RESUMO
OBJECTIVE: To compare the efficacy of monthly administrations of the luteinizing hormone-releasing hormone agonists triptorelin pamoate and leuprolide acetate to induce and maintain castrate levels of serum testosterone in men with advanced prostate cancer. PATIENTS AND METHODS: Men with advanced prostate cancer were randomly assigned to receive triptorelin 3.75 mg or leuprolide 7.5 mg. The agent was injected intramuscularly every 28 days for nine injections. Primary endpoints were the percentages of men whose serum testosterone concentrations declined to and were maintained at or below castrate levels (= 1.735 nmol/L or = 500 ng/L) during 9 months (253 days) of treatment. Secondary endpoints were luteinizing hormone levels, bone pain, prostate specific antigen levels, quality of life, testosterone pharmacodynamics, survival, and safety variables. RESULTS: In all, 284 men received either triptorelin (140) or leuprolide (144). The percentage of men with castrate levels of serum testosterone was lower at 29 days for triptorelin than for leuprolide (91.2% vs 99.3%; point estimate - 8.0, 95% confidence interval - 16.9% to - 1.4%), but equivalent at 57 days (97.7% vs 97.1%). The mean (98.8% vs 97.3%) and cumulative (96.2% vs 91.2%) castration maintenance rates between 29 and 253 days were equivalent between the treatment groups. Secondary endpoints were equivalent between treatment groups except for the 9-month survival rate, which was significantly higher for triptorelin than for leuprolide (97.0% vs 90.5%; P = 0.033). Both treatments were well tolerated. CONCLUSION: Triptorelin reduced testosterone concentrations less rapidly, but maintained castration as effectively as leuprolide. There was no evidence that the slower onset of castration caused deleterious effects.
Assuntos
Antineoplásicos Hormonais/administração & dosagem , Hormônio Liberador de Gonadotropina/agonistas , Leuprolida/administração & dosagem , Neoplasias da Próstata/tratamento farmacológico , Testosterona/sangue , Pamoato de Triptorrelina/análogos & derivados , Pamoato de Triptorrelina/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Analgésicos/uso terapêutico , Antineoplásicos Hormonais/efeitos adversos , Castração/métodos , Humanos , Leuprolida/efeitos adversos , Masculino , Pessoa de Meia-Idade , Neoplasias da Próstata/sangue , Análise de Sobrevida , Resultado do Tratamento , Pamoato de Triptorrelina/efeitos adversosRESUMO
A randomized double-blind cross-over study compared the clinical effectiveness of a 14-day treatment with 400 mg X day-1 of sobrerol and placebo in 23 patients with stable chronic bronchial disease. During the seven week trial, subjective symptoms and findings (cough frequency and severity, difficulty in raising sputum, dyspnoea) were recorded, pulmonary function tests performed and sputum physical characteristics (24-h sputum volume, purulence, cell concentration, protein, sputum dry weight and "apparent" viscosity) determined on a regular basis. Side-effects were closely monitored. Both subjective assessment of overall clinical efficacy as well as statistical analysis of the above mentioned factors failed to show any significant advantage of sobrerol to placebo--except for a transient decrease of the 24-h sputum volume. Sobrerol appears to be another example of an expectorant lacking evidence of clinical effectiveness in the management of chronic bronchial secretions.
Assuntos
Broncopatias/tratamento farmacológico , Expectorantes/uso terapêutico , Terpenos/uso terapêutico , Doença Crônica , Ensaios Clínicos como Assunto , Método Duplo-Cego , Feminino , Humanos , Masculino , Distribuição AleatóriaRESUMO
A randomized double-blind crossover study compared the clinical effectiveness of 14-day treatment with 400 mg/day of sobrerol and placebo in 23 patients with stable chronic bronchial disease. In a further open trial phase all patients received 2.0 g glyceringuaiacol per day. During the 9-week trial, subjective symptoms and findings were recorded by numerical code, side-effects listed, pulmonary function tests performed and sputum physical characteristics determined on a weekly basis. Data was statistically analyzed using an analysis of variance adapted from HILLS and ARMITAGE, the Wilcoxon matched-pairs signed-ranks test, the paired t-test and the %2 test. Both subjective assessment of overall clinical efficacy and statistical analysis of the above factors failed to show any significant advantage of sobrerol over placebo. Sputum physical characteristics failed to reveal a significant difference between sobrerol and placebo, with the exception of a temporary reduction in sputum volume (p less than 0.05) on the fourth day of therapy with sobrerol. Similarly, 2.0 g glyceringuaiacol for 14 days failed to influence subjective symptoms, pulmonary function tests or sputum physical characteristics. In conclusion, sobrerol is a further example of an expectorant lacking evidence of clinical effectiveness in the management of bronchial secretions in patients with stable chronic bronchial disease.