Tan A, Schulze A, O'Donnell C P F, Davis P G
Cochrane Database Syst Rev. 2005 Apr 18;2005(2):CD002273. doi: 10.1002/14651858.CD002273.pub3.
100% oxygen is the commonly recommended gas for the resuscitation of infants at birth. There is growing evidence from both animal and human studies that room air is as effective as 100% oxygen and that 100% oxygen may have adverse effects on breathing physiology and cerebral circulation. There is also the theoretical risk of tissue damage due to free oxygen radicals when 100% oxygen is given. The use of room air has, therefore, been suggested as a safer and possibly more effective alternative.
In newborn infants requiring resuscitation, does the use of room air reduce the incidence of death, neurological disability and short term morbidity when compared with the use of 100% oxygen?
This included searches of the Oxford Database of Perinatal Trials, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2004) and MEDLINE PubMed 1966 to December 2003, and handsearches of reference lists of relevant articles and conference proceedings.
All randomised and quasi-randomised studies comparing the use of room air or any other concentration of oxygen versus 100% oxygen in the resuscitation of infants at birth.
Three authors assessed the methodological quality of eligible trials and extracted data independently. When appropriate, meta-analysis was conducted to provide a pooled estimate of effect. For categorical data the relative risk (RR), risk difference (RD) and number needed to treat (NNT) with 95% confidence intervals (CI) were calculated. Continuous data were analysed using weighted mean difference (WMD).
Five studies were identified which enrolled a total of 1302 infants. In two studies allocation was randomised and the caregivers were blinded to intervention group. In the other three studies, allocation was quasi-randomised and the caregivers were not blinded. Pooled analysis of the four trials reporting effect on death showed a significant reduction in the rate of death in the group resuscitated with room air [typical RR 0.71 (0.54, 0.94), typical RD -0.05 (-0.08, -0.01), NNT 20 (12, 100)]. There were no significant differences between the groups with respect to rates of grade 2 or 3 hypoxic ischaemic encephalopathy. One of the four trials reported a statistically significant difference in median 5 minute Apgar scores, favouring the group allocated to room air. However, the absolute difference between the medians was small and there were no significant differences in the median 10 minute Apgar scores in the three trials reporting this outcome. One trial followed up a selected subgroup of survivors to 18-24 months. There were no significant differences in rates of adverse neurodevelopmental outcomes including cerebral palsy and failure to achieve various milestones; however, the proportion of eligible patients seen was less than 70%. Analyses that were planned for this review, but not able to be carried out because of lack of published data, included a sub-analysis stratified by gestational age and assessments of the effect on bronchopulmonary dysplasia and retinopathy of prematurity.
AUTHORS' CONCLUSIONS: There is insufficient evidence at present on which to recommend a policy of using room air over 100% oxygen, or vice versa, for newborn resuscitation. A reduction in mortality has been seen in infants resuscitated with room air, and no evidence of harm has been demonstrated. However, the small number of identified studies and their methodologic limitations dictate caution in interpreting and applying these results. We note the use of back-up 100% oxygen in more than a quarter of infants randomised to room air. Therefore, on the basis of currently available evidence, if one chooses room air as the initial gas for resuscitation, supplementary oxygen should continue to be made available.
100%氧气是目前普遍推荐用于新生儿复苏的气体。越来越多的动物和人体研究证据表明,空气与100%氧气在复苏效果上相当,且100%氧气可能对呼吸生理和脑循环产生不利影响。此外,给予100%氧气时,理论上还存在因游离氧自由基导致组织损伤的风险。因此,有人建议使用空气作为更安全且可能更有效的替代方法。
对于需要复苏的新生儿,与使用100%氧气相比,使用空气是否能降低死亡、神经残疾和短期发病的发生率?
检索了牛津围产期试验数据库、Cochrane对照试验中心注册库(CENTRAL,Cochrane图书馆,2004年第1期)以及1966年至2003年12月的MEDLINE PubMed,并手工检索了相关文章的参考文献列表和会议论文集。
所有比较在新生儿复苏中使用空气或其他任何氧气浓度与100%氧气的随机和半随机研究。
三位作者独立评估符合条件试验的方法学质量并提取数据。在适当情况下,进行荟萃分析以提供合并效应估计值。对于分类数据,计算相对风险(RR)、风险差(RD)和治疗所需人数(NNT)及95%置信区间(CI)。连续数据采用加权均数差(WMD)进行分析。
共确定了5项研究,纳入了总计1302名婴儿。其中2项研究的分配是随机的,护理人员对干预组不知情。另外3项研究的分配是半随机的,护理人员未被设盲。对4项报告死亡影响的试验进行的汇总分析显示,使用空气复苏的组死亡率显著降低[典型RR 0.71(0.54,0.94),典型RD -0.05(-0.08,-0.01),NNT 20(12,100)]。两组在2级或3级缺氧缺血性脑病发生率方面无显著差异。4项试验中的1项报告5分钟阿氏评分中位数有统计学显著差异,空气组更具优势。然而,中位数之间的绝对差异较小,在报告该结果的3项试验中,10分钟阿氏评分中位数无显著差异。1项试验对选定的存活亚组随访至18 - 24个月。包括脑瘫和未达到各种发育里程碑在内的不良神经发育结局发生率无显著差异;然而,纳入的符合条件患者比例不到70%。本综述计划进行但因缺乏已发表数据而未能开展的分析包括按胎龄分层的亚组分析以及对支气管肺发育不良和早产儿视网膜病变影响的评估。
目前尚无足够证据推荐在新生儿复苏中使用空气而非100%氧气的政策,反之亦然。使用空气复苏的婴儿死亡率有所降低,且未证明有危害证据。然而,已确定的研究数量较少及其方法学局限性表明在解释和应用这些结果时需谨慎。我们注意到,在随机分配至空气组的婴儿中,超过四分之一的婴儿使用了备用的100%氧气。因此,基于现有证据,如果选择空气作为复苏的初始气体,应继续提供补充氧气。