pharmacokinetic comparability of prolastin?-c to prolastin? in alpha1-antitrypsin deficiency a randomized study药代动力学的可比性prolastin - c prolastin alpha1-antitrypsin缺乏随机研究.pdfVIP
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pharmacokinetic comparability of prolastin?-c to prolastin? in alpha1-antitrypsin deficiency a randomized study药代动力学的可比性prolastin - c prolastin alpha1-antitrypsin缺乏随机研究
Stocks et al. BMC Clinical Pharmacology 2010, 10:13
/1472-6904/10/13
RESEARCH ARTICLE Open Access
Pharmacokinetic comparability of Prolastin®-C to
Prolastin® in alpha1-antitrypsin deficiency: a
randomized study
1* 2 3 4 5
James M Stocks , Mark L Brantly , Laurene Wang-Smith , Michael A Campos , Kenneth R Chapman ,
Friedrich Kueppers6 7 8 9
, Robert A Sandhaus , Charlie Strange , Gerard Turino
Abstract
Background: Alpha -antitrypsin (AAT) deficiency is characterized by low blood levels of alpha -proteinase inhibitor
1 1
(alpha -PI) and may lead to emphysema. Alpha -PI protects pulmonary tissue from damage caused by the action
1 1
of proteolytic enzymes. Augmentation therapy with Prolastin® (Alpha1-Proteinase Inhibitor [Human]) to increase the
levels of alpha1-PI has been used to treat individuals with AAT deficiency for over 20 years. Modifications to the
Prolastin manufacturing process, incorporating additional purification and pathogen-reduction steps, have led to
the development of an alpha -PI product, designated Prolastin®-C (Alpha -Proteinase inhibitor [Human]). The
1 1
pharmacokinetic comparability of Prolastin-C to Prolastin was assessed in subjects with AAT deficiency.
Methods: In total, 24 subjects were randomized to receive 60 mg/kg of functionally active Prolastin-C or Prolastin
by weekly intravenous infusion for 8 weeks before crossover to the
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