Ho Jacqueline J, Subramaniam Prema, Davis Peter G
Department of Paediatrics, Penang Medical College, 4 Sepoy Lines, Penang, Malaysia, 10450.
Cochrane Database Syst Rev. 2015 Jul 4;2015(7):CD002271. doi: 10.1002/14651858.CD002271.pub2.
Respiratory distress syndrome (RDS) is the single most important cause of morbidity and mortality in preterm infants. In infants with progressive respiratory insufficiency, intermittent positive pressure ventilation (IPPV) with surfactant is the standard treatment for the condition, but it is invasive, potentially resulting in airway and lung injury. Continuous distending pressure (CDP) has been used for the prevention and treatment of RDS, as well as for the prevention of apnoea, and in weaning from IPPV. Its use in the treatment of RDS might reduce the need for IPPV and its sequelae.
To determine the effect of continuous distending pressure (CDP) on the need for IPPV and associated morbidity in spontaneously breathing preterm infants with respiratory distress.Subgroup analyses were planned on the basis of birth weight (> or < 1000 or 1500 g), gestational age (groups divided at about 28 weeks and 32 weeks), methods of application of CDP (i.e. CPAP and CNP), application early versus late in the course of respiratory distress and high versus low pressure CDP and application of CDP in tertiary compared with non-tertiary hospitals, with the need for sensitivity analysis determined by trial quality.At the 2008 update, the objectives were modified to include preterm infants with respiratory failure.
We used the standard search strategy of the Neonatal Review Group. This included searches of the Oxford Database of Perinatal Trials, the Cochrane Central Register of Controlled Trials (CENTRAL, 2015 Issue 4), MEDLINE (1966 to 30 April 2015) and EMBASE (1980 to 30 April 2015) with no language restriction, as well as controlled-trials.com, clinicaltrials.gov and the International Clinical Trials Registry Platform of the World Health Organization (WHO).
All random or quasi-random trials of preterm infants with respiratory distress were eligible. Interventions were continuous distending pressure including continuous positive airway pressure (CPAP) by mask, nasal prong, nasopharyngeal tube or endotracheal tube, or continuous negative pressure (CNP) via a chamber enclosing the thorax and the lower body, compared with spontaneous breathing with oxygen added as necessary.
We used standard methods of The Cochrane Collaboration and its Neonatal Review Group, including independent assessment of trial quality and extraction of data by each review author.
We included six studies involving 355 infants - two using face mask CPAP, two CNP, one nasal CPAP and one both CNP (for less ill babies) and endotracheal CPAP (for sicker babies). For this update, we included no new trials.Continuous distending pressure (CDP) is associated with lower risk of treatment failure (death or use of assisted ventilation) (typical risk ratio (RR) 0.65, 95% confidence interval (CI) 0.52 to 0.81; typical risk difference (RD) -0.20, 95% CI -0.29 to -0.10; number needed to treat for an additional beneficial outcome (NNTB) 5, 95% CI 4 to 10; six studies; 355 infants), lower overall mortality (typical RR 0.52, 95% CI 0.32 to 0.87; typical RD -0.15, 95% CI -0.26 to -0.04; NNTB 7, 95% CI 4 to 25; six studies; 355 infants) and lower mortality in infants with birth weight above 1500 g (typical RR 0.24, 95% CI 0.07 to 0.84; typical RD -0.28, 95% CI -0.48 to -0.08; NNTB 4, 95% CI 2.00 to 13.00; two studies; 60 infants). Use of CDP is associated with increased risk of pneumothorax (typical RR 2.64, 95% CI 1.39 to 5.04; typical RD 0.10, 95% CI 0.04 to 0.17; number needed to treat for an additional harmful outcome (NNTH) 17, 95% CI 17.00 to 25.00; six studies; 355 infants). We found no difference in bronchopulmonary dysplasia (BPD), defined as oxygen dependency at 28 days (three studies, 260 infants), as well as no difference in outcome at nine to 14 years (one study, 37 infants).
