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.
OBJECTIVE: What is the incidence of adverse drug events after the administration of flumazenil in patients with suspected iatrogenic BZD delirium?
METHODS: 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.
METHODS: 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.
OBJECTIVE: What is the incidence of adverse drug events after the administration of flumazenil in patients with suspected iatrogenic BZD delirium?
METHODS: 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.
METHODS: 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.
摘要：
背景：氟马西尼是一种竞争性苯二氮卓（BZD）拮抗剂，大多数用于治疗BZD过量的谵妄。自推出以来,许多人对其安全性表示担忧，其次是诱发BZD戒断和难治性癫痫发作的风险。
目的：疑似医源性BZD谵妄患者服用氟马西尼后药物不良事件的发生率是多少？
方法：这是一项回顾性横断面研究，对2010年至2013年来自单个中心的患者进行研究。如果在医院接受BZD后出现谵妄的患者进行了床边毒理学咨询，并服用了氟马西尼。如果患者被给予BZD用于乙醇戒断，或者如果他们在氟马西尼给药之前和之后没有精神状态文件，则被排除在外。计算描述性统计数据。
方法：主要结果是氟马西尼给药后药物不良事件的发生率。次要结局是氟马西尼的疗效，由患者的精神状态决定。
结果：共审查了501份患者记录，最终分析包括206例患者。这些病人中,氟马西尼给药后1小时内，172人（83.5％）的精神状态得到了客观改善。共有5例患者出现不良事件（2.4%），95%置信区间(0.78,5.54)。其中,3例患者在没有药物干预的情况下出现轻微的躁动或躁动。两名患者经历了中度躁动或躁动，通过氟哌啶醇或毒扁豆碱给药解决。没有病人报告癫痫发作,95%置信区间(0.0,1.77)。
结论：氟马西尼似乎是逆转医源性BZD继发谵妄的安全有效的干预措施。
目的：疑似医源性BZD谵妄患者服用氟马西尼后药物不良事件的发生率是多少？
方法：这是一项回顾性横断面研究，对2010年至2013年来自单个中心的患者进行研究。如果在医院接受BZD后出现谵妄的患者进行了床边毒理学咨询，并服用了氟马西尼。如果患者被给予BZD用于乙醇戒断，或者如果他们在氟马西尼给药之前和之后没有精神状态文件，则被排除在外。计算描述性统计数据。
方法：主要结果是氟马西尼给药后药物不良事件的发生率。次要结局是氟马西尼的疗效，由患者的精神状态决定。
结果：共审查了501份患者记录，最终分析包括206例患者。这些病人中,氟马西尼给药后1小时内，172人（83.5％）的精神状态得到了客观改善。共有5例患者出现不良事件（2.4%），95%置信区间(0.78,5.54)。其中,3例患者在没有药物干预的情况下出现轻微的躁动或躁动。两名患者经历了中度躁动或躁动，通过氟哌啶醇或毒扁豆碱给药解决。没有病人报告癫痫发作,95%置信区间(0.0,1.77)。
结论：氟马西尼似乎是逆转医源性BZD继发谵妄的安全有效的干预措施。
