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[Blue Journal读者来信]:我们不赞同SALT研究
2018年01月27日 研究点评, 进展交流 暂无评论

We don’t appreciate SALT

Jean-Louis Vincent and Daniel De Backer

Am J Respir Crit Care Med. 2017 Dec 18.

doi: 10.1164/rccm.201709-1874LE

To the Editor: 致编辑

In this era of personalized medicine (1, 2), it is quite surprising to see counterexamples like the Isotonic Solution Administration Logistical Testing (SALT) trial (3), a perfect illustration of the wrong use of a randomized, controlled trail (RCT). The same is true for the Plasma-Lyte 148 versUS Saline (PLUS) study (4).

在目前个体化医疗盛行的时代,看到SALT试验这样的反例令人奇怪。SALT研究是错误使用随机对照临床试验(RCT)的典型代表。比较Plasma-Lyte 148与生理盐水的PLUS研究也是如此。

We are not dealing here with a new drug or procedure whose effects need further exploration in humans. Rather, we are dealing with intravenous solutions whose composition is quite simple and well known. No-one would dispute that giving large amounts of a solution including 154 mEq/L of chloride will result in hyperchloremia, which cannot be good for the patient. Even without reviewing in detail all the potentially harmful effects of hyperchloremia, anyone can appreciate that any electrolyte abnormality can have harmful effects. From the opposite perspective, no-one has ever suggested that hyperchloremia could be beneficial in any situation. The authors of the SALT study publication avoided any discussion of this issue highlighted recently (5) following the SPLIT study, which was a similar example (6).

我们并非研究疗效有待证实的新的药物或操作。相反,我们讨论的静脉溶液其成分非常简单且众所周知。没有人会反对这一观点,即给予大量氯浓度154 mEq/L的溶液可导致高氯血症,这对于患者可能造成不良影响。即使没有详细了解高氯血症所有的有害影响,大家也能够赞同任何电解质紊乱都有不良作用。从另一方面讲,没有任何人曾经表示在任何条件下高氯血症可能有益。尽管在另一相似研究即SPLIT研究发表后,这一问题即引发热议,但SALT研究的作者没有就此进行讨论。

Giving any kind of fluid in small amounts cannot be very toxic. Saline solutions are cheap and there is no reason to entirely prohibit their use in all patients. They also have a specific indication in the management of metabolic alkalosis or hyponatremia. However, it is not good medical practice to continue to give 0.9% saline solutions when chloride levels increase above the normal range. One would not do a study comparing crystalloids with or without potassium chloride without monitoring potassium levels. More generally, one would not give any electrolyte supplementation when levels of that electrolyte are more than adequate. Any biochemical abnormality is associated with worse outcomes; why would this be different for chloride? Such RCTs therefore raise ethical questions, as equipoise is no longer present when patients who have developed hyperchloremia continue to receive chloride. We would not want to be randomized to that group, as the treatment offered would represent poor clinical management.

输注少量任何种类的液体都不可能有害。生理盐水价格便宜,因此没有理由在所有患者都禁止其使用。治疗代谢性碱中毒或低钠血症时有指证使用生理盐水。然而,当血氯水平增加超过正常值上限时,就不应继续使用0.9%生理盐水。在没有监测血钾水平的情况下,人们也不会进行比较含钾与不含钾晶体液的研究。更进一步讲,当某种电解质超过正常时,没有人会继续补充该电解质。任何生化异常都伴随不良预后;氯为何会例外呢?因此,上述RCT当患者发生高氯血症时继续使用氯,这就提出了重要的伦理问题。我们自己并不希望被随机分配到研究组,因为研究组进行的临床治疗并不正确。

 

The authors of the SALT trial call for a larger trial on this question: they would be wise to abandon their plans and, instead, start to monitor chloride levels in their patients.

SALT研究作者呼吁就此问题进行更大样本的研究:其实,更明智的选择是终止其研究方案,转而开始监测患者的血氯水平。

Reference

1. Vincent JL. The future of critical care medicine: Integration and personalization. Crit Care Med 2016;44:386-389.

2. Vincent JL. Individual gene expression and personalised medicine in sepsis. Lancet Respir Med 2016;4:242-243.

3. Semler MW, Wanderer JP, Ehrenfeld JM, Stollings JL, Self WH, Siew ED, Wang L, Byrne DW, Shaw AD, Bernard GR, Rice TW. Balanced crystalloids versus saline in the intensive care unit. The SALT randomized trial. Am J Respir Crit Care Med 2017;195:1362-1372.

4. Hammond NE, Bellomo R, Gallagher M, Gattas D, Glass P, Mackle D, Micallef S, Myburgh J, Saxena M, Taylor C, Young P, Finfer S. The Plasma-Lyte 148 v Saline (PLUS) study protocol: a multicentre, randomised controlled trial of the effect of intensive care fluid therapy on mortality. Crit Care Resusc 2017;19:239-246.

5. Vincent JL, De Backer D. Saline versus balanced solutions: are clinical trials comparing two crystalloid solutions really needed? Crit Care 2016;20:250.

6. Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, McGuinness S, Mehrtens J, Myburgh J, Psirides A, Reddy S, Bellomo R. Effect of a buffered crystalloid solution vs saline on acute kidney injury among patients in the intensive care unit: The SPLIT randomized clinical trial. JAMA 2015;314:1701-1710.

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