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PURPOSE: Communication among healthcare providers, caregivers and children with asthma is challenging and sometimes may exclude the child. This may result in delay in recognizing and responding appropriately to asthma symptoms. The purpose was to test an instrument's subscale for content validity related to communication with the healthcare provider by examining age appropriateness, readability and clarity for children with asthma. DESIGN AND METHODS: This was a mixed method explanatory sequential design to examine age appropriateness, readability and clarity for a 15-item subscale of an instrument for children. The qualitative arm (focus groups) was used to enrich the questionnaire. The sample included children ages 8 to 12 with asthma (N = 25). RESULTS: The perspective of children with asthma provided enriched information to influence the development of instrument subscale on communication. CONCLUSIONS: The subscale revealed internal consistency with Cronbach Alpha 0.85. One of the children reported that using the term "provider" was clearer as oppose to healthcare provider. Children participating in the study found readable and clear. A readability analysis revealed the items were readable at a 6th grade level. PRACTICE IMPLICATION: Although the instrument is designed for primary care providers (physicians, nurse practitioners, physician assistants), the information gained from this pilot increases understanding about including the child in a triadic discussion. Further research will lead to next step toward computing reliability of the full measure and a factor analysis.
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Asma , Actitud Frente a la Salud , Comunicación , Educación del Paciente como Asunto , Relaciones Profesional-Paciente , Niño , Comprensión , Femenino , Grupos Focales , Humanos , Masculino , Proyectos Piloto , PsicometríaRESUMEN
Traditional methods of assessing personality traits in medical school selection have been heavily criticised. To address this at the point of selection, "non-cognitive" tests were included in the UK Clinical Aptitude Test, the most widely-used aptitude test in UK medical education (UKCAT: http://www.ukcat.ac.uk/ ). We examined the predictive validity of these non-cognitive traits with performance during and on exit from medical school. We sampled all students graduating in 2013 from the 30 UKCAT consortium medical schools. Analysis included: candidate demographics, UKCAT non-cognitive scores, medical school performance data-the Educational Performance Measure (EPM) and national exit situational judgement test (SJT) outcomes. We examined the relationships between these variables and SJT and EPM scores. Multilevel modelling was used to assess the relationships adjusting for confounders. The 3343 students who had taken the UKCAT non-cognitive tests and had both EPM and SJT data were entered into the analysis. There were four types of non-cognitive test: (1) libertariancommunitarian, (2) NACE-narcissism, aloofness, confidence and empathy, (3) MEARS-self-esteem, optimism, control, self-discipline, emotional-nondefensiveness (END) and faking, (4) an abridged version of 1 and 2 combined. Multilevel regression showed that, after correcting for demographic factors, END predicted SJT and EPM decile. Aloofness and empathy in NACE were predictive of SJT score. This is the first large-scale study examining the relationship between performance on non-cognitive selection tests and medical school exit assessments. The predictive validity of these tests was limited, and the relationships revealed do not fit neatly with theoretical expectations. This study does not support their use in selection.
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Logro , Personalidad , Criterios de Admisión Escolar/estadística & datos numéricos , Facultades de Medicina/estadística & datos numéricos , Facultades de Medicina/normas , Adolescente , Estudios de Cohortes , Evaluación Educacional , Femenino , Humanos , Juicio , Estudios Longitudinales , Masculino , Valor Predictivo de las Pruebas , Psicometría , Reproducibilidad de los Resultados , Factores Socioeconómicos , Reino Unido , Adulto JovenRESUMEN
Situational Judgment Tests (SJTs) are increasingly used for medical school selection. Scoring an SJT is more complicated than scoring a knowledge test, because there are no objectively correct answers. The scoring method of an SJT may influence the construct and concurrent validity and the adverse impact with respect to non-traditional students. Previous research has compared only a small number of scoring methods and has not studied the effect of scoring method on internal consistency reliability. This study compared 28 different scoring methods for a rating SJT on internal consistency reliability, adverse impact and correlation with personality. The scoring methods varied on four aspects: the way of controlling for systematic error, and the type of reference group, distance and central tendency statistic. All scoring methods were applied to a previously validated integrity-based SJT, administered to 931 medical school applicants. Internal consistency reliability varied between .33 and .73, which is likely explained by the dependence of coefficient alpha on the total score variance. All scoring methods led to significantly higher scores for the ethnic majority than for the non-Western minorities, with effect sizes ranging from 0.48 to 0.66. Eighteen scoring methods showed a significant small positive correlation with agreeableness. Four scoring methods showed a significant small positive correlation with conscientiousness. The way of controlling for systematic error was the most influential scoring method aspect. These results suggest that the increased use of SJTs for selection into medical school must be accompanied by a thorough examination of the scoring method to be used.
