Hydrocortisone therapy for patients with septic shock

Hydrocortisone therapy for patients with septic shock
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DOI:
10.1056/nejmoa071366
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发表时间:
2008-01-10
影响因子:
158.5
通讯作者:
Briegel, Josef
Briegel, Josef
中科院分区:
医学1区
文献类型:
--
作者:
Sprung, Charles L.;Annane, Djillali;Briegel, Josef

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工作背景:氢化可的松被广泛用于脓毒性休克患者,尽管仅在液体和血管加压剂复苏后仍然肿胀的患者以及促肾上腺皮质激素给药后血浆皮质醇水平未适当升高的患者中报告了生存益处。在这项多中心、随机、双盲、安慰剂对照试验中,我们将251名患者分配接受50 mg静脉注射氢化可的松,248名患者接受安慰剂,每6小时一次,共5天;然后在6天内逐渐减少剂量。在第28天,主要结果是谁没有反应的促肾上腺皮质激素test.Results:在研究的499例患者中,233(46.7%)没有反应的促肾上腺皮质激素(125氢化可的松组和108安慰剂组)的患者死亡。28天时,两个研究组中对促肾上腺皮质激素无反应的患者(氢化可的松组为39.2%,安慰剂组为36.1%,P = 0.69)或对促肾上腺皮质激素有反应的患者(氢化可的松组为28.8%,安慰剂组为28.7%,P = 1.00)之间的死亡率无显著差异。第28天,氢化可的松组251例患者中有86例(34.3%)和安慰剂组248例患者中有78例(31.5%)死亡(P = 0.51)。在氢化可的松组中,休克的逆转比安慰剂组更快。然而,有更多的重叠感染,包括新的脓毒症和脓毒性shock.Conclusions:氢化可的松没有提高生存率或逆转休克感染性休克患者,无论是整体或谁没有反应的促肾上腺皮质激素的患者,虽然氢化可的松加速逆转休克的患者中,休克被逆转。(ClinicalTrials.gov编号,NCT00147004)。
Background: Hydrocortisone is widely used in patients with septic shock even though a survival benefit has been reported only in patients who remained hypotensive after fluid and vasopressor resuscitation and whose plasma cortisol levels did not rise appropriately after the administration of corticotropin.Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, we assigned 251 patients to receive 50 mg of intravenous hydrocortisone and 248 patients to receive placebo every 6 hours for 5 days; the dose was then tapered during a 6-day period. At 28 days, the primary outcome was death among patients who did not have a response to a corticotropin test.Results: Of the 499 patients in the study, 233 (46.7%) did not have a response to corticotropin (125 in the hydrocortisone group and 108 in the placebo group). At 28 days, there was no significant difference in mortality between patients in the two study groups who did not have a response to corticotropin (39.2% in the hydrocortisone group and 36.1% in the placebo group, P=0.69) or between those who had a response to corticotropin (28.8% in the hydrocortisone group and 28.7% in the placebo group, P=1.00). At 28 days, 86 of 251 patients in the hydrocortisone group (34.3%) and 78 of 248 patients in the placebo group (31.5%) had died (P=0.51). In the hydrocortisone group, shock was reversed more quickly than in the placebo group. However, there were more episodes of superinfection, including new sepsis and septic shock.Conclusions: Hydrocortisone did not improve survival or reversal of shock in patients with septic shock, either overall or in patients who did not have a response to corticotropin, although hydrocortisone hastened reversal of shock in patients in whom shock was reversed. (ClinicalTrials.gov number, NCT00147004.).