Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.
Crit Care Med. 2010 Feb;38(2):428-37. doi: 10.1097/ccm.0b013e3181c58715.
To demonstrate the feasibility of a placebo-controlled trial of antipsychotics for delirium in the intensive care unit and to test the hypothesis that antipsychotics would improve days alive without delirium or coma.
Randomized, double-blind, placebo-controlled trial.
Six tertiary care medical centers in the US.
One hundred one mechanically ventilated medical and surgical intensive care unit patients.
Patients were randomly assigned to receive haloperidol or ziprasidone or placebo every 6 hrs for up to 14 days. Twice each day, frequency of study drug administration was adjusted according to delirium status, level of sedation, and side effects.
The primary end point was the number of days patients were alive without delirium or coma. During the 21-day study period, patients in the haloperidol group spent a similar number days alive without delirium or coma (median [interquartile range], 14.0 [6.0-18.0] days) as did patients in the ziprasidone (15.0 [9.1-18.0] days) and placebo groups (12.5 [1.2-17.2] days; p = 0.66). No differences were found in secondary clinical outcomes, including ventilator-free days (p = .25), hospital length of stay (p = .68), and mortality (p = .81). Ten (29%) patients in the haloperidol group reported symptoms consistent with akathisia, compared with six (20%) patients in the ziprasidone group and seven (19%) patients in the placebo group (p = .60), and a global measure of extrapyramidal symptoms was similar between treatment groups (p = .46).
A randomized, placebo-controlled trial of antipsychotics for delirium in mechanically ventilated intensive care unit patients is feasible. Treatment with antipsychotics in this limited pilot trial did not improve the number of days alive without delirium or coma, nor did it increase adverse outcomes. Thus, a large trial is needed to determine whether use of antipsychotics for intensive care unit delirium is appropriate.
展示抗精神病药治疗 ICU 谵妄的安慰剂对照试验的可行性，并检验抗精神病药可改善无谵妄或昏迷天数的假设。
随机、双盲、安慰剂对照试验。
美国六所三级护理医疗中心。
101 名机械通气的内科和外科重症监护病房患者。
患者随机接受氟哌啶醇、齐拉西酮或安慰剂，每 6 小时一次，最多 14 天。每天两次，根据谵妄状态、镇静水平和副作用调整研究药物的给药频率。
主要终点是患者无谵妄或昏迷天数。在 21 天的研究期间，氟哌啶醇组患者无谵妄或昏迷天数（中位数[四分位距]，14.0 [6.0-18.0] 天）与齐拉西酮组（15.0 [9.1-18.0] 天）和安慰剂组（12.5 [1.2-17.2] 天；p = 0.66）相似。次要临床结局无差异，包括无呼吸机天数（p = 0.25）、住院时间（p = 0.68）和死亡率（p = 0.81）。氟哌啶醇组 10 例（29%）患者报告有静坐不能症状，齐拉西酮组 6 例（20%）和安慰剂组 7 例（19%）（p = 0.60），两组间锥体外系症状的总体测量无差异（p = 0.46）。
在机械通气的重症监护病房患者中进行抗精神病药治疗谵妄的随机、安慰剂对照试验是可行的。在这项有限的试验中，抗精神病药治疗并未改善无谵妄或昏迷天数，也未增加不良结局。因此，需要进行大型试验来确定抗精神病药治疗 ICU 谵妄是否合适。
