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')_(2)2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。
Objective To evaluate the safety,efficacy and economy of equine tetanus immunoglobulin F(ab')_(2),so as to provide reference for its clinical application.Methods Patients 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 10000 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).Results A 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.
作者
吕慧
王瑞兰
雷鸣
周慧芳
管健
叶树培
任兆俊
黄仲义
LV Hui;WANG Ruilan;LEI Ming;ZHOU Huifang;GUAN Jian;YE Shupei;REN Zhaojun;HUANG Zhongyi(Department of Emergency Critical Care Medicine,Shanghai General Hospital,Shanghai 201600,China;不详)
出处
《中国生物制品学杂志》
2026年第3期309-313,325,共6页
Chinese Journal of Biologicals
