RESUMEN
OBJECTIVE: To determine the safety, tolerance, pharmacokinetics and efficacy of linezolid, a new oxazolidinone antibiotic in the treatment of community-acquired pneumonia in hospitalized children. DESIGN: A Phase II, open label multicenter study of intravenous linezolid followed by oral linezolid suspension, both at a dose of 10 mg/kg every 12 h. Efficacy was assessed at 7 to 14 days after the last dose of linezolid. PATIENTS: Children 12 months to 17 years old with community-acquired pneumonia admitted to the hospital of 14 participating centers. RESULTS: From July 21, 1998, through May 14, 1999, 79 children were enrolled and 78 received linezolid. Sixty-six children completed treatment and follow-up and were evaluable for clinical outcome. The median age of the evaluable patients was 3 years (range, 1 to 12 years); 47 were 2 to 6 years old. Pathogens were isolated from blood or pleural fluid cultures in 8 children: Streptococcus pneumoniae, 6 (2 penicillin-resistant); Group A Streptococcus, 1; methicillin-resistant Staphylococcus aureus, 1. Chest tubes were placed in 9 patients. The mean total duration of intravenous and oral administration was 12.2 +/- 6.2 days (range, 6 to 41 days). The mean peak and trough plasma concentrations of linezolid were 9.5 +/- 4.8 and 0.8 +/- 1.2 microg/ml, respectively. At the follow-up visit 7 to 14 days after the last dose of linezolid, 61 patients (92.4%) were considered cured including all the patients with proven pneumococcal pneumonia, one failed (methicillin-resistant Staphylococcus aureus) and 4 were considered indeterminate. The most common adverse effects in the intent to treat group were diarrhea (10.3%), neutropenia (6.4%) and elevation in alanine aminotransferase (6.4%). CONCLUSIONS: Linezolid was well-tolerated and could be considered an alternative to vancomycin for treating serious infections caused by antibiotic-resistant Gram-positive cocci in children pending results of additional studies.
Asunto(s)
Acetamidas/uso terapéutico , Antiinfecciosos/uso terapéutico , Infecciones Comunitarias Adquiridas/tratamiento farmacológico , Hospitalización , Oxazolidinonas/uso terapéutico , Neumonía Bacteriana/tratamiento farmacológico , Acetamidas/administración & dosificación , Acetamidas/efectos adversos , Adolescente , Antiinfecciosos/administración & dosificación , Antiinfecciosos/efectos adversos , Niño , Preescolar , Farmacorresistencia Microbiana , Femenino , Humanos , Lactante , Linezolid , Masculino , Oxazolidinonas/administración & dosificación , Oxazolidinonas/efectos adversos , Factores de TiempoRESUMEN
A program for (1) coordinating the care of patients suspected of abusing prescription medications and (2) providing data on the long-term outcomes of these interventions is described. A substance abuse committee composed of physicians, psychologists, pharmacists, and administrators was established to review individual cases of suspected misuse or abuse of medications at a large Department of Veterans Affairs medical center. After reviewing each case, the committee recommended specific actions, such as requesting that the identified medication be restricted from the patient or that the patient receive counseling or treatment for substance abuse. To evaluate the program's effectiveness, the records of the 161 cases referred to the committee between 1981 and 1992 were reviewed. The patient's outcome one year after committee intervention could be determined in 105 cases. Of those, 70 revealed either no evidence of continuing prescription drug abuse or reduced use of the targeted medication in the medical center. Eighteen other patients were no longer receiving care at the institution. A multidisciplinary substance abuse committee helped identify and treat patients suspected of abusing prescription drugs.
Asunto(s)
Prescripciones de Medicamentos , Comité de Profesionales/organización & administración , Trastornos Relacionados con Sustancias/prevención & control , Control de Medicamentos y Narcóticos , Hospitales de Veteranos/organización & administración , Humanos , Registros Médicos , Oklahoma , Farmacéuticos , Médicos , Factores de Riesgo , Trastornos Relacionados con Sustancias/psicologíaRESUMEN
This article reviews the role of a new depot antipsychotic dosage form, haloperidol decanoate (HD), in relationship to other comparable pharmacotherapies (oral and injectable). The chemistry, indications, contraindications, and pharmacokinetics of HD are discussed. The available clinical research in humans is presented and evaluated with respect to efficacy, adverse effects, and dosing. HD is clearly an effective antipsychotic dosage form. Certainly, HD can improve compliance and possibly outcome for selected patients. HD should be reserved for chronic relapsing schizophrenic patients who have responded to oral haloperidol. Considering the pharmacokinetics, potential risks, and cost of HD, the clinician needs to be prepared with recommendations to effect optimal use of HD (guidelines are presented).