Clinical Research Department, Emergent BioSolutions Canada, Inc., Winnipeg.
Pharmacovigilance Department, Emergent BioSolutions Canada, Inc., Winnipeg.
Clin Infect Dis. 2020 Apr 15;70(9):1950-1957. doi: 10.1093/cid/ciz515.
Botulism is a rare, life-threatening paralytic illness. Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine) (BAT) manufactured by Emergent BioSolutions Canada Inc is an equine-derived heptavalent botulinum antitoxin product indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A-G in adults and pediatric patients. BAT product was US-licensed in 2013.
In the United States, from October 2014 through July 2017, safety and clinical outcomes data were collected under a registry for patients treated with BAT product.
Registry patients had a median age of 51 years (range, 32 days to 92 years). Among 162 patients, 7 (4.3%) experienced BAT product-related serious adverse events, including 1 (0.6%) report each of pneumonia, pneumonia aspiration, ventricular tachycardia, upper gastrointestinal hemorrhage, anaphylactic reaction, acute kidney injury, and acute myocardial infarction. Thirty-one (19.1%) patients had 41 BAT product-related adverse events. Six (3.7%) deaths were reported in the registry. All deaths were attributed to the underlying illness and were assessed as unlikely related to BAT product. Among 113 (69.8%) patients with a final diagnosis of botulism, those treated early (≤2 days) spent fewer days in the hospital (5 vs 15.5 days), in the intensive care unit (ICU) (4 vs 12 days), and on mechanical ventilation (6 vs 14.5 days) than those treated late (>2 days), respectively.
BAT product was well tolerated in patients. Treatment with BAT product at ≤2 days of symptom onset was associated with shorter hospital and ICU stays, and shorter duration and need for mechanical ventilation, showing clinical benefit associated with early treatment.
肉毒中毒是一种罕见的、危及生命的麻痹性疾病。由加拿大Emergent BioSolutions 公司生产的马源七价肉毒抗毒素（A、B、C、D、E、F、G）（BAT）是一种马源七价肉毒抗毒素产品，用于治疗成人和儿科患者在有记录或疑似暴露于 A-G 型肉毒梭菌神经毒素后出现的有症状的肉毒中毒。BAT 产品于 2013 年获得美国许可。
在美国，从 2014 年 10 月至 2017 年 7 月，根据一项针对接受 BAT 产品治疗的患者的登记处，收集了安全性和临床结局数据。
登记处患者的中位年龄为 51 岁（范围为 32 天至 92 岁）。在 162 名患者中，有 7 名（4.3%）发生了与 BAT 产品相关的严重不良事件，包括 1 例（0.6%）肺炎、肺炎吸入、室性心动过速、上消化道出血、过敏性反应、急性肾损伤和急性心肌梗死各 1 例。31 名（19.1%）患者发生了 41 例与 BAT 产品相关的不良事件。登记处报告了 6 例（3.7%）死亡。所有死亡均归因于基础疾病，且评估为与 BAT 产品不太可能相关。在 113 名（69.8%）最终诊断为肉毒中毒的患者中，那些早期（≤2 天）接受治疗的患者在医院（5 天与 15.5 天）、重症监护病房（ICU）（4 天与 12 天）和机械通气（6 天与 14.5 天）的时间均较短，而那些晚期（>2 天）接受治疗的患者则较长。
BAT 产品在患者中耐受良好。症状发作后≤2 天接受 BAT 产品治疗与较短的住院和 ICU 停留时间以及较短的机械通气时间和需求相关，表明早期治疗与临床获益相关。