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Prueba de Admisión Académica , Juicio , Personalidad , Facultades de Medicina/normas , Adolescente , Femenino , Humanos , Masculino , Grupos Minoritarios , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados , Factores Socioeconómicos , Adulto JovenRESUMEN
BACKGROUND: Widening access to medicine in the UK is a recalcitrant problem of increasing political importance, with associated strong social justice arguments but without clear evidence of impact on service delivery. Evidence from the United States suggests that widening access may enhance care to underserved communities. Additionally, rural origin has been demonstrated to be the factor most strongly associated with rural practice. However the evidence regarding socio-economic and rural background and subsequent practice locations in the UK has not been explored. The aim of this study was to investigate the association between general practitioners' (GPs) socio-economic and rural background at application to medical school and demographic characteristics of their current practice. METHOD: The study design was a cross-sectional email survey of general practitioners practising in Scotland. Socio-economic status of GPs at application to medical school was assessed using the self-coded National Statistics Socio-Economic Classification. UK postcode at application was used to define urban-rural location. Current practice deprivation and remoteness was measured using NHS Scotland defined measures based on registered patients' postcodes. RESULTS: A survey was sent to 2050 Scottish GPs with a valid accessible email address, with 801 (41.5 %) responding. GPs whose parents had semi-routine or routine occupations had 4.3 times the odds of working in a deprived practice compared to those with parents from managerial and professional occupations (95 % CI 1.8-10.2, p = 0.001). GPs from remote and rural Scottish backgrounds were more likely to work in remote Scottish practices, as were GPs originating from other UK countries. CONCLUSION: This study showed that childhood background is associated with the population GPs subsequently serve, implying that widening access may positively affect service delivery in addition to any social justice rationale. Longitudinal research is needed to explore this association and the impact of widening access on service delivery more broadly.
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Actitud del Personal de Salud , Selección de Profesión , Medicina General , Médicos Generales/estadística & datos numéricos , Selección de Personal/métodos , Características de la Residencia , Adulto , Intervalos de Confianza , Estudios Transversales , Femenino , Medicina General/educación , Humanos , Masculino , Área sin Atención Médica , Persona de Mediana Edad , Ubicación de la Práctica Profesional/estadística & datos numéricos , Factores de Riesgo , Población Rural , Facultades de Medicina , Escocia , Factores Socioeconómicos , Recursos HumanosRESUMEN
Multiple Mini Interview (MMI) is a new selection tool for medical school applicants. Developed at McMaster University in 2004 it comprises a series of interview stations designed to measure performance across a range of competencies including communication skills, team work, and ethical reasoning. In September 2012, 109 First Year Medical students underwent the MMI. It consisted of 10 stations. The median total score, out of 150, was 100 (min 63, max 129). Cronbach Alphas for the 10 individual stations range from 0.74 to 0.80. Overall Cronbach Alpha of MMI items was 0.78. Staff and student feedback was positive. The outline cost per student was estimated at Euro 145. This study demonstrates that it is feasible to hold a MMI with acceptable levels of reliability and stakeholder approval in an Irish setting. Further work is ongoing to establish the concurrent and predictive validity of MMI in this cohort of medica students.
