RESUMEN
The aim of this study was to compare bambuterol oral solution (10 mg) administered once daily in the evening with terbutaline oral solution (0.075 mg/kg body weight) administered three times daily in 2-5-year-old children and to compare bambuterol tablets (10 mg or 20 mg) administered once daily in the evening with terbutaline tablets (2.5 mg) administered three times daily in 6-12-year-old children with asthma. The study was of an open, randomized, parallel-group design, and lasted 1 year. The primary objective was to evaluate safety (pulse rate, blood pressure, adverse events, hematology, and clinical chemistry). Plasma terbutaline concentrations were also measured. Evaluation of efficacy (FEV(1)) was a secondary objective. A total of 141 patients (83 boys, 58 girls) were randomized and treated with the study drugs, i.e., 43 patients in the terbutaline group (30 on oral solution and 13 on tablets) and 98 patients in the bambuterol group (62 on oral solution and 36 on tablets). A total of 11 patients discontinued the study: 3 were on terbutaline, and 8 were on bambuterol. There were no clinically important differences between treatment groups regarding pulse rate, or systolic or diastolic blood pressure. There were no clinically important findings in the laboratory tests (hematology and clinical chemistry). Both terbutaline and bambuterol were well-tolerated, and the reported adverse events were mostly mild or moderate. Mean steady state plasma terbutaline concentrations at the visits ranged between 8.0-11.5 nmol/L in the bambuterol tablet group and between 10.6-15.2 nmol/L in the terbutaline tablet group. The corresponding values in children on oral solution were 10.3-11.3 nmol/L in the bambuterol group and 7.5-9.7 nmol/L in the terbutaline group. FEV(1) measured in the 6-12-year-old children increased by more than 0.2 L in both treatment groups during the year in the study. In conclusion, bambuterol tablets or oral solution once daily and terbutaline tablets or oral solution three times daily showed a comparable and favorable safety profile.
Asunto(s)
Asma/tratamiento farmacológico , Broncodilatadores/administración & dosificación , Terbutalina/análogos & derivados , Terbutalina/administración & dosificación , Administración Oral , Asma/fisiopatología , Presión Sanguínea , Broncodilatadores/efectos adversos , Broncodilatadores/farmacología , Niño , Preescolar , Esquema de Medicación , Femenino , Frecuencia Cardíaca , Humanos , Masculino , Terbutalina/efectos adversos , Terbutalina/farmacologíaRESUMEN
The aim of this study was to compare safety and efficacy of bambuterol hydrochloride (10 mg) oral solution administered once daily in the evening with terbutaline sulphate (0.075 mg/kg body weight) oral solution administered three times daily in 2-5-year-old children with asthma. There were two treatment groups: (2/3) of the patients received bambuterol and (1/3) received terbutaline. The study was double-blind, randomized, and of a parallel group design, and it lasted for 3 months after a 2-week run-in period. The primary objective was to evaluate safety (adverse events, and changes in blood pressure, pulse rate, hematology, and clinical chemistry parameters). Plasma concentrations of terbutaline and/or bambuterol were also measured. Evaluation of efficacy (diary card data) was a secondary objective. A total of 155 patients (range, 2-6 years; 3 patients were 6 years old at randomization) were treated with the study drugs; 104 patients received bambuterol and 51 patients received terbutaline. Both treatments showed a good safety profile with respect to clinical and laboratory tests, and they were generally well tolerated. Reported adverse events were mild to moderate. There were no statistically significant differences between treatment groups in any of the efficacy variables (diary variables: peak expiratory flow (PEF), asthma symptoms, restlessness, other reported symptoms, use of inhaled bronchodilators, and nighttime awakenings). For morning PEF, the mean increase from run-in to treatment was 16.9 L/min in the terbutaline group and 23.3 L/min in the bambuterol group. For evening PEF, the mean increase was 20.2 L/min in the terbutaline group and 20.6 L/min in the bambuterol group. In conclusion, once-daily bambuterol is as safe and effective as terbutaline given three times daily. The study also confirmed that bambuterol has a 24-hr duration of action, and therefore its once daily administration, makes it a preferred bronchodilator agent. Pediatr Pulmonol. 2000:29:194-201.
Asunto(s)
Asma/tratamiento farmacológico , Broncodilatadores/uso terapéutico , Profármacos/uso terapéutico , Terbutalina/análogos & derivados , Terbutalina/uso terapéutico , Administración Oral , Asma/fisiopatología , Presión Sanguínea/efectos de los fármacos , Broncodilatadores/administración & dosificación , Broncodilatadores/efectos adversos , Broncodilatadores/sangre , Niño , Preescolar , Ritmo Circadiano , Método Doble Ciego , Esquema de Medicación , Femenino , Frecuencia Cardíaca/efectos de los fármacos , Humanos , Masculino , Registros Médicos , Ápice del Flujo Espiratorio/efectos de los fármacos , Profármacos/administración & dosificación , Profármacos/efectos adversos , Profármacos/análisis , Agitación Psicomotora/fisiopatología , Seguridad , Sueño/fisiología , Terbutalina/administración & dosificación , Terbutalina/efectos adversos , Terbutalina/sangreRESUMEN
We examined all babies born live (4346) at two Finnish hospitals in the course of one year to determine the frequency of birthmarks, specially pigmented lesions, among Finnish newborns. All birthmarks excluding common salmon patches on the forehead and neck were recorded and photographed at birth. The babies were re-examined at the age of three months. Various birthmarks were recorded for 241 of 4346 babies, i.e. for 5.5% of all newborns. Ninety-one (2.1%) infants had congenital pigmented skin lesions, 167 (3.8%) had various vascular lesions and 21 (0.5%) had other birthmarks. The frequency of congenital melanocytic naevi was 1.5%. Most of the naevi were less than 20 mm in diameter. Only one child had a giant naevus. The frequency of congenital naevi in our study was the same or somewhat higher than previously described (1-8) but fewer other pigmented skin lesions were found than in previous studies perhaps due to racial differences.