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[Intensive Care Med在线发表]:特利加压素不降低感染性休克病死率,增加不良事件发生率
2018年07月11日 时讯速递, 进展交流 暂无评论

Terlipressin versus norepinephrine as infusion in patients with septic shock: a multicentre, randomised, double-blinded trial

Zi-Meng Liu, Juan Chen, Qiuye Kou, et al

Intensive Care Med 2018

DOI: https://doi.org/10.1007/s00134-018-5267-9

Purpose 目的

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.

近期临床资料提示,与儿茶酚胺相比,特利加压素(一种血管加压素类似物)对于感染性休克患者更有益。然而,尚不清楚特利加压素对病死率的影响。我们希望明确与去甲肾上腺素(NE)相比,持续输注特利加压素对感染性休克患者的疗效及安全性。

Methods 方法

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.

这项多中心随机双盲试验中,中国11个省21个ICU收治的感染性休克患者按照1:1的比例被随机分为两组,在接受开放标签升压药前使用特利加压素(20–160 µg/h,最大剂量4 mg/d)或 NE (4–30 µg/min)。主要预后终点为开始输注研究药物后28天病死率。主要疗效终点分析及安全性分析采用校正后意向治疗分析。

Results 结果

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).

2013年1月1日至2016年2月28日间,共有617名患者接受随机分组(312名患者分至特利加压素组,305名患者分至NE组)。校正后意向治疗人群包括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%)间28天病死率没有差异(比数比 0.93 [95% CI 0.55–1.56]; p = 0.80)。两组间第7天SOFA评分的变化相似:特利加压素组− 7 (IQR − 11 to 3),NE组 − 6 (IQR − 10 to 5)。两组患者无升压药的存活天数也没有差异。特利加压素组严重不良事件发生率高于NE组(30% vs 12%; p < 0.001)。

Conclusions 结论

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.

这项多中心随机双盲临床试验中,我们并未观察到输注特利加压素与NE对感染性休克患者病死率有不同影响。特利加压素组患者严重不良事件显著增加。

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