Original Investigation | October 03, 2016
Adjunctive hydrocortisone therapy is suggested by the Surviving Sepsis Campaign in refractory septic shock only. The efficacy of hydrocortisone in patients with severe sepsis without shock remains controversial.
拯救全身性感染行动建议仅对于顽固性感染性休克患者使用辅助性氢化可的松治疗。对于未合并休克的严重全身性感染患者，氢化可的松的疗效仍存在争议。
To determine whether hydrocortisone therapy in patients with severe sepsis prevents the development of septic shock.
确定严重全身性感染患者接受氢化可的松治疗能否预防感染性休克的发生。
Double-blind, randomized clinical trial conducted from January 13, 2009, to August 27, 2013, with a follow-up of 180 days until February 23, 2014. The trial was performed in 34 intermediate or intensive care units of university and community hospitals in Germany, and it included 380 adult patients with severe sepsis who were not in septic shock.
2009年1月13日至2013年8月27日期间进行的双盲随机临床试验，180天随访期至2014年2月23日结束。试验在德国大学或社区医院的34个过渡ICU或ICU中进行，入选了380名严重全身性感染但未合并休克的成年患者。
Patients were randomly allocated 1:1 either to receive a continuous infusion of 200 mg of hydrocortisone for 5 days followed by dose tapering until day 11 (n?=?190) or to receive placebo (n?=?190).
患者按照1:1的比例被分为激素治疗组（即持续输注200 mg氢化可的松共5天后逐渐减量直至第11天）(n = 190)或安慰剂组(n = 190)。
The primary outcome was development of septic shock within 14 days. Secondary outcomes were time until septic shock, mortality in the intensive care unit or hospital, survival up to 180 days, and assessment of secondary infections, weaning failure, muscle weakness, and hyperglycemia (blood glucose level >150 mg/dL [to convert to millimoles per liter, multiply by 0.0555]).
主要预后指标为14天内发生感染性休克。次要指标为发生感染性休克的时间，ICU及住院病死率，180天生存率，继发感染，脱机失败，肌肉无力以及高血糖（血糖水平> 150 mg/dL）。
The intention-to-treat population consisted of 353 patients (64.9% male; mean [SD] age, 65.0 [14.4] years). Septic shock occurred in 36 of 170 patients (21.2%) in the hydrocortisone group and 39 of 170 patients (22.9%) in the placebo group (difference, ?1.8%; 95% CI, ?10.7% to 7.2%; P?=?.70). No significant differences were observed between the hydrocortisone and placebo groups for time until septic shock; mortality in the intensive care unit or in the hospital; or mortality at 28 days (15 of 171 patients [8.8%] vs 14 of 170 patients [8.2%], respectively; difference, 0.5%; 95% CI, ?5.6% to 6.7%; P?=?.86), 90 days (34 of 171 patients [19.9%] vs 28 of 168 patients [16.7%]; difference, 3.2%; 95% CI, ?5.1% to 11.4%; P?=?.44), and 180 days (45 of 168 patients [26.8%] vs 37 of 167 patients [22.2%], respectively; difference, 4.6%; 95% CI, ?4.6% to 13.7%; P?=?.32). In the hydrocortisone vs placebo groups, 21.5% vs 16.9% had secondary infections, 8.6% vs 8.5% had weaning failure, 30.7% vs 23.8% had muscle weakness, and 90.9% vs 81.5% had hyperglycemia.
意向治疗人群包括353名患者（男性64.9%，平均[SD]年龄65.0 [14.4]岁）。氢化可的松组170名患者中36名(21.2%)发生感染性休克，安慰剂组170名患者中39名(22.9%)发生感染性休克（差异，?1.8%; 95% CI, ?10.7% to 7.2%; P?=?.70）。氢化可的松组与安慰剂组发生感染性休克的时间、ICU或住院病死率无显著差异，28天病死率（分别为8.8% [15/171] vs 8.2% [14/170]，差异0.5%；95% CI, ?5.6% to 6.7%; P?=?.86），90天病死率（19.9% [34/171] vs 16.7% [28/168]；差异3.2%; 95% CI, ?5.1% to 11.4%; P?=?.44），以及180天病死率（26.8% [45/168] vs 22.2% [37/167]；差异4.6%; 95% CI, ?4.6% to 13.7%; P?=?.32）。氢化可的松组及安慰剂组发生继发感染比例分别为21.5% vs 16.9%，脱机失败分别为8.6% vs 8.5%，肌肉无力分别为30.7% vs 23.8%，高血糖分别为90.9% vs 81.5%。
Among adults with severe sepsis not in septic shock, use of hydrocortisone compared with placebo did not reduce the risk of septic shock within 14 days. These findings do not support the use of hydrocortisone in these patients.
在未合并休克的严重全身性感染成年患者中，与安慰剂相比，使用氢化可的松不能降低14天内感染性休克的风险。这些发现不支持在这些患者使用氢化可的松。
clinicaltrials.gov Identifier: NCT00670254
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