人凝血酶原复合物治疗乙型血友病的多中心Ⅲ期临床研究  

A multicenter phaseⅢclinical study of human prothrombin complex concentrate in treatment of hemophilia B

作　　者：张伟 刘依润 吴燕 钟璇林 宋清爽 陈诗涛 王雪云 郭采平 张战 张运佳 ZHANG Wei;LIU Yirun;WU Yan;ZHONG Xuanlin;SONG Qingshuang;CHEN Shitao;WANG Xueyun;GUO Caiping;ZHANG Zhan;ZHANG Yunjia(Shenzhen Weiguang Biological Products Co.,Ltd,Shenzhen 518107,China.)

机构地区：[1]深圳市卫光生物制品股份有限公司,广东深圳518107

出　　处：《中国输血杂志》2022年第9期915-919,共5页Chinese Journal of Blood Transfusion

摘　　要：目的评价一种人凝血酶原复合物治疗乙型血友病患者的临床疗效和安全性。方法回顾性分析2018年5月至2019年4月期间使用深圳市卫光生物制品股份有限公司生产的人凝血酶原复合物治疗35例乙型血友病患者的临床资料,分析其临床有效性和安全性。结果本试验共35例受试者进入全分析集(FAS)和安全性分析集(SS),33例受试者进入符合方案集(PPS)。FAS受试者首次输注后30 min,凝血因子Ⅸ活性由(3.93±0.975)IU/dL提高至(25.61±9.337)IU/dL,输注效率值为(96.43±22.007)%;凝血因子Ⅱ活性增加值为(73.25±14.874)IU/dL;凝血因子Ⅶ因子活性增加值为(42.79±16.847)IU/dL;凝血因子Ⅹ活性增加值为(65.29±17.042)IU/dL;凝血因子Ⅸ活性增加值为(21.68±9.434)IU/dL。FAS受试者首次输注后24 h,出血症状和体征改善情况为优良的有21例(60%),改善14例(40.0%),有效率为100%。不良反应发生率2.9%(1/35),未见人凝血因子Ⅸ抗体及新增病毒感染。结论输注深圳市卫光生物制品股份有限公司生产的人凝血酶原复合物治疗乙型血友病临床疗效显著且安全性良好。Objective To evaluate the clinical efficacy and safety of one kind of human prothrombin complex concentrate in treatment of patients with hemophilia B.Methods The clinical data of 36 patients with hemophilia B treated with human prothrombin complex concentrate produced by Shenzhen Weiguang Biological Products Co.Ltd.from May 2018 to April 2019 were retrospectively analyzed,and its clinical efficacy and safety were analyzed.Results A total of 35 subjects entered the full analysis set(FAS)and safety set(SS),33 subjects entered the per protocol Set(PPS).Thirty minutes after the first infusion of FAS subjects,the activity of coagulation factorⅨincreased from(3.93±0.975)IU/dL to(25.61±9.337)IU/dL,and the infusion efficiency was(96.43±22.007)%.The increased value of coagulation factorⅡactivity was(73.25±14.874)IU/dL.The activity of coagulation factorⅦwas(42.79±16.847)IU/dL.The increased value of coagulation factorⅩactivity was(65.29±17.042)IU/dL.The increased value of coagulation factorⅨactivity was(21.68±9.434%)IU/dL.Twenty-four hours after the first infusion of FAS subjects,the improvement of bleeding symptoms and signs was excellent in 21 cases(60%),improved in 14 cases(40.0%),and the effective rate was 100%.The incidence of adverse reactions was 2.9%(1/35),and there was no antibody to human coagulation factorⅨand new virus infection.Conclusion Infusion of human prothrombin complex concentrate produced by Shenzhen Weiguang Biological Products Co.Ltd.in the treatment of hemophilia B has significant clinical efficacy and good safety.

关 键 词：人凝血酶原复合物 乙型血友病 凝血因子Ⅸ 

分 类 号：R554.1[医药卫生—血液循环系统疾病] R973.2[医药卫生—内科学]