Hickey A R, Wenger T L, Carpenter V P, Tilson H H, Hlatky M A, Furberg C D, Kirkpatrick C H, Strauss H C, Smith T W
Medical Division, Burroughs Wellcome Co., Research Triangle Park, North Carolina 27709.
J Am Coll Cardiol. 1991 Mar 1;17(3):590-8. doi: 10.1016/s0735-1097(10)80170-6.
An observational surveillance study was conducted to monitor the safety and effectiveness of treatment with Digoxin Immune Fab (Ovine) (Digibind) in patients with digitalis intoxication. Before April 1986, a relatively limited number of patients received treatment with digoxin-specific Fab fragments through a multicenter clinical trial. Beginning with commercial availability in July 1986, this study sought additional, voluntarily reported clinical data pertaining to treatment through a 3 week follow-up. The study included 717 adults who received Digoxin Immune Fab (Ovine). Most patients were greater than or equal to 70 years old and developed toxicity during maintenance dosing with digoxin. Fifty percent of patients were reported to have a complete response to treatment, 24% a partial response and 12% no response. The response for 14% of patients was not reported or reported as uncertain. Six patients (0.8%, 95% confidence interval 0.3% to 1.8%) had an allergic reaction to digoxin-specific antibody fragments. Three of the six had a history of allergy to antibiotic drugs. Twenty patients (2.8%, 95% confidence interval 1.7% to 4.3%) developed recrudescent toxicity. Risk of recrudescent toxicity increased sixfold when less than 50% of the estimated dose of antibody was administered. A total of 215 patients experienced posttreatment adverse events. The events for 163 patients (76%) were judged to result from manifestations of underlying disease and thus considered unrelated to Fab treatment. Digoxin-specific antibody fragments were generally well tolerated and clinically effective in patients judged by treating physicians to have potentially life-threatening digitalis intoxication.
开展了一项观察性监测研究，以监测地高辛免疫Fab（羊源性）（Digibind）治疗洋地黄中毒患者的安全性和有效性。1986年4月之前，通过一项多中心临床试验，相对较少的患者接受了地高辛特异性Fab片段治疗。从1986年7月该药上市开始，本研究通过3周的随访寻求更多自愿报告的与治疗相关的临床数据。该研究纳入了717例接受地高辛免疫Fab（羊源性）治疗的成年人。大多数患者年龄大于或等于70岁，在维持使用地高辛期间出现中毒。据报告，50%的患者对治疗有完全反应，24%有部分反应，12%无反应。14%患者的反应未报告或报告为不确定。6例患者（0.8%，95%置信区间0.3%至1.8%）对地高辛特异性抗体片段有过敏反应。这6例中有3例有抗生素药物过敏史。20例患者（2.8%，95%置信区间1.7%至4.3%）出现复发性中毒。当给予的抗体估计剂量少于50%时，复发性中毒风险增加至6倍。共有215例患者经历了治疗后不良事件。163例患者（76%）的事件被判定为由基础疾病表现所致，因此被认为与Fab治疗无关。经治疗医生判断，地高辛特异性抗体片段在有潜在致命性洋地黄中毒的患者中通常耐受性良好且临床有效。
