Mount Sinai Hospital, 60 Murray St., Toronto, Ontario.
Can J Surg. 2010 Dec;53(6):415-7.
To evaluate the efficacy and safety of low-dose hydrocortisone therapy in patients with septic shock.
Multicentre, randomized, double-blind, placebo-controlled trial.
Nine centres (including 52 intensive care units) in Europe and the Middle East.
Patients with clinical evidence of infection, evidence of systemic response to infection and onset of shock within the previous 72 hours (defined by systolic blood pressure < 90 mm Hg despite adequate fluid replacement or a need for vasopressors for at least 1 hour) and hypoperfusion or organ dysfunction attributable to sepsis.
INTERVENTION group (n = 251) was randomly assigned to receive 50 mg of hydrocortisone intravenously, and the control group (n = 248) was randomly assigned to receive placebo every 6 hours for 5 days; the dose was tapered during a 6-day period.
Death at 28 days in patients who did not have a response to corticotrophin.
In all, 233 (46.7%) patients did not have a response to corticotrophin (125 in the treatment group and 108 in the placebo group). At 28 days, there was no significant difference in mortality between patients in the 2 groups who did not have a response to corticotropin (39.2% in the treatment group and 36.1% in the placebo group, p = 0.69) or between those who had a response to corticotropin (28.8% in the treatment group and 28.7% in the placebo group, p = 1.00). At 28 days, 86 of 251 (34.3%) patients in the treatment group and 78 of 248 (31.5%) in the placebo group had died (p = 0.51). In the treatment group, shock was reversed more quickly than in the placebo group. However, there were more episodes of superinfection, including new sepsis and septic shock.
Hydrocortisone cannot be recommended as general adjuvant therapy for septic shock (vasopressor responsive), nor can corticotrophin testing be recommended to determine which patients should receive hydrocortisone therapy.
评估小剂量氢化可的松治疗感染性休克患者的疗效和安全性。
多中心、随机、双盲、安慰剂对照试验。
欧洲和中东的 9 个中心（包括 52 个重症监护病房）。
具有感染的临床证据、全身对感染的反应证据以及在过去 72 小时内出现休克（定义为尽管充分补液但收缩压 < 90mmHg 或需要血管加压药至少 1 小时）和灌注不足或器官功能障碍归因于败血症的患者。
干预组（n = 251）随机接受静脉注射 50mg 氢化可的松，对照组（n = 248）随机接受每 6 小时一次的安慰剂治疗 5 天；在 6 天的时间内逐渐减少剂量。
未对促皮质素产生反应的患者在 28 天时的死亡情况。
共有 233 名（46.7%）患者未对促皮质素产生反应（治疗组 125 例，安慰剂组 108 例）。在 28 天时，未对促皮质素产生反应的两组患者之间的死亡率无显著差异（治疗组 39.2%，安慰剂组 36.1%，p = 0.69），对促皮质素产生反应的两组患者之间的死亡率也无显著差异（治疗组 28.8%，安慰剂组 28.7%，p = 1.00）。在 28 天时，治疗组 251 例患者中有 86 例（34.3%）死亡，安慰剂组 248 例患者中有 78 例（31.5%）死亡（p = 0.51）。在治疗组中，休克的逆转速度快于安慰剂组。然而，发生了更多的继发感染，包括新发感染性休克。
氢化可的松不能作为感染性休克（血管加压素反应性）的常规辅助治疗推荐，也不能推荐使用促皮质素检测来确定哪些患者应接受氢化可的松治疗。
