Sheikh Sophia, Munson Taylor, Garvan Gerard, Layton Claire, Sollee Dawn, Cowdery Colleen, Peterson Alexa, Rothstein Lindsay Schaack, Henson Morgan, Gartner Hayley, Ujhelyi Michael
Department of Emergency Medicine, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.
Florida/USVI Poison Information Center-Jacksonville, UF Health Jacksonville, 655 West 8th Street, Jacksonville, FL, 32209, USA.
Drugs Real World Outcomes. 2024 Sep;11(3):377-388. doi: 10.1007/s40801-024-00435-0. Epub 2024 Jun 5.
Digoxin is a widely prescribed drug for congestive heart failure and atrial fibrillation. Digoxin has a narrow therapeutic index and toxicity can develop quite easily. Digoxin immune fab (DIF) is an effective treatment for toxicity, however there are limited studies characterizing its impact on clinical outcomes in real-world clinical practice.
The aim of this study was to identify factors and healthcare outcomes associated with digoxin immune fab (DIF) treatment in patients with confirmed/suspected digoxin toxicity.
An IRB-approved retrospective chart review of digoxin toxic patients (2011-2020) presenting at an academic healthcare system was conducted. Demographic and clinical data were collected. Patients were stratified by DIF treatment versus non-DIF treatment. DIF utilization patterns (appropriate, use when not indicated, or underutilized) were determined using pre-defined criteria. Severe digoxin toxicity was defined as having one or more of the following: mental status disturbances, antiarrhythmic therapy, acute renal impairment or dehydration, serum digoxin concentration (SDC) > 4 ng/mL, or serum K+ > 5 mEq/mL. Logistic multivariable regression analysis evaluated factors associated with DIF use. All statistical analyses were performed in R version 4.1.
Data from 96 patients (non-DIF treated group = 49; DIF treated group = 47) were analyzed. DIF was used appropriately in 70 patients (73%), underutilized in 19 (20%), and administered to 7 (7%) patients when it was not indicated. Several clinical parameters differentiated the DIF from the non-DIF group (p < 0.05) including higher mean SDC (3.41 ± 1.63 vs 2.87 ± 1.17), higher mean potassium (5.33 ± 1.48 vs 4.55 ± 0.87), more toxicity severity (85% vs 49%), and more likely to require cardiac pacing (26% vs 4%). Digoxin toxicity resolved sooner in the DIF group (coefficient - 0.702, 95% CI - 1.137 to - 0.267) (p < 0.01) and they had shorter intensive care unit lengths of stay (12.4 ± 20.3 vs 24.4 ± 28.7 days; p = 0.018). The all-cause mortality rate in patients appropriately managed with DIF therapy versus those patients where DIF was underutilized was 11% and 21%, respectively.
Based on our study population, DIF therapy appears to be beneficial in limiting duration of toxicity and intensive care unit lengths of stay in digoxin toxic patients. Although DIF was appropriately utilized in most cases, there was a relatively high proportion of cases in which DIF treatment was either underutilized or not indicated.
地高辛是一种广泛用于治疗充血性心力衰竭和心房颤动的药物。地高辛的治疗指数较窄,很容易发生毒性反应。地高辛免疫Fab片段(DIF)是治疗地高辛中毒的有效方法,然而,在实际临床实践中,关于其对临床结局影响的研究有限。
本研究的目的是确定确诊/疑似地高辛中毒患者接受地高辛免疫Fab片段(DIF)治疗的相关因素和医疗结局。
对一家学术医疗系统中2011年至2020年出现的地高辛中毒患者进行了一项经机构审查委员会批准的回顾性病历审查。收集了人口统计学和临床数据。患者按DIF治疗与非DIF治疗进行分层。使用预定义标准确定DIF的使用模式(适当、未指明时使用或使用不足)。严重地高辛中毒定义为具有以下一项或多项:精神状态障碍、抗心律失常治疗、急性肾功能损害或脱水、血清地高辛浓度(SDC)>4 ng/mL或血清钾>5 mEq/mL。逻辑多变量回归分析评估与DIF使用相关的因素。所有统计分析均在R 4.1版中进行。
分析了96例患者的数据(非DIF治疗组=49例;DIF治疗组=47例)。70例患者(73%)DIF使用适当,19例(20%)使用不足,7例(7%)患者在未指明时使用。几个临床参数区分了DIF组和非DIF组(p<0.05),包括更高的平均SDC(3.41±1.63对2.87±1.17)、更高的平均钾水平(5.33±1.48对4.55±0.87)、更高的毒性严重程度(85%对49%)以及更可能需要心脏起搏(26%对4%)。DIF组地高辛中毒缓解更快(系数-0.702,95%CI-1.137至-0.267)(p<0.01),且重症监护病房住院时间更短(12.4±20.3天对24.4±28.7天;p=0.018)。接受适当DIF治疗的患者与DIF使用不足的患者的全因死亡率分别为11%和21%。
基于我们的研究人群,DIF治疗似乎有助于缩短地高辛中毒患者的毒性持续时间和重症监护病房住院时间。虽然大多数情况下DIF使用适当,但仍有相对较高比例的病例DIF治疗使用不足或未指明。