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姑息治疗/临终关怀中的药物警戒学:氟哌啶醇治疗谵妄的净效应。

Pharmacovigilance in hospice/palliative care: net effect of haloperidol for delirium.

机构信息

1 Discipline of Medicine, University of Adelaide , Adelaide, Australia .

出版信息

J Palliat Med. 2013 Nov;16(11):1335-41. doi: 10.1089/jpm.2013.0230. Epub 2013 Oct 18.

DOI:10.1089/jpm.2013.0230
PMID:24138282
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3822394/
Abstract

INTRODUCTION

Prescribing practice in hospice/palliative care is largely extrapolated from other areas of clinical practice, with few studies of net medication effects (benefits and harms) in hospice/palliative care to guide prescribing decisions. Hospice/palliative care patients differ in multiple ways from better studied participant groups, hence the applicability of studies in other participant groups is uncertain. Haloperidol, a butyrophenone derivative and dopamine antagonist, is commonly prescribed for nausea, vomiting, and delirium in hospice/palliative care. Its frequent use in delirium occurs despite little evidence of the effect of antipsychotics on the untreated course of delirium. The aim of this study was to examine the immediate and short-term clinical benefits and harms of haloperidol for delirium in hospice/palliative care patients.

METHOD

A consecutive cohort of participants from 14 centers across four countries who had haloperidol commenced for delirium were recruited. Data were collected at three time points: baseline, 48 hours (clinical benefits), and day 10 (clinical harms). Investigators were also able to report clinical harms at any time up to 14 days after it was commenced.

RESULTS

Of the 119 participants included, the average dose was 2.1 mg per 24 hours; 42 of 106 (35.2%) reported benefit at 48 hours. Harm was reported in 14 of 119 (12%) at 10 days, the most frequent being somnolence (n=11) and urinary retention (n=6). Seven participants had their medication ceased due to harms (2 for somnolence and 2 for rigidity). Approximately half (55/119) were still being treated with haloperidol after 10 days.

CONCLUSION

Overall, 1 in 3 participants gained net clinical benefit at 10 days.

摘要

介绍

临终关怀/姑息治疗中的处方实践主要是从其他临床实践领域推断而来,很少有研究关注临终关怀/姑息治疗中的药物净效应(益处和危害),因此无法为处方决策提供指导。临终关怀/姑息治疗患者与其他研究人群在多个方面存在差异,因此其他研究人群中的研究结果的适用性尚不确定。氟哌啶醇是一种丁酰苯类衍生物和多巴胺拮抗剂,常用于临终关怀/姑息治疗中的恶心、呕吐和谵妄。尽管抗精神病药对未经治疗的谵妄病程没有影响的证据很少,但它在谵妄中的频繁使用仍存在。本研究旨在检查氟哌啶醇治疗临终关怀/姑息治疗患者谵妄的即刻和短期临床益处和危害。

方法

从四个国家的 14 个中心连续招募了因谵妄而开始使用氟哌啶醇的参与者。数据在三个时间点收集:基线、48 小时(临床益处)和第 10 天(临床危害)。研究者还能够在开始使用后 14 天内的任何时间报告临床危害。

结果

119 名参与者中,平均剂量为 2.1mg/24 小时;106 名中的 42 名(35.2%)在 48 小时时报告有获益。在第 10 天,119 名中的 14 名(12%)报告了危害,最常见的是嗜睡(n=11)和尿潴留(n=6)。有 7 名参与者因危害而停止用药(2 名因嗜睡,2 名因僵直)。大约一半(55/119)在第 10 天后仍在接受氟哌啶醇治疗。

结论

总体而言,1/3 的参与者在第 10 天获得了净临床获益。

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