本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2305582

摘要内容如下：

背景

环氧化酶抑制剂布洛芬可用于治疗早产儿动脉导管未闭（PDA）。使用布洛芬选择性早期治疗大型PDA是否会改善短期结果尚不清楚。

方法

我们进行了一项多中心、随机、双盲、安慰剂对照试验，以评估布洛芬早期（出生后≤72小时）治疗极早产儿（在妊娠23周0天至28周6天之间出生）大PDA（直径≥1.5 mm，伴有搏动血流）的疗效。主要转归是在月经后36周时评估的死亡或中度或重度支气管肺发育不良的复合转归。

结果

共有326名婴儿接受布洛芬治疗，327名婴儿接受安慰剂治疗。324和322分别有可用于结果分析的数据。布洛芬组318名婴儿中有220名（69.2%）发生主要转归事件，安慰剂组318名婴儿中有202名（63.5%）发生主要转归事件（校正风险比为1.09；95%置信区间[CI]，0.98至1.20；P=0.10）。布洛芬组323名婴儿中的44名（13.6%）和安慰剂组321名婴儿中的33名（10.3%）死亡（校正风险比为1.32；95%置信区间，0.92至1.90）。在存活至月经后年龄36周的婴儿中，布洛芬组274名婴儿中有176名（64.2%）发生中度或重度支气管肺发育不良，安慰剂组285名婴儿中有169名（59.3%）发生中度或重度支气管肺发育不良（校正风险比为1.09；95%置信区间，0.96至1.23）。发生了两起可能与布洛芬有关的不可预见的严重不良事件。

结论

与接受安慰剂的婴儿相比，接受布洛芬早期治疗的婴儿在月经后36周时的死亡或中度或重度支气管肺发育不良的风险并未显著降低。（由国家卫生研究所卫生技术评估计划资助；Baby-Oscar ISRCTN注册编号为ISRCTN84264977。）

英文原文如下：

Abstracts

BACKGROUND  The cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus (PDA) in preterm infants. Whether selective early treatment of large PDAs with ibuprofen would improve short-term outcomes is not known.

METHODS  We conducted a multicenter, randomized, double-blind, placebo-controlled trial evaluating early treatment (≤72 hours after birth) with ibuprofen for a large PDA (diameter of ≥1.5 mm with pulsatile flow) in extremely preterm infants (born between 23 weeks 0 days' and 28 weeks 6 days' gestation). The primary outcome was a composite of death or moderate or severe bronchopulmonary dysplasia evaluated at 36 weeks of postmenstrual age.

RESULTS  A total of 326 infants were assigned to receive ibuprofen and 327 to receive placebo; 324 and 322, respectively, had data available for outcome analyses. A primary-outcome event occurred in 220 of 318 infants (69.2%) in the ibuprofen group and 202 of 318 infants (63.5%) in the placebo group (adjusted risk ratio, 1.09; 95% confidence interval [CI], 0.98 to 1.20; P = 0.10). A total of 44 of 323 infants (13.6%) in the ibuprofen group and 33 of 321 infants (10.3%) in the placebo group died (adjusted risk ratio, 1.32; 95% CI, 0.92 to 1.90). Among the infants who survived to 36 weeks of postmenstrual age, moderate or severe bronchopulmonary dysplasia occurred in 176 of 274 (64.2%) in the ibuprofen group and 169 of 285 (59.3%) in the placebo group (adjusted risk ratio, 1.09; 95% CI, 0.96 to 1.23). Two unforeseeable serious adverse events occurred that were possibly related to ibuprofen.

CONCLUSIONS  The risk of death or moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age was not significantly lower among infants who received early treatment with ibuprofen than among those who received placebo. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Baby-OSCAR ISRCTN Registry number, ISRCTN84264977.).

-----------分割线---------

点击链接：https://www.mediecogroup.com/community/user/vip/categories/ ，成为医咖会员，获取12项专属权益。

现在购买可享受最大优惠（买一年送三个月，买两年送一年），2024年2月10日起将不再享有该优惠。