Division of Hospital Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota, USA.
Subst Use Misuse. 2023;58(13):1643-1650. doi: 10.1080/10826084.2023.2236223. Epub 2023 Jul 19.
Patients hospitalized with alcohol withdrawal syndrome (AWS) are typically treated with CIWA-directed benzodiazepines to prevent complications, such as seizures and delirium tremens. Gabapentin is an evidence-based alternative to benzodiazepines in the outpatient setting, but there is limited data for hospitalized patients with AWS. This study compared fixed-dose gabapentin to CIWA-directed benzodiazepines for AWS in the hospital setting. This open-label, randomized controlled trial enrolled 88 adults from February 1, 2017 to August 16, 2020 with a risk of complicated alcohol withdrawal as defined by the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) ≥4. Patients were randomized within 16 h of admission to either fixed-dose gabapentin taper or continued CIWA-directed benzodiazepine administration. The primary outcome was the length of stay (LOS). Secondary outcomes included seizure, delirium tremens, ICU transfer, and patient-reported symptoms (alcohol cravings, anxiety, sleepiness). LOS was shorter, but not statistically different in the gabapentin group compared to the benzodiazepine group. Because benzodiazepines were received in both gabapentin and benzodiazepine groups before randomization, the mean amount of benzodiazepines received in each group was also not statistically different, although the amount received by the gabapentin group was less than half of that received by the benzodiazepine group (4.3 10.6 mg, = 0.146 by per protocol analysis). There were no statistical differences in secondary measures. Fixed-dose gabapentin taper showed similar outcomes compared to CIWA-directed benzodiazepines for the treatment of hospitalized patients with mild/moderate AWS, but the interpretation of the results is limited due to under-enrollment and the use of benzodiazepines in both groups pre-enrollment.Clinical trial registration: NCT03012815.
患有酒精戒断综合征 (AWS) 的住院患者通常接受 CIWA 指导的苯二氮䓬类药物治疗以预防并发症，如癫痫发作和震颤谵妄。加巴喷丁是苯二氮䓬类药物在门诊环境中的一种基于证据的替代药物，但对于 AWS 的住院患者，数据有限。这项研究比较了固定剂量加巴喷丁与 CIWA 指导的苯二氮䓬类药物在医院环境中的 AWS 治疗效果。这是一项开放标签、随机对照试验，纳入了 2017 年 2 月 1 日至 2020 年 8 月 16 日期间符合预测酒精戒断严重程度量表 (PAWSS) ≥4 分的酒精戒断风险的 88 名成年人。患者在入院后 16 小时内随机分为固定剂量加巴喷丁滴定组或继续 CIWA 指导的苯二氮䓬类药物治疗组。主要结局是住院时间 (LOS)。次要结局包括癫痫发作、震颤谵妄、转入 ICU 以及患者报告的症状 (酒精渴求、焦虑、嗜睡)。加巴喷丁组的 LOS 较短，但与苯二氮䓬类药物组相比无统计学差异。由于在加巴喷丁和苯二氮䓬类药物组中都在随机分组前接受了苯二氮䓬类药物治疗，因此两组接受的苯二氮䓬类药物的平均剂量也无统计学差异，尽管加巴喷丁组接受的剂量不到苯二氮䓬类药物组的一半（4.3 ± 10.6 mg，= 0.146，按意向治疗分析）。次要措施无统计学差异。对于轻度/中度 AWS 的住院患者，固定剂量加巴喷丁滴定与 CIWA 指导的苯二氮䓬类药物治疗的结果相似，但由于入组人数不足以及两组在入组前均使用苯二氮䓬类药物，结果的解释受到限制。临床试验注册：NCT03012815。
