Beractant and poractant alfa in premature neonates with respiratory distress syndrome: a systematic review of real-world evidence studies and randomized controlled trials.,Journal of Perinatology

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Beractant and poractant alfa in premature neonates with respiratory distress syndrome: a systematic review of real-world evidence studies and randomized controlled trials.
Journal of Perinatology ( IF 2.4 ) Pub Date : 2020-02-12 , DOI: 10.1038/s41372-020-0603-7
Manuel Sánchez Luna ₁ , Peter Bacher ₂ , Kristina Unnebrink ₃ , Marisol Martinez-Tristani ₂ , Cristina Ramos Navarro ₁

Affiliation

Findings from previous meta-analyses of randomized clinical trials (RCTs) in premature infants with respiratory distress syndrome (RDS) varied as to whether clinical outcomes differed by type of animal-derived pulmonary surfactant; real-world evidence (RWE) was excluded. We extracted study characteristics and outcomes from full-text articles from a systematic search for studies that compared beractant with poractant alfa for RDS in preterm infants. RWE data were tabulated; RCT data were subjected to meta-analyses. Designs, patient characteristics, and follow-up durations varied widely among studies (4 RWE, 15 RCT). RWE studies with adjusted odds ratios (ORs) found no statistically significant between-treatment differences in outcomes. In RCT meta-analyses, no statistically significant between-treatment differences were observed for death (OR [95% confidence interval], 1.35 [0.98-1.86]), bronchopulmonary dysplasia (1.25 [0.96-1.62]), pneumothorax (1.21 [0.72-2.05]), and air leak syndrome (2.28 [0.82-6.39]). Collectively, outcomes were similar with beractant and poractant alfa in RWE studies and pooled RCTs.

中文翻译：

患有呼吸窘迫综合征的早产儿的 Beractant 和 poractant alfa：对真实世界证据研究和随机对照试验的系统评价。

先前对患有呼吸窘迫综合征 (RDS) 的早产儿进行的随机临床试验 (RCT) 的荟萃分析的结果在临床结果是否因动物源性肺表面活性剂类型而异；排除真实世界证据（RWE）。我们从系统搜索的全文文章中提取了研究特征和结果，这些研究比较了 beractant 和 poractant alfa 治疗早产儿 RDS 的研究。RWE 数据被制成表格；RCT 数据进行荟萃分析。研究的设计、患者特征和随访时间差异很大（4 RWE，15 RCT）。调整优势比 (OR) 的 RWE 研究未发现治疗间的结果差异具有统计学意义。在 RCT 荟萃分析中，在死亡（OR [95% 置信区间]，1.35 [0.98-1.86]）、支气管肺发育不良（1.25 [0.96-1.62]）、气胸（1.21 [0.72-2.05]）和漏气综合征 (2.28 [0.82-6.39])。总的来说，在 RWE 研究和汇总 RCT 中，beractant 和 poractant alfa 的结果相似。

更新日期：2020-02-12

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