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[Lancet Respir Med]: 生理盐水或白蛋白复苏的效果:FEAST试验的再分析
2019年10月20日 时讯速递, 进展交流 暂无评论

ARTICLES| VOLUME 7, ISSUE 7, P581-593, JULY 01, 2019

Effects of saline or albumin fluid bolus in resuscitation: evidence from re-analysis of the FEAST trial

Michael Levin, Aubrey J Cunnington, Clare Wilson, et al

Lancet Respir Med 2019; 7: 581-593 DOI:https://doi.org/10.1016/S2213-2600(19)30114-6

Background 背景

Fluid resuscitation is the recommended management of shock, but increased mortality in febrile African children in the FEAST trial. We hypothesised that fluid bolus-induced deaths in FEAST would be associated with detectable changes in cardiovascular, neurological, or respiratory function, oxygen carrying capacity, and blood biochemistry.

液体复苏是推荐的休克治疗,但FEAST试验显示,对于发热的非洲儿童,液体复苏增加病死率。我们作出假设,FEAST试验中快速补液导致的死亡可能伴随心血管、神经系统或呼吸功能、携氧能力及血生化检查结果的改变。

Methods 方法

We developed composite scores for respiratory, cardiovascular, and neurological function using vital sign data from the FEAST trial, and used them to compare participants from FEAST with those from four other cohorts and to identify differences between the bolus (n=2097) and no bolus (n=1044) groups of FEAST. We calculated the odds of adverse outcome for each ten-unit increase in baseline score using logistic regression for each cohort. Within FEAST participants, we also compared haemoglobin and plasma biochemistry between bolus and non-bolus patients, assessed the effects of these factors along with the vital sign scores on the contribution of bolus to mortality using Cox proportional hazard models, and used Bayesian clustering to identify subgroups that differed in response to bolus. The FEAST trial is registered with ISRCTN, number ISRCTN69856593.

我们根据FEAST试验的生命体征资料,建立了包括呼吸、心血管和神经系统功能在内的复合评分,并用于FEAST研究人群与其他4个队列患者的比较,以确定FEAST试验中快速补液组(n=2097)与非快速补液组(n=1044)的差异。对于每个队列,我们采用logisitic回归模型,计算基线评分每增加10分所对应的不良结局比数。对于FEAST研究人群,我们还比较了快速补液组与非快速补液组患者的血红蛋白和血生化 结果,并采用Cox比例风险模型,评估这些因素与生命体征评分对快速补液相关死亡的共同影响,我们还采用Bayesian群组以区分对快速补液治疗反应不同的亚组。FEAST试验在ISRCTN注册,注册号ISRCTN69856593。

Findings 结果

Increasing respiratory (odds ratio 1·09, 95% CI 1·07–1·11), neurological (1·26, 1·21–1·31), and cardiovascular scores (1·09, 1·05–1·14) were associated with death in FEAST (all p<0·0001), and with adverse outcomes for specific scores in the four other cohorts. In FEAST, fluid bolus increased respiratory and neurological scores and decreased cardiovascular score at 1 h after commencement of the infusion. Fluid bolus recipients had mean 0·33 g/dL (95% CI 0·20–0·46) reduction in haemoglobin concentration after 8 h (p<0·0001), and at 24 h had a decrease of 1·41 mEq/L (95% CI 0·76–2·06; p=0·0002) in mean base excess and increase of 1·65 mmol/L (0·47–2·8; p=0·0070) in mean chloride, and a decrease of 0·96 mmol/L (0·45 to 1·47; p=0·0003) in bicarbonate. There were similar effects of fluid bolus in three patient subgroups, identified on the basis of their baseline characteristics. Hyperchloraemic acidosis and respiratory and neurological dysfunction induced by saline or albumin bolus explained the excess mortality due to bolus in Cox survival models.

呼吸(比数比1·09, 95% CI 1·07–1·11)、神经(1·26, 1·21–1·31)和心血管(1·09, 1·05–1·14)评分与FEAST试验死亡相关(所有 p<0·0001),且与其他4个队列中不良结局的特异性评分相关。在FEAST试验中,开始快速补液后1小时,呼吸和神经系统评分增加,心血管评分降低。接受快速补液的患者8小时后血红蛋白平均下降0·33 g/dL (95% CI 0·20–0·46) (p<0·0001),24小时后平均碱剩余下降1·41 mEq/L (95% CI 0·76–2·06; p=0·0002),平均血氯增加 1·65 mmol/L (0·47–2·8; p=0·0070),碳酸氢根降低 0·96 mmol/L (0·45 to 1·47; p=0·0003)。快速补液对根据基线特征区分的三个亚组患者的影响相似。生理盐水或白蛋白导致的高氯血症性酸中毒、呼吸和神经系统功能障碍能够解释Cox生存模型中快速补液组的病死率增加。

Interpretation 结论

In the resuscitation of febrile children, albumin and saline boluses can cause respiratory and neurological dysfunction, hyperchloraemic acidosis, and reduction in haemoglobin concentration. The findings support the notion that fluid resuscitation with unbuffered electrolyte solutions may cause harm and their use should be cautioned. The effects of lower volumes of buffered solutions should be evaluated further.

对发热儿童进行复苏时,快速输注白蛋白和生理盐水能够引起呼吸和神经系统功能障碍,高氯血症性酸中毒,及血红蛋白水平下降。这些结果支持以下说法,即使用非平衡电解质溶液进行液体复苏可能造成危害,因此需谨慎使用。对于小剂量平衡溶液的效果需要进一步评价。

Funding 资助

Medical Research Council, Department for International Development, National Institute for Health Research, Imperial College Biomedical Research Centre.

评论[仅代表个人观点]

  • 非常有趣的想法,希望分析FEAST研究得到阴性甚至是相反结果的机制
  • 这一研究的难点还在于如何得到上述几个研究的原始数据?我的理解,这需要研究者自己的credit
  • 不知道近期各大杂志要求发表文章公开研究原始数据的声明能否使得其他人更容易得到自己感兴趣的数据?我个人对此表示悲观(看到过很多作者在声明中表示,可以根据要求提供,态度似乎很暧昧,尽管可以理解)
  • 后续的争论敬请关注读者来信(待续)

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