RESUMO
【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.
RESUMO
【Objective】 To study the application effect of gel adsorbent tank in the production of human prothrombin complex concentrate(PCC). 【Methods】 Six batches of PCC were produced from 1000 L cryoprecipitated plasma, using the same gel twice for adsorption within the tank.The number of gel repeated application was examined by retrospective confirmation, and the adsorption rate, specific activity and residue of finished virus inactivation reagent were determined before and after adsorption. 【Results】 All 6 batches of PPC, produced by the same gel, satisfied quality criteria. Both PPC solution and the gel presented good color. The average activities of coagulation Factors Ⅱ, Ⅶ, Ⅸ and Ⅹ of six batches of PCC were 118.2%, 157.0%, 140.5% and 176.8%, respectively. The The adsorption capacity of coagulation factor Ⅱ, Ⅸ and Ⅹ were both 100% in the first and second adsorption, while coagulation factor Ⅶ were 75% and 81%, respectively. The average specific activity of coagulation factor Ⅸ was 0.7 IU/mg. The average residues of polysorbate 80 and tributyl phosphate products were 0 μg/mL and 33 μg/mL, respectively. The same batch of gel can be repeatedly used up to 6 times during the PCC process. 【Conclusion】 The gel adsorption tank presents good application value in the production of PCC, which can realize process amplification and automatic control.