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Titolo:
A double-blind study of the sedative effects of the thalidomide enantiomers in humans
Autore:
Hoglund, P; Eriksson, T; Bjorkman, S;
Indirizzi:
Univ Lund Hosp, Dept Clin Pharmacol, S-22185 Lund, Sweden Univ Lund Hosp Lund Sweden S-22185 Clin Pharmacol, S-22185 Lund, Sweden Malmo Univ Hosp, Hosp Pharm, Malmo, Sweden Malmo Univ Hosp Malmo SwedenMalmo Univ Hosp, Hosp Pharm, Malmo, Sweden
Titolo Testata:
JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS
fascicolo: 4, volume: 26, anno: 1998,
pagine: 363 - 383
SICI:
0090-466X(199808)26:4<363:ADSOTS>2.0.ZU;2-7
Fonte:
ISI
Lingua:
ENG
Soggetto:
CONTINUOUS REACTION-TIMES; HEPATIC-ENCEPHALOPATHY; PHARMACOKINETICS; VOLUNTEERS; RESPONSES; ANALOGS; PLASMA; BLOOD;
Keywords:
concentration-effect relationship; enantiomers; stereospecific analysis; chiral inversion; thalidomide; sedative effects; continuous reaction times; logistic regression; Cox regression;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
33
Recensione:
Indirizzi per estratti:
Indirizzo: Hoglund, P Univ Lund Hosp, Dept Clin Pharmacol, S-22185 Lund, Sweden Univ Lund Hosp Lund Sweden S-22185 acol, S-22185 Lund, Sweden
Citazione:
P. Hoglund et al., "A double-blind study of the sedative effects of the thalidomide enantiomers in humans", J PHAR BIOP, 26(4), 1998, pp. 363-383

Abstract

This study investigated the sedative effects of the enantiomers of thalidomide in humans. Since the enantiomers undergo chiral inversion in vivo thisentailed application of suitable statistical methodology to distinguish the effects of each enantiomer in the presence of the other one. Six healthy male volunteers received single oral doses of (+)-(R)-thalidomide, (-)-(S)-thalidomide or racemic thalidomide in a double-blind study, and the resultsof this study were compared with those of a similar study where three subjects received (+)-(R)-thalidomide, (-)-(S)-thalidomide or placebo in a double-blind fashion. Blood samples for analysis of (+)-(R)-thalidomide and (-)(S)-thalidomide were obtained. Prior to sampling it was noted whether the subject was awake or asleep, and his feelings of tiredness and heaviness were estimated using Borg scales. After blood sampling continuous reaction time was measured by a 10-min series of auditory signals. The concentration-effect relationships were analyzed by logistic regression techniques and Cox regression far the reaction lime data The (+)-(R)-thalidomide concentrations, but not the (-)(S)-thalidomide concentrations, exhibited significant positive influences on all sedative effects studied (sleep, tiredness, and reaction times). In some of the analyses of reaction times the (-)(S)-thalidomide concentrations had a significant effect in the apposite direction. The time course and intensify of sedative effect is thus influenced by which enantiomer is administered and by the kinetics of in vivo chiral inversion.

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Documento generato il 19/09/20 alle ore 11:01:26