【摘要】 目的 评价马破伤风免疫球蛋白F（ab’）₂的安全性、有效性和经济性，以期为其临床应用提供参考。方法 选取2021年11月23日—2022年10月31日因创伤就诊于6家研究中心，且需要注射破伤风免疫球蛋白制剂的患者为研究对象，观察马破伤风免疫球蛋白F（ab’）₂的皮肤过敏试验（简称皮试）阳性率和注射后不良事件（adverse event,AE）的发生率。抽取1家研究中心，评估该中心患者在接受马破伤风免疫球蛋白F（ab’）₂注射后破伤风的发生率。同时构建1个每万名患者的药物经济性模型，比较患者首选接种破伤风抗毒素（tetanus antitoxin,TAT）或马破伤风免疫球蛋白F（ab’）₂2种情景下因皮试阳性而改用人破伤风免疫球蛋白（tetanus immunoglobulin,TIG）后的药物成本差异。结果 共纳入422例患者，其中419例接受了马破伤风免疫球蛋白F（ab’）₂皮试，416例取得皮试结果，皮试阳性率为5.05%（21/416）。在395例皮试阴性且完成马破伤风免疫球蛋白F（ab’）₂注射的患者中，5例（1.27%）患者发生了与马破伤风免疫球蛋白F（ab’）₂相关的AE，主要包括皮疹和瘙痒；2例（0.51%）患者发生了与马破伤风免疫球蛋白F（ab’）₂相关的≥3级的AE，其中1例为速发严重过敏反应，1例为瘙痒；无患者发生与马破伤风免疫球蛋白F（ab’）₂相关的过敏性休克或死亡。抽取的研究中心的患者注射马破伤风免疫球蛋白F（ab’）₂后，均未发生破伤风。药物经济性评估模型显示，与TAT及TIG比较，马破伤风免疫球蛋白F（ab’）₂具有较高的药物经济性价值。结论 马破伤风免疫球蛋白F（ab’）₂在预防破伤风方面具有良好的真实世界疗效和安全性，且具有较高的药物经济学价值。更多还原

【Abstract】 ObjectiveTo evaluate the safety, efficacy and economy of equine tetanus immunoglobulin F（ab’）₂, so as to provide reference for its clinical application.MethodsPatients who were admitted to six research centers for trauma from November 23, 2021 to October 31, 2022 and required a tetanus immunoglobulin injection were selected as the research subjects to observe the positive rate of skin sensitization test of equine tetanus immunoglobulin F（ab’）₂ and the incidence of adverse events（AEs） after injection. In addition, one of the study centers was selected to evaluate the incidence of tetanus in patients receiving equine tetanus immune globulin F（ab’）₂ injection in this center. Meanwhile, a pharmacoeconomic model per 10 000 patients was constructed to compare the difference in drug costs of switching to human tetanus immunoglobulin（TIG） due to a positive skin sensitization test when patients preferred tetanus antitoxin（TAT） or equine tetanus immunoglobulin F（ab’）₂.ResultsA total of 422 patients were enrolled in the study, of whom 419 underwent an equine tetanus immunoglobulin F（ab’）₂ skin sensitization test and 416 received a test result, with a positive skin sensitization test rate of 5. 05%（21/416）. Among the 395 patients who had a negative skin sensitization test and completed equine tetanus immunoglobulin F（ab’）₂ injection, five（1. 27%） patients developed AEs related to equine tetanus immunoglobulin F（ab’）₂, mainly including rash and pruritus, and two（0. 51%） patients had grade ≥ 3 AEs related to equine tetanus immunoglobulin F（ab’）₂, including one case of immediate anaphylaxis and one case of pruritus. None of the patients developed anaphylactic shock or death related to equine tetanus immunoglobulin F（ab’）₂. None of the patients in the selected research center developed tetanus after administration of equine tetanus immunoglobulin F（ab’）₂. In addition, the pharmacoeconomic evaluation model showed that equine tetanus immunoglobulin F（ab’）₂ had a higher drug economic value compared to TAT and TIG.Conclusion Equine tetanus immunoglobulin F（ab’）₂ has shown good efficacy and safety in preventing tetanus in the real world with high pharmacoeconomic value.更多还原