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Evaluación Educacional/métodos , Entrevistas como Asunto/métodos , Criterios de Admisión Escolar , Facultades de Medicina/organización & administración , Facultades de Medicina/normas , Estudios de Factibilidad , Femenino , Humanos , Irlanda , MasculinoRESUMEN
A three-dimensional (3D) knee joint computational model was developed and validated to predict knee joint contact forces and pressures for different degrees of malalignment. A 3D computational knee model was created from high-resolution radiological images to emulate passive sagittal rotation (full-extension to 65°-flexion) and weight acceptance. A cadaveric knee mounted on a six-degree-of-freedom robot was subjected to matching boundary and loading conditions. A ligament-tuning process minimised kinematic differences between the robotically loaded cadaver specimen and the finite element (FE) model. The model was validated by measured intra-articular force and pressure measurements. Percent full scale error between FE-predicted and in vitro-measured values in the medial and lateral compartments were 6.67% and 5.94%, respectively, for normalised peak pressure values, and 7.56% and 4.48%, respectively, for normalised force values. The knee model can accurately predict normalised intra-articular pressure and forces for different loading conditions and could be further developed for subject-specific surgical planning.
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Simulación por Computador , Articulación de la Rodilla/anatomía & histología , Modelos Anatómicos , Osteoartritis/cirugía , Algoritmos , Fenómenos Biomecánicos , Cartílago/fisiología , Análisis de Elementos Finitos , Humanos , Articulación de la Rodilla/fisiología , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Presión , Rango del Movimiento Articular , Rotación , Soporte de PesoRESUMEN
BACKGROUND: A previous study has shown that shorter bevacizumab infusions (0.5 mg/kg/min) can be safely administered without increasing the risk of infusion-related hypersensitivity reactions (HSRs). However, the risk of proteinuria and hypertension in patients receiving shorter infusions of bevacizumab is undetermined. PATIENTS AND METHODS: This was a multicenter, prospective, observational study in patients receiving <10 mg/kg of bevacizumab infused over 0.5 mg/kg/min. Patients were observed until discontinuation of bevacizumab for progression of cancer or toxicity. The incidence of hypertension and proteinuria was compared with a prior cohort of patients who had received standard duration infusions of bevacizumab. RESULTS: Sixty-three patients received a total of 392 doses of shorter bevacizumab infusions. Nineteen (30.2%) patients experienced proteinuria while receiving bevacizumab. Out of 19 patients, 13 had grade 1 and 6 had grade 2 proteinuria. None of the patients experienced grade 3 or 4 proteinuria. Hypertension was reported in 32 (50.8%) patients receiving bevacizumab. Twelve (19%) patients developed grade 3 or greater hypertension on bevacizumab. The incidence of proteinuria and hypertension was 38.3% and 56.6%, respectively, in patients (N = 120, 1347 infusions) receiving standard duration infusions of bevacizumab. CONCLUSIONS: Shorter bevacizumab infusions (0.5 mg/kg/min) do not increase the risk of proteinuria and hypertension.
