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复苏中的淀粉安全性——我们何时才能吸取教训?

Starch safety in resuscitation - when will we ever learn?

机构信息

Department of Internal Medicine, Frere and Cecilia Makiwane Hospitals, East London, South Africa.

出版信息

S Afr Med J. 2013 Apr 29;103(6):365-7. doi: 10.7196/samj.6969.

DOI:10.7196/samj.6969
PMID:23725952
Abstract

Recent trials have failed to demonstrate a survival benefit from the use of hydroxyethyl starches (HES) as a colloid in fluid resuscitation and have raised concerns of renal harm. In severe sepsis, there is a concerning signal of increased mortality. New high-quality systematic reviews consistently demonstrate a statistically non-significant relative risk of death of 1.08 - 1.10 and a significant 25% increased chance of requiring renal replacement therapy. The HES literature contains many industry-affiliated reviews of indifferent quality. Traditional efficacy confidence limits may warrant re-evaluation when considering these harms. Newer formulations of HES and more focused indications for use show benefit on surrogate endpoints, but these trials are currently underpowered to ensure safety.

摘要

最近的试验未能证明羟乙基淀粉(HES)作为胶体在液体复苏中的使用有生存获益,并引起了对肾脏损害的关注。在严重脓毒症中,死亡率增加的信号令人担忧。新的高质量系统评价一致显示,死亡的相对风险没有统计学意义,为 1.08-1.10,而需要肾脏替代治疗的几率显著增加 25%。HES 文献中包含许多质量一般的行业相关综述。在考虑这些危害时,传统的疗效置信区间可能需要重新评估。HES 的新型制剂和更有针对性的适应证在替代终点上显示出获益,但这些试验目前的效力不足以确保安全性。

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