AUTHORS' CONCLUSIONS: In preterm infants with respiratory distress, the application of CDP as CPAP or CNP is associated with reduced respiratory failure and mortality and an increased rate of pneumothorax. Four out of six of these trials were done in the 1970s. Therefore, the applicability of these results to current practice is difficult to assess. Further research is required to determine the best mode of administration.
呼吸窘迫综合征(RDS)是早产儿发病和死亡的最重要单一原因。对于进行性呼吸功能不全的婴儿,使用表面活性剂的间歇正压通气(IPPV)是该病的标准治疗方法,但它具有侵入性,可能导致气道和肺损伤。持续扩张压力(CDP)已用于预防和治疗RDS,以及预防呼吸暂停和撤离IPPV。其用于治疗RDS可能会减少对IPPV及其后遗症的需求。
确定持续扩张压力(CDP)对患有呼吸窘迫的自主呼吸早产儿使用IPPV的需求及相关发病率的影响。计划根据出生体重(>或<1000或1500g)、胎龄(约28周和32周划分组)、CDP的应用方法(即持续气道正压通气(CPAP)和持续负压通气(CNP))、呼吸窘迫过程中应用的早晚、高低压力CDP以及三级医院与非三级医院应用CDP情况进行亚组分析,并根据试验质量确定是否需要进行敏感性分析。在2008年更新时,目标修改为纳入呼吸衰竭的早产儿。
我们采用了新生儿综述组的标准检索策略。这包括检索牛津围产期试验数据库、Cochrane对照试验中心注册库(CENTRAL,2015年第4期)、MEDLINE(1966年至2015年4月30日)和EMBASE(1980年至2015年4月30日),无语言限制,以及controlled-trials.com、clinicaltrials.gov和世界卫生组织(WHO)的国际临床试验注册平台。
所有关于患有呼吸窘迫的早产儿的随机或半随机试验均符合条件。干预措施为持续扩张压力,包括通过面罩、鼻导管、鼻咽管或气管内导管进行持续气道正压通气(CPAP),或通过包裹胸部和下半身的腔室进行持续负压通气(CNP),与必要时添加氧气的自主呼吸进行比较。
我们采用了Cochrane协作网及其新生儿综述组的标准方法,包括独立评估试验质量和每位综述作者提取数据。
我们纳入了六项研究,涉及355名婴儿——两项使用面罩CPAP,两项使用CNP,一项使用鼻CPAP,一项对病情较轻的婴儿使用CNP,对病情较重的婴儿使用气管内CPAP。本次更新未纳入新的试验。持续扩张压力(CDP)与治疗失败(死亡或使用辅助通气)风险较低相关(典型风险比(RR)0.65,95%置信区间(CI)0.52至0.81;典型风险差(RD)-0.20,95%CI -0.29至-0.10;为获得额外有益结果所需治疗人数(NNTB)5,95%CI 4至10;六项研究;355名婴儿),总体死亡率较低(典型RR 0.52,95%CI 0.32至0.87;典型RD -0.15,95%CI -0.26至-0.04;NNTB 7,95%CI 4至25;六项研究;355名婴儿),出生体重超过1500g的婴儿死亡率较低(典型RR 0.24,95%CI 0.07至0.84;典型RD -0.28,95%CI -0.48至-0.08;NNTB 4,95%CI 2.00至13.00;两项研究;60名婴儿)。使用CDP与气胸风险增加相关(典型RR 2.64,95%CI 1.39至5.(此处原文95%CI 1.39至5.04后多了个分号,应删除)04;典型RD 0.10,95%CI 0.04至0.17;为获得额外有害结果所需治疗人数(NNTH)17,95%CI 17.00至25.00;六项研究;355名婴儿)。我们发现支气管肺发育不良(定义为28天时依赖氧气)无差异(三项研究,260名婴儿),9至14岁时的结局也无差异(一项研究,37名婴儿)。
在患有呼吸窘迫的早产儿中,应用CDP作为CPAP或CNP与呼吸衰竭和死亡率降低以及气胸发生率增加相关。这些试验中有六分之四是在20世纪70年代进行的。因此,这些结果对当前实践的适用性难以评估。需要进一步研究以确定最佳给药方式。