摘要
目的评价上海生物制品研究所生产的人凝血因子Ⅷ(FⅧ)制剂的临床有效性和安全性。方法采用多中心、开放、单组设计,共选择国内6家知名三甲医院参与研究,所有参与本研究的55名血友病A患者,均进入单一试验组,按照临床出血的轻重程度,选择相应的剂量和时间,统一输注上海生物制品研究所生产的FⅧ,观察其使用前后各指标的变化进行。测定患者使用FⅧ制剂前和使用后10 min及1 h的FⅧ活性水平(FⅧ∶C),评估该FⅧ制剂的输注有效率及改善率,同时检测血常规、肝肾功能、血生化等相关安全性的实验室指标。结果使用该FⅧ试剂治疗的55位血友病A患者,用药后10 min,其FⅧ∶C中位值有由2.20%升至34.90%,输注效率中位值达到144.00%,用药后1 h输注效率值中位值达到138.80%;治疗后临床症状改善率达到100%(优良63.64%、改善36.36%)。血常规、肝肾功能、血生化、心电图以及发生的不良反应等输注FⅧ前后无明显变化,药物的安全性好。结论所评价的FⅧ制剂,输注效率高,输注后患者FⅧ∶C明显升高,临床症状改善明显,并且药物的安全性好。
Objective To evaluate the efficacy and safety of the human coagulation factor Ⅷ（ FⅧ） produced by Shanghai Institute of Biological Products. Methods This study was a multi-center,open,single-group design study that a total of 6 domestic well-known top hospitals involved in it. All 50 subjects with hemophilia A in the study entered single test group. Appropriate dose and time were selected in accordance with clinical severity of bleeding. All subjects injected entirely the human coagulation factor Ⅷ produced by Shanghai Institute of Biological Products,then the changes of indicators before and after the injection was observed. Measure in patients the activity level of FⅧ（ FⅧ∶ C） 10 minutes / one hour before / after the injection of FⅧ preparation,to assess the infusion efficiency and the improvement rate of FⅧ preparation,and at the same time test liver and kidney function,blood chemistry and other related laboratory safety index. Results In the 50 patients with hemophilia A treated by FⅧ,10 minutes after administration,median of FⅧ∶ C increased from 2. 20% to 34. 90%,median of infusion efficiency reached 144. 00%,1 hour after administration,median of injection efficiency reached 138. 80%; after treatment,clinical improvement rate reached 100%（ of which 63. 64% are excellent,36. 36% are improved）. All safety indexes test,including liver and kidney function,blood biochemistry,ECG and adverse reactions,etc,had no significant changes before and after drug infusion,which means the good safety of the drug. Conclusion The human coagulation factor Ⅷ produced by Shanghai Institute of Biological Products has high infusion efficiency. After the treatment,the activity level of factor Ⅷ is significantly increased,the clinical symptoms are greatly improved,and also the drug has a good safety.
出处
《中国输血杂志》
CAS
CSCD
北大核心
2013年第12期1208-1211,共4页
Chinese Journal of Blood Transfusion
