Incidence of Adverse Events Using Flumazenil in Patients With Iatrogenic Benzodiazepine Delirium: A Retrospective Study.

IF 2.9 4区 医学 Q2 PHARMACOLOGY & PHARMACY American journal of therapeutics Pub Date : 2024-07-01 DOI:10.1097/MJT.0000000000001686
Michelle A Hieger, Philip W Moore, Kevin F Maskell
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Abstract

Background: Flumazenil is a competitive benzodiazepine (BZD) antagonist most used for treating delirium in BZD overdoses. Since its introduction, many have expressed concerns about its safety secondary to the risk of inducing BZD withdrawal and refractory seizures.

Study question: What is the incidence of adverse drug events after the administration of flumazenil in patients with suspected iatrogenic BZD delirium?

Study design: This is a retrospective cross-sectional study of patients from a single center from 2010 to 2013. Patients experiencing delirium after receiving BZDs in the hospital were included if they had a bedside toxicology consult and were administered flumazenil. Patients were excluded if they were given BZDs for ethanol withdrawal or if they did not have mental status documentation before and after flumazenil administration. Descriptive statistics were calculated.

Measures and outcomes: The primary outcome was the incidence of adverse drug events after flumazenil administration. The secondary outcome was the efficacy of flumazenil determined by the patient's mental status.

Results: A total of 501 patient records were reviewed, and 206 patients were included in the final analysis. Of those patients, 172 (83.5%) experienced an objective improvement in their mental status within 1 hour after flumazenil administration. A total of 5 patients experienced adverse events (2.4%), 95% confidence interval (0.78, 5.54). Of these, 3 patients experienced minor agitation or restlessness without pharmacologic intervention. Two patients experienced moderate agitation or restlessness that resolved with haloperidol or physostigmine administration. No patients had a reported seizure, 95% confidence interval (0.0, 1.77).

Conclusions: Flumazenil seems to be a safe and effective intervention for the reversal of delirium secondary to iatrogenic BZD administration.

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使用氟马西尼治疗苯二氮卓类药物所致谵妄患者的不良事件发生率:回顾性研究。
背景:氟马西尼是一种竞争性苯并二氮卓(BZD)拮抗剂,最常用于治疗BZD过量引起的谵妄。自问世以来,许多人对其安全性表示担忧,因为它有诱发 BZD 戒断和难治性癫痫发作的风险:研究问题:对疑似先天性 BZD 谵妄的患者使用氟马西尼后,药物不良事件的发生率如何?这是一项回顾性横断面研究,研究对象为 2010 年至 2013 年期间来自一个中心的患者。在医院接受 BZDs 治疗后出现谵妄的患者,如果进行了床旁毒理学会诊并服用了氟马西尼,则纳入研究对象。如果患者因乙醇戒断而服用了BZDs,或在服用氟马西尼前后没有精神状态记录,则排除在外。计算了描述性统计:主要结果是服用氟马西尼后药物不良反应的发生率。次要结果是根据患者的精神状态判断氟马西尼的疗效:共审查了 501 份病历,206 名患者被纳入最终分析。在这些患者中,有 172 人(83.5%)在服用氟马西尼后 1 小时内精神状态得到客观改善。共有 5 名患者出现不良反应(2.4%),95% 置信区间(0.78, 5.54)。其中,3 名患者在没有药物干预的情况下出现了轻微的躁动或不安。两名患者出现了中度躁动或不安,但在服用氟哌啶醇或波司的明后症状得到缓解。没有患者出现癫痫发作,95% 置信区间为 (0.0, 1.77):氟马西尼似乎是一种安全有效的干预措施,可逆转因先天性服用 BZD 而导致的谵妄。
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来源期刊
American journal of therapeutics
American journal of therapeutics PHARMACOLOGY & PHARMACY-
CiteScore
5.50
自引率
9.50%
发文量
142
审稿时长
6-12 weeks
期刊介绍: American Journal of Therapeutics is an indispensable resource for all prescribing physicians who want to access pharmacological developments in cardiology, infectious disease, oncology, anesthesiology, nephrology, toxicology, and psychotropics without having to sift through stacks of medical journals. The journal features original articles on the latest therapeutic approaches as well as critical articles on the drug approval process and therapeutic reviews covering pharmacokinetics, regulatory affairs, pediatric clinical pharmacology, hypertension, metabolism, and drug delivery systems.
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