Afshari Arash, Bastholm Bille Anders, Allingstrup Mikkel
Juliane Marie Centre - Anaesthesia and Surgical Clinic Department 4013, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Cochrane Database Syst Rev. 2017 Aug 14;7(7):CD007733. doi: 10.1002/14651858.CD007733.pub3.
Acute respiratory distress syndrome (ARDS) is a critical condition that is associated with high mortality and morbidity. Aerosolized prostacyclin has been used to improve oxygenation despite the limited evidence available so far.This review was originally published in 2010 and updated in 2017.
To assess the benefits and harms of aerosolized prostacyclin in adults and children with ARDS.
In this update, we searched CENTRAL (2017, Issue 4); MEDLINE (OvidSP), Embase (OvidSP), ISI BIOSIS Previews, ISI Web of Science, LILACS, CINAHL (EBSCOhost), and three trials registers. We handsearched the reference lists of the latest reviews, randomized and non-randomized trials, and editorials, and cross-checked them with our search of MEDLINE. We contacted the main authors of included studies to request any missed, unreported or ongoing studies. The search was run from inception to 5 May 2017.
We included all randomized controlled trials (RCTs), irrespective of publication status, date of publication, blinding status, outcomes published or language. We contacted trial investigators and study authors to retrieve relevant and missing data.
Three authors independently abstracted data and resolved any disagreements by discussion. Our primary outcome measure was all-cause mortality. We planned to perform subgroup and sensitivity analyses to assess the effect of aerosolized prostacyclin in adults and children, and on various clinical and physiological outcomes. We assessed the risk of bias through assessment of methodological trial components and the risk of random error through trial sequential analysis.
We included two RCTs with 81 participants.One RCT involved 14 critically ill children with ARDS (very low quality of evidence), and one RCT involved 67 critically ill adults (very low quality evidence).Only one RCT (paediatric trial) provided data on mortality and found no difference between intervention and control. However, this trial was eligible for meta-analysis due to a cross-over design.We assessed the benefits and harms of aerosolized prostacyclin. One RCT found no difference in improvement of partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO/FiO) ratio (mean difference (MD) -25.35, 95% confidence interval (CI) -60.48 to 9.78; P = 0.16; 67 participants, very low quality evidence).There were no adverse events such as bleeding or organ dysfunction in any of the included trials. Due to the limited number of RCTs, we were unable to perform the prespecified subgroup and sensitivity analyses or trial sequential analysis.
AUTHORS' CONCLUSIONS: We are unable to tell from our results whether the intervention has an important effect on mortality because the results were too imprecise to rule out a small or no effect. Therefore, no current evidence supports or refutes the routine use of aerosolized prostacyclin for people with ARDS. There is an urgent need for more RCTs.
急性呼吸窘迫综合征(ARDS)是一种与高死亡率和高发病率相关的危急病症。尽管目前证据有限,但雾化吸入前列环素已被用于改善氧合。本综述最初发表于2010年,并于2017年更新。
评估雾化吸入前列环素对成人和儿童ARDS患者的益处和危害。
在本次更新中,我们检索了Cochrane系统评价数据库(CENTRAL,2017年第4期)、MEDLINE(OvidSP)、Embase(OvidSP)、ISI生物学文摘数据库、ISI科学网、拉丁美洲及加勒比地区卫生科学数据库(LILACS)、护理学与健康领域数据库(CINAHL,EBSCOhost)以及三个试验注册库。我们手工检索了最新综述、随机和非随机试验以及社论的参考文献列表,并与我们对MEDLINE的检索结果进行交叉核对。我们联系了纳入研究的主要作者,以获取任何遗漏、未报告或正在进行的研究。检索时间从数据库建立至2017年5月5日。
我们纳入了所有随机对照试验(RCT),无论其发表状态、发表日期、盲法状态、已发表的结果或语言如何。我们联系了试验研究者和研究作者以获取相关和缺失的数据。
三位作者独立提取数据,并通过讨论解决任何分歧。我们的主要结局指标是全因死亡率。我们计划进行亚组分析和敏感性分析,以评估雾化吸入前列环素对成人和儿童以及各种临床和生理结局的影响。我们通过评估试验方法学组成部分来评估偏倚风险,并通过试验序贯分析来评估随机误差风险。
我们纳入了两项RCT,共81名参与者。一项RCT纳入了14名患有ARDS的危重症儿童(证据质量极低),另一项RCT纳入了67名危重症成人(证据质量极低)。只有一项RCT(儿科试验)提供了死亡率数据,且未发现干预组与对照组之间存在差异。然而,由于该试验采用交叉设计,故符合Meta分析的条件。我们评估了雾化吸入前列环素的益处和危害。一项RCT发现动脉血氧分压/吸入氧分数值(PaO₂/FiO₂)比值改善方面无差异(平均差(MD)-25.35,95%置信区间(CI)-60.48至9.78;P = 0.16;67名参与者,证据质量极低)。纳入的任何试验中均未出现出血或器官功能障碍等不良事件。由于RCT数量有限,我们无法进行预先设定的亚组分析和敏感性分析或试验序贯分析。
我们无法从结果中判断该干预措施对死亡率是否有重要影响,因为结果过于不精确,无法排除微小或无影响的可能性。因此,目前没有证据支持或反驳对ARDS患者常规使用雾化吸入前列环素。迫切需要更多的RCT。