RESUMO
INTRODUCTION: Antacids are commonly used during pregnancy, and they are approved for the relief of symptoms of gastroesophageal reflux disease (GERD) during pregnancy. However, there are no reports of the quantification of the absorption of aluminum and magnesium in the antacid magaldrate in women. The aim of this study was to quantify the rate and magnitude of absorption of aluminum and magnesium in magaldrate. METHODS: An open-label, controlled, randomized, one-treatment study with a two-group design was conducted in healthy women in a fed state. The volunteers had a standard breakfast, and 30 min later, they were given a single-medication sachet containing 500 mg of sodium alginate, 267 mg of sodium bicarbonate, 800 mg of magaldrate, and 120 mg of simethicone (group A, n = 8) or no medication (group B, n = 2). Blood samples were obtained 36 h before and up to 12 h after antacid administration. The method used for quantification was inductively coupled plasma-mass spectrometry. RESULTS: There was no absorption of aluminum in any of the blood samples from the healthy volunteers who received the drug or in those from the control group. Magnesium was detected at normal concentrations. CONCLUSION: These findings suggest that the use of this antacid is safe and without risk in healthy women, including pregnant women. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov registration: NCT06367452.
Assuntos
Alumínio , Antiácidos , Magnésio , Humanos , Feminino , Antiácidos/administração & dosagem , Adulto , Magnésio/administração & dosagem , Alumínio/administração & dosagem , Administração Oral , Adulto Jovem , Hidróxido de Alumínio/administração & dosagem , Hidróxido de Magnésio/administração & dosagem , Bicarbonato de Sódio/administração & dosagem , Combinação de Medicamentos , Alginatos/administração & dosagem , Simeticone/administração & dosagemRESUMO
BACKGROUND AND AIM: Upper GI endoscopy (UGE) is essential for the diagnosis of gastrointestinal diseases. Mucus and bubbles may decrease mucosal visibility. The use of mucolytics could improve visualization. Our aim was to determine whether premedication with simethicone or simethicone plus N-acetylcysteine is effective in improving visibility during UGE. METHODS: This was a randomized, double-blinded, placebo-controlled trial with 2 control groups: no intervention and water 100 mL (W); and 3 intervention groups: simethicone 200 mg (S); S + N-acetylcysteine (NAC) 500 mg (S+NAC500); and S + NAC 1000 mg (S+NAC1000). The solution was ingested 20 minutes before UGE. Gastric visibility was evaluated in 4 segments with a previously described scale. A score of less than 7 points was defined as adequate visibility (AV). Water volume was used to improve visibility, and adverse reactions were evaluated as a secondary outcome. Multiple group comparison was performed using non-parametric one-way analysis of variance (ANOVA). RESULTS: Two hundred thirty patients were included in the study, 68% female, mean age 49 years. The most common indication for UGE was epigastric pain/dyspepsia (33%). AV was more frequent in the S+NAC500 and S+NAC1000 groups (65% and 67%) compared with no intervention (44%, P = .044) and water (41%, P = .022). The gastric total visibility scale (TVS) was significantly better in the S+NAC500 and S+NAC1000 groups compared with water (P = .03 and P = .008). Simethicone was not different from no intervention and water. S+NAC1000 required less water volume to improve visibility. No adverse reactions from the study drugs were observed. CONCLUSIONS: Premedication with S+NAC500 and S+NAC1000 improves visibility during UGE. The use of simethicone did not show improvements in gastric visibility. TVS was worse in patients using water alone. (Clinical trial registration number: NCT 01653171.).
Assuntos
Acetilcisteína/administração & dosagem , Antiespumantes/administração & dosagem , Endoscopia Gastrointestinal/métodos , Expectorantes/administração & dosagem , Mucosa Gástrica/diagnóstico por imagem , Simeticone/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Gastropatias/diagnóstico por imagem , Água/administração & dosagemRESUMO
Presence of significant quantities of gas in the intestines may hinder a proper conduction of abdominal ultrasonography. In humans, preparatory techniques are used to solve this, but measures to avoid ultrasonographic complications due to intestinal gas in rabbits have not been reported. The objective of this study was to evaluate the influence of fasting and simethicone administered orally on the quality of ultrasonographic images of the gallbladder, kidneys, and jejunum in adult New Zealand White (NZW) rabbits. A total of 28 adult NZW rabbits were included in a crossover design study, involving four groups: F: fasting for 4-6 h before the examination; FS: fasting and application of simethicone (20 mg/kg, orally) 20 to 30 min before the examination; S: application of simethicone 20-30 min before the examination without fasting; and C: controls without fasting and no application of simethicone. Evaluation of the ultrasonographic images was done in terms of percentage of visualization of each organ and image quality using a 3-point scoring system (unacceptable, acceptable, or excellent). The kidneys and the gallbladder were visualized at an equal frequency in all groups, while the jejunum was visualized more frequently in the FS group. The image quality scores for gallbladder, right kidney, and left kidney was similar for all groups, but for the jejunum, a higher number of images with acceptable scores was found within the FS group.