无创辅助通气联合氦氧混合气治疗早产儿呼吸窘迫综合征疗效和安全性的系统评价和Meta分析

目的系统评价无创通气(NIV)联合氦氧混合气(heliox)治疗早产儿呼吸窘迫综合征的有效性及安全性,以期为临床应用提供证据。方法计算机检索OVID、EMBASE、Pub Med、Cochrane图书馆、中国生物医学文献数据库、中国知网、维普中文科技期刊数据库及万方数据库,检索时间均为建库至2014年12月,纳入NIV联合heliox与NIV联合标准医疗气体(空氧混合气)为对照的RCT文献或半随机对照试验。以气管插管率、Pa CO2和heliox相关不良事件为主要结局指标,以支气管肺发育不良等并发症发生率、NIV持续时间、住院时间等为次要结局指标。采用Review Manager 5.2软件进行Meta分析。结果 3篇文献进入系统评价,共纳入123例早产儿。2篇文献随机化方法和分配隐藏为低度偏倚,3篇文献的结果数据均完整,均未选择性报告结果,但均未提及盲法实施。1与标准医疗气体比较,heliox显著降低了气管插管率(RR=0.42,95%CI:0.23~0.78)和Pa CO2水平(MD=-9.61 mm Hg,95%CI:-15.76~-3.45 mm Hg)。23篇文献均未观察到heliox相关的不良事件。3支气管肺发育不良、动脉导管未闭、早产儿视网膜病变和坏死性小肠结肠炎等并发症的发生率,两组差异均无统计学意义(P0.05)。结论与标准医疗气体相比,NIV联合heliox可显著改善通气,并降低气管插管率。鉴于本研究样本量有限,NIV联合heliox的临床价值尚需大样本RCT进行验证。

Efficacy and safety of noninvasive ventilation with heliox treatment for respiratory distress syndrome in preterm infants: a systematic review and meta-analysis

Objective To assess the effectiveness and safety of non-invasive ventilation with heliox in preterm infants with respiratory distress syndrome (RDS) and to compare with medical gas. Methods A search of major electronic databases for randomized or quasi-randomized controlled trials that compared non-invasive ventilation with heliox versus non-invasive ventilation with medical gas for preterm infants with RDS was performed. Data from included trials were extracted, on standard data collection forms, independently by three reviewers. The incidence of intubation and level of PaCO2 were selected as primary outcomes, and the incidence of compliactions and duration of NIV were selected as secondary outcomes. Review Manager 5.2 software was used to perform the Meta-analysis. Results Three trials including 123 preterm infants were assessed in the review. Two of three trials had low risk of randomization and allocation. The results of 3 trials were complete. The blinding of participants was unknown in 3 trials. Heliox was found to significantly decrease the incidence of intubation (RR=0.42, 95%CI: 0.23 to 0.78) and the level of PaCO2 (Mean difference=-9.61 mmHg, 95%CI: -15.76 to -3.45 mmHg) compared with medical gas. No heliox related adverse events were reported in 3 inclued trials. No significant differences were found in BPD and other outcome variables between the two groups. Conclusion Non-invasive ventilation with heliox could reduce the incidence of intubation and the level of PaCO2 in preterm infants suffering from RDS. Larger trials with enough samples and long duration of heliox administration are needed to verify the beneficial effects.