(风险差异,1.7% [95% CI, −1.3% to 4.6%];相对危险度 [RR],1.04 [95% CI, 0.98 to 1.09], P = .21)。在16项次要预后指标中,11项无差异,低Spo2 目标组2项次要预后指标较好,高Spo2 目标组3项次要预后指标较好。低Spo2 目标组2433名婴儿中484名(19.9%),高Spo2 目标组中2440名婴儿中418名(17.1%)死亡(风险差异,2.8% [95% CI, 0.6% to 5.0%]; RR, 1.17 [95% CI, 1.04 to 1.31], P = .01)。低Spo2 目标组2020名婴儿中220名(10.9%)以及高Spo2 目标组2065名婴儿中308名(14.9%)接受了针对早产儿视网膜病的治疗(风险差异,-4.0% [95% CI, -6.1% to -2.0%]; RR, 0.74 [95% CI, 0.63 to 0.86], P < .001)。低Spo2 目标组2464名婴儿中227名(9.2%)以及高Spo2 目标组2465名婴儿中170名(6.9%)发生严重坏死性肠炎(风险差异,2.3% [95% CI, 0.8% to 3.8%]; RR, 1.33 [95% CI, 1.10 to 1.61], P = .003)。

Conclusions and Relevance 结论与意义

In this prospectively planned meta-analysis of individual participant data from extremely preterm infants, there was no significant difference between a lower Spo2 target range compared with a higher Spo2 target range on the primary composite outcome of death or major disability at a corrected age of 18 to 24 months. The lower Spo2 target range was associated with a higher risk of death and necrotizing enterocolitis, but a lower risk of retinopathy of prematurity treatment.

在这项针对极早产儿个人资料的前瞻计划meta分析中,低Spo2 目标与高Spo2 目标对校正年龄18至24个月时包括死亡或主要并发症在内的主要复合预后终点没有显著差异。低Spo2 目标范围伴随较高病死率及坏死性肠炎发生率,但针对早产儿视网膜病治疗的风险较低。

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