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Titolo:
The French haemophilia cohort: rationale and organization of a long-term national pharmacosurveillance system
Autore:
Calvez, T; Biou, M; Costagliola, D; Jullien, AM; Laurian, Y; Rossi, F; Rothschild, C; Sie, P;
Indirizzi:
Fac Med St Antoine, INSERM SC4, F-75571 Paris 12, France Fac Med St Antoine Paris France 12 INSERM SC4, F-75571 Paris 12, France CHU St Antoine, Paris, France CHU St Antoine Paris FranceCHU St Antoine, Paris, France Minist Emploi Solidarite, Direct Gen Sante, Paris, France Minist Emploi Solidarite Paris France , Direct Gen Sante, Paris, France CHU Bicetre, Le Kremlin Bicetre, France CHU Bicetre Le Kremlin Bicetre France cetre, Le Kremlin Bicetre, France Agence Francaise Secur Sanitaire Prod Sante, St Denis, France Agence Francaise Secur Sanitaire Prod Sante St Denis France nis, France CHU Necker, Paris, France CHU Necker Paris FranceCHU Necker, Paris, France Ctr Hosp Univ, Hop Purpan, Toulouse, France Ctr Hosp Univ Toulouse France r Hosp Univ, Hop Purpan, Toulouse, France
Titolo Testata:
HAEMOPHILIA
fascicolo: 1, volume: 7, anno: 2001,
pagine: 82 - 88
SICI:
1351-8216(200101)7:1<82:TFHCRA>2.0.ZU;2-P
Fonte:
ISI
Lingua:
ENG
Soggetto:
RECOMBINANT FACTOR-VIII; HEMOPHILIA-A PATIENTS; PREVIOUSLY UNTREATED PATIENTS; MULTITRANSFUSED HEMOPHILIA; INHIBITORS; SAFETY; CONCENTRATE; EFFICACY; SURVEILLANCE; NETHERLANDS;
Keywords:
clotting factor preparations; cohort study; France; haemophilia; health-watch policy; pharmacoepidemiology;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
27
Recensione:
Indirizzi per estratti:
Indirizzo: Calvez, T Fac Med St Antoine, INSERM SC4, 27 Rue Chaligny, F-75571 Paris 12, France Fac Med St Antoine 27 Rue Chaligny Paris France 12 s 12, France
Citazione:
T. Calvez et al., "The French haemophilia cohort: rationale and organization of a long-term national pharmacosurveillance system", HAEMOPHILIA, 7(1), 2001, pp. 82-88

Abstract

Medicinal products of biological origin still carry a specific iatrogenic risk, mainly because of their starting material, mode of preparation and variability. Careful postmarketing surveillance systems are therefore necessary. To assess the long-term safety of haemophilia treatment with plasma-derived and recombinant clotting factor products, a cohort study was set up inFrance in 1994. Participants were patients with haemophilia A and B, with or without previous clotting factor therapy. Clinical events, treatments, biological data and adverse events were recorded on standard forms. Blood samples were separated into serum, plasma and peripheral blood mononuclear cells, frozen, and banked in a central laboratory. The same data and samples were collected at yearly follow-up visits. As of December 1999 1234 haemophiliacs were enrolled in 39 haemophilia centres. At enrolment, 50.2% of patients were under 15 years of age, and the cumulative number of days of exposure to the product was below 50 in 35.1% of cases. The median duration of follow-up was 26.9 months, with a total of 2729 patient-years (135 947 days of exposure and 211 million units of factor VIII or IX). To date, only 17 patients were lost to follow-up. The initial results show good compliance with this health-watch policy among patients and clinicians specializing in haemophilia. The regular follow-up data and centralized sample bank will serve to investigate rapidly any suspected outbreaks as soon as reliable biological tests become available in the future.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 19/01/20 alle ore 09:53:15