Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock
Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock
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DOI：
10.1001/jama.288.7.862
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发表时间：
2002-08-21
影响因子：
120.7
通讯作者：
Bellissant, E
中科院分区：
文献类型：
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作者：
Annane, D;Sébille, V;Bellissant, E
感染性休克可能与相对的肾上腺功能不全有关。因此，低剂量皮质类固醇替代疗法已被提出来治疗脓毒性休克。目的评估低剂量皮质类固醇是否改善脓毒性休克和相对肾上腺功能不全患者的28天生存率。设计和设置安慰剂对照，随机，双盲，平行组试验在19个重症监护病房在法国从1995年10月9日至2月23日，300例符合感染性休克常规标准的成年患者在接受短期促肾上腺皮质激素试验后被纳入研究。（每6小时静脉推注50 mg）和氟氢可的松（50 μ g片剂，每日一次）（n=151）或相匹配的安慰剂（n=149）治疗7天。主要指标相对肾上腺功能不全患者28天生存率分布结果皮质类固醇组1例患者因撤回知情同意而被排除。促肾上腺皮质激素试验无应答者229例（安慰剂组115例，皮质类固醇组114例），促肾上腺皮质激素试验应答者70例（安慰剂组34例，皮质类固醇组36例）。在无应答者中，安慰剂组有73例死亡（63%），皮质类固醇组有60例死亡（53%）（风险比，0.67; 95%置信区间，0.47-0.95; P= 0.02）。安慰剂组有46名患者（40%）在28天内停止血管加压药治疗，皮质类固醇组有65名患者（57%）在28天内停止血管加压药治疗（风险比，1.91; 95%可信区间，1.29-2.84; P=.001）。两组之间的应答者无显著差异。不良事件发生率在2 groups.Conclusion相似，在我们的试验中，7天的治疗与低剂量的氢化可的松和氟氢可的松显着降低死亡的风险，感染性休克和相对肾上腺皮质功能不全的患者没有增加不良事件。
Context Septic shock maybe associated with relative adrenal insufficiency. Thus, a replacement therapy of low doses of corticosteroids has been proposed to treat septic shock.Objective To assess whether low doses of corticosteroids improve 28-day survival in patients with septic shock and relative adrenal insufficiency.Design and Setting Placebo-controlled, randomized, double-blind, parallel-group trial performed in 19 intensive care units in France from October 9, 1995, to February 23, 1999.Patients Three hundred adult patients who fulfilled usual criteria for septic shock were enrolled after undergoing a short corticotropin test.Intervention Patients were randomly assigned to receive either hydrocortisone (50-mg intravenous bolus every 6 hours) and fludrocortisone (50-mug tablet once daily) (n=151) or matching placebos (n=149) for 7 days.Main Outcome Measure Twenty-eight-day survival distribution in patients with relative adrenal insufficiency (nonresponders to the corticotropin test).Results One patient from the corticosteroid group was excluded from analyses because of consent withdrawal. There Were 229 nonresponders to the corticotropin test (placebo, 115; corticosteroids, 114) and 70 responders to the corticotropin test (placebo, 34; corticosteroids, 36). In nonresponders, there were 73 deaths (63%) in the placebo group and 60 deaths (53%) in the corticosteroid group (hazard ratio, 0.67; 95% confidence interval, 0.47-0.95; P=.02). Vasopressor therapy was withdrawn within 28 days in 46 patients (40%) in the placebo group and in 65 patients (57%) in the corticosteroid group (hazard ratio, 1.91; 95% confidence interval, 1.29-2.84; P=.001). There was no significant difference between groups in responders. Adverse events rates were similar in the 2 groups.Conclusion In our trial, a 7-day treatment with low doses of hydrocortisone and fludrocortisone significantly reduced the risk of death in patients with septic shock and relative adrenal insufficiency without increasing adverse events.