氢化可的松改善支气管肺发育不良生存率。
Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia.
机构信息
From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (B.B.P., S.M.), and the Department of Pediatrics, Nationwide Children's Hospital, Ohio State University College of Medicine, Columbus (M.M., N.L.M.) - all in Ohio; the Social, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park (L.L.), the Department of Pediatrics, Duke University, Durham (R.N.G., C.M.C., W.F.M.), and the Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill (M.M.L.) - all in North Carolina; the Department of Pediatrics, Wayne State University (S.C., G.N.), and the Department of Pediatrics, Central Michigan University (S.C.) - both in Detroit; the University of Rochester School of Medicine and Dentistry, Rochester (C.T.D., P.R.C.), and the Department of Pediatrics, University of Buffalo Women's and Children's Hospital of Buffalo, Buffalo (A.M.R.) - both in New York; the Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto (S.R.H., K.P.V.M.), and the Department of Pediatrics, University of California, Los Angeles, Los Angeles (M.G., I.B.P.) - both in California; the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (B.A.Y., S.W.); the Department of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston (K.A.K., G.E.M., A.M.K., R.A.M.), and the Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (M.H.W., R.J.H.) - both in Texas; the Social, Statistical, and Environmental Sciences Unit, RTI International, Rockville (A.D., M.M.C.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda (R.D.H.) - both in Maryland; the Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI (M.K., E.C.M.); the Department of Pediatrics, Indiana University School of Medicine, Indianapolis (G.M.S., A.C.H.); Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (B.B.P., R.M.P., N.L.M., I.A.-C.); the Division of Neonatology, University of Alabama at Birmingham, Birmingham (N.A., M.P.-C.); the Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO (W.E.T., H.W.K.); the Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, Philadelphia (B.S., S.B.D.); the Department of Pediatrics, University of Iowa, Iowa City (E.F.B., H.M.H.); the Department of Pediatrics, Sanford School of Medicine, University of South Dakota, Sioux Falls (L.R.M., L.A.H.); and the College of Health and Human Services, George Mason University, Fairfax, VA (R.D.H.).
出版信息
N Engl J Med. 2022 Mar 24;386(12):1121-1131. doi: 10.1056/NEJMoa2114897.
BACKGROUND
Bronchopulmonary dysplasia is a prevalent complication after extremely preterm birth. Inflammation with mechanical ventilation may contribute to its development. Whether hydrocortisone treatment after the second postnatal week can improve survival without bronchopulmonary dysplasia and without adverse neurodevelopmental effects is unknown.
METHODS
We conducted a trial involving infants who had a gestational age of less than 30 weeks and who had been intubated for at least 7 days at 14 to 28 days. Infants were randomly assigned to receive either hydrocortisone (4 mg per kilogram of body weight per day tapered over a period of 10 days) or placebo. Mandatory extubation thresholds were specified. The primary efficacy outcome was survival without moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age, and the primary safety outcome was survival without moderate or severe neurodevelopmental impairment at 22 to 26 months of corrected age.
RESULTS
We enrolled 800 infants (mean [±SD] birth weight, 715±167 g; mean gestational age, 24.9±1.5 weeks). Survival without moderate or severe bronchopulmonary dysplasia at 36 weeks occurred in 66 of 398 infants (16.6%) in the hydrocortisone group and in 53 of 402 (13.2%) in the placebo group (adjusted rate ratio, 1.27; 95% confidence interval [CI], 0.93 to 1.74). Two-year outcomes were known for 91.0% of the infants. Survival without moderate or severe neurodevelopmental impairment occurred in 132 of 358 infants (36.9%) in the hydrocortisone group and in 134 of 359 (37.3%) in the placebo group (adjusted rate ratio, 0.98; 95% CI, 0.81 to 1.18). Hypertension that was treated with medication occurred more frequently with hydrocortisone than with placebo (4.3% vs. 1.0%). Other adverse events were similar in the two groups.
CONCLUSIONS
In this trial involving preterm infants, hydrocortisone treatment starting on postnatal day 14 to 28 did not result in substantially higher survival without moderate or severe bronchopulmonary dysplasia than placebo. Survival without moderate or severe neurodevelopmental impairment did not differ substantially between the two groups. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01353313.).
背景
支气管肺发育不良是极早产儿出生后的一种常见并发症。炎症和机械通气可能会促进其发展。在出生后第 2 周后使用氢化可的松治疗是否可以改善无支气管肺发育不良和无不良神经发育影响的生存率尚不清楚。
方法
我们进行了一项试验，涉及胎龄小于 30 周且出生后 14 至 28 天内至少接受 7 天插管的婴儿。婴儿被随机分配接受氢化可的松（4 毫克/千克/天，在 10 天内逐渐减少）或安慰剂。规定了强制性拔管阈值。主要疗效结局是在出生后 36 周时无中度或重度支气管肺发育不良的生存率，主要安全性结局是在 22 至 26 个月时无中度或重度神经发育障碍的生存率。
结果
我们共纳入 800 名婴儿（平均[±SD]出生体重 715±167g；平均胎龄 24.9±1.5 周）。在接受氢化可的松治疗的 398 名婴儿中有 66 名（16.6%）和接受安慰剂治疗的 402 名婴儿中有 53 名（13.2%）在出生后 36 周时无中度或重度支气管肺发育不良（调整后的比率，1.27；95%置信区间[CI]，0.93 至 1.74）。91.0%的婴儿知道 2 年的结果。在接受氢化可的松治疗的 358 名婴儿中有 132 名（36.9%）和接受安慰剂治疗的 359 名婴儿中有 134 名（37.3%）在出生后 2 年时无中度或重度神经发育障碍（调整后的比率，0.98；95%CI，0.81 至 1.18）。接受药物治疗的高血压在氢化可的松组比安慰剂组更常见（4.3%比 1.0%）。两组的其他不良事件相似。
结论
在这项涉及早产儿的试验中，在出生后第 14 至 28 天开始使用氢化可的松治疗并未导致无中度或重度支气管肺发育不良的生存率显著高于安慰剂。两组之间无中度或重度神经发育障碍的生存率无显著差异。（由美国国立卫生研究院资助；临床试验.gov 编号，NCT01353313）。
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