Jansen Esther J S, Hundscheid Tim, Onland Wes, Kooi Elisabeth M W, Andriessen Peter, de Boode Willem P
Radboud University Medical Center Nijmegen, Radboud Institute for Health Sciences, Amalia Children's Hospital, Nijmegen, Netherlands.
Emma Children's Hospital, Amsterdam University Medical Centers, VU University Medical Center, University of Amsterdam, Amsterdam, Netherlands.
Front Pediatr. 2021 Feb 9;9:626262. doi: 10.3389/fped.2021.626262. eCollection 2021.
There is an ongoing debate on the optimal management of patent ductus arteriosus (PDA) in preterm infants. Identifying subgroup of infants who would benefit from pharmacological treatment might help. To investigate the modulating effect of the differences in methodological quality, the rate of open-label treatment, and patient characteristics on relevant outcome measures in randomized controlled trials (RCTs). Electronic database search between 1950 and May 2020. RCTs that assessed pharmacological treatment compared to placebo/no treatment. Data is extracted following the PRISMA guidelines. Outcome measures were failure to ductal closure, surgical ligation, incidence of necrotizing enterocolitis, bronchopulmonary dysplasia, sepsis, periventricular leukomalacia, intraventricular hemorrhage (IVH) grade ≥3, retinopathy of prematurity and mortality. Forty-seven studies were eligible. The incidence of IVH grade ≥3 was lower in the treated infants compared to the placebo/no treatment (RR 0.77, 95% CI 0.64-0.94) and in the subgroups of infants with either a gestational age <28 weeks (RR 0.77, 95% CI 0.61-0.98), a birth weight <1,000 g (RR 0.77, 95% CI 0.61-0.97), or if untargeted treatment with indomethacin was started <24 h after birth (RR 0.70, 95% CI 0.54-0.90). Statistical heterogeneity caused by missing data and variable definitions of outcome parameters. Although the quality of evidence is low, this meta-analysis suggests that pharmacological treatment of PDA reduces severe IVH in extremely preterm, extremely low birth weight infants or if treatment with indomethacin was started <24 h after birth. No other beneficial effects of pharmacological treatment were found.
关于早产儿动脉导管未闭（PDA）的最佳管理，目前仍存在争议。确定能从药物治疗中获益的婴儿亚组可能会有所帮助。为了研究方法学质量差异、开放标签治疗率和患者特征对随机对照试验（RCT）中相关结局指标的调节作用。检索了1950年至2020年5月的电子数据库。评估药物治疗与安慰剂/不治疗对比的RCT。按照PRISMA指南提取数据。结局指标包括导管未闭失败、手术结扎、坏死性小肠结肠炎发病率、支气管肺发育不良、败血症、脑室周围白质软化、脑室内出血（IVH）≥3级、早产儿视网膜病变和死亡率。47项研究符合条件。与安慰剂/不治疗相比，接受治疗的婴儿中IVH≥3级的发病率较低（RR 0.77，95%CI 0.64 - 0.94），在胎龄<28周（RR 0.77，95%CI 0.61 - 0.98）、出生体重<1000g（RR 0.77，95%CI 0.61 - 0.97）或出生后<24小时开始使用吲哚美辛进行非靶向治疗的婴儿亚组中也是如此（RR 0.70，95%CI 0.54 - 0.90）。数据缺失和结局参数定义的差异导致了统计异质性。尽管证据质量较低，但这项荟萃分析表明，PDA的药物治疗可降低极早产儿、极低出生体重儿或出生后<24小时开始使用吲哚美辛治疗时严重IVH的发生率。未发现药物治疗的其他有益效果。