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Anticuerpos Monoclonales Humanizados/administración & dosificación , Neoplasias Colorrectales/tratamiento farmacológico , Hipertensión/patología , Proteinuria/patología , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/efectos adversos , Bevacizumab , Neoplasias Colorrectales/complicaciones , Neoplasias Colorrectales/patología , Progresión de la Enfermedad , Esquema de Medicación , Femenino , Humanos , Hipertensión/inducido químicamente , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Proteinuria/inducido químicamenteRESUMEN
INTRODUCTION: Telephone consulting is increasingly used to improve access to care and optimise resources for day-time work. However, there remains a debate about how such consultations differ from face-to-face consultations in terms of content quality and/or safety. To investigate this, a comparison of family doctors' telephone and face-to-face consultations was conducted. METHODS: 106 audio-recordings (from 19 doctors in nine practices) of telephone and face-to-face consultations, stratified at doctor level, were compared using the Roter Interaction Analysis Scale (RIAS) (content measure), the OPTION (observing patient involvement in decision making scale) and a modified scale based on the Royal College of General Practitioners (RCGP) consultation assessment instrument (measuring quality and safety). Patient satisfaction and enablement were measured using validated instruments. The Roter Interaction Analysis Scale scores were compared by multiple linear regression adjusting for covariates; other continuous measures by chi(2) and Student t tests and binary measures as odds ratios. RESULTS: Telephone consultations were shorter (4.6 vs 9.7 min, p<0.001), presented fewer problems (1.2 vs 1.8, p<0.001) and included less data gathering, counselling/advice and rapport building (all p<0.001) than face-to-face consultations. These differences remained significant when consultation length and number of problems were taken into account. Telephone consultations were judged less likely to include sufficient information to exclude important serious illnesses. Patient involvement and satisfaction outcomes were similar in both consultation types. CONCLUSION: Although telephone consultations are convenient and judged satisfactory by patients and doctors, they may compromise patient safety more than face-to-face consultations and further research is required to elucidate this. Telephone consultations may be more suited to follow-up and management of long-term conditions than for in-hours acute management.
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Consentimiento Informado/normas , Seguridad del Paciente/normas , Médicos de Familia/psicología , Consulta Remota/métodos , Teléfono/estadística & datos numéricos , Adulto , Toma de Decisiones , Femenino , Accesibilidad a los Servicios de Salud , Humanos , Entrevistas como Asunto , Modelos Lineales , Masculino , Satisfacción del Paciente , Médicos de Familia/estadística & datos numéricos , Escocia , Grabación en Cinta , Teléfono/instrumentaciónRESUMEN
The effects of femoral prosthetic heads of diameters 22 and 28 mm were investigated on the stability of reconstructed hemi-pelves with cement mantles of thicknesses 1-4 mm and different bone qualities. Materialise medical imaging package and I-Deas finite element (FE) software were used to create accurate geometry of a hemi-pelvis from CT-scan images. Our FE results show an increase in cement mantle stresses associated with the larger femoral head. When a 22 mm femoral head is used on acetabulae of diameters 56 mm and above, the probability of survivorship can be increased by creating a cement mantle of at least 1 mm thick. However, when a 28 mm femoral head is used, a cement mantle thickness of at least 4 mm is needed. Poor bone quality resulted in an average 45% increase in the tensile stresses of the cement mantles, indicating resulting poor survivorship rate.
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Artroplastia de Reemplazo de Cadera , Índice de Masa Corporal , Prótesis de Cadera , Diseño de Prótesis , Análisis de Elementos Finitos , Humanos , Probabilidad , Resistencia a la Tracción , Tomografía Computarizada por Rayos XRESUMEN
Our survey of current practice among UK orthopaedic surgeons shows wide variations in fixation techniques. The aim of this study, is to investigate the effect of drilling different configurations of anchorage holes in the acetabulum on implant stability. To avoid variables that could incur during in vitro testing, we used commercially available COSMOS finite element analysis package to investigate the stress distributions, deformations, and strains on the cement mantle when drilling three large anchorage holes and six smaller ones, with straight and rounded cement pegs. The results, which are in line with our in vitro studies on simulated reconstructed acetabulae, indicate better stability of the acetabular component when three larger holes than six smaller holes are drilled and when the necks of the anchorage holes are rounded. The longevity of total hip replacements could be improved by drilling three large anchorage holes, rather than many smaller ones, as initially proposed by Charnley.
