| 摘要: |
| 目的：采用Meta分析的方法评估肺表面活性物质联合气管内滴入布地奈德预防支气管肺发育不良的安全性和疗效。方法：检索PubMed、the Cochrane Library、EMBASE、中国知网及万方数据库，检索时间均为建库至2017年11月，搜索相关随机对照试验（RCT）研究文献。观察的主要结局指标有BPD发生率、BPD相关病死率、BPD发生或相关病死率，次要结局指标有相关并发症的发生率。应用Cochrane风险偏倚评估工具进行文献偏倚评价，应用RevMan 5.3软件进行Meta分析，应用Egger’s检验进行发表偏倚评估。结果：5项RCT共纳入495例受试者，其中试验组242例，观察组253例。Meta分析结果显示，试验组及对照组的BPD发生率差异有统计学意义（[RR=0.56，95%CI（0.43，0.72），P<0.001）]，试验组及对照组的BPD相关病死率差异有统计学意义[RR=0.64，95%CI（0.41，0.99），P<0.05]，试验组及对照组的脑室内出血、感染/败血症、早产儿视网膜病变（ROP）、动脉导管未闭（PDA）、坏死性小肠结肠炎（NEC）、高血糖、高血压发生率差异均无统计学意义。结论：肺表面活性物质联合布地奈德气管内滴入可降低BPD发生率及BPD相关病死率，且不会增加短期相关并发症发生的风险，但考虑到纳入研究的样本量较小及偏倚存在，该治疗的安全性及疗效仍需要大样本、多中心临床随机对照试验进一步明确，且对相关长期并发症如神经发育障碍发生的影响仍需进一步研究。 |
| 关键词: 肺表面活性物质 布地奈德 支气管肺发育不良 系统评价 Meta分析 |
| DOI：doi:10.13407/ j.cnki.jpp.1672-108X.2019.05.001 |
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| 基金项目: |
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| Meta-Analysis of Safety and Efficacy of Pulmonary Surfactant Combined with Intratracheal Instillation of Budesonide for Prevention of Bronchopulmonary Dysplasia |
| Guo Yangyang, Chen Han, Yu Jialin |
| (Children’s Hospital of Chongqing Medical University, Chongqing 400014, China) |
| Abstract: |
| Objective: To evaluate the safety and efficacy of pulmonary surfactant combined with intratracheal instillation of budesonide for prevention of bronchopulmonary dysplasia (BPD). Methods: PubMed, the Cochrane Library, EMBASE, CNKI and Wanfang database were retrieved for the related randomized controlled trials (RCT), the retrieved time was from establishment of the database to Nov. 2017. The main outcome indicators were the incidence of BPD, BPD-related mortality, and the secondary outcome indicators were the incidence of related complications. The Cochrane handbook was used to evaluate the methodological quality, RevMan 5.3 software was used for Meta-analysis and Egger’s test was used to evaluate the publication bias. Results: A total of 495 subjects were enrolled in 5 RCT, including 242 cases in the experimental group and 253 cases in the observation group. Meta-analysis showed that there was statistically significant difference in the incidence of BPD between the experimental group and the control group (RR=0.56, 95% CI (0.43, 0.72), P<0.001), and the difference of the BPD-related mortality was statistically significant in the experimental group and the control group (RR=0.64, 95% CI (0.41, 0.99), P<0.05). There was no significant difference in the incidence of intraventricular hemorrhage, infection/sepsis, retinopathy of preterm infants (ROP), patent ductus arteriosus (PDA), necrotizing enterocolitis (NEC), hyperglycemia or hypertension between the experimental group and the control group. Conclusion: Pulmonary surfactant combined with intratracheal instillation of budesonide for prevention of BDP can reduce the incidence of BPD and BPD-related mortality, and do not increase the risk of short-term related complications, but in view of the small sample size and bias involved in the study, the safety and efficacy still need to be further clarified in large-sample, multi-center clinical RCT, and the impact on long-term complications such as neurodevelopmental disorders also needs the further study. |
| Key words: pulmonary surfactant budesonide bronchopulmonary dysplasia meta-analysis |
