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

被引：110

作者：

Liu, Zi-Meng ^{[1
]}

Chen, Juan ^{[1
]}

Kou, Qiuye ^{[2
]}

Lin, Qinhan ^{[3
]}

Huang, Xiaobo ^{[4
,5
]}

Tang, Zhanhong ^{[6
]}

Kang, Yan ^{[7
]}

Li, Ke ^{[8
]}

Zhou, Lixin ^{[9
]}

Song, Qing ^{[10
]}

Sun, Tongwen ^{[11
]}

Zhao, Ling ^{[12
]}

Wang, Xue ^{[13
]}

He, Xiandi ^{[14
]}

Wang, Chunting ^{[15
]}

Wu, Benquan ^{[16
]}

Lin, Jiandong ^{[17
]}

Yuan, Shiying ^{[18
]}

Gu, Qin ^{[19
]}

Qian, Kejian ^{[20
]}

Shi, Xianqing ^{[21
]}

Feng, Yongwen ^{[22
]}

Lin, Aihua ^{[23
]}

He, Xiaoshun ^{[1
]}

Guan, Xiang-Dong ^{[1
]}

机构：

[1] Sun Yat Sen Univ, Affiliated Hosp 1, Dept Crit Care Med, 58 Zhongshan 2nd Rd, Guangzhou 510080, Guangdong, Peoples R China

[2] Sun Yat Sen Univ, Affiliated Hosp 6, Dept Crit Care Med, 26 Yuancun Erheng Rd, Guangzhou 510080, Guangdong, Peoples R China

[3] Guangzhou Med Univ, Affiliated Hosp 6, Qingyuan Peoples Hosp, Dept Crit Care Med, 24 Yinquan Rd, Qingyuan 511500, Guangdong, Peoples R China

[4] Sichuan Acad Med Sci, Dept Crit Care Med, 32 West Second Sect First Ring Rd, Chengdu 610000, Sichuan, Peoples R China

[5] Sichuan Prov Peoples Hosp, 32 West Second Sect First Ring Rd, Chengdu 610000, Sichuan, Peoples R China

[6] GuangXi Med Univ, Affiliated Hosp 1, Dept Crit Care Med, 6 Shuangyong Rd, Nanning 530021, Guangxi, Peoples R China

[7] Sichuan Univ, West China Hosp, Dept Crit Care Med, 37 Guo Xue Xiang, Chengdu 610041, Sichuan, Peoples R China

[8] Chinese PLA 302 Hosp, Dept Crit Care Med, 100 Xisihuan Middle Rd, Beijing 100000, Peoples R China

[9] Foshan First Municipal Peoples Hosp, Dept Crit Care Med, 81 Lingnan North Rd, Foshan 528000, Guangdong, Peoples R China

[10] Chinese Peoples Liberat Army Gen Hosp, Dept Crit Care Med, 28 Fuxing Rd, Beijing 100000, Peoples R China

[11] Zhengzhou Univ, Affiliated Hosp 1, Dept Crit Care Med, 1 Jianshe East Rd, Zhengzhou 450000, Henan, Peoples R China

[12] Zhuhai Peoples Hosp, Dept Crit Care Med, 79 Kangning Rd, Zhuhai 519000, Guangdong, Peoples R China

[13] Xi An Jiao Tong Univ, Affiliated Hosp 1, Dept Crit Care Med, 277 Yanta West Rd, Xian 710000, Shaanxi, Peoples R China

[14] Bengbu Med Coll, Affiliated Hosp 1, Dept Crit Care Med, 287 Changhuai Rd, Bengbu 233000, Henan, Peoples R China

[15] Shandong Prov Hosp, Dept Crit Care Med, 324 Jingwuweiqi Rd, Jinan 250000, Shandong, Peoples R China

[16] Sun Yat Sen Univ, Affiliated Hosp 3, Dept Crit Care Med, Guangzhou 510080, Guangdong, Peoples R China

[17] Fujian Prov Hosp, Dept Crit Care Med, 134 East St Fuzhou, Fujian 350000, Peoples R China

[18] Huazhong Univ Sci & Technol, Wuhan Union Hosp, Dept Crit Care Med, Tongji Med Coll, 127 Jiefangda Rd, Wuhan 430000, Hubei, Peoples R China

[19] Nanjing Univ, Dept Crit Care Med, Med Sch, Affiliated Drum Tower Hosp, 321 Zhongshan Rd, Nanjing 210000, Jiangsu, Peoples R China

[20] Nanchang Univ, Affiliated Hosp 1, Dept Crit Care Med, 17 Yongwaizheng Rd, Nanchang 330006, Jiangxi, Peoples R China

[21] Guizhou Prov Hosp, Dept Crit Care Med, 97 Boai Rd, Guiyang 550002, Guizhou, Peoples R China

[22] Second Peoples Hosp Shenzhen, Dept Crit Care Med, Sungang Rd, Shenzhen 518000, Guangdong, Peoples R China

[23] Sun Yat Sen Univ, Sch Publ Hlth, 74 Zhongshan 2nd Rd, Guangzhou 510080, Guangdong, Peoples R China

来源：

INTENSIVE CARE MEDICINE | 2018年 / 44卷 / 11期

关键词：

Terlipressin; Norepinephrine; Septic shock; SOFA score; INTENSIVE-CARE UNITS; ARGININE-VASOPRESSIN; VASODILATORY SHOCK; SOFA SCORE; SEPSIS;

D O I：

10.1007/s00134-018-5267-9

中图分类号：

R4 [临床医学];

学科分类号：

100218 [急诊医学];

摘要：

PurposeRecent 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.MethodsIn 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 mu g/h with maximum infusion rate of 4mg/day) or NE (4-30 mu g/min) before open-label vasopressors. The primary endpoint was mortality 28days after the start of infusion. Primary efficacy endpoint analysis and safety analysis were performed on the data from a modified intention-to-treat population.ResultsBetween 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).ConclusionsIn 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 registrationThis trial is registered at ClinicalTrials.gov: ID NCT01697410.

引用

页码：1816 / 1825

页数：10

共 28 条

[1]

Terlipressin or norepinephrine in hyperdynamic septic shock:: A prospective, randomized study [J].