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Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection

หน่วยงาน มหาวิทยาลัยเชียงใหม่

รายละเอียด

ชื่อเรื่อง : Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection
นักวิจัย : Colvin,R.A. , Tanwandee,T. , Piratvisuth,T. , Thongsawat,S. , Hui,A. , Zhang,H. , Ren,H. , Chen,P. , Chuang,W. , Sobhonslidsuk,A. , Li,R. , Qi,Y. , Præstgaard,J.T. , Han,Y. , Xu,J. , Stein,D.S. , Chien,R. , Flisiak,R. , Jabłkowski,M.S. , Liaw,Y. , Sung,J.J.Y.
คำค้น : Hepatology , Gastroenterology
หน่วยงาน : มหาวิทยาลัยเชียงใหม่
ผู้ร่วมงาน : -
ปีพิมพ์ : 2558
อ้างอิง : 08159319 , 2-s2.0-84919608802 , 10.1111/jgh.12671 , http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84919608802&origin=inward , http://cmuir.cmu.ac.th/handle/6653943832/38355
ที่มา : -
ความเชี่ยวชาญ : -
ความสัมพันธ์ : -
ขอบเขตของเนื้อหา : -
บทคัดย่อ/คำอธิบาย :

© 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd. Background and Aims: Albinterferon is a fusion of albumin and interferon-α2b developed to improve the pharmacokinetics, convenience, and potential efficacy of interferon-α for the treatment of chronic hepatitis infections. Methods: This open-label, randomized, active-controlled, multicenter study investigated the safety and efficacy of albinterferon in patients with chronic hepatitis B virus (HBV) infection who were e-antigen (HBeAg) positive. One hundred and forty-one patients received one of four albinterferon doses/regimens or pegylated-interferon-α2a. Primary efficacy outcomes were changes in serum HBeAg and antibody, HBV-DNA, and alanine aminotransferase. Principal safety outcomes were changes in laboratory values, pulmonary function, and adverse events. Results: The study was prematurely terminated as phase III trials in hepatitis C infection indicated noninferior efficacy but inferior safety compared with pegylated-interferon-α2a. Here, all treatment groups had a significant reduction in HBV-DNA from baseline. Reductions in HBV-DNA were not significantly different, except the 1200μg every 4 weeks albinterferon dose which was inferior compared with pegylated-interferon-α2a. The serum alanine aminotransferase levels decreased in all arms. The per-patient incidence of adverse events was not significantly different for albinterferon (96.4-100%) and pegylated-interferon-α2a (93.1%). Total adverse events, however, were higher for albinterferon and correlated to dose. Decreased lung function was found in all arms (∼93% of patients), and was more common in some albinterferon groups. Conclusions: Albinterferon doses with similar anti-HBV efficacy to pegylated-interferon-α2a had higher rates of certain adverse events, particularly changes in lung diffusion capacity (http://www.clinicaltrials.gov number NCT00964665).

บรรณานุกรม :
Colvin,R.A. , Tanwandee,T. , Piratvisuth,T. , Thongsawat,S. , Hui,A. , Zhang,H. , Ren,H. , Chen,P. , Chuang,W. , Sobhonslidsuk,A. , Li,R. , Qi,Y. , Præstgaard,J.T. , Han,Y. , Xu,J. , Stein,D.S. , Chien,R. , Flisiak,R. , Jabłkowski,M.S. , Liaw,Y. , Sung,J.J.Y. . (2558). Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection.
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ .
Colvin,R.A. , Tanwandee,T. , Piratvisuth,T. , Thongsawat,S. , Hui,A. , Zhang,H. , Ren,H. , Chen,P. , Chuang,W. , Sobhonslidsuk,A. , Li,R. , Qi,Y. , Præstgaard,J.T. , Han,Y. , Xu,J. , Stein,D.S. , Chien,R. , Flisiak,R. , Jabłkowski,M.S. , Liaw,Y. , Sung,J.J.Y. . 2558. "Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection".
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ .
Colvin,R.A. , Tanwandee,T. , Piratvisuth,T. , Thongsawat,S. , Hui,A. , Zhang,H. , Ren,H. , Chen,P. , Chuang,W. , Sobhonslidsuk,A. , Li,R. , Qi,Y. , Præstgaard,J.T. , Han,Y. , Xu,J. , Stein,D.S. , Chien,R. , Flisiak,R. , Jabłkowski,M.S. , Liaw,Y. , Sung,J.J.Y. . "Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection."
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ , 2558. Print.
Colvin,R.A. , Tanwandee,T. , Piratvisuth,T. , Thongsawat,S. , Hui,A. , Zhang,H. , Ren,H. , Chen,P. , Chuang,W. , Sobhonslidsuk,A. , Li,R. , Qi,Y. , Præstgaard,J.T. , Han,Y. , Xu,J. , Stein,D.S. , Chien,R. , Flisiak,R. , Jabłkowski,M.S. , Liaw,Y. , Sung,J.J.Y. . Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection. เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ ; 2558.