Real-world study on the safety of tetanus immunoglobulin F(ab')₂, equine for short-term passive immunization against Clostridium tetani infection
马破伤风免疫球蛋白F(ab′)2预防破伤风梭菌感染短期被动免疫的安全性真实世界调查研究

摘要

目的 评价马破伤风免疫球蛋白F(ab′)₂在真实世界中用于预防破伤风感染短期被动免疫的安全性。方法 回顾性分析3023例外伤患者使用马破伤风免疫球蛋白F(ab′)₂的临床资料，统计用药的皮试阳性率、过敏反应及其他不良事件发生情况。结果 在3023例外伤患者中，皮试阳性率为1.16%（35/3023），皮试阴性且实际注射马破伤风免疫球蛋白F(ab′)₂的外伤患者共2988例。本次共报告不良事件31例（1.03%），其中26例（0.99%）判定为与药物相关，无药物相关的严重不良事件报告。结论 本真实世界研究证实，马破伤风免疫球蛋白F(ab′)₂用于预防破伤风梭菌感染的短期被动免疫，安全性良好，适用于具有破伤风感染风险的外伤患者。

Abstract

Objective To evaluate the safety of Tetanus Immunoglobulin F(ab′)2, Equine for short-term passive immunization in the prevention of tetanus infection in a real-world setting.
Methods A retrospective analysis was conducted on the clinical data of 3023 trauma patients who received Tetanus Immunoglobulin F(ab′)2, Equine. The rates of positive skin tests, allergic reactions, and other adverse events were statistically analyzed.
Results Among the 3023 trauma patients, the positive skin test rate was 1.16% (35/3023). A total of 2988 patients who had a negative skin test actually received the injection of Tetanus Immunoglobulin F(ab′)2, Equine. In total, 31 adverse events were reported (1.03%), of which 26 (0.99%) were judged to be drug-related. No drug-related serious adverse events were reported.
Conclusion   This real-world study confirms that Tetanus Immunoglobulin F(ab′)2, Equine demonstrates a favorable safety profile for short-term passive immunization in the prevention of Clostridium tetani infection, making it suitable for use in trauma patients at risk of tetanus infection.