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小剂量氢化可的松预防极早产儿肾上腺皮质功能不全的效果:一项个体患者数据荟萃分析。

Effect of Prophylaxis for Early Adrenal Insufficiency Using Low-Dose Hydrocortisone in Very Preterm Infants: An Individual Patient Data Meta-Analysis.

机构信息

Department of Statistics, University of Washington, Seattle, WA.

Division of Neonatology and Pediatric Intensive Care, Department of Pediatrics, University Hospitals Geneva, Geneva, Switzerland; University of Geneva, Switzerland; University Paris Diderot, Paris, France.

出版信息

J Pediatr. 2019 Apr;207:136-142.e5. doi: 10.1016/j.jpeds.2018.10.004. Epub 2018 Nov 8.

DOI:10.1016/j.jpeds.2018.10.004
PMID:30416014
Abstract

OBJECTIVE

To assess the effect of prophylaxis for early adrenal insufficiency using low-dose hydrocortisone on survival without bronchopulmonary dysplasia (BPD) in very preterm infants using an individual patient data meta-analysis.

STUDY DESIGN

All existing randomized controlled trials testing the efficacy of the prophylaxis of early adrenal insufficiency using low-dose hydrocortisone on survival without BPD were considered for inclusion when data were available. The primary outcome was the binary variable survival without BPD at 36 weeks of postmenstrual age.

RESULTS

Among 5 eligible studies, 4 randomized controlled trials had individual patient data available (96% of participants identified; n = 982). Early low-dose hydrocortisone treatment for 10-15 days was associated with a significant increase in survival without BPD (OR, 1.45; 95% CI, 1.11-1.90; P = .007; I = 0%), as well as with decreases in medical treatment for patent ductus arteriosus (OR, 0.72; 95% CI, 0.56-0.93; P = .01; I = 0%) and death before discharge (OR, 0.70; 95% CI, 0.51-0.97; P = .03; I = 0%). The therapy was associated with an increased risk of spontaneous gastrointestinal perforation (OR, 2.50; 95% CI, 1.33-4.69; P = .004; I = 31.9%) when hydrocortisone was given in association with indomethacin exposure. The incidence of late-onset sepsis was increased in infants exposed to hydrocortisone (OR, 1.34; 95% CI, 1.02-1.75; P = .04; I = 0%), but no adverse effects were reported for either death or 2-year neurodevelopmental outcomes as assessed in an aggregate meta-analysis.

CONCLUSIONS

This individual patient data meta-analysis showed that early low-dose hydrocortisone therapy is beneficial for survival without BPD in very preterm infants.

摘要

目的

通过个体患者数据荟萃分析,评估使用小剂量氢化可的松预防早产儿早期肾上腺功能不全对避免发生支气管肺发育不良(BPD)的影响。

研究设计

当有数据可用时,考虑纳入所有已发表的使用小剂量氢化可的松预防早产儿早期肾上腺功能不全以避免发生 BPD 的随机对照试验。主要结局为校正胎龄 36 周时无 BPD 的生存的二项变量。

结果

在 5 项合格的研究中,有 4 项随机对照试验有个体患者数据(96%的被识别参与者;n=982)。接受 10-15 天的早期小剂量氢化可的松治疗与无 BPD 的存活率显著提高有关(OR,1.45;95%CI,1.11-1.90;P=0.007;I=0%),同时也降低了对未闭动脉导管的药物治疗(OR,0.72;95%CI,0.56-0.93;P=0.01;I=0%)和出院前死亡的风险(OR,0.70;95%CI,0.51-0.97;P=0.03;I=0%)。当氢化可的松与吲哚美辛暴露同时使用时,该治疗与自发性胃肠道穿孔的风险增加相关(OR,2.50;95%CI,1.33-4.69;P=0.004;I=31.9%)。在接受氢化可的松治疗的婴儿中,迟发性败血症的发生率增加(OR,1.34;95%CI,1.02-1.75;P=0.04;I=0%),但在汇总荟萃分析中,无论是死亡还是 2 年神经发育结局都没有报告任何不良影响。

结论

本项个体患者数据荟萃分析表明,早期小剂量氢化可的松治疗对避免极低出生体重儿发生 BPD 有益。

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