特利加压素与去甲肾上腺素治疗感染性休克患者的比较：一项多中心、随机、双盲试验。
Terlipressin versus norepinephrine as infusion in patients with septic shock: a multicentre, randomised, double-blinded trial.
机构信息
Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, 58 Zhongshan 2nd Road, Guangzhou, 510080, China.
Department of Critical Care Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, 26 Yuancun Erheng Road, Guangzhou, 510080, China.
出版信息
Intensive Care Med. 2018 Nov;44(11):1816-1825. doi: 10.1007/s00134-018-5267-9. Epub 2018 Jul 3.
PURPOSE
Recent clinical data suggest that terlipressin, a vasopressin analogue, may be more beneficial in septic shock patients than catecholamines. However, terlipressin's effect on mortality is unknown. We set out to ascertain the efficacy and safety of continuous terlipressin infusion compared with norepinephrine (NE) in patients with septic shock.
METHODS
In this multicentre, randomised, double-blinded trial, patients with septic shock recruited from 21 intensive care units in 11 provinces of China were randomised (1:1) to receive either terlipressin (20-160 µg/h with maximum infusion rate of 4 mg/day) or NE (4-30 µg/min) before open-label vasopressors. The primary endpoint was mortality 28 days after the start of infusion. Primary efficacy endpoint analysis and safety analysis were performed on the data from a modified intention-to-treat population.
RESULTS
Between 1 January 2013 and 28 February 2016, 617 patients were randomised (312 to the terlipressin group, 305 to the NE group). The modified intention-to-treat population comprised 526 (85.3%) patients (260 in the terlipressin group and 266 in the NE group). There was no significant difference in 28-day mortality rate between the terlipressin group (40%) and the NE group (38%) (odds ratio 0.93 [95% CI 0.55-1.56]; p = 0.80). Change in SOFA score on day 7 was similar between the two groups: - 7 (IQR - 11 to 3) in the terlipressin group and - 6 (IQR - 10 to 5) in the NE group. There was no difference between the groups in the number of days alive and free of vasopressors. Overall, serious adverse events were more common in the terlipressin group than in the NE group (30% vs 12%; p < 0.001).
CONCLUSIONS
In this multicentre, randomised, double-blinded trial, we observed no difference in mortality between terlipressin and NE infusion in patients with septic shock. Patients in the terlipressin group had a higher number of serious adverse events.
TRIAL REGISTRATION
This trial is registered at ClinicalTrials.gov: ID NCT01697410.
目的
最近的临床数据表明，血管加压素类似物特利加压素在感染性休克患者中的疗效可能优于儿茶酚胺。然而，特利加压素对死亡率的影响尚不清楚。我们旨在确定持续特利加压素输注与去甲肾上腺素（NE）在感染性休克患者中的疗效和安全性。
方法
在这项多中心、随机、双盲试验中，从中国 11 个省的 21 个重症监护病房招募了感染性休克患者，将其随机（1:1）分配接受特利加压素（20-160μg/h，最大输注速率为 4mg/天）或 NE（4-30μg/min）治疗，然后进行开放性升压药物治疗。主要终点为输注开始后 28 天的死亡率。主要疗效终点分析和安全性分析均基于改良意向治疗人群进行。
结果
在 2013 年 1 月 1 日至 2016 年 2 月 28 日期间，共招募了 617 名患者（特利加压素组 312 名，NE 组 305 名）。改良意向治疗人群包括 526 名（85.3%）患者（特利加压素组 260 名，NE 组 266 名）。特利加压素组（40%）与 NE 组（38%）28 天死亡率无显著差异（比值比 0.93 [95%CI 0.55-1.56]；p=0.80）。两组第 7 天 SOFA 评分变化相似：特利加压素组为 -7（IQR -11 至 3），NE 组为 -6（IQR -10 至 5）。两组存活且无需升压药物的天数无差异。总体而言，特利加压素组严重不良事件发生率高于 NE 组（30%比 12%；p<0.001）。
结论
在这项多中心、随机、双盲试验中，我们观察到感染性休克患者中特利加压素与 NE 输注的死亡率无差异。特利加压素组患者严重不良事件的发生率更高。
试验注册
本试验在 ClinicalTrials.gov 注册：ID NCT01697410。
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