An overview of adverse events reported by participants in CDC's Anthrax Vaccine and Antimicrobial Availability Program
An overview of adverse events reported by participants in CDC's Anthrax Vaccine and Antimicrobial Availability Program
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DOI：
10.1002/pds.1085
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发表时间：
2005-06-01
影响因子：
2.6
通讯作者：
McNeil, MM
中科院分区：
文献类型：
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作者：
Martin, SW;Tierney, BC;McNeil, MM
美国疾病控制与预防中心（CDC）的炭疽疫苗和抗生素可获得性项目是在一项新药研究（IND）申请下实施的，旨在为可能暴露于炭疽芽孢杆菌的个体提供额外的暴露后预防。参与者有两种选择：(1)额外40天的抗微生物预防治疗（即环丙沙星、多西环素或阿莫西林）；或(2)额外40天的抗菌素预防加上三剂吸附炭疽疫苗（AVA）。方法监测参与者的不良事件（ae）。参与者被要求在入组后6周内完成为期2周的AE日记，入组后约2个月，通过电话采访对1113名（64%）参与者进行主动监测。结果在约1万名先前接受预防的患者中，共有1727人接受了40天的额外抗生素治疗。其中，199人在入组时选择接受三剂AVA，外加40天的抗生素治疗。总的来说，28%的参与者在他们的日记中报告了至少一次AE。结果因监测机制而异，日记数据显示，仅接受抗生素治疗的参与者和接受抗生素和AVA治疗的参与者报告ae的比例存在差异。然而，在活跃的2个月电话随访期间，仅抗生素和抗生素加AVA治疗方案报告的不良反应发生率相似。此外，环丙沙星和多西环素具有相似的AE特征，只有环丙沙星接受者报告的严重程度明显更高。总的来说，考虑到潜在炭疽芽孢杆菌暴露的严重性，所有参与者经历的不良反应发生率都是可以接受的。版权所有(c) 2005 John Wiley & Sons, Ltd。
Purpose The CDC's Anthrax Vaccine and Antibiotic Availability Program was implemented under an Investigational New Drug (IND) application to provide additional post-exposure prophylaxis for individuals potentially exposed to Bacillus anthracis in the fall of 2001. Participants were provided with two options: (1) 40 additional days of antimicrobial prophylaxis (i.e., ciprofloxacin, doxycycline, or amoxicillin); or (2) 40 additional days of antimicrobial prophylaxis plus three doses of anthrax vaccine adsorbed (AVA).Methods Participants were monitored for adverse events (AEs). Participants were asked to complete 2-week AE diaries for 6 weeks post-enrollment, and approximately 2 months after enrollment, active surveillance was conducted through telephone interviews with 1113 (64%) participants.Results A total of 1727 of approximately 10 000 previously prophylaxed persons enrolled to receive 40 additional days of antibiotics. Of these, 199 opted at enrollment to receive three doses of AVA in addition to the additional 40 days of antibiotic. Overall, 28% of participants reported at least one AE on their diaries. Results varied by surveillance mechanism, the diary data indicated differences in the proportion reporting AEs between participants receiving antibiotic only and participants receiving antibiotic and AVA. However, during the active 2-month telephone follow-up, the rates of AEs reported for both the antibiotic only and antibiotic plus AVA treatment regimens were similar. Additionally, ciprofloxacin and doxycycline had similar AE profiles, with only rigors reported significantly more often among ciprolloxacin recipients.Conclusions Overall, the rates of AEs experienced by all participants were acceptable given the seriousness of potential B. anthracis exposure. Copyright (c) 2005 John Wiley & Sons, Ltd.