Hydroxyethyl starch - the importance of being earnest
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- 作者：Daniel Chappell (1)
Matthias Jacob (1) - 关键词：Colloids ; Crystalloids ; Fluid therapy ; Hydroxyethyl starch ; Sepsis
- 刊名：Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine
- 出版年：2013
- 出版时间：December 2013
- 年：2013
- 卷：21
- 期：1
- 全文大小：158KB
- 参考文献：1. Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M: A rational approach to perioperative fluid management. / Anesthesiology 2008, 109:723-40. 10.1097/ALN.0b013e3181863117">CrossRef
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6. Jacob M, Chappell D, Hofmann-Kiefer K, Helfen T, Schuelke A, Jacob B, Burges A, Conzen P, Rehm M: The intravascular volume effect of Ringer’s lactate is below 20%: a prospective study in humans. / Crit Care 2012, 16:R86. 10.1186/cc11344">CrossRef
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9. Rehm M, Haller M, Orth V, Kreimeier U, Jacob M, Dressel H, Mayer S, Brechtelsbauer H, Finsterer U: Changes in blood volume and hematocrit during acute preoperative volume loading with 5% albumin or 6% hetastarch solutions in patients before radical hysterectomy. / Anesthesiology 2001, 95:849-56. 10.1097/00000542-200110000-00011">CrossRef
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11. Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, / et al.: Intensive insulin therapy and pentastarch resuscitation in severe sepsis. / N Engl J Med 2008, 358:125-39. 10.1056/NEJMoa070716">CrossRef
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14. Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, / et al.: Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. / Intensive Care Med 2013, 39:165-28. 10.1007/s00134-012-2769-8">CrossRef
15. Van Der Linden P, James M, Mythen M, Weiskopf RB: Safety of modern starches used during surgery. / Anesth Analg 2013, 116:35-8. 10.1213/ANE.0b013e31827175da">CrossRef - 作者单位：Daniel Chappell (1)
Matthias Jacob (1)
1. Department of Anaesthesiology, University Hospital of Munich, Nussbaumstrasse 20, 80336, Munich, Germany
文摘
Despite ongoing controversial expert discussions the European Medicines Agency (EMA) recently recommended to suspend marketing authorisations for hydroxyethyl starch. This comment critically evaluates the line of arguments. Basically, the only indication for a colloid is intravascular hypovolemia. Crystalloid use appears reasonable to compensate ongoing extracellular losses beyond. In the hemodynamically instable patient this leads to the distinction between an initial resuscitation phase where colloids might be indicated and a crystalloidal maintenance phase thereafter. It is important to bear this in mind when reevaluating the studies the EMA referred to in the context of its recent decision: i) VISEP compared ringer’s lactate to 10% HES 200/0.5 in septic patients and found an increased incidence of renal failure in HES receivers. Unfortunately, study treatment was started only after initial stabilization with HES, randomizing hemodynamically stable patients into a rational (crystalloids) and an irrational (high dose starch until ICU discharge) maintenance treatment. ii) 6S compared ringer’s acetate to 6% HES 130/0.42 for fluid resuscitation in septic patients and found an increased need of renal replacement therapy and a higher mortality in the HES group. However, patients of both groups were again randomized only after initial stabilization with colloids, the actual comparison was, therefore, again rational vs. irrational. Beyond that, the documentation is partly fragmentary, leaving many important questions around the fate of the patients unanswered. iii) CHEST randomized ICU patients to receive saline or 6% HES 130/0.4 for fluid resuscitation. Actually, despite partly discussed in a different way, this trial showed no relevant differences in outcome. In all, two studies showed what happens to septic patients if starches are used in a way we do not observe in daily practice. The third one actually proves their safety. The benefit of perioperative goal-directed preload optimization using starches is unquestioned. Taking these informations into account, the recommendation of the EMA starches to be generally dangerous remains mysterious and incomprehensible. An authority being able to dictate behavior should stand clear from oppressively ending a worldwide expert discussion and step back into the role of the observer until science achieves an agreement.