CC:特利加压素辅助治疗难治性脓毒性休克与安慰剂的比较：一项随机、安慰剂对照试验

Background

Terlipressin’s role as an adjunctive vasopressor in septic shock remains controversial. We aimed to evaluate the efficacy of terlipressin versus placebo as an additional vasopressor in refractory septic shock.特利加压素作为脓毒性休克辅助升压药的作用仍存在争议。本研究旨在评估在难治性脓毒性休克中，与安慰剂相比，特利加压素作为额外升压药的疗效。

Methods

We conducted a single-center, prospective, double-blind, randomized controlled trial in a medical intensive care unit. Adult patients with septic shock requiring norepinephrine > 0.2 mcg/kg/min or epinephrine were randomly assigned (1:1) to receive terlipressin or placebo. The primary outcome was the proportion of patients achieving mean arterial pressure ≥ 65 mmHg with total catecholamine equivalent dose below 0.2 mcg/kg/min at 6 h after randomization.我们在重症医学科开展了一项单中心、前瞻性、双盲、随机对照试验。将需要去甲肾上腺素＞0.2 微克/（千克·分钟）或肾上腺素的脓毒性休克成年患者按 1:1 的比例随机分配至特利加压素组或安慰剂组。主要结局指标为随机分组后 6 小时内，达到平均动脉压≥65 毫米汞柱且总儿茶酚胺当量剂量低于 0.2 微克/（千克·分钟）的患者比例。

Results

A total of 130 patients were enrolled: 66 in the terlipressin group and 64 in the placebo group. Baseline characteristics were comparable. The median (interquartile range) baseline norepinephrine equivalent dose was 0.39 (0.29 − 0.73) mcg/kg/min for terlipressin versus 0.39 (0.27 − 0.62) mcg/kg/min for placebo. Pneumonia (57.6% vs 48.4%) and intra-abdominal infection (21.2% vs 23.4%) were the most common etiologies in the terlipressin and placebo arms, respectively. Significantly more patients met the primary outcome with terlipressin than with placebo (22.7% vs 9.4%; relative risk [RR] = 1.53, 95% confidence interval [CI] = 1.09–2.14; P = 0.039). The 28-day mortality was 60.6% in the terlipressin group versus 64.1% in the placebo group (RR = 0.93, 95% CI = 0.66–1.31; P = 0.68). Digital ischemia occurred in 28.8% versus 27.4% (P = 0.86).共纳入 130 例患者，其中特利加压素组 66 例，安慰剂组 64 例。两组患者的基线特征具有可比性。特利加压素组和安慰剂组的基线儿茶酚胺当量剂量中位数（四分位数间距）分别为 0.39（0.29 – 0.73）微克/（千克·分钟）和 0.39（0.27 – 0.62）微克/（千克·分钟）。特利加压素组和安慰剂组最常见的病因分别是肺炎（57.6% vs 48.4%）和腹腔内感染（21.2% vs 23.4%）。特利加压素组达到主要结局指标的患者显著多于安慰剂组（22.7% vs 9.4%；相对危险度[RR] = 1.53，95%置信区间[CI] = 1.09 – 2.14；P = 0.039）。特利加压素组 28 天死亡率为 60.6%，安慰剂组为 64.1%（RR = 0.93，95% CI = 0.66 – 1.31；P = 0.68）。特利加压素组和安慰剂组指端缺血的发生率分别为 28.8% 和 27.4%（P = 0.86）。

Conclusions

Among patients with refractory septic shock, adjunctive terlipressin reduced the proportion of patients requiring high-dose catecholamines at 6 h, without significantly altering mortality or digital ischemia risk.在难治性脓毒性休克患者中，辅助使用特利加压素可降低 6 小时内需要大剂量儿茶酚胺的患者比例，且未显著改变死亡率或指端缺血风险。