丹麦欧登塞大学医院Palle Toft研究团队比较了重症机械通气患者的非镇静或轻度镇静疗效。相关论文发表在2020年2月16日出版的《新英格兰医学杂志》上。

在重症机械通气患者中，每天中断镇静治疗可缩短通气时间和在重症监护室（ICU）的住院时间。但与轻度镇静方案相比，无镇静方案是否影响死亡率尚不确定。

在一项多中心、随机、对照试验中，研究组招募了710例机械通气的ICU患者，将其按1：1随机分为无镇静组和轻度镇静组。采用Richmond躁动-镇静评分量表（RASS）对镇静程度进行评估。

共有700例患者纳入最终分析。两组患者基线检查时的临床资料相差不大。非镇静组的RASS评分从第1天的-1.3分增加到第7天的-0.8分，轻度镇静组从第1天的-2.3分增加到第7天的-1.8分。治疗90天后，非镇静组和轻度镇静组的死亡率分别为42.4%和37.0%，差异不显著。

两组间的无ICU天数和无呼吸机天数均无显著差异。非镇静组平均27天无昏迷或谵妄，镇静组为26天。非镇静组中主要血栓栓塞事件的发生率为0.3%，显著低于镇静组（2.8%），差异具有统计学意义。

总之，对于机械通气的ICU患者，采用非镇静计划与每日间断轻度镇静计划相比，90天死亡率并无显著差异。

附：英文原文

Title: Nonsedation or Light Sedation in Critically Ill, Mechanically Ventilated Patients | NEJM

Author: Hanne T. Olsen, M.D.,, Helene K. Nedergaard, M.D., Ph.D.,, Thomas Strm, M.D., Ph.D.,, Jakob Oxlund, M.D.,, Karl-Andre Wian, M.D.,, Lars M. Ytreb, M.D., Ph.D.,, Bjrn A. Kroken, M.D.,, Michelle Chew, M.D., Ph.D.,, Serkan Korkmaz,, Jrgen T. Lauridsen, M.Sc.,, and Palle Toft, M.D., D.M.Sc.

Issue&Volume: February 16, 2020

Abstract: AbstractBackgroundIn critically ill, mechanically ventilated patients, daily interruption of sedation has been shown to reduce the time on ventilation and the length of stay in the intensive care unit (ICU). Data on whether a plan of no sedation, as compared with a plan of light sedation, has an effect on mortality are lacking.MethodsIn a multicenter, randomized, controlled trial, we assigned, in a 1:1 ratio, mechanically ventilated ICU patients to a plan of no sedation (nonsedation group) or to a plan of light sedation (i.e., to a level at which the patient was arousable, defined as a score of 2 to 3 on the Richmond Agitation and Sedation Scale [RASS], on which scores range from 5 [unresponsive] to +4 [combative]) (sedation group) with daily interruption. The primary outcome was mortality at 90 days. Secondary outcomes were the number of major thromboembolic events, the number of days free from coma or delirium, acute kidney injury according to severity, the number of ICU-free days, and the number of ventilator-free days. Between-group differences were calculated as the value in the nonsedation group minus the value in the sedation group.ResultsA total of 710 patients underwent randomization, and 700 were included in the modified intention-to-treat analysis. The characteristics of the patients at baseline were similar in the two trial groups, except for the score on the Acute Physiology and Chronic Health Evaluation (APACHE) II, which was 1 point higher in the nonsedation group than in the sedation group, indicating a greater chance of in-hospital death. The mean RASS score in the nonsedation group increased from 1.3 on day 1 to 0.8 on day 7 and, in the sedation group, from 2.3 on day 1 to 1.8 on day 7. Mortality at 90 days was 42.4% in the nonsedation group and 37.0% in the sedated group (difference, 5.4 percentage points; 95% confidence interval [CI], 2.2 to 12.2; P=0.65). The number of ICU-free days and of ventilator-free days did not differ significantly between the trial groups. The patients in the nonsedation group had a median of 27 days free from coma or delirium, and those in the sedation group had a median of 26 days free from coma or delirium. A major thromboembolic event occurred in 1 patient (0.3%) in the nonsedation group and in 10 patients (2.8%) in the sedation group (difference, 2.5 percentage points; 95% CI, 4.8 to 0.7 [unadjusted for multiple comparisons]).ConclusionsAmong mechanically ventilated ICU patients, mortality at 90 days did not differ significantly between those assigned to a plan of no sedation and those assigned to a plan of light sedation with daily interruption. (Funded by the Danish Medical Research Council and others; NONSEDA ClinicalTrials.gov number, NCT01967680.)

DOI: 10.1056/NEJMoa1906759

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1906759