Evaluation of the efficacy and safety of human coagulation factor Ⅷ in the treatment of hemophilia A patients
10.13303/j.cjbt.issn.1004-549x.2022.12.008
- VernacularTitle:评价人凝血因子Ⅷ治疗甲型血友病患者的有效性和安全性
- Author:
Ruyi CHEN
1
;
Yan WU
1
;
Yiyun LIU
1
;
Mingxia HOU
1
;
Qingshuang SONG
1
;
Xuanlin ZHONG
1
;
Xueyun WANG
1
;
Wenjie XIE
1
;
Caiping GUO
1
;
Zhan ZHANG
1
;
Yunjia ZHANG
1
Author Information
1. Shenzhen Weiguang Biological Co Ltd, Shenzhen 518107, China
- Publication Type:Journal Article
- Keywords:
hemophilia A;
human coagulation factor Ⅷ;
safety;
efficacy
- From:
Chinese Journal of Blood Transfusion
2022;35(12):1220-1225
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To evaluate the efficacy and safety of human coagulation factor Ⅷ developed by Shenzhen Weiguang Biological products Co, Ltd in the treatment of patients with hemophilia A. 【Methods】 A prospective, multi-center, open, single-group clinical study was conducted. A total of 65 subjects with hemophilia A were enrolled, and human coagulation factor Ⅷ(FⅧ) was injected according to the patients’ bleeding severity. The improvement score of bleeding symptoms and signs after the first infusion of the first bleeding event and the transfusion efficiency of FⅧ activity at 10 min and 1 hour after infusion were taken as the main efficacy indexes. The improvement scores of bleeding symptoms and signs after the first infusion and the increase of FⅧ activity at 10 min and 1 hour after infusion were the secondary efficacy indexes. 【Results】 The 65 subjects were enrolled in safety analysis set (SS) and full analysis set (FAS), and 58 of them were enrolled in protocol analysis set (PPS). Ten minutes and one hour after the first infusion, the level of factor Ⅷ activity in the subjects increased significantly, and the FⅧ activity increased by 100% or more in more than 79% of the subjects. The average infusion efficiency of FⅧ activity in all subjects was more than 100%. In 70% of the subjects, the pain was relieved rapidly and /or the bleeding symptoms were significantly improved 8 hours after each bleeding infusion, and the improvement rate of bleeding symptoms and signs reached 100% 72 hours after infusion. 【Conclusion】 After infusion of human coagulation factor Ⅷ, the activity level of factor Ⅷ in patients with hemophilia A significantly increased. The infusion efficiency can reach a optimal level, and the bleeding symptoms can be significantly improved.
