RESUMO
INTRODUCTION: The aim of the study is to test whether nizatidine delivered via a unique bimodal pulsatile-controlled release system, nizatidine controlled release (CR), accelerates gastric emptying in patients with gastroesophageal reflux disease (GERD). METHODS: Combined data were analyzed on 39 patients with delayed gastric emptying (DGE) from 2 studies (n = 84) assessing the prokinetic effect of nizatidine CR. A single-blind placebo baseline was followed by double-blind nizatidine CR (150 and 300 mg) in randomized sequence, 2 to 5 days apart. Each dose was followed 1 hour later by an egg-beater meal, labeled with Tc99m. Gamma camera images were obtained at meal completion, 1-, 2-, 3- and 4-hour postmeal. All the 84 patients were classified at baseline with DGE (gastric retention >6.3% at 4 hours) or normal gastric emptying. RESULTS: In the 39 patients identified with DGE, change from placebo baseline (CFB) for percent gastric retention at 4-hour postmeal with nizatidine CR (150 and 300 mg) was each improved and statistically significant (P < 0.05). In a subgroup of diabetic patients with DGE (n = 10), the CFB with nizatidine CR (300 mg) was significant (P < 0.05) at 3- and 4-hour postmeal. CONCLUSIONS: Nizatidine CR (150 and 300 mg) significantly enhanced gastric emptying of a standard meal in patients with GERD with DGE.
Assuntos
Refluxo Gastroesofágico/tratamento farmacológico , Antagonistas dos Receptores H2 da Histamina/administração & dosagem , Nizatidina/administração & dosagem , Estudos Cross-Over , Preparações de Ação Retardada , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Esvaziamento Gástrico/efeitos dos fármacos , Refluxo Gastroesofágico/diagnóstico por imagem , Humanos , Masculino , Cintilografia , TecnécioRESUMO
GOALS: This double-blind, multicenter study evaluated the safety and efficacy of intravenous fospropofol (6.5 mg/kg vs. 2 mg/kg) for moderate sedation in patients undergoing colonoscopy. METHODS: In all, 314 patients >or=18 years (American Society of Anesthesiologists PS1 to PS3) were randomized to receive fospropofol 2 mg/kg, fospropofol 6.5- mg/kg, or midazolam 0.02 mg/kg, after pretreatment with intravenous fentanyl 50 mcg. Supplemental doses of study medication were permitted to achieve a Modified Observer's Assessment of Alertness/Sedation scale score Assuntos
Colonoscopia/métodos
, Hipnóticos e Sedativos/uso terapêutico
, Midazolam/uso terapêutico
, Propofol/análogos & derivados
, Adulto
, Idoso
, Período de Recuperação da Anestesia
, Anestésicos Intravenosos/uso terapêutico
, Relação Dose-Resposta a Droga
, Método Duplo-Cego
, Feminino
, Fentanila/uso terapêutico
, Humanos
, Hipnóticos e Sedativos/administração & dosagem
, Hipnóticos e Sedativos/efeitos adversos
, Masculino
, Memória/efeitos dos fármacos
, Midazolam/efeitos adversos
, Pessoa de Meia-Idade
, Propofol/administração & dosagem
, Propofol/efeitos adversos
, Propofol/uso terapêutico
, Resultado do Tratamento