Iloprost for the Treatment of Severe Septic Shock with Persistent Hypoperfusion: A Double-Blind, Randomized Controlled Trial.

However, its effect on organ failure remains unclear.

然而，它对器官衰竭的影响仍不清楚。

Objectives: To investigate whether iloprost provides organ protection in septic shock with hypoperfusion.

目的：研究伊洛前列素是否在伴有灌注不足的脓毒性休克中提供器官保护。

Methods: In this multicenter, double-blind, randomized controlled trial, adults with septic shock and persistent hypoperfusion (i.e., increased capillary refill time and/or skin mottling) were randomized to receive a 48-hour intravenous infusion of iloprost or placebo.

方法：在这项多中心、双盲、随机对照试验中，伴有持续灌注不足（即毛细血管再充盈时间增加和/或皮肤花斑）的成人脓毒性休克患者被随机分配接受48小时的伊洛前列素或安慰剂静脉输注。

The primary outcome was the change in the Sequential Organ Failure Assessment (SOFA) score from randomization to Day 7.

主要结果是从随机化至第7天的序贯器官衰竭评分（SOFA）的变化。

Secondary outcomes included mortality at Day 28, organ support-free days by Day 28, and mean daily SOFA score.

次要结果包括第28天的死亡率、第28天的器官支持自由天数以及平均每日SOFA评分。

Measurements and Main Results: A total of 240 patients were randomized, and 236 were included in the analysis.

测量和主要结果：共随机分配了240名患者，236名患者被纳入分析。

Median (IQR) changes in SOFA score were -4 (-7 to 7) in the iloprost group and -5 (-8 to 5) in the placebo group (median difference, 1; 95% CI, 0-3; P = 0.12).

SOFA评分的中位数（四分位数间距）变化为：伊洛前列素组为-4（-7至7），安慰剂组为-5（-8至5）（中位数差异，1；95%置信区间，0-3；P = 0.12）。

At 28 days, 48 patients (42%) had died in the iloprost group and 47 (39%) had died in the placebo group (relative risk, 1.08; 95% CI, 0.80-1.5).

在28天时，48名患者（42%）在伊洛前列素组中死亡，而在安慰剂组中47名患者（39%）死亡（相对风险，1.08；95%置信区间，0.80-1.5）。

The median average SOFA score was 11.2 (7.4-15.9) in the iloprost group, compared with 10.5 (6.8-16.5) in the placebo group (median difference, 0.25; 95% CI, -1.1 to 1.8).

伊洛前列素组的SOFA平均中位数评分为11.2（7.4-15.9），与安慰剂组的10.5（6.8-16.5）相比（中位数差异，0.25；95%置信区间，-1.1至1.8）。

Median (95% confidence interval) between-group differences in 28-day ventilation-, vasopressor-, and renal replacement therapy-free survival days were 0 (0-0), 0 (-1 to 1), and 0 (0-0), respectively.

28天无机械通气、血管加压剂和肾脏替代治疗生存天数的组间差异的中位数（95%置信区间）分别为0（0-0）、0（-1至1）和0（0-0）。

Severe adverse events occurred in 15% of patients in the iloprost group and 7% of patients in the placebo group (P = 0.06).

在伊洛前列素组中有15%的患者出现了严重不良事件，在安慰剂组中有7%的患者出现了严重不良事件（P = 0.06）。

Conclusions: Among patients with septic shock and persistent hypoperfusion, iloprost did not reduce the severity of organ failure.

结论：在持续低灌注的败血性休克患者中，伊洛前列素并未减轻器官衰竭的严重程度。

Clinical trial registered with www.clinicaltrials.gov (NCT03788837) and EudraCT (2018-001709-10).

临床试验已在www.clinicaltrials.gov (NCT03788837)和EudraCT (2018-001709-10)上注册。