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Acetábulo/fisiopatología , Acetábulo/cirugía , Artroplastia de Reemplazo de Cadera/instrumentación , Artroplastia de Reemplazo de Cadera/métodos , Cementación/métodos , Análisis de Falla de Equipo/métodos , Modelos Biológicos , Adhesividad , Simulación por Computador , Análisis de Elementos Finitos , Humanos , Diseño de Prótesis , Falla de Prótesis , Resultado del TratamientoRESUMEN
If it is accepted that new doctors must be 'Fit to Practice' in a standard clinical house job, they should be competent in basic communication skills. Although these skills may be assessed as part of a routine OSCE-style exam in the course of the curriculum, the question is raised whether students who fail to demonstrate a minimal level of competence in this area should to be allowed to progress to the next stage of the course and eventually graduate. This paper describes our experiences with introducing 'barrier' stations in communication skills into the OSCE. Students who failed these stations, irrespective of their overall exam performance, undertook remedial studies in a compulsory two-week directed study module followed by a four-station OSCE.
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Competencia Clínica , Comunicación , Educación de Pregrado en Medicina , Reentrenamiento en Educación Profesional , Evaluación Educacional , Derivación y Consulta , Estudiantes de Medicina , HumanosRESUMEN
OBJECTIVE: Taxanes are commonly used anticancer agents with a potential of producing an allergic or hypersensitivity reaction (HSR). We performed a randomized study to evaluate the value of a test dose given prior to the full dose of either paclitaxel or docetaxel. RESEARCH DESIGN AND METHODS: Patients were randomly assigned to either the administration of the full dose or to the prior administration of a 1 mg intravenous test dose of either paclitaxel or docetaxel. The primary endpoints were severity of the HSR and the cost of drug wastage due to a HSR. RESULTS: Two hundred and eighteen patients were randomized from three different treatment sites. The overall incidence of HSR was 6.5% and there was no significant difference in the incidence of HSR in either group. The mean HSR severity grade was 2.8 for patients without a test dose and 2.3 for those receiving a test dose. There was, however, a reduction in the wastage of taxane in the test dose arm. Wastage avoided in the test dose arm was $1573 per patient who had a HSR and $104 per patient treated with a taxane. CONCLUSION: Although a test dose may not reduce the severity of a HSR with the administration of a taxane, it does reduce the cost associated with drug wastage.
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Antineoplásicos Fitogénicos/administración & dosificación , Taxoides/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Control de Costos , Docetaxel , Hipersensibilidad a las Drogas/etiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/tratamiento farmacológico , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Taxoides/efectos adversos , Taxoides/economíaRESUMEN
Current theatre practice and protocol involves the use of pressure sore prevention pads in the positioning and support of all patients undergoing orthopaedic surgery. Microbiological swabs were taken from those pads placed adjacent to the operative field immediately before implant surgery. Eleven out of the 13 pads sampled yielded bacterial growth capable of causing deep-seated infection. The transfer of these pads between the designated orthopaedic theatres and the rest of the theatre complex was also noted. We recommend that the use of these pads should be closely reviewed. They should either be used with stricter guidelines for decontamination between use or disposable 'clean' alternatives sought.
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Contaminación de Equipos , Equipo Ortopédico/microbiología , Úlcera por Presión/prevención & control , Ropa de Cama y Ropa Blanca/microbiología , Infección Hospitalaria/prevención & control , Humanos , QuirófanosRESUMEN
This study aims to demonstrate that postoperative immobilisation in a cast is unnecessary following suture repair of the patella tendon and retinacula protected by a cerlage wire. We present 11 patients mean age 42 years evaluated at a mean of 26 months (range 14-38 months). The mean Lysholm knee score at review was 97 (range 92-100). The mean Insall Salvati measurement (length patella/length tendon (LP/LT)) was 1 (range 0.95-1.1). No patients had fixed flexion deformities or demonstrated an extensor lag and the average range of motion was 0-137 degrees. The difference between the operated and control knee at the time of assessment was: a mean loss of power of 6% (range 2-11) when measuring concentric extension and a mean loss of 7% power (range 13 to an increase of 12) in concentric flexion. We conclude that primary repair protected with a cerlage wire and early mobilisation gives excellent results in the treatment of isolated traumatic patella tendon ruptures and cast immobilisation postoperatively is not required.
