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[MEDSCAPE述评]:得到阴性结果的APRV治疗ARDS的临床试验
2018年07月12日 研究点评, 进展交流 暂无评论

COMMENTARY

A Negative APRV Trial in ARDS

Aaron B. Holley, MD

June 29, 2018

Recently, I reviewed a randomized, controlled trial (RCT)[1] comparing acute respiratory distress syndrome (ARDS) management with protocolized airway pressure release ventilation (APRV) with low-tidal-volume (LTV) ventilation. APRV showed superiority for the primary outcome, ventilator-free days, and a number of secondary outcomes. Mortality in the intensive care unit and hospital days were not significantly different, but both showed trends toward improvement with APRV. I saw this trial, in conjunction with previously published physiologic data, as a major step forward in supporting APRV for ARDS outside the setting of "rescue therapy."

近期,我审阅了一项比较气道压力释放通气(APRV)与小潮气量(LTV)通气治疗ARDS的RCT。APRV组患者的主要预后指标(无机械通气时间)以及很多次要预后指标均显著优于LTV组。ICU病死率及总住院日没有显著差异,但APRV组这两项指标均呈现改善趋势。结合既往发表的生理学研究资料,我认为这项研究结果是支持APRV作为“挽救治疗”措施之外,常规用于ARDS治疗方面的一大进展。

An RCT published online recently found that APRV dramatically increased mortality in children with ARDS when compared with LTV.[2] The study was stopped early, after only 52 children were enrolled, because of the mortality difference (53.8% versus 26.9% among controls; relative risk, 3.2 [1.0-10.1]; P = .089).

近期在线发表的一项RCT发现,与LTV相比,APRV显著增加ARDS患儿的病死率。在入选52名患儿后,由于两组患者病死率的差异(53.8% vs 26.9%; 相对危险度, 3.2 [1.0-10.1]; P = .089),导致这项研究被迫提前终止。

This prompted two pediatricians to write an editorial.[3] While they conclude their piece by advising caution before using APRV in children, they use data applicable to adults to help make their case.

这一结果促使两名儿科医生撰写了一篇述评。作者在文中阐明了自己的观点,即建议在儿童谨慎使用APRV,同时他们认为这一结论也适用于成年患者。

So, should the pediatric RCT or the accompanying editorial influence our opinion of APRV for ARDS in adults?

因此,是否在儿童进行的RCT或发表的述评应当影响我们有关APRV治疗成年ARDS患者的意见呢?

Looking closely at the pediatric RCT, it seems the groups were unbalanced at baseline. Patients randomized to APRV had a significantly lower PaO2:FiO2 and higher oxygenation index, suggesting they had worse disease at enrollment. The authors of the editorial suggest that this imbalance is not enough to account for the large 28-day mortality difference—ergo, it must be due to APRV.

仔细阅读在儿童进行的RCT,我们发现两组患者的基线水平并不均衡。随机分至APRV组的患者PaO2:FiO2较低,而氧合指数较高,提示入选时APRV组患者病情较重。述评作者认为,上述情况并不足以解释28天病死率的巨大差异—因此,这一差异一定源于APRV。

I have two issues with this logic:

对于这一观点我发表2点看法:

  • It seems even less likely that APRV could generate such a large increase in mortality; and

APRV似乎不会导致病死率如此大的差异

  • The authors of the editorial criticize the positive APRV adult trial[1] for having similar imbalances at baseline (in this case, the APRV group had a lower burden of comorbid disease and less pressor use).

述评作者对得到阳性结果的成年患者APRV研究也进行了批评,即基线水平同样显示两组患者病情不均衡(APRV组患者合并疾病较少,使用升压药物患者较少)

So how do we reconcile the disparate results between these two RCTs?

那么,我们如何综合理解这两项RCT的不一致结果呢?

The APRV titration strategies were slightly different, there were some imbalances at baseline, and one enrolled adults and the other enrolled children. More important, though, they were both small, single-center studies. The most likely reason for the discrepant results is type I error. In fact, this should be expected given the sample sizes. When it comes to biologic plausibility, I do not believe APRV, when compared with LTV, could dramatically increase ventilator-free days or double mortality at the 28-day mark.

APRV治疗策略略有不同,基线水平存在不均衡的情况,一项研究关注成年患者,另一项研究入选儿童患者。更为重要的是,两者均为小样本单中心研究。造成研究结果不一致的最可能原因是一类错误。事实上,鉴于研究的样本量较小,可以预见到这一结果。从生理学角度考虑,与LTV相比,我不认为APRV能够显著增加无机械通气时间抑或导致28天病死率加倍。

We will keep waiting for that large RCT we all want. Until then, I would recommend sticking with LTV. If you have experienced physicians and respiratory therapists, APRV could be considered a first-line treatment for ARDS. If you are a physician, do not consider yourself "experienced" unless you are using APRV on a regular basis and understand the physiology outlined in the review by Habashi.[4]

我们应当继续等待期待中的大规模RCT结果。在此之前,我建议继续使用LTV。如果你的医生和呼吸治疗师经验丰富,APRV可以作为ARDS的一线治疗。作为一名医生,除非你常规使用APRV并理解Habashi在综述中阐明的生理学原理,否则你不应当认为自己对APRV具有“丰富”的经验。

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