Neonatology Department, Baoding No.1 Central Hospital, Baoding, China.
Infection control office, Baoding No.1 Central Hospital, Baoding, China.
Cardiol Young. 2024 Jun;34(6):1334-1341. doi: 10.1017/S1047951123004456. Epub 2024 Feb 8.
Persistent pulmonary hypertension of the newborn is a life-threatening condition that affects about 1-2 per 1,000 live births worldwide. Bosentan is an oral dual endothelin receptor antagonist that may have a beneficial effect on persistent pulmonary hypertension of the newborn by reducing pulmonary vascular resistance and improving oxygenation. However, its role in persistent pulmonary hypertension of the newborn remains unclear.
To systematically evaluate the efficacy and safety of bosentan as an adjuvant therapy for persistent pulmonary hypertension of the newborn in newborns.
We searched six English and two Chinese databases from their inception to 1 January 2023 following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We included randomised controlled trials and retrospective studies that compared bosentan with placebo or other drugs for persistent pulmonary hypertension of the newborn in newborns. We performed a meta-analysis using random-effects models and assessed the risk of bias and heterogeneity in the included studies.
We included 10 studies with a total of 550 participants. Bosentan significantly reduced the treatment failure rate (relative risk = 0.25, P < 0.001), pulmonary artery pressure (mean difference = -11.79, P < 0.001), and length of hospital stay (mean difference = -1.04, P = 0.003), and increased the partial pressure of oxygen (mean difference = 10.02, P < 0.001) and blood oxygen saturation (SpO2) (mean difference = 8.24, P < 0.001) compared with a placebo or other drugs. The occurrence of adverse reactions was not significantly different between bosentan and a placebo or other drugs.
Bosentan is effective in the treatment of persistent pulmonary hypertension of the newborn but adverse reactions such as abnormal liver function should be observed when using it.
新生儿持续性肺动脉高压是一种危及生命的疾病，全球约每 1000 例活产中就有 1-2 例。波生坦是一种口服双重内皮素受体拮抗剂，通过降低肺血管阻力和改善氧合，可能对新生儿持续性肺动脉高压有有益作用。然而，其在新生儿持续性肺动脉高压中的作用仍不清楚。
系统评价波生坦作为辅助治疗新生儿持续性肺动脉高压的疗效和安全性。
我们按照系统评价和荟萃分析的首选报告项目的指导原则，从成立到 2023 年 1 月 1 日，检索了 6 个英文数据库和 2 个中文数据库。我们纳入了比较波生坦与安慰剂或其他药物治疗新生儿持续性肺动脉高压的随机对照试验和回顾性研究。我们使用随机效应模型进行荟萃分析，并评估纳入研究的偏倚风险和异质性。
我们纳入了 10 项研究，共计 550 名参与者。波生坦显著降低了治疗失败率（相对风险=0.25，P<0.001）、肺动脉压（平均差=-11.79，P<0.001）和住院时间（平均差=-1.04，P=0.003），并增加了部分氧分压（平均差=10.02，P<0.001）和血氧饱和度（SpO2）（平均差=8.24，P<0.001），与安慰剂或其他药物相比。波生坦与安慰剂或其他药物相比，不良反应的发生率无显著差异。
波生坦在治疗新生儿持续性肺动脉高压方面有效，但使用时应观察肝功能异常等不良反应。
