Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, China.
Faculty of Medicine, International School, Jinan University, Guangzhou, China.
Pediatr Pulmonol. 2021 Aug;56(8):2399-2412. doi: 10.1002/ppul.25444. Epub 2021 May 13.
To provide an updated review and meta-analysis on the efficacy and safety of sildenafil for treating persistent pulmonary hypertension in neonates (PPHN).
PubMed/Medline, SCOPUS, Cochrane Central Register of Controlled Trials, and Web of Science were searched from the inception of publication to January 2021. The principal outcomes include oxygenation parameters, hemodynamic metrics and echocardiographic measurements, as well as adverse outcomes.
A total of eight studies were included with 216 term and premature neonates with PPHN. Compelling evidence showed the use of sildenafil could improve the prognosis of PPHN neonates, compared with baseline or placebo in neonates with PPHN, and a time-dependent pattern of the improvements can be observed. After 24 h of treatment, the Oxygenation index suggested a steady decrease (SD: -1.80, 95% confidence interval [CI]: -2.92, -0.67) and sildenafil exerted peak effects after 72 h of treatment (SD: -4.02, 95% CI: -5.45, -2.59). No clinically significant side effects were identified. Egger's test and funnel plots of the major outcomes were performed, and the publication bias was not significant.
Improvements were shown in oxygenation index, pulmonary arterial pressure, and adverse outcomes after using sildenafil for PPHN in neonates. However, future research with robust longitudinal or randomized controlled design is still needed.
对西地那非治疗新生儿持续性肺动脉高压（PPHN）的疗效和安全性进行更新的综述和荟萃分析。
从发表之初到 2021 年 1 月，检索了 PubMed/Medline、SCOPUS、Cochrane 对照试验中心注册库和 Web of Science。主要结局包括氧合参数、血液动力学指标和超声心动图测量值以及不良结局。
共纳入 8 项研究，涉及 216 例足月和早产儿 PPHN 患儿。有强有力的证据表明，与 PPHN 新生儿的基线或安慰剂相比，西地那非可改善 PPHN 新生儿的预后，且可观察到改善呈时间依赖性。治疗 24 小时后，氧合指数呈稳定下降趋势（SD：-1.80，95%可信区间[CI]：-2.92，-0.67），西地那非在治疗 72 小时后发挥最大效应（SD：-4.02，95%CI：-5.45，-2.59）。未发现有临床意义的副作用。对主要结局进行了 Egger 检验和漏斗图分析，未发现发表偏倚。
在新生儿 PPHN 中使用西地那非后，氧合指数、肺动脉压和不良结局均有所改善。然而，仍需要进行具有稳健纵向或随机对照设计的未来研究。
