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1996-02-27
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Document 0469
DOCN M9630469
TI Approaching the ideal: therapeutic requirements for factor VIII
concentrates.
DT 9603
AU Vermylen J; Centre of Molecular and Vascular Biology, Campus
Gasthuisberg,; Leuven, Belgium.
SO Blood Coagul Fibrinolysis. 1995 Jul;6 Suppl 2:S36-9. Unique Identifier :
AIDSLINE MED/96076197
AB The requirements that a factor VIII concentrate should fulfil, as
adopted by the Belgian Health Council, are reviewed. Lack of
immunogenicity is an important issue; the Belgian experience suggests
that a prospective randomized trial allows rather rapid detection of
grossly increased immunogenicity. An alternative is provided by
prospective cohort studies, using a uniform protocol to evaluate the
behavior of each product, and an independent data monitoring centre.
Residual infectivity is illustrated by an outbreak of hepatitis A in
heavily treated patients. A prospective randomized trial in Belgium is
planned to evaluate the benefits and risks of a double-virus inactivated
product.
DE Belgium/EPIDEMIOLOGY Factor VIII/IMMUNOLOGY/*STANDARDS Hepatitis
A/EPIDEMIOLOGY/IMMUNOLOGY Hepatitis Antibodies/*BLOOD Human HIV
Antibodies/*BLOOD Prospective Studies Randomized Controlled Trials
Risk Factors JOURNAL ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).