RESUMEN
PURPOSE: To evaluate the learning curve for an add-on 14 G stereotactic core needle biopsy (SCNB). MATERIAL AND METHODS: A total of 231 non-palpable breast lesions that had undergone add-on SCNB were evaluated in this prospective study. Five radiologists performed their first three biopsies under supervision. Subsequent, independently performed, biopsies were also evaluated. The samples were collected in three different containers: the first sample in container A, the second and third samples in container B, and subsequent samples in container C (available for four radiologists from the first biopsy on). Technically successful biopsies and false-negative rate in three container combinations (A, A+B, A+B+C) were reported as a function of operator experience. RESULTS: Technically unsuccessful biopsies occurred significantly more often in microcalcifications than in masses (14.9% versus 3.8%; P=0.04). For microcalcifications, the rate of successful biopsies was 75% (18/24) for the first 5 biopsies and 87.8% (79/90) for the subsequent biopsies (P=0.335); rates for the masses were 95.7% (22/23) and 96.3% (79/82) (P=1.0), respectively. A tendency was noted for the false-negative rate to be higher for the first five biopsies in three container combinations than in subsequent cases. CONCLUSION: Our results support the existence of a learning curve, especially in the biopsy of microcalcifications. More than three mentor-guided biopsies are needed.
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Biopsia con Aguja , Mama/patología , Biopsia con Aguja/métodos , Calcinosis , Reacciones Falso Positivas , Humanos , Estudios ProspectivosRESUMEN
The aim of this study was to compare high-resolution computed tomography (HRCT) findings of long-term farmer's lung (FL) patients and control farmers. We studied 88 FL patients and 83 matched control farmers with a mean follow-up time of 14 years. Emphysematous, fibrotic, and miliary changes were recorded by HRCT. The pattern of emphysema and location and distribution of other findings were evaluated in detail. Emphysema was found in 20 (23%) FL patients and in 6 (7%) controls (p=0.005). Recurrences of FL attacks increased (p=0.021) the risk of emphysema. Prevalence of fibrosis (17 vs 10%, p=0.16) and miliary changes (11 vs 4%, p=0.06) did not differ significantly in patients and controls. Among FL patients, emphysematous, fibrous, and miliary changes were more pronounced at the base than in the upper parts of the lung (p<0.02). In slice analysis, the pattern of emphysema was more polymorphous (p=0.001) and the distribution of fibrotic and miliary changes was more variable among FL patients than controls. Emphysema in HRCT is more common in FL patients than matched control farmers, and the occurrence is increased by recurrences of FL. Emphysematous, fibrous, and miliary changes in FL patients HRCT are multiform and predominate in the lower parts of the lung.
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Pulmón de Granjero/diagnóstico por imagen , Tomografía Computarizada por Rayos X , Adulto , Anciano , Pulmón de Granjero/complicaciones , Pulmón de Granjero/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Enfisema Pulmonar/epidemiología , Enfisema Pulmonar/etiología , Fibrosis Pulmonar/epidemiología , Fibrosis Pulmonar/etiología , Factores de TiempoRESUMEN
The objective of this multicenter study was to compare the clinical efficacy, safety, and acceptability of Easyhaler and Turbuhaler for the delivery of budesonide 200 micrograms/dose twice daily in steroid-naïve asthmatic patients. Three hundred and twenty-six newly diagnosed, steroid-naïve adult patients with mild-to-moderate asthma were recruited into this randomized, double-blind, double-dummy, parallel-group study, comprising a 2-week run-in period and 8 weeks of treatment. Patients received budesonide inhalation powder 400 micrograms/day either via Easyhaler (n = 159) or via Turbuhaler (n = 167), plus salbutamol inhalation powder (100 micrograms/dose) via Easyhaler as rescue therapy. The study was completed by 292 patients: 143 in the Easyhaler group and 149 in the Turbuhaler group. The primary outcome variable, mean morning peak expiratory flow (PEF), improved significantly and almost similarly by 36.3 and 30.6 l/min, respectively, from run-in to weeks 7-8. At weeks 7-8, the mean (SE) difference in morning PEF between the two treatments was 7.1 (9.4) l/min (90% CI from -8.4 to 22.6) on per protocol analysis, which was within the defined limits for therapeutic equivalence. There were no significant differences between treatments in terms of secondary efficacy variables or adverse events. However, patients found Easyhaler more acceptable than Turbuhaler. The results show that budesonide via Easyhaler is clinically as effective as Pulmicort Turbuhaler when equal daily doses of budesonide are delivered to steroid-naïve asthmatic patients. Moreover, patients found Easyhaler more acceptable than Turbuhaler, and a majority would prefer Easyhaler if given a choice.
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Asma/tratamiento farmacológico , Broncodilatadores/administración & dosificación , Budesonida/administración & dosificación , Administración por Inhalación , Adulto , Método Doble Ciego , Femenino , Volumen Espiratorio Forzado/fisiología , Humanos , Masculino , Satisfacción del Paciente , Ápice del Flujo Espiratorio/fisiología , Resultado del Tratamiento , Capacidad Vital/fisiologíaRESUMEN
PURPOSE: We evaluated the reproducibility of three visual scoring methods of emphysema and compared these methods with pulmonary function tests (VC, DLCO, FEV1 and FEV%) among farmer's lung patients and farmers. MATERIAL AND METHODS: Three radiologists examined high-resolution CT images of farmer's lung patients and their matched controls (n=70) for chronic interstitial lung diseases. Intraobserver reproducibility and interobserver variability were assessed for three methods: severity, Sanders' (extent) and Sakai. Pulmonary function tests as spirometry and diffusing capacity were measured. RESULTS: Intraobserver kappa-values for all three methods were good (0.51-0.74). Interobserver kappa varied from 0.35 to 0.72. The Sanders' and the severity methods correlated strongly with pulmonary function tests, especially DLCO and FEV1. CONCLUSION: The Sanders' method proved to be reliable in evaluating emphysema, in terms of good consistency of interpretation and good correlation with pulmonary function tests.