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Ambulación Precoz , Traumatismos de la Rodilla/cirugía , Rótula/lesiones , Traumatismos de los Tendones/cirugía , Adulto , Hilos Ortopédicos , Moldes Quirúrgicos , Humanos , Traumatismos de la Rodilla/rehabilitación , Articulación de la Rodilla/fisiopatología , Masculino , Persona de Mediana Edad , Rótula/cirugía , Rango del Movimiento Articular , Estudios Retrospectivos , Rotura/cirugía , Traumatismos de los Tendones/rehabilitación , Resultado del TratamientoRESUMEN
Previous finite element studies and laboratory investigations on reconstructed acetabulum joints show that long-term fixation of the acetabular cup in total hip replacements (THRs) is influenced by surgical fixation techniques. The aim of this study is to determine and understand the reasons of current practice in the cement fixation of the acetabular cup in THRs in the UK. Following a pilot study, a postal survey was carried out among 1350 orthopaedic consultants. Response rate was 40% and data obtained from the returned questionnaires provided information about the current practice of 431 consultants with an average of 16.5 years of experience and who perform an average of 55 cemented THR operations annually. The survey showed wide variations in the fixation methods of the acetabular component. 95% of the respondents use cement to fix the acetabular cup, 46% maintain the subchondral bone and 63% use a flanged acetabular cup. The numbers of anchorage holes drilled vary from zero to thirty-six and drill diameters vary from 2 to 15 mm. Anchorage hole depths vary from 3 to 20 mm. Given the variability of surgical fixation methods, further studies need to be carried out to determine how fixation techniques could be improved to increase the longevity of the acetabular component in THRs. Further investigations could lead to a better understanding of the factors that contribute to the stability of THRs. (Hip International 2004; 14: 155-62).
RESUMEN
The physical demand of the modern game of cricket on the fast bowler is known to cause stress fractures of the lumbar spine. Between 1983 and 2001, we diagnosed pars interarticularis defects in 18 professional cricketers contracted to a single English County Cricket Club. Eight of these players were treated conservatively, with rest, supervised rehabilitation, bowling action analysis and re-education where necessary. The remaining 10 were treated operatively, 9 by Buck's repair of the spondylolytic lesion. All 18 players returned to professional sport.We recommend treatment of this select group of sportsmen in a unit consisting of a specialist physiotherapist, a bowling coach and a spinal surgeon. Should conservative measures fail, we recommend Buck's repair as the operation of choice.
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Traumatismos en Atletas/rehabilitación , Fracturas por Estrés/etiología , Vértebras Lumbares/lesiones , Enfermedades Profesionales/rehabilitación , Fracturas de la Columna Vertebral/etiología , Adolescente , Adulto , Traumatismos en Atletas/diagnóstico por imagen , Traumatismos en Atletas/cirugía , Estudios de Seguimiento , Fijación de Fractura/métodos , Fracturas por Estrés/diagnóstico por imagen , Fracturas por Estrés/rehabilitación , Humanos , Vértebras Lumbares/diagnóstico por imagen , Masculino , Enfermedades Profesionales/cirugía , Modalidades de Fisioterapia , Fracturas de la Columna Vertebral/diagnóstico por imagen , Fracturas de la Columna Vertebral/rehabilitación , Tomografía Computarizada por Rayos XRESUMEN
