喹硫平与氟哌啶醇治疗谵妄的双盲、随机对照试验
Quetiapine versus haloperidol in the treatment of delirium: a double-blind, randomized, controlled trial.
作者信息
Maneeton Benchalak, Maneeton Narong, Srisurapanont Manit, Chittawatanarat Kaweesak
机构信息
Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
出版信息
Drug Des Devel Ther. 2013 Jul 24;7:657-67. doi: 10.2147/DDDT.S45575. Print 2013.
BACKGROUND
Atypical antipsychotic drugs may have low propensity to induce extrapyramidal side effects in delirious patients. This study aimed to compare the efficacy and tolerability between quetiapine and haloperidol in controlling delirious behavior.
METHODS
A 7-day prospective, double-blind, randomized controlled trial was conducted from June 2009 to April 2011 in medically ill patients with delirium. Measures used for daily assessment included the Delirium Rating Scale-revised-98 (DRS-R-98) and total sleep time. The Clinical Global Impression, Improvement (CGI-I) and the Modified (nine-item) Simpson- Angus Scale were applied daily. The primary outcome was the DRS-R-98 severity scores. The data were analyzed on an intention-to-treat basis.
RESULTS
Fifty-two subjects (35 males and 17 females) were randomized to receive 25-100 mg/day of quetiapine (n = 24) or 0.5-2.0 mg/day of haloperidol (n = 28). Mean (standard deviation) doses of quetiapine and haloperidol were 67.6 (9.7) and 0.8 (0.3) mg/day, respectively. Over the trial period, means (standard deviation) of the DRS-R-98 severity scores were not significantly different between the quetiapine and haloperidol groups (-22.9 [6.9] versus -21.7 [6.7]; P = 0.59). The DRS-R-98 noncognitive and cognitive subscale scores were not significantly different. At end point, the response and remission rates, the total sleep time, and the Modified (nine-item) Simpson-Angus scores were also not significantly different between groups. Hypersomnia was common in the quetiapine-treated patients (33.3%), but not significantly higher than that in the haloperidol-treated group (21.4%).
LIMITATIONS
Patients were excluded if they were not able to take oral medications, and the sample size was small.
CONCLUSION
Low-dose quetiapine and haloperidol may be equally effective and safe for controlling delirium symptoms.
CLINICAL TRIALS REGISTRATION NUMBER
clinicaltrials.gov NCT00954603.
背景
非典型抗精神病药物在谵妄患者中诱发锥体外系副作用的倾向可能较低。本研究旨在比较喹硫平和氟哌啶醇在控制谵妄行为方面的疗效和耐受性。
方法
2009年6月至2011年4月，对患有谵妄的内科疾病患者进行了为期7天的前瞻性、双盲、随机对照试验。每日评估所用的指标包括谵妄评定量表修订版98（DRS-R-98）和总睡眠时间。每日应用临床总体印象改善量表（CGI-I）和改良版（九项）辛普森-安格斯量表。主要结局为DRS-R-98严重程度评分。数据按意向性分析。
结果
52名受试者（35名男性和17名女性）被随机分组，分别接受25 - 100mg/天的喹硫平（n = 24）或0.5 - 2.0mg/天的氟哌啶醇（n = 28）。喹硫平和氟哌啶醇的平均（标准差）剂量分别为67.6（9.7）mg/天和0.8（0.3）mg/天。在试验期间，喹硫平组和氟哌啶醇组的DRS-R-98严重程度评分均值（标准差）无显著差异（-22.9 [6.9] 对 -21.7 [6.7]；P = 0.59）。DRS-R-98非认知和认知子量表评分也无显著差异。在终点时，两组间的缓解率、缓解率、总睡眠时间和改良版（九项）辛普森-安格斯评分也无显著差异。嗜睡在喹硫平治疗的患者中很常见（33.3%），但并不显著高于氟哌啶醇治疗组（21.4%）。
局限性
无法口服药物的患者被排除在外，且样本量较小。
结论
低剂量喹硫平和氟哌啶醇在控制谵妄症状方面可能同样有效且安全。
临床试验注册号
clinicaltrials.gov NCT00954603。
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