A systematic review and meta-analysis of anti-toxin treatments in animal models of live B. anthracis infection

活炭疽杆菌感染动物模型抗毒素治疗的系统回顾和荟萃分析

• 批准号: 9549540
• 负责人: Peter Eichacker
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9549540
• 关键词: Address; Aftercare; Animal Model; Anthrax antitoxin; Anthrax disease; Antibiotics; Antitoxins; Bacillus anthracis; Bioterrorism; Clinical; Edema; Effectiveness; Evaluation; Human; Infection; Manuscripts; Meta-Analysis; Modeling; Pathogenesis; Patients; Pre-Clinical Model; Production; Publications; Research Design; Review Literature; Testing; The Sun; Toxin; base; clinically relevant; pre-clinical; preclinical trial; systematic review; weapons

Invasive B. anthracis infection is a relatively rare but highly lethal infection in humans. Production of lethal and edema toxin are believed to be central to the pathogenesis of B. anthracis infection. Due to the infrequency of invasive B. anthracis infection, but its potential use as a weapon of bioterror, the FDA permits the evaluation and approval of adjunctive therapy of this infection based on studies performed in at least two clinically relevant animal models. To what extent models that have been used to date to test anti-toxin agents have simulated the conditions encountered in patients presenting with invasive anthrax infection is unclear. Also, whether the effectiveness of anti-toxin agents is influenced when conditions do approach those encountered clinically (e.g. treatment after infection has manifested itself and in combination with other therapies) has not been investigated. To address these questions we are performing a systematic review of the literature and a meta-analysis of all preclinical models employing live B. anthracis challenge and testing anthrax anti-toxin treatments with or without accompanying antibiotic support. A manuscript has been accepted for publication. W. Xu, L. Ohanjandian J. Sun, X. Cui, D. Suffredini, Y. Li, J. Welsh, and P.Q. Eichacker. A Systematic Review and Meta-analysis of Preclinical Trials Testing Anti-toxin Therapies forB. anthracisInfection: A Need for More Robust Study Designs and Results. PLoS One

侵入性B。炭疽病在人类中是一种相对罕见但高度致命的感染。致死毒素和水肿毒素的产生被认为是B的发病机制的中心。炭疽感染。由于侵袭性B的不常见。炭疽感染，但其作为生物恐怖武器的潜在用途，FDA允许基于在至少两种临床相关动物模型中进行的研究来评估和批准这种感染的预防性治疗。迄今为止，用于测试抗毒素剂的模型在多大程度上模拟了侵袭性炭疽感染患者的情况尚不清楚。此外，尚未研究当疾病确实接近临床上遇到的情况时（例如，感染后的治疗以及与其他疗法联合使用），抗毒素剂的有效性是否受到影响。为了解决这些问题，我们正在对文献进行系统综述，并对所有采用活B的临床前模型进行荟萃分析。炭疽挑战和测试炭疽抗毒素治疗，有或没有伴随抗生素支持。一份手稿已被接受出版。 W.许湖，澳-地Ohanjandian J. Sun，X. Cui，L. Suffredini，Y. Li，J. Welsh和P.Q.艾查克 抗乙型肝炎病毒药物临床前试验的系统评价和荟萃分析炭疽感染：需要更稳健的研究设计和结果。PLOS ONE