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Pulmón de Granjero/diagnóstico por imagen , Enfisema Pulmonar/diagnóstico por imagen , Reproducibilidad de los Resultados , Tomografía Computarizada por Rayos X , Percepción Visual , Anciano , Pulmón de Granjero/complicaciones , Pulmón de Granjero/fisiopatología , Femenino , Humanos , Pulmón/diagnóstico por imagen , Pulmón/fisiopatología , Masculino , Persona de Mediana Edad , Enfisema Pulmonar/etiología , Enfisema Pulmonar/fisiopatología , Pruebas de Función Respiratoria , Índice de Severidad de la EnfermedadRESUMEN
The main objective of this study was to show dose-dependent equivalence in the systemic activity of budesonide 800 microg day(-1) and 1600 microg day(-1) delivered from either Easyhaler or Turbuhaler in healthy male subjects. This single-centre study was carried out according to a randomized, double-blind, double-dummy, five-way crossover design over a 9-week period. All subjects received 1 week of treatment with the following, in randomized order, with a washout week between each treatment: budesonide Easyhaler 800 microg day(-1) plus placebo Turbuhaler; budesonide Easyhaler 1600 microg day(-1) plus placebo Turbuhaler; placebo Easyhaler plus Pulmicort Turbuhaler 800 microg day(-1); placebo Easyhaler plus Pulmicort Turbuhaler 1600 microg day(-1); placebo Easyhaler plus placebo Turbuhaler. The final inhalation of study drug was performed at the study centre, where blood and urine samples were collected. Fifteen subjects were recruited and all completed the study. Mean serum cortisol AUC0-20 values (the primary outcome variable) were comparable for each device at the two dose levels, and met the defined criteria for equivalence (90% CI 0.8-1.25 for between-treatment difference). Budesonide 800 microg day(-1) caused minimal suppression of serum cortisol AUC0-20 values, Budesonide 1600 microg day(-1) statistically significantly suppressed serum cortisol AUC0-20 values compared with placebo. Mean morning serum cortisol values were within the reference range in al treatment groups. At a budesonide dose of 800 microg day(-1) mean urine cortisol/creatinine ratio was statistically significantly higher with Easyhaler than with Turbuhaler, but there was no significant difference between the devices at the 1600 microg day(-1) dose. Serum budesonide concentrations were equivalent for each device at both dose levels. Adverse drug reactions were infrequent and mild in nature and there were no clinically significant changes in laboratory safety variables. In conclusion, in healthy male volunteers, budesonide 800 microg day(-1) and 1600 microg day inhaled from Easyhaler had comparable systemic effects to the same doses inhaled via Turbuhaler.
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Antiasmáticos/farmacología , Budesonida/farmacología , Nebulizadores y Vaporizadores , Adolescente , Adulto , Análisis de Varianza , Antiasmáticos/administración & dosificación , Área Bajo la Curva , Budesonida/administración & dosificación , Intervalos de Confianza , Creatinina/orina , Estudios Cruzados , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Diseño de Equipo , Humanos , Hidrocortisona/sangre , Masculino , Equivalencia TerapéuticaRESUMEN
OBJECTIVE: The objective of this study was to compare the systemic effects of a moderate dose (800 microg/day) with the highest recommended dose (1600 microg/day) of beclomethasone dipropionate (BDP) inhaled via either Easyhaler or Diskhaler in 15 healthy adult male volunteers. METHODS: This was an open, placebo-controlled, randomised study conducted according to a crossover design and consisting of a 1-week baseline period and five 1-week treatment periods, each separated by a 1-week washout period. Subjects received in randomised order 800 microg/day BDP via Easyhaler, 1600 microg/day BDP via Easyhaler, placebo via Easyhaler, 800 microg/day BDP via Diskhaler and 1600 microg/day BDP via Diskhaler. Subjects inhaled BDP twice daily at 0800 hours and 2000 hours. The last dose of each period was inhaled at the study site. Venous blood samples were drawn prior to and at 2-hour intervals for 20 h after the last dose. Serum cortisol area under the curve (AUC0-20) and morning serum cortisol values were determined using radioimmunoassay. Urine for analysis of urine cortisol/creatinine ratios (UCC) was collected over a 12-h period after the last dose of each treatment period. RESULTS: According to serum cortisol values, no systemic effects were detected with BDP 800 microg/day inhaled via Easyhaler. The mean (+/-SD) change in serum cortisol AUC0-20 was +118.3+/-1391 nmol h/l compared with placebo. Mean (SD) changes from placebo in serum cortisol AUC0-20 values after BDP 1600 microg/day were--546.3+/-1004 nmol h/l with Easyhaler and -769.3+/-596 nmol h/l with Diskhaler. However, there were no statistically significant differences in systemic bioactivity between the active treatments. Morning serum cortisol levels and UCC ratios were consistent with the serum cortisol AUC0-20 data. CONCLUSIONS: In conclusion, BDP 800 microg/day inhaled via Easyhaler did not reduce serum cortisol AUC0-20 compared with placebo. Although the decrease in hypothalamic pituitary-adrenal (HPA) axis function after BDP 1600 microg/day was statistically significant compared with placebo, the reduction was small and similar with both devices.