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背景 乙型血友病是一种X相关的出血疾病,患病率为1/ 25,000男性。急性出血发作的治疗包括源自血浆(pd—F IX)或重组(r—F IX)浓缩物的输注。设计与方法 双盲双期交叉研究pd-F IX和 r-F IX的药物动力学,以及寻找可能影响体内回收的病人特异性变量。病人在未出血状况下,以前曾使用研究用制品(50IU/kg)单次到43次,并用药48小时后测 F IX:C水平。结果 在pd-F IX组体内回收的均值为1.71+/-0.73 IU/dL/
Background Hemophilia B is an X-related bleeding disorder with a prevalence of 1 / 25,000 males. Treatments for acute bleeding episodes include those derived from plasma (pd-F IX) or recombinant (r-F IX) concentrates. Design and Methods Double-blind, double-phase crossover studies of the pharmacokinetics of pd-F IX and r-F IX and the search for patient-specific variables that may affect in vivo recovery. In the absence of a hemorrhagic condition, the patient previously used the investigational product (50 IU / kg) single time to 43 times and measured F IX: C levels 48 hours after dosing. Results The average recovery in the pd-F IX group was 1.71 +/- 0.73 IU / dL /