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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes (see comments)
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Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes (see comments)

机译：阈值性早熟视网膜病变的补充治疗性氧（STOP-ROP），一项随机对照试验。 I：主要结果（请参阅评论）

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摘要

OBJECTIVE: To determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation. METHODS: Premature infants with confirmed prethreshold ROP in at least 1 eye and median pulse oximetry <94% saturation were randomized to a conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation or a supplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints. Certified examiners masked to treatment assignment conducted weekly eye examinations until each study eye reached ophthalmic endpoint. An adverse ophthalmic endpoint for an infant was defined as reaching threshold criteria for laser or cryotherapy in at least 1 study eye. A favorable ophthalmic endpoint was regression of the ROP into zone III for at least 2 consecutive weekly examinations or full retinal vascularization. At 3 months after the due date of the infant, ophthalmic findings, pulmonary status, growth, and interim illnesses were again recorded. RESULTS: Six hundred forty-nine infants (325 conventional and 324 supplemental) were enrolled from 30 centers over 5 years. Five hundred ninety-seven (92.0%) infants attained known ophthalmic endpoints, and 600 (92%) completed the ophthalmic 3-month assessment. The rate of progression to threshold in at least 1 eye was 48% in the conventional arm and 41% in the supplemental arm. After adjustment for baseline ROP severity stratum, plus disease, race, and gestational age, the odds ratio (supplemental vs conventional) for progression was.72 (95% confidence interval:.52, 1.01). Final structural status of all study eyes at 3 months of corrected age showed similar rates of severe sequelae in both treatment arms: retinal detachments or folds (4.4% conventional vs 4.1% supplemental), and macular ectopia (3.9% conventional vs 3.9% supplemental). Within the prespecified ROP severity strata, ROP progression rates were lower with supplemental oxygen than with conventional oxygen, but the differences were not statistically significant. A post hoc subgroup analysis of plus disease (dilated and tortuous vessels in at least 2 quadrants of the posterior pole) suggested that infants without plus disease may be more responsive to supplemental therapy (46% progression in the conventional arm vs 32% in the supplemental arm) than infants with plus disease (52% progression in conventional vs 57% in supplemental). Pneumonia and/or exacerbations of chronic lung disease occurred in more infants in the supplemental arm (8.5% conventional vs 13.2% supplemental). Also, at 50 weeks of postmenstrual age, fewer conventional than supplemental infants remained hospitalized (6.8% vs 12.7%), on oxygen (37.0% vs 46.8%), and on diuretics (24.4% vs 35. 8%). Growth and developmental milestones did not differ between the 2 arms. CONCLUSIONS: Use of supplemental oxygen at pulse oximetry saturations of 96% to 99% did not cause additional progression of prethreshold ROP but also did not significantly reduce the number of infants requiring peripheral ablative surgery. A subgroup analysis suggested a benefit of supplemental oxygen among infants who have prethreshold ROP without plus disease, but this finding requires additional study. Supplemental oxygen increased the risk of adverse pulmonary events including pneumonia and/or exacerbations of chronic lung disease and the need for oxygen, diuretics, and hospitalization at 3 months of corrected age. Although the relative risk/benefit of supplemental oxygen for each infant must be individually considered, clinicians need no longer be concerned that supplemental oxygen, as used in this study, will exacerbate active prethreshold ROP.
机译：目的：确定补充治疗性氧气对早产儿阈值性视网膜病（ROP）婴儿的疗效和安全性，以减少进展为阈值ROP的可能性和周边视网膜消融的必要性。方法：将具有至少1只眼的门限前ROP且中位脉搏血氧饱和度<94％的早产儿随机分配到常规氧疗，将脉搏血氧饱和度的目标定为89％至94％饱和度，或将辅助臂的血氧饱和度定为96％饱和度至少达到99％，持续至少2周，直到两只眼睛都处于研究终点为止。面罩有治疗任务的合格检查员每周进行眼科检查，直到每只研究用眼达到眼科终点。婴儿的眼科不良终点定义为至少一只研究用眼达到激光或冷冻疗法的阈值标准。眼科方面的一个有利终点是至少连续2次每周检查或完全视网膜血管化将ROP退入III区。在婴儿的到期日后三个月，再次记录眼科检查结果，肺部状况，生长和临时疾病。结果：5年内从30个中心招募了649例婴儿（常规325例，补充324例）。五百九十七（92.0％）的婴儿达到了已知的眼科终点，而600名婴儿（92％）完成了三个月的眼科评估。至少一只眼睛的进展至阈值的比率在传统手臂中为48％，在补充手臂中为41％。在调整了基线ROP严重程度分层，加上疾病，种族和胎龄后，进展的几率（补充性与常规性）为72（95％置信区间：.52、1.01）。在校正年龄的3个月时，所有研究眼睛的最终结构状态在两个治疗组中均显示出相似的严重后遗症发生率：视网膜脱离或褶皱（4.4％常规vs补充4.1％）和黄斑性近视（3.9％常规vs补充3.9％） 。在预先确定的ROP严重程度分层中，补充氧气的ROP进展率低于常规氧气，但差异无统计学意义。对正性疾病（后极至少2个象限中扩张和曲折的血管）的事后亚组分析表明，没有正性疾病的婴儿对辅助治疗的反应可能更高（常规臂的进展为46％，辅助臂的进展为32％患疾病的婴儿（常规进展为52％，补充疾病进展为57％）。补充组的更多婴儿发生肺炎和/或慢性肺病恶化（常规组为8.5％，补充组为13.2％）。同样，在月经后50周，住院的常规婴儿比补充婴儿的比例要低（6.8％vs. 12.7％），吸氧（37.0％vs 46.8％）和利尿剂（24.4％vs 35. 8％）。两个部门之间的增长和发展里程碑没有差异。结论：在脉搏血氧饱和度为96％至99％的情况下使用补充氧气不会导致阈前ROP进一步发展，但也不会显着减少需要进行周边消融手术的婴儿数量。一项亚组分析表明，对于阈值前ROP且无其他疾病的婴儿，补充氧气是有益的，但是这一发现需要进一步的研究。补充氧气会增加不良肺部事件的风险，包括肺炎和/或慢性肺病的恶化，以及在校正后的3个月内需要氧气，利尿剂和住院治疗。尽管必须单独考虑每个婴儿补充氧气的相对风险/益处，但是临床医生不必再担心本研究中使用的补充氧气会加剧活动性阈前ROP。

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