摘要破伤风是一种影响神经系统的潜在致命性疾病,创伤后破伤风的防治是关注的重点。由于我国尚未在成人中普及破伤风疫苗加强免疫,创伤后多使用破伤风被动免疫制剂预防和治疗破伤风。传统破伤风被动免疫制剂主要包括马源性破伤风抗毒素(TAT)和人源性破伤风人免疫球蛋白(HTIG),其中TAT由于安全性问题未得到世界卫生组织(WHO)认可,但仍在我国广泛使用,而HTIG面临供应短缺和潜在传染病病原体传播风险。近期,全球首创利用基因重组技术开发的重组抗破伤风毒素单克隆抗体获批上市,在临床实践中具有替代HTIG和TAT的巨大潜力,有望为全球破伤风防控带来更加安全、高效和可及的选择。为深入了解现有破伤风被动免疫制剂在临床应用的研究进展,笔者就创伤后传统破伤风被动免疫制剂应用现状和新一代破伤风被动免疫制剂重组抗破伤风毒素单克隆抗体的关键技术特点、中和性抗原表位及临床应用进行综述,为提高对科学应用破伤风被动免疫制剂的认识、规范化指导创伤后破伤风防治工作实践提供科学参考。
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abstractsTetanus is a potentially life-threatening neurological condition, and the prevention and treatment of post-traumatic tetanus remain the primary focus. which remains a significant public health challenge at present. In China, because tetanus booster vaccination is not yet widespread among adults, post-traumatic treatment and prophylaxis predominantly rely on passive immunotherapies for tetanus. Conventional passive immunizing agents include equine-derived tetanus antitoxin (TAT) and human tetanus immunoglobulin (HTIG). Although TAT remains widely used domestically, it is not recommended by the World Health Organization (WHO) due to safety concerns, while HTIG faces supply constraints and potential risks of pathogen transmission. The recent approval of the world′s first recombinant anti-tetanus toxin monoclonal antibody, developed through genetic recombination technology, offers a promising alternative to HTIG and TAT in clinical practice. This innovative agent has the potential to provide safer, more effective, and accessible tetanus prevention globally. To deepen the understanding of research progress in clinical applications of existing passive immunizing agents for tetanus, the authors reviewed the current application status of conventional agents and explored the key technical characteristics, neutralizing antigenic epitopes, and clinical application of the novel recombinant anti-tetanus toxin monoclonal antibody for passive immunotherapy for tetanus, providing scientific reference to improve the rational use of these agents and standardize post-traumatic tetanus prevention and treatment practices.
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