早期经气管内给予皮质类固醇和肺表面活性物质预防新生儿呼吸窘迫综合征早产儿支气管肺发育不良的 Meta 分析。
Early Intratracheal Administration of Corticosteroid and Pulmonary Surfactant for Preventing Bronchopulmonary Dysplasia in Preterm Infants with Neonatal Respiratory Distress Syndrome: A Meta-analysis.
机构信息
Department of Pediatrics, Huazhong University of Science and Technology Hospital, Wuhan, 430074, China.
Neonatal Intensive Care Unit, Hubei Maternity and Children's Hospital, Wuhan, 430070, China.
出版信息
Curr Med Sci. 2019 Jun;39(3):493-499. doi: 10.1007/s11596-019-2064-9. Epub 2019 Jun 17.
There is uncertain result with regard to the use of inhalation or instillation steroids to prevent bronchopulmonary dysplasia in preterm infants. This meta-analysis was designed to evaluate the efficacy and safety of early airway administration (within 2 days after birth) of corticosteroids and pulmonary surfactant (PS) for preventing bronchopulmonary dysplasia (BPD) in premature infants with neonatal respiratory distress syndrome (NRDS). The related studies were retrieved in PubMed, EMBASE, the Cochrane Library, Clinical Trial, CNKI, Wanfang and VIP Database from inception to August 2018. Two reviewers independently screened the studies to ensure that all patients with diagnosis of NRDS were enrolled to studies within 1 day after birth, assessed the quality of included studies by GRADEpro system and extracted the data for review. The meta-analysis was performed by RevMan 5.2 software. A subgroup analysis about inhaled corticosteroid (ICS) delivery method was made between ICS inhalation subgroup [inhalation of ICS by nebulizer or metered dose inhaler (MDI)] and ICS intratracheal instillation subgroup (PS used as a vehicle). Eight randomized controlled trials were enrolled in the meta-analysis, 5 trials of which stated the randomized method, grouping and blinded method, and the follow-up procedures were reported. GRADEpro system showed high quality of 4 trials (5 articles), and the rest 4 trials had moderate quality. Meta-analysis showed that the incidence of BPD was decreased in ICS group, the relative risk (RR) was 0.56 (95% CI: 0.42-0.76), and similar trends were found in ICS inhalation subgroup and ICS intratracheal instillation subgroup, with the corresponding RR being 0.58 (95% CI: 0.41-0.82) and 0.47 (95% CI: 0.24-0.95) respectively. ICS could also significantly reduce the mortality risk as compared with placebo control group (RR: 0.67; 95% CI: 0.45-0.99), with RR of ICS inhalation subgroup and ICS intratracheal instillation subgroup being 0.81 (95% CI: 0.34-1.94) and 0.64 (95% CI: 0.41-0.99) respectively. Moreover, the percentage of infants using PS more than one time was lower in ICS group than in the placebo control group, with the RR and 95% CI being 0.55 (95% CI: 0.45-0.67), and that in ICS intratracheal instillation subgroup lower than in ICS inhalation subgroup (RR: 0.56; 95% CI: 0.45-0.69, and RR: 0.35; 95% CI: 0.08-1.52 respectively). There was no significant difference in the incidence of infection or retinopathy of prematurity and neuro-motor system impairment between ICS group and placebo control group, with the corresponding RR being 0.95 (95% CI: 0.59-1.52), 0.92 (95% CI: 0.62-1.38) and 1.13 (95% CI: 0.92-1.39), respectively. It was concluded that early administration of ICS and PS is an effective and safe option for preterm infants with NRDS in preventing BPD and reducing mortality, decreasing the additional PS usage, especially for the ICS intratracheal instillation subgroup. Furthermore, the appropriate dose and duration of ICS, combined use of inhalation or instillation of ICS with PS and the long-term safety of airway administration of corticosteroids need to be assessed in large trials.
对于早产儿支气管肺发育不良(BPD),吸入或滴注类固醇的使用效果不确定。本荟萃分析旨在评估早期气道给予皮质类固醇和肺表面活性剂(PS)对新生儿呼吸窘迫综合征(NRDS)早产儿预防 BPD 的疗效和安全性。检索了 PubMed、EMBASE、Cochrane 图书馆、临床试验、CNKI、万方和 VIP 数据库,检索时间为 2018 年 8 月之前。两位审阅者独立筛选研究,以确保所有诊断为 NRDS 的患者均被纳入在出生后 1 天内进行的研究中,通过 GRADEpro 系统评估纳入研究的质量并提取数据进行综述。使用 RevMan 5.2 软件进行荟萃分析。对 ICS 吸入组[通过雾化器或计量吸入器(MDI)吸入 ICS]和 ICS 气管内滴注组(PS 作为载体)之间的 ICS 给药方法进行了亚组分析。荟萃分析共纳入 8 项随机对照试验,其中 5 项试验报告了随机方法、分组和盲法,以及随访程序。GRADEpro 系统显示 4 项试验(5 篇文章)的质量为高质量,其余 4 项试验的质量为中等。荟萃分析显示 ICS 组的 BPD 发生率降低,相对风险(RR)为 0.56(95%CI:0.42-0.76),ICS 吸入组和 ICS 气管内滴注组也有类似的趋势,相应的 RR 为 0.58(95%CI:0.41-0.82)和 0.47(95%CI:0.24-0.95)。与安慰剂对照组相比,ICS 还能显著降低死亡率(RR:0.67;95%CI:0.45-0.99),ICS 吸入组和 ICS 气管内滴注组的 RR 分别为 0.81(95%CI:0.34-1.94)和 0.64(95%CI:0.41-0.99)。此外,ICS 组使用 PS 超过 1 次的婴儿比例低于安慰剂对照组,RR 和 95%CI 分别为 0.55(95%CI:0.45-0.67),ICS 气管内滴注组低于 ICS 吸入组(RR:0.56;95%CI:0.45-0.69,RR:0.35;95%CI:0.08-1.52)。ICS 组与安慰剂对照组在感染或早产儿视网膜病变和神经运动系统损伤的发生率方面无显著差异,相应的 RR 分别为 0.95(95%CI:0.59-1.52)、0.92(95%CI:0.62-1.38)和 1.13(95%CI:0.92-1.39)。结论:对于 NRDS 早产儿,早期给予 ICS 和 PS 是预防 BPD 和降低死亡率的有效且安全的选择,可减少 PS 的额外使用,尤其是 ICS 气管内滴注组。此外,还需要在大型试验中评估 ICS 的适当剂量和持续时间、ICS 吸入或滴注联合 PS 的使用以及皮质类固醇气道给药的长期安全性。