The pharmacokinetics and pharmacodynamics of drugs are significantly altered in the burn patient, and the burn patient population shows wide inter- and intraindividual variation in drug handling. Burn injury evolves in two phases. The first phase corresponds to the burn shock, which occurs during the first 48 hours after thermal injury. In this phase, hypovolaemia, oedema, hypoalbuminaemia and a low glomerular filtration rate are observed, which result in a slower rate of drug distribution and lower renal clearance. The second phase (beyond 48 hours after injury) is a hyperdynamic state with high blood flow in the kidneys and liver, an increased alpha1-acid-glycoprotein level and loss of the drug with exudate leakage. As a result, protein binding, drug distribution and clearance may be altered. Because of the alteration in these variables, wide intraindividual variation of pharmacokinetic parameters occurs depending upon the time since thermal injury and fluid resuscitation. Interindividual variations may be correlated with the percentage of the body surface area that is burnt, creatinine clearance, albuminaemia or the alpha1-acid-glycoprotein level. A number of important variations in pharmacodynamic parameters have been described, but their mechanisms are poorly understood. From a practical point of view, for the subpopulation of burn patients who eliminate drugs extremely rapidly, higher doses and/or shorter dosing intervals are required to avoid treatment inefficacy. Drug concentration measurements help to take into account interindividual variability. However, adaptation of doses based on Bayesian methods is frequently not possible because the distribution of pharmacokinetic parameters is poorly characterized in this population. Methods based only on individual data or on a surrogate marker for efficacy may be used to optimize the dosing regimen in this population.

Influence of burns on pharmacokinetics and pharmacodynamics of drugs used in the care of burn patients.

Resume Chez le grand brule, lors de l'utilisation des aminosides en administration pluriquotidienne, il est difficile d'obtenir des taux seriques suffisants. Des etudes, menees chez des patients de reanimation polyvalente ont montre l'interet de l'administration de l'amikacine en dose unique journaliere. Nous avons analyse chez 29 brules recevant cet aminoside a la dose de 15 mg/kg/24 h administre sur une seule perfusion, les variations des taux seriques, les correlations eventuelles avec les parametres caracterisant la brulure ainsi que la tolerance. Ont ete egalement etudies les resultats bacteriologiques et cliniques, ainsi que les relations eventuelles entre les valeurs des pics seriques et les succes therapeutiques. Il apparait que pour les posologies usuelles, seule la dose unique journaliere permet de se rapprocher des seuils therapeutiques, sans que l'on puisse mettre en evidence de correlation entre la cinetique et la clinique.

Utilisation de l'amikacine en dose unique journalière chez le brûlé : étude pharmacocinétique et clinique

Resume L'etude pharmacocinetique pilote de l'association amikacine (AMK) plus teicoplanine (TCN) a ete conduite chez 6 sujets (35,3 ± 13,2 ans et 68,3 ± 8,6 kg) gravement brules infectes (43,0 ± 23,8 % en 3e degre). L'AMK a ete administree en 30 min a la posologie de 10 mg/kg/12 h (683 ± 76 mg). La TCN a ete injectee en 10 min a raison de 12 mg/kg/12 h pendant 48 h puis de 12 mg/kg/24 h (820 ± 90 mg). La caracterisation cinetique simultanee a ete realisee a J1 (leres perfusions conjointes) et a J5 ( i.e. respectivement 9e et 7e dose). Les urines ont ete recueillies a J1. L'AMK et la TCN ont ete dosees respectivement par FPIA et par CLHP. L'analyse cinetique et graphique fait appel a une methode non compartimentale. La tolerance et l'efficacite de l'association ont ete satisfaisantes. La duree du traitement a ete de 8,1 ± 2,9 et 7,8 ± 2,7 j respectivement pour l'AMK et la TCN. La cinetique de l'association reste lineaire a l'equilibre. Il n'existe pas de difference significative entre les marqueurs cinetiques determines a J1 vs J5. Compte tenu des objectifs poursuivis, les Cmax d'AMK sont un peu insuffisantes (33,5-53,0 mg/l) et pour 5/6 sujets, l'aminoside n'est plus detectable dans le serum des la 10e h. Les Cmax de la TCN sont relativement elevees (91,9-197,5 mg/l) mais les Cmin sont insuffisantes i.e. Cmin 12 h (J1) = 9,0 ± 4,4 mg/l et Cmin 24 h (J5) = 7,6 ± 3,4 mg/l, Une revision posologique est proposee afin de disposer : 1) pour l'AMK, de Cmax de l'ordre de 50 mg/l, de Cmin quantifiables (∼ 0,9 mg/l) et, 2) pour la TCN, de Cmax ≤ 100 mg/l et de Cmin ≥ 12 mg/l. Un nouveau schema posologique est propose pour la poursuite de l'etude : 1) pour l'AMK : 12 mg/kg/12 h (dose quotidienne de 1 680 mg vs 1400 mg initialement) et, 2) pour la TCN, 10 mg/kg/12 h (dose quotidienne de 1 400 mg et suppression de la dose de charge). L'association sera perfusee en 20 min. La revision a fait l'objet d'un amendement avalise par le CCPPRB et 10 nouveaux patients seront inclus. Dans des situations physiopathologiques complexes, la revision d'un protocole securise le traitement et augmente les chances de disposer de recommandations therapeutiques concretes au terme de l'essai.

Etude pilote de la pharmacocinétique de l'association amikacine-teicoplanine chez le sujet gravement brûlé infecté

Pharmacocinétique chez les brûlés

Pharmacocinétique de l'amikacine chez le brûlé de gravité moyenne.

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Pharmacocinétique de l'amikacine chez le brûlé de gravité moyenne.