晚期表面活性剂制剂的疗效和安全性比较：一项回顾性研究。
Comparative efficacy and safety of late surfactant preparations: a retrospective study.
机构信息
Duke Clinical Research Institute, Duke University, Durham, NC, USA.
Department of Pediatrics, Duke University, Durham, NC, USA.
出版信息
J Perinatol. 2021 Nov;41(11):2639-2644. doi: 10.1038/s41372-021-01142-2. Epub 2021 Jul 20.
OBJECTIVE
Characterize the use, efficacy, and safety of poractant alfa and calfactant surfactants compared to beractant in preterm infants receiving late surfactant.
STUDY DESIGN
We included infants <37 weeks gestational age (GA) discharged from Pediatrix Medical Group-managed neonatal intensive care units (1997-2017). Efficacy and safety outcomes of interest were analyzed.
RESULTS
Of 184,770 infants administered surfactant at any time, 7846 (4.23%) received late surfactant at a median (25th, 75th percentile) PNA of 8 days (3, 22); specifically, 2976 received poractant alfa (38%), 2890 beractant (37%), and 1936 calfactant (25%). We identified no significant differences in composite efficacy or safety outcomes between surfactants in the primary analysis, but 33-36 week GA infants administered poractant alfa had significantly greater odds of developing a safety event.
CONCLUSIONS
Compared to beractant, there is no evidence of overall superior efficacy or safety of poractant alfa.
目的
比较猪肺磷脂和牛肺表面活性剂与固尔苏在早产儿接受晚期表面活性剂治疗中的使用、疗效和安全性。
研究设计
我们纳入了 1997 年至 2017 年期间从 Pediatrix 医疗集团管理的新生儿重症监护病房出院的 <37 周胎龄（GA）的婴儿。分析了感兴趣的疗效和安全性结果。
结果
在接受任何时间表面活性剂治疗的 184770 名婴儿中，7846 名（4.23%）在中位（25%，75%分位数）生后第 8 天（3，22）接受了晚期表面活性剂治疗；具体来说，2976 名接受猪肺磷脂（38%），2890 名接受固尔苏（37%），1936 名接受牛肺表面活性剂（25%）。在主要分析中，我们没有发现不同表面活性剂之间在复合疗效或安全性结果方面存在显著差异，但接受猪肺磷脂治疗的 33-36 周 GA 婴儿发生安全事件的可能性显著增加。
结论
与固尔苏相比，猪肺磷脂在总体疗效或安全性方面没有证据表明更优。
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