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Titolo:
Safety of human albumin based on spontaneously reported serious adverse events
Autore:
von Hoegen, I; Waller, C;
Indirizzi:
Plasma Prot Therapeut Assoc, B-1200 Brussels, Belgium Plasma Prot Therapeut Assoc Brussels Belgium B-1200 00 Brussels, Belgium
Titolo Testata:
CRITICAL CARE MEDICINE
fascicolo: 5, volume: 29, anno: 2001,
pagine: 994 - 996
SICI:
0090-3493(200105)29:5<994:SOHABO>2.0.ZU;2-#
Fonte:
ISI
Lingua:
ENG
Soggetto:
DRUG-REACTIONS; RISKS;
Keywords:
serum albumin; human; fluid therapy; drug therapy; adverse drug reaction reporting systems; pharmacoepidemiology; product surveillance; postmarketing; safety; hospitals; hospital mortality;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
10
Recensione:
Indirizzi per estratti:
Indirizzo: von Hoegen, I Plasma Prot Therapeut Assoc, Blvd Brand Whitlock,114-5, B-1200 Brussels, Belgium Plasma Prot Therapeut Assoc Blvd Brand Whitlock,114-5 Brussels Belgium B-1200
Citazione:
I. von Hoegen e C. Waller, "Safety of human albumin based on spontaneously reported serious adverse events", CRIT CARE M, 29(5), 2001, pp. 994-996

Abstract

Objective: To evaluate the safety of human albumin administered for therapeutic purposes. Design: Retrospective compilation of spontaneously reported serious adverse events. Setting: Records of serious adverse event reports received from 1990 through 1997 by nine major suppliers of therapeutic human albumin worldwide. Patients: Primarily hospitalized patients. Interventions: Administration of human albumin. Measurements and Main Results: The number of 40-g doses distributed by thenine suppliers during the study period was 95.4 x 10(6), corresponding to 3.82 x 10(6) kg albumin, and reported serious adverse events totaled 123. The incidence of all serious adverse events was 1.29 per 10(6) doses (95% confidence interval, 1.07 per 10(6) to 1.54 per 10(6) doses). No patient death was judged to be probably attributable to albumin administration. The incidence of fatal serious adverse events possibly related to albumin was 5.24per 10(8) doses (95% confidence interval, 1.70 per 10(8) to 12.24 per 10(8) doses). Conclusions: Although underreporting must be recognized as a limitation ofspontaneous adverse event reports, this study encompassing approximately 100 million albumin doses provides evidence that both nonfatal and fatal serious adverse events in albumin recipients are very rare. These results provide further support far the excellent long-term safety record of human albumin.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 20/01/20 alle ore 07:36:37