The purpose of this study was to characterize the pharmacokinetics of gemtuzumab ozogamicin (Mylotarg; Wyeth-Ayerst Laboratories, St. Davids, PA) in patients with acute myeloid leukemia (AML) in first relapse. Gemtuzumab ozogamicin is an antibody-chemotherapeutic conjugate characterized as antibody-targeted chemotherapy, consisting of an engineered human anti-CD33 antibody (hP67.6) linked to a potent cytotoxic agent, N-acetyl-gamma calicheamicin DMH. The pharmacokinetics of gemtuzumab ozogamicin was evaluated in 59 adult AML patients in first relapse, enrolled in a phase II study. Plasma was collected following each dose at specified times, and the pharmacokinetics was characterized by measures of hP67.6, total calicheamicin derivatives, and unconjugated calicheamicin derivatives. After administration of the first 9 mg/m2 dose of gemtuzumab ozogamicin, the pharmacokinetic parameters (mean +/- SD) of hP67.6 following the first dose were as follows: peak plasma concentration, 2.86 +/- 1.35 mg/L; AUC, 123 +/- 105 mg x h/L; t 1/2, 72.4 +/- 42.0 hours; and clearance, 0.265 +/- 0.229L/h. Increased concentrations were observed after the second dose and are believed to be due to a decrease in clearance by CD33-positive blast cells, a result of the reduced tumor burden following the first dose. The concentration profiles of calicheamicin followed the same time course as hP67.6, evidence that calicheamicin remained conjugated to the antibody and delivered to leukemic cells. No relationship was found between plasma concentration and response at the recommended dose. The pharmacokinetics of gemtuzumab ozogamicin has been characterized in AML patients receiving doses at the proposed therapeutic level.
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Aminoglicósidos , Antibacterianos/farmacocinética , Anticuerpos Monoclonales/farmacocinética , Antígenos CD/metabolismo , Antígenos de Diferenciación Mielomonocítica/metabolismo , Inmunotoxinas/farmacocinética , Leucemia Mieloide/metabolismo , Enfermedad Aguda , Adulto , Anciano , Anciano de 80 o más Años , Antibacterianos/sangre , Antibacterianos/química , Antibióticos Antineoplásicos/sangre , Antibióticos Antineoplásicos/farmacocinética , Anticuerpos Monoclonales/sangre , Anticuerpos Monoclonales/química , Anticuerpos Monoclonales Humanizados , Antineoplásicos/uso terapéutico , Área Bajo la Curva , Moléculas de Adhesión Celular/metabolismo , Enediinos , Femenino , Gemtuzumab , Humanos , Inmunotoxinas/sangre , Inmunotoxinas/química , Infusiones Intravenosas , Leucemia Mieloide/tratamiento farmacológico , Leucemia Mieloide/prevención & control , Masculino , Glicoproteínas de Membrana/metabolismo , Tasa de Depuración Metabólica , Persona de Mediana Edad , Modelos Biológicos , Recurrencia , Lectina 3 Similar a Ig de Unión al Ácido SiálicoRESUMEN
STUDY OBJECTIVE: To determine the pharmacokinetic parameters of the components of gemtuzumab ozogamicin and to assess the possible influence of age and gender on the values. DESIGN: Phase II, multicenter, open-label, nonrandomized, parallel study SETTING: Hospitals and outpatient oncology clinics. PATIENTS: Fifty-eight patients with acute myeloid leukemia in first relapse participated. Demographic data included 29 men and 29 women; 34 were younger than 60 years of age (mean age 53+/-16 yrs). INTERVENTION: Patients received gemtuzumab ozogamicin as a single 2-hour infusion of 9 mg/m2. Serial plasma samples were collected over 10 days after the beginning of the infusion. MEASUREMENTS AND MAIN RESULTS: Plasma concentrations of components of gemtuzumab ozogamicin (hP67.6 antibody, total and unconjugated calicheamicin derivatives) were measured by validated enzyme-linked immunosorbent assays. Pharmacokinetic parameters were determined by noncompartmental methods and comparisons between groups were made by analysis of variance. No significant differences were seen between men and women or between those over 60 and those less than 60 years of age in maximum concentration, time to maximum concentration, area under the curve, clearance, or volume of distribution for components of gemtuzumab ozogamicin. CONCLUSION: No differences occur in the pharmacokinetics of the components of gemtuzumab ozogamicin (hP67.6 or calicheamicin) based on gender or age.