Evaluation of the efficacy and safety of human coagulation factor Ⅷ in the treatment of hemophilia A patients
Journal Title: Chinese Journal of Blood Transfusion - Year 2022, Vol 35, Issue 12
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.
Authors and Affiliations
Ruyi CHEN, Yan WU, Yiyun LIU, Mingxia HOU, Qingshuang SONG, Xuanlin ZHONG, Xueyun WANG, Wenjie XIE, Caiping GUO, Zhan ZHANG, Yunjia ZHANG
Keywords
Related Articles
- EP ID EP738431
- DOI 10.13303/j.cjbt.issn.1004-549x.2022.12.008
- Views 38
- Downloads 0
External quality assessment of laboratories in blood stations of Hebei Province in 2022: a retrospective analysis of HeBEQA project
Objective To conduct the laboratory quality assessment between 12 blood stations in Hebei province, analyze the results and explore the accuracy and comparability of testing, so as to improve the level of testing ability...
Study on the production efficiency of platelet components in 24 prefecture-level blood stations in China
Objective To learn the production efficient of platelet components among prefecture-level blood stations in China, to provide supporting data for those blood stations to optimize the production mode of platelet component...
Retrospective analysis of quality data of different blood components in Chongqing
Objective To provide reference for formulating relatively unified quality control strategies and meeting the requirements of homogenization construction of blood banks across Chongqing area by retrospectively analyzing s...
Application of hazard vulnerability analysis on risk assessment in a blood bank
Objective To conduct hazard vulnerability analysis(HVA) in a blood bank, aimed to identify high-risk events and optimize emergency management measures. Methods The risk event evaluation index system was established by re...
Evolution of resuscitation fluid for hemorrhagic shock——low titer group O whole blood is becoming preferred emergent universal bridging resuscitation fluid
Timely and effective blood resuscitation is very important for patients with severe blood loss. The resuscitation fluids for hemorrhagic shock have evolved from whole blood to crystalloid/colloid solutions, crystalloid c...