Department of Internal Medicine, VU University Medical Centre, Amsterdam, The Netherlands.
Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis (OLVG Hospital), Amsterdam, The Netherlands.
Age Ageing. 2018 Jan 1;47(1):48-55. doi: 10.1093/ageing/afx124.
because the few randomised placebo-controlled trials investigating the potential role for prophylactic haloperidol in delirium prevention have focused on specific surgical populations, we investigated its efficacy and safety in acutely hospitalised older patients.
this multi-centre, double-blind, stratified, block randomised, placebo-controlled trial was conducted at six Dutch hospitals. Patients age ≥70 years, acutely admitted through the emergency department for general medicine or surgical specialties and at risk for delirium were randomised (n = 245) to haloperidol or placebo 1 mg orally twice-daily (maximum of 14 doses) on top of standard nonpharmacological prevention strategies. The primary outcome was delirium incidence. Other endpoints included delirium severity and duration, drug safety and clinical outcomes.
intention-to-treat analysis included 242 participants (calculated sample size n = 390, statistical power of current sample 59%) allocated to haloperidol (n = 118) or placebo (n = 124). In the haloperidol and placebo group, delirium incidence was 19.5 versus 14.5% (OR 1.43, 95% CI 0.72 to 2.78); median (IQR) delirium duration 4 (2, 5) versus 3 (1, 6) days (P = 0.366); maximum DRS-R-98 score 16 (9.8, 19.5) versus 10 (5.5, 22.5) (P = 0.549; 53.7% missing data); hospital LOS 7 (4, 10.3) versus 7 (5, 11.8) days (P = 0.343); 3-month mortality 9.9 versus 12.5% (OR 0.77, 95% CI 0.34 to 1.75), respectively. No treatment-limiting side effects were noted.
prophylactic low-dose oral haloperidol did not reduce delirium incidence in acutely hospitalised older patients. Therefore, prophylactic use of haloperidol in this population is not recommended.
由于少数随机安慰剂对照试验研究了预防性氟哌啶醇在预防谵妄中的潜在作用，但这些试验仅关注特定的手术人群，因此我们调查了氟哌啶醇在急性住院老年患者中的疗效和安全性。
这是一项多中心、双盲、分层、区组随机、安慰剂对照试验，在荷兰的六家医院进行。年龄≥70 岁、因一般医学或外科专业急症入住急诊科且有发生谵妄风险的患者，被随机分配（n=245）接受氟哌啶醇或安慰剂 1mg 口服，每日两次（最多 14 剂），同时接受标准的非药物预防策略。主要结局是谵妄发生率。其他结局包括谵妄严重程度和持续时间、药物安全性和临床结局。
意向治疗分析纳入了 242 名参与者（计算得出的样本量 n=390，当前样本的统计效力为 59%），被分配至氟哌啶醇组（n=118）或安慰剂组（n=124）。氟哌啶醇组和安慰剂组的谵妄发生率分别为 19.5%和 14.5%（OR 1.43，95%CI 0.72 至 2.78）；谵妄持续时间中位数（IQR）分别为 4（2，5）天和 3（1，6）天（P=0.366）；最大 DRS-R-98 评分分别为 16（9.8，19.5）分和 10（5.5，22.5）分（P=0.549；53.7%缺失数据）；住院 LOS 分别为 7（4，10.3）天和 7（5，11.8）天（P=0.343）；3 个月死亡率分别为 9.9%和 12.5%（OR 0.77，95%CI 0.34 至 1.75）。未观察到治疗相关的不良反应。
预防性低剂量口服氟哌啶醇不能降低急性住院老年患者的谵妄发生率。因此，不建议在该人群中预防性使用氟哌啶醇。
