Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen, Denmark.
Centre for Research in Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Acta Anaesthesiol Scand. 2020 Feb;64(2):254-266. doi: 10.1111/aas.13501. Epub 2019 Nov 23.
Haloperidol is the most frequently used drug to treat delirium in the critically ill patients. Yet, no systematic review has focussed on the effects of haloperidol in critically ill patients with delirium.
We conducted a systematic review with meta-analysis and Trial Sequential Analysis of randomized clinical trials (RCTs) assessing the effects of haloperidol vs any intervention on all-cause mortality, serious adverse reactions/events, days alive without delirium, health-related quality of life (HRQoL), cognitive function and delirium severity in critically ill patients with delirium. We also report on QTc prolongation, delirium resolution and extrapyramidal symptoms.
We included 8 RCTs with 11 comparisons (n = 951). We adjudicated one trial as having overall low risk of bias. Three trials used rescue haloperidol; excluding these, we did not find an effect of haloperidol vs control on all-cause mortality (RR 1.01; 95% CI 0.33-3.06; I = 0%; 112 participants; 3 trials; 4 comparisons; very low certainty) or delirium severity (SMD -0.15; 95% CI -0.61-0.30; I = 27%; 134 participants; 3 trials; 4 comparisons; very low certainty). No trials reported adequately on serious adverse reactions/events. Only one trial reported on days alive without delirium, cognitive function and QTc prolongation, and no trials reported on HRQoL. Sensitivity analyses, including trials using rescue haloperidol, did not change the results.
The evidence for the use of haloperidol to treat critically ill patients with delirium is sparse, of low quality and inconclusive. We therefore have no certainty regarding any beneficial, harmful or neutral effects of haloperidol in these patients.
氟哌啶醇是治疗重症患者谵妄最常用的药物。然而，尚无系统评价专门关注氟哌啶醇治疗重症谵妄患者的效果。
我们对评估氟哌啶醇与任何干预措施对所有原因死亡率、严重不良反应/事件、无谵妄天数、健康相关生活质量（HRQoL）、认知功能和谵妄严重程度的影响的随机临床试验（RCT）进行了系统评价和荟萃分析及试验序贯分析。我们还报告了 QTc 延长、谵妄缓解和锥体外系症状。
我们纳入了 8 项 RCT（n=951），其中 11 项比较。我们判定一项试验整体偏倚风险低。有 3 项试验使用了抢救性氟哌啶醇；排除这些试验后，我们未发现氟哌啶醇与对照组相比对所有原因死亡率（RR 1.01；95%CI 0.33-3.06；I²=0%；112 名参与者；3 项试验；4 项比较；极低确定性）或谵妄严重程度（SMD -0.15；95%CI -0.61-0.30；I²=27%；134 名参与者；3 项试验；4 项比较；极低确定性）有影响。没有试验充分报告严重不良反应/事件。仅有一项试验报告了无谵妄天数、认知功能和 QTc 延长，没有试验报告 HRQoL。敏感性分析，包括使用抢救性氟哌啶醇的试验，并未改变结果。
氟哌啶醇治疗重症患者谵妄的证据稀少、质量低且不一致。因此，我们无法确定氟哌啶醇对这些患者是否有益、有害或无影响。
