A multicenter phase Ⅲ clinical study of human prothrombin complex concentrate in treatment of hemophilia B
10.13303/j.cjbt.issn.1004-549x.2022.09.008
- VernacularTitle: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
- Author:
Wei ZHANG
1
;
Yirun LIU
1
;
Yan WU
1
;
Xuanlin ZHONG
1
;
Qingshuang SONG
1
;
Shitao CHEN
1
;
Xueyun WANG
1
;
Caiping GUO
1
;
Zhan ZHANG
1
;
Yunjia ZHANG
1
Author Information
1. Shenzhen Weiguang Biological Products Co., Ltd, Shenzhen 518107, China
- Publication Type:Journal Article
- Keywords:
human prothrombin complex concentrate;
hemophilia B;
coagulation factor Ⅸ
- From:
Chinese Journal of Blood Transfusion
2022;35(9):915-919
- CountryChina
- Language:Chinese
-
Abstract:
【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 factor Ⅸ increased 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 factor Ⅱ activity was (73.25±14.874) IU/dL. The activity of coagulation factor Ⅶ was (42.79±16.847) IU/dL. The increased value of coagulation factor Ⅹ activity was (65.29±17.042) IU/dL. The increased value of coagulation factor Ⅸ activity 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 factor Ⅸ and 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.
