人凝血酶原复合物治疗乙型血友病的有效性和安全性评价  

Evaluate the efficacy and safety on human prothrombin complex concentration treated hemophilia B

作　　者：马山 张振 高超 

机构地区：[1]山东泰邦生物制品有限公司,山东泰安271000

出　　处：《中国输血杂志》2016年第9期945-947,共3页Chinese Journal of Blood Transfusion

摘　　要：目的评价人凝血酶原复合物(PCC)治疗乙型血友病的有效性和安全性。方法采用多中心、开放、自身对照设计,用目标值法评价PCC的有效性。试验入组54例乙型血友病受试者,根据出血状况和凝血因子水平不同,确定输注的剂量,输注后30 min测定凝血因子Ⅸ效率值,24 h观察出血症状和体征改善,用药结束后90 d检测凝血因子Ⅸ抗体及HBs Ag、抗-HCV和抗-HIV。结果受试者首次输注后30 min,凝血因子Ⅸ活性由2.03%提高至29.49%±14.86%,输注效率值为104.86%±34.45%;输注后24 h,出血症状和体征改善评分经研究者判定:"优良"38.9%(21例)、"改善"61.1%(33例),总改善率为100%;不良反应发生率3.7%(2/54),均为轻度发热,未见凝血因子Ⅸ抗体及新增病毒病例。结论输注本公司生产的人凝血酶原复合物用于治疗乙型血友病,其输注效率值能达到良好水平,出血症状和体征的总改善率达到优良水平,总体安全性良好。Objective To evaluate the efficacy and safety of the human prothrombin complex concentration treated Hemophilia B. Methods This study was a multi-center, open, single-group design study, the efficacy of prothrombin complex concentrate was evaluated in method of objective performance criteria. All 54 subjects with hemophilia B entered the study, appropriate dose were selected in accordance with clinical severity of bleeding, measure in patients the activity level of FIX 30 minutes after the injection,to assess the infusion efficiency; observe the bleedingand the symp- tom improvement,24 hours after the injection; The F IX antibodies, HBsAg, HCV antibodies, and HIV antibodies were proposed to detect on the ninety day after the end of the treatment. Results 30minutes after infusion of prothrombin complex concentrate, the activity of coagulation factor IX were increased from 2.03% to 29. 49% - 14. 86%, he efficiency of injection were 104. 86% - 34. 45% ,with a few of side effects. The incidence rate of adverse drug reactions was 3.7% withoutany FIX antibodies and virus infection cases. Conclusion The efficiency of injection can reach a good level, the bleeding and the symptom improvementrate reached excellent level, the total security is good.

关 键 词：人凝血酶原复合物 乙型血友病 有效性评价 安全性评价 

分 类 号：R457.1[医药卫生—治疗学] R554.1[医药卫生—临床医学]