Efficacy and safety of quetiapine in critically ill patients with delirium: A prospective, multicenter, randomized, double-blind, placebo-controlled pilot study
Efficacy and safety of quetiapine in critically ill patients with delirium: A prospective, multicenter, randomized, double-blind, placebo-controlled pilot study
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DOI：
10.1097/ccm.0b013e3181b9e302
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发表时间：
2010-02-01
影响因子：
8.8
通讯作者：
Garpestad, Erik
中科院分区：
文献类型：
--
作者：
Devlin, John W.;Roberts, Russel J.;Garpestad, Erik
目的：比较预定喹硫平与安慰剂治疗需要氟哌啶醇的危重患者谵妄的疗效和安全性。设计：前瞻性、随机、双盲、安慰剂对照研究。地点：三个学术医疗中心。患者：36 名成人重症监护室谵妄患者（重症监护谵妄筛查检查表评分 >= 4）， 能够耐受肠内营养，并且没有复杂的神经系统疾病。 干预措施：患者随机接受喹硫平 50 mg 每 12 小时一次或安慰剂治疗。如果在前 24 小时内服用超过一剂氟哌啶醇，则每 24 小时增加喹硫平剂量（每 12 小时 50 至 100 至 150 至 200 mg）。研究药物持续使用，直到重症监护病房团队因谵妄消退、治疗≥10天或重症监护病房出院而停止使用。测量和主要结果：喹硫平组（n = 18）和安慰剂组（n = 18）的基线特征相似。喹硫平与谵妄首次缓解的时间较短[1.0（四分位距[IQR]，0.5-3.0）对比4.5天（IQR，2.0-7.0；p = 0.001）]，谵妄持续时间缩短[36（IQR，12-87）对比120小时（IQR，60-195；p = 0.001）] .006)]，并且更少的搅动 （镇静-躁动量表评分 >= 5）[6（IQR，0-38）与 36 小时（IQR，11-66；p = .02）]。尽管死亡率（11% 喹硫平 vs. 17%）和重症监护病房住院时间（16 天喹硫平 vs. 16 天）相似，但接受喹硫平治疗的受试者更有可能出院回家或接受康复治疗（89% 喹硫平 vs. 56%；p = .06）。使用喹硫平治疗的受试者需要较少天数的按需氟哌啶醇 [3 [(IQR, 2-4)] vs. 4 天 (IQR, 3-8; p = .05)]。尽管各组之间 QTc 延长和锥体外系症状的发生率相似，但喹硫平组出现更多嗜睡症状（22% vs. 11%；p = .66）。 结论：将喹硫平添加到按需氟哌啶醇中可以更快地缓解谵妄，减少躁动，并提高回家或康复的比率。未来的研究应评估喹硫平对更广泛患者群体的死亡率、资源利用、重症监护病房后认知和出院后依赖性的影响。 （《重症监护医学》2010 年；38：419-427）
Objective: To compare the efficacy and safety of scheduled quetiapine to placebo for the treatment of delirium in critically ill patients requiring as-needed haloperidol.Design: Prospective, randomized, double-blind, placebo-controlled study.Setting: Three academic medical centers.Patients: Thirty-six adult intensive care unit patients with delirium (intensive Care Delirium Screening Checklist score >= 4), tolerating enteral nutrition, and without a complicating neurologic condition.Interventions: Patients were randomized to receive quetiapine 50 mg every 12 hrs or placebo. Quetiapine was increased every 24 hrs (50 to 100 to 150 to 200 mg every 12 hrs) if more than one dose of haloperidol was given in the previous 24 hrs. Study drug was continued until the intensive care unit team discontinued it because of delirium resolution, therapy >= 10 days, or intensive care unit discharge.Measurements and Main Results: Baseline characteristics were similar between the quetiapine (n = 18) and placebo (n = 18) groups. Quetiapine was associated with a shorter time to first resolution of delirium [1.0 (interquartile range [IQR], 0.5-3.0) vs. 4.5 days (IQR, 2.0-7.0; p = .001)], a reduced duration of delirium [36 (IQR, 12-87) vs. 120 hrs (IQR, 60-195; p = .006)], and less agitation (Sedation-Agitation Scale score >= 5) [6 (IQR, 0-38) vs. 36 hrs (IQR, 11-66; p = .02)]. Whereas mortality (11% quetiapine vs. 17%) and intensive care unit length of stay (16 quetiapine vs. 16 days) were similar, subjects treated with quetiapine were more likely to be discharged home or to rehabilitation (89% quetiapine vs. 56%; p = .06). Subjects treated with quetiapine required fewer days of as-needed haloperidol [3 [(IQR, 2-4)] vs. 4 days (IQR, 3-8; p = .05)]. Whereas the incidence of QTc prolongation and extrapyramidal symptoms was similar between groups, more somnolence was observed with quetiapine (22% vs. 11%; p = .66).Conclusions: Quetiapine added to as-needed haloperidol results in faster delirium resolution, less agitation, and a greater rate of transfer to home or rehabilitation. Future studies should evaluate the effect of quetiapine on mortality, resource utilization, post-intensive care unit cognition, and dependency after discharge in a broader group of patients. (Crit Care Med 2010; 38: 419-427)