布洛芬选择性早期治疗动脉导管未闭的试验
Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.
作者信息
Gupta Samir, Subhedar Nimish V, Bell Jennifer L, Field David, Bowler Ursula, Hutchison Elizabeth, Johnson Sam, Kelsall Wilf, Pepperell Justine, Roberts Tracy, Sinha Sunil, Stanbury Kayleigh, Wyllie Jonathan, Hardy Pollyanna, Juszczak Edmund
机构信息
From the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
出版信息
N Engl J Med. 2024 Jan 25;390(4):314-325. doi: 10.1056/NEJMoa2305582.
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.).
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）。布洛芬选择性早期治疗大型PDA是否能改善短期预后尚不清楚。
方法
我们进行了一项多中心、随机、双盲、安慰剂对照试验，评估极早产儿（孕龄在23周0天至28周6天之间）大型PDA（直径≥1.5mm且有搏动血流）出生后≤72小时使用布洛芬进行早期治疗的效果。主要结局是在月经后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结局。
结果
共有326名婴儿被分配接受布洛芬治疗，327名接受安慰剂治疗；分别有324名和322名婴儿的数据可用于结局分析。布洛芬组318名婴儿中有220名（69.2%）发生主要结局事件，安慰剂组318名婴儿中有202名（63.5%）发生主要结局事件（调整风险比为1.09；95%置信区间[CI]为0.98至1.20；P = 0.10）。布洛芬组323名婴儿中有44名（13.6%）死亡，安慰剂组321名婴儿中有33名（10.3%）死亡（调整风险比为1.32；95%CI为0.92至1.90）。在存活至月经后36周的婴儿中，布洛芬组274名中有176名（64.2%）发生中度或重度支气管肺发育不良，安慰剂组285名中有169名（59.3%）发生中度或重度支气管肺发育不良（调整风险比为1.09；95%CI为0.96至1.23）。发生了两起可能与布洛芬相关的不可预见的严重不良事件。
结论
接受布洛芬早期治疗的婴儿在月经后36周时死亡或中度或重度支气管肺发育不良的风险并不显著低于接受安慰剂治疗的婴儿。（由英国国家卫生研究院卫生技术评估项目资助；Baby-OSCAR国际标准随机对照试验编号，ISRCTN84264977。）
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