Schaeffer Tammi H, Mlynarchek Sara L, Stanford Christopher F, Delgado João, Holstege Christopher P, Olsen Dean, Bogdan Gregory M
Rocky Vista University College of Osteopathic Medicine in Parker,Colorado, USA.
J Am Osteopath Assoc. 2010 Oct;110(10):587-92.
Digoxin is used in the treatment of patients with cardiac dysfunction, though toxicity sometimes results from the use of this medication. In 1986, the US Food and Drug Administration (FDA) approved a digoxin immune Fab for the treatment of such patients. In 2001, the FDA approved a newer digoxin immune Fab, a digoxin-specific antibody (DSAb) known as DigiFab (Protherics Inc, Brentwood, Tennessee), though minimal literature exists on the clinical effects of this DSAb.
To characterize a cohort of patients presenting with chronic digoxin toxicity and to describe the clinical course of these patients with the use of DSAb.
A retrospective study included patients with life-threatening cardiotoxicity and serum digoxin level greater than 2 ng/mL who were treated at two US hospitals from 2003 to 2006. Trained investigators abstracted data from patients' medical records and assessed changes in clinical and laboratory parameters at regular intervals (0-4, >4-12, >12-24, and >24-72 hours) after treatment with DSAb. An expert panel reviewed electrocardiogram results to identify life-threatening manifestations of digoxin toxicity before and after DSAb treatment. Efficacy of treatment was assessed as rates of improvement in clinical parameters and cardiotoxic effects. Rates of adverse drug reactions were used to characterize safety. All data were analyzed with descriptive statistics.
Fourteen patients (mean [SD] age, 71.3 [10.4] years) were treated for chronic digoxin toxicity. At presentation, 12 patients had a heart rate of less than 45 beats per minute, 1 had third-degree heart block, and 1 had asystole. Mean serum digoxin level was 3.6 ng/mL. Eleven patients had abnormal renal function. After administration of DSAb, clinical parameters improved in all patients. Within 24 hours, cardiotoxicity resolved in 7 of 9 evaluable patients. Two adverse drug reactions possibly related to DigiFab occurred, both of which resolved with conventional measures. Two patients died from conditions unrelated to treatment.
The newer DSAb appears to be a safe and effective treatment for resolving digoxin toxicity in adults, as indicated by electrocardiogram and clinical assessments. Because patients with multiple comorbidities may be at greater risk for digoxin toxicity, they should be closely monitored during treatment with digoxin.
地高辛用于治疗心功能不全患者，不过使用该药物有时会导致中毒。1986年，美国食品药品监督管理局（FDA）批准了地高辛免疫Fab用于治疗此类患者。2001年，FDA批准了一种更新的地高辛免疫Fab，一种称为DigiFab（Protherics公司，田纳西州布伦特伍德）的地高辛特异性抗体（DSAb），不过关于这种DSAb临床效果的文献极少。
对一组慢性地高辛中毒患者进行特征描述，并描述使用DSAb治疗这些患者的临床过程。
一项回顾性研究纳入了2003年至2006年在美国两家医院接受治疗、患有危及生命的心脏毒性且血清地高辛水平高于2 ng/mL的患者。经过培训的研究人员从患者病历中提取数据，并在使用DSAb治疗后的定期时间点（0 - 4小时、>4 - 12小时、>12 - 24小时和>24 - 72小时）评估临床和实验室参数的变化。一个专家小组审查心电图结果，以确定DSAb治疗前后地高辛毒性的危及生命的表现。治疗效果通过临床参数和心脏毒性作用的改善率来评估。药物不良反应发生率用于描述安全性。所有数据均采用描述性统计进行分析。
14例（平均[标准差]年龄，71.3[10.4]岁）患者因慢性地高辛中毒接受治疗。就诊时，12例患者心率低于每分钟45次，1例有三度房室传导阻滞，1例有心搏停止。平均血清地高辛水平为3.6 ng/mL。11例患者肾功能异常。给予DSAb后，所有患者的临床参数均有改善。在24小时内，9例可评估患者中的7例心脏毒性得到缓解。发生了2例可能与DigiFab相关的药物不良反应，均通过常规措施得到缓解。2例患者死于与治疗无关的疾病。
如心电图和临床评估所示，更新的DSAb似乎是一种安全有效的治疗方法，可用于解决成人地高辛中毒问题。由于患有多种合并症的患者可能发生地高辛中毒的风险更高，因此在使用地高辛治疗期间应密切监测他们。
