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[NEJM在线发表]:氟哌啶醇及齐哌西酮治疗危重病患者的谵妄
2018年10月28日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness

Timothy D. Girard, Matthew C. Exline, Shannon S. Carson, et al.

N Engl J Med October 22, 2018

DOI: 10.1056/NEJMoa1808217

Abstract

BACKGROUND 背景

There are conflicting data on the effects of antipsychotic medications on delirium in patients in the intensive care unit (ICU).

抗精神病药物对ICU患者谵妄的疗效数据相互矛盾。

METHODS 方法

In a randomized, double-blind, placebo-controlled trial, we assigned patients with acute respiratory failure or shock and hypoactive or hyperactive delirium to receive intravenous boluses of haloperidol (maximum dose, 20 mg daily), ziprasidone (maximum dose, 40 mg daily), or placebo. The volume and dose of a trial drug or placebo was halved or doubled at 12-hour intervals on the basis of the presence or absence of delirium, as detected with the use of the Confusion Assessment Method for the ICU, and of side effects of the intervention. The primary end point was the number of days alive without delirium or coma during the 14-day intervention period. Secondary end points included 30-day and 90-day survival, time to freedom from mechanical ventilation, and time to ICU and hospital discharge. Safety end points included extrapyramidal symptoms and excessive sedation.

在这项随机双盲安慰剂对照临床试验中,我们将急性呼吸功能衰竭或休克伴少动型或亢奋型谵妄患者随机分组,分别接受静脉推注氟哌啶醇(每日最大剂量20 mg)、齐哌西酮(每日最大剂量40 mg)或安慰剂。根据CAM-ICU确定患者是否出现谵妄,以及是否出现副作用,在12小时内将试验药物或安慰剂剂量加倍或减半。主要预后终点为14天治疗期间没有谵妄或昏迷的存活天数。次要预后终点包括30天及90天生存率,脱离机械通气时间,转出ICU及出院时间。安全性终点包括锥体外系症状及过度镇静。

RESULTS 结果

Written informed consent was obtained from 1183 patients or their authorized representatives. Delirium developed in 566 patients (48%), of whom 89% had hypoactive delirium and 11% had hyperactive delirium. Of the 566 patients, 184 were randomly assigned to receive placebo, 192 to receive haloperidol, and 190 to receive ziprasidone. The median duration of exposure to a trial drug or placebo was 4 days (interquartile range, 3 to 7). The median number of days alive without delirium or coma was 8.5 (95% confidence interval [CI], 5.6 to 9.9) in the placebo group, 7.9 (95% CI, 4.4 to 9.6) in the haloperidol group, and 8.7 (95% CI, 5.9 to 10.0) in the ziprasidone group (P=0.26 for overall effect across trial groups). The use of haloperidol or ziprasidone, as compared with placebo, had no significant effect on the primary end point (odds ratios, 0.88 [95% CI, 0.64 to 1.21] and 1.04 [95% CI, 0.73 to 1.48], respectively). There were no significant between-group differences with respect to the secondary end points or the frequency of extrapyramidal symptoms.

共1183名患者或其授权代表签署知情同意书。其中566名(48%)患者发生谵妄,少动型和亢奋型各占89%和11%。在566名患者中,184名患者分至安慰剂组,192名患者使用氟哌啶醇,190名患者使用齐哌西酮。试验药物或安慰剂的中位暴露时间为4天(四分位区间3-7)。安慰剂组无谵妄或昏迷的中位天数为8.5天(95%可信区间[CI],5.6-9.9),氟哌啶醇组为7.9天 (95% CI, 4.4 to 9.6),齐哌西酮组为 8.7 天(95% CI, 5.9 to 10.0)(组间比较总体P=0.26)。与安慰剂相比,氟哌啶醇或齐哌西酮对主要预后终点没有显著影响(比数比分别为0.88 [95% CI, 0.64 to 1.21] 和 1.04 [95% CI, 0.73 to 1.48])。各组间次要预后终点或锥体外系症状发生率无显著差异。

CONCLUSIONS 结论

The use of haloperidol or ziprasidone, as compared with placebo, in patients with acute respiratory failure or shock and hypoactive or hyperactive delirium in the ICU did not significantly alter the duration of delirium.

对于急性呼吸功能衰竭或休克伴少动型或亢奋型谵妄的患者,与安慰剂对照相比,氟哌啶醇或齐哌西酮不能显著改变谵妄持续时间。

(Funded by the National Institutes of Health and the VA Geriatric Research Education and Clinical Center; MIND-USA ClinicalTrials.gov number, NCT01211522.)

 

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