Australian and New Zealand Intensive care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia -
Minerva Anestesiol. 2013 Sep;79(9):1088-92.
The infusion of hydroxyethylstarch (HES) containing fluids has been extremely common worldwide over the last decade. Until recently, HES was probably the most commonly prescribed colloidal preparation in the world. Such prescription continued despite concerns that starch molecules might accumulate in vital organs and that starch preparations might decrease the coagulability of blood. These concerns have led to two pivotal multicenter double-blind controlled trials in critically ill patients, one conducted in Scandinavia in septic Intensive Care Unit (ICU) patients, and the other conducted in Australia and New Zealand in a heterogeneous group of ICU patients. Both studies found that the infusion of HES increased the risk of needing renal replacement therapy. In addition, the Scandinavian study found that HES increased mortality. Subsequent meta-analyses have confirmed these findings. In response to such strong evidence, over the last few weeks, the Food and Drug Administration has issued a major warning and, in Europe, the EMA suspended the marketing authorization for HES. At least in Europe, the clinical story of HES seems to have come to an end.
在过去十年中，羟乙基淀粉（HES）类输液在全球范围内被广泛应用。直到最近，HES 可能仍是世界上最常被开的胶体制剂。尽管人们担心淀粉分子可能在重要器官中蓄积，而且淀粉制剂可能降低血液的凝血能力，但这种处方仍在继续。这些担忧导致了两项关键的多中心、双盲对照试验，一项在斯堪的纳维亚的脓毒症重症监护病房（ICU）患者中进行，另一项在澳大利亚和新西兰的一组异质 ICU 患者中进行。这两项研究都发现，输注 HES 增加了需要肾脏替代治疗的风险。此外，斯堪的纳维亚的研究还发现 HES 增加了死亡率。随后的荟萃分析证实了这些发现。鉴于这些强有力的证据，在过去的几周里，美国食品和药物管理局发布了一项重大警告，而在欧洲，EMA 暂停了 HES 的营销授权。至少在欧洲，HES 的临床故事似乎已经结束。
