El Shahed Amr I, Dargaville Peter A, Ohlsson Arne, Soll Roger
The Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto, Ontario, Canada. Egyptian Neonatal Network (EGNN),Mansoura, Egypt.
Cochrane Database Syst Rev. 2014 Dec 14;2014(12):CD002054. doi: 10.1002/14651858.CD002054.pub3.
Surfactant replacement therapy has been proven beneficial in the prevention and treatment of neonatal respiratory distress syndrome (RDS). The deficiency of surfactant or surfactant dysfunction may contribute to respiratory failure in a broader group of disorders, including meconium aspiration syndrome (MAS).
To evaluate the effect of surfactant administration in the treatment of late preterm and term infants with meconium aspiration syndrome.
We searched The Cochrane Library (Issue 4, 2006), MEDLINE and EMBASE (1985 to December 2006), previous reviews including cross-references, abstracts, conference and symposia proceedings, expert informants, and journal handsearching, without language restrictions. We contacted study authors for additional data.We ran an updated search in November 2014 and searched the following sites for ongoing or recently completed trials: www.clinicaltrials.gov; www.controlled-trials.com; and www.who.int/ictrp.
Randomised controlled trials which evaluated the effect of surfactant administration in late preterm and term infants with meconium aspiration syndrome are included in the analyses.
We extracted data on clinical outcomes including mortality, treatment with extracorporeal membrane oxygenation (ECMO), pneumothorax, duration of assisted ventilation, duration of supplemental oxygen, intraventricular haemorrhage (any grade and severe IVH), and chronic lung disease. We conducted data analyses in accordance with the standards of the Cochrane Neonatal Review Group.
Four randomised controlled trials met our inclusion criteria. The meta-analysis of four trials (326 infants) showed no statistically significant effect on mortality [typical risk ratio (RR) 0.98, 95% confidence interval (CI) 0.41 to 2.39; typical risk difference (RD) -0.00, 95% CI -0.05 to 0.05]. There was no heterogeneity for this outcome (I² = 0% for both RR and RD). The risk of requiring extracorporeal membrane oxygenation was significantly reduced in a meta-analysis of two trials (n = 208); [typical RR 0.64, 95% CI 0.46 to 0.91; typical RD -0.17, 95% CI -0.30 to -0.04; number needed to treat for an additional beneficial outcome (NNTB) 6, 95% CI 3 to 25]. There was no heterogeneity for RR (1² = 0%) but moderate heterogeneity for RD (I² = 50%). One trial (n = 40) reported a statistically significant reduction in the length of hospital stay (mean difference -8 days, 95% CI -14 to -3 days; test for heterogeneity not applicable). There were no statistically significant reductions in any other outcomes studied (duration of assisted ventilation, duration of supplemental oxygen, pneumothorax, pulmonary interstitial emphysema, air leaks, chronic lung disease, need for oxygen at discharge or intraventricular haemorrhage).
AUTHORS' CONCLUSIONS: In infants with MAS, surfactant administration may reduce the severity of respiratory illness and decrease the number of infants with progressive respiratory failure requiring support with ECMO. The relative efficacy of surfactant therapy compared to, or in conjunction with, other approaches to treatment including inhaled nitric oxide, liquid ventilation, surfactant lavage and high frequency ventilation remains to be tested.
表面活性剂替代疗法已被证明对预防和治疗新生儿呼吸窘迫综合征(RDS)有益。表面活性剂缺乏或表面活性剂功能障碍可能在包括胎粪吸入综合征(MAS)在内的更广泛的疾病组中导致呼吸衰竭。
评估表面活性剂给药对晚期早产儿和足月儿胎粪吸入综合征的治疗效果。
我们检索了考克兰图书馆(2006年第4期)、MEDLINE和EMBASE(1985年至2006年12月),包括交叉引用、摘要、会议和研讨会记录、专家提供的信息以及期刊手工检索在内的以往综述,无语言限制。我们联系研究作者获取额外数据。我们在2014年11月进行了更新检索,并在以下网站搜索正在进行或最近完成的试验:www.clinicaltrials.gov;www.controlled-trials.com;以及www.who.int/ictrp。
评估表面活性剂给药对晚期早产儿和足月儿胎粪吸入综合征效果的随机对照试验纳入分析。
我们提取了包括死亡率、体外膜肺氧合(ECMO)治疗、气胸、辅助通气时间、吸氧时间、脑室内出血(任何级别和重度脑室内出血)以及慢性肺病等临床结局的数据。我们按照考克兰新生儿综述小组的标准进行数据分析。
四项随机对照试验符合我们的纳入标准。四项试验(326名婴儿)的荟萃分析显示对死亡率无统计学显著影响[典型风险比(RR)0.98,95%置信区间(CI)0.41至2.39;典型风险差(RD)-0.00,95%CI -0.05至0.05]。该结局无异质性(RR和RD的I²均 = 0%)。两项试验(n = 208)的荟萃分析显示需要体外膜肺氧合的风险显著降低;[典型RR 0.64,95%CI 0.46至0.91;典型RD -0.17,95%CI -0.30至 -0.04;为获得额外有益结局所需治疗人数(NNTB)6,95%CI 3至25]。RR无异质性(I² = 0%),但RD有中度异质性(I² = 50%)。一项试验(n = 40)报告住院时间有统计学显著缩短(平均差 -8天,95%CI -14至 -3天;异质性检验不适用)。所研究的任何其他结局(辅助通气时间、吸氧时间、气胸、肺间质肺气肿、气漏、慢性肺病、出院时吸氧需求或脑室内出血)均无统计学显著降低。
在患有MAS的婴儿中,表面活性剂给药可能降低呼吸疾病的严重程度,并减少需要ECMO支持的进行性呼吸衰竭婴儿的数量。与包括吸入一氧化氮、液体通气、表面活性剂灌洗和高频通气在内的其他治疗方法相比,或与之联合使用时,表面活性剂疗法的相对疗效仍有待检验。