早产儿视网膜病变治疗后的神经发育结局。
Neurodevelopmental Outcomes of Preterm Infants With Retinopathy of Prematurity by Treatment.
机构信息
Department of Pediatrics, Wayne State University, Detroit, Michigan;
Department of Pediatrics, Wayne State University, Detroit, Michigan.
出版信息
Pediatrics. 2019 Aug;144(2). doi: 10.1542/peds.2018-3537. Epub 2019 Jul 23.
OBJECTIVE
Among extremely preterm infants, we evaluated whether bevacizumab therapy compared with surgery for retinopathy of prematurity (ROP) is associated with adverse outcomes in early childhood.
METHODS
This study was a retrospective analysis of prospectively collected data on preterm (22-26 + 6/7 weeks' gestational age) infants admitted to the National Institute of Child Health and Human Development Neonatal Research Network centers who received bevacizumab or surgery exclusively for ROP. The primary outcome was death or severe neurodevelopmental impairment (NDI) at 18 to 26 months' corrected age (Bayley Scales of Infant and Toddler Development, Third Edition cognitive or motor composite score <70, Gross Motor Functional Classification Scale level ≥2, bilateral blindness or hearing impairment).
RESULTS
The cohort ( = 405; 214 [53%] boys; median [interquartile range] gestational age: 24.6 [23.9-25.3] weeks) included 181 (45%) infants who received bevacizumab and 224 (55%) who underwent ROP surgery. Infants treated with bevacizumab had a lower median (interquartile range) birth weight (640 [541-709] vs 660 [572.5-750] g; = .02) and longer durations of conventional ventilation (35 [21-58] vs 33 [18-49] days; = .04) and supplemental oxygen (112 [94-120] vs 105 [84.5-120] days; = .01). Death or severe NDI (adjusted odds ratio [aOR] 1.42; 95% confidence interval [CI] 0.94 to 2.14) and severe NDI (aOR 1.14; 95% CI 0.76 to 1.70) did not differ between groups. Odds of death (aOR 2.54 [95% CI 1.42 to 4.55]; = .002), a cognitive score <85 (aOR 1.78 [95% CI 1.09 to 2.91]; = .02), and a Gross Motor Functional Classification Scale level ≥2 (aOR 1.73 [95% CI 1.04 to 2.88]; = .04) were significantly higher with bevacizumab therapy.
CONCLUSIONS
In this multicenter cohort of preterm infants, ROP treatment modality was not associated with differences in death or NDI, but the bevacizumab group had higher mortality and poor cognitive outcomes in early childhood. These data reveal the need for a rigorous appraisal of ROP therapy.
目的
在极早产儿中，我们评估贝伐单抗治疗与早产儿视网膜病变（ROP）手术相比，是否与儿童早期的不良结局相关。
方法
本研究是对前瞻性收集的资料进行的回顾性分析，纳入在国立儿童健康与人类发展研究所新生儿研究网络中心接受贝伐单抗或手术治疗 ROP 的 22-26+6/7 周胎龄的早产儿。主要结局为校正年龄 18 至 26 个月时死亡或严重神经发育障碍（NDI）（贝利婴幼儿发展量表第三版认知或运动综合评分<70，粗大运动功能分类量表≥2 级，双侧失明或听力损伤）。
结果
该队列（n=405；214[53%]名男孩；中位[四分位间距]胎龄：24.6[23.9-25.3]周）包括 181 名（45%）接受贝伐单抗治疗和 224 名（55%）接受 ROP 手术的婴儿。接受贝伐单抗治疗的婴儿出生体重中位数（四分位间距）较低（640[541-709] vs 660[572.5-750]g；P=0.02），且常规通气时间（35[21-58] vs 33[18-49]天；P=0.04）和补充氧气时间（112[94-120] vs 105[84.5-120]天；P=0.01）更长。两组间死亡或严重 NDI（调整后的优势比[aOR]1.42；95%置信区间[CI]0.94 至 2.14）和严重 NDI（aOR 1.14；95%CI 0.76 至 1.70）无差异。贝伐单抗治疗组的死亡率（aOR 2.54[95%CI 1.42 至 4.55]；P=0.002）、认知评分<85（aOR 1.78[95%CI 1.09 至 2.91]；P=0.02）和粗大运动功能分类量表≥2 级（aOR 1.73[95%CI 1.04 至 2.88]；P=0.04）显著升高。
结论
在本项多中心早产儿队列研究中，ROP 治疗方式与死亡或 NDI 无差异，但贝伐单抗治疗组儿童早期死亡率更高，认知结局较差。这些数据揭示了需要对 ROP 治疗进行严格评估。
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