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혈우병 A형 환자에서 재조합 혈액응고인자 VIII (그린진주$^{TM}$)의 내약성 및 약동학적 특성에 관한 연구
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  • 혈우병 A형 환자에서 재조합 혈액응고인자 VIII (그린진주$^{TM}$)의 내약성 및 약동학적 특성에 관한 연구
저자명
한혜경,신광희,백상훈,정재용,임경수,조주연,윤서현,신상구,장인진,유경상,Han. Hye-Kyung,Shin. Kwang-Hee,Paik. Sang-Hoon,Chung. Jae-Yong,Lim. Kyoung-Soo,Cho. Joo-
간행물명
臨床藥理學會誌= The journal of Korean Society for Clinical Pharmacology and Therapeutics
권/호정보
2011년|19권 2호|pp.144-151 (8 pages)
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대한임상약리학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Background: $GreenGene^{TM}$ (Green Cross Corp.) is a recombinant clotting factor VIII which is used for hemophilia A. This study aimed to investigate the pharmacokinetics and safety profiles of 25 IU/kg and 50 IU/kg of $GreenGene^{TM}$ in Korean hemophilia A patients. Methods: A dose-block randomized, single-blind, active drug-controlled, single and multiple dose, parallel-group study was conducted with 16 hemophilia A patients (25 IU/kg: 50 IU/kg = 8:8). They received $GreenGene^{TM}$ or $GreenMono^{TM}$(active control) intravenously on day 1 and every other day from day 4 to 10. FVIII:C (Factor VIII procoagulant activity) was measured to determine the pharmacokinetics (PK) at baseline and up to 48 hours for single and multiple administration. PK parameters were determined using noncompartmental methods. Results: The maximum concentration ($C_{max}$) and the area under the concentration-time curve ($AUC_{0-48}$) of the $GreenGene^{TM}$ 25 IU/kg ($mean{pm}SD$) were $59.00{pm}19.26$ % and $774.40{pm}380.13%{cdot}h$ respectively, while those of 50 IU/kg were $131.50{pm}39.81$ % and $1462.44{pm}397.09%{cdot}h$ after single administration. The $C_{max}$ and $AUC_{0-48}$ in steady state of the $GreenGene^{TM}$ 25 IU/kg were $68.17{pm}22.75$ % and $863.30{pm}334.40%{cdot}h$, while those of 50 IU/kg were $147.17{pm}18.47$ % and $1820.08{pm}704.42%{cdot}h$. No serious adverse event was observed. Conclusion: The $GreenGene^{TM}$ to hemophilia A patients appeared to be well tolerated within range of 25-50 IU/kg. The PK parameters of factor VIII showed dose-independent manner with 25 IU/kg and 50 IU/kg dose ranges.