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1.
Eur J Gastroenterol Hepatol ; 30(7): 709-717, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29642094

RESUMEN

BACKGROUND: In physically less fit patients and patients requiring repeated exams, adequate bowel preparation for colonoscopy remains problematic, particularly because patients need to drink large volumes of unpleasant-tasting fluids. A further concern is potential unwarranted fluid shifts. AIMS: This study aimed to compare the safety and burden of a small-volume sodium picosulphate/magnesium citrate preparation (SPS-MC) with a 2-l ascorbic-acid-enriched polyethylene glycol solution plus bisacodyl pretreatment (PEG-Asc+B). PATIENTS AND METHODS: Patients referred for colonoscopy were randomized to SPS-MC or PEG-Asc+B administered as a split-dose regimen. Patients received advice on the recommended 4-l SPS-MC and 2-l PEG-Asc+B fluid intake. Safety was assessed by blood sampling before and after the preparation and during a 30-day follow-up period. A questionnaire assessed tolerability and perceived burden of the preparation. RESULTS: A total of 341 patients underwent colonoscopy. Blood sampling showed a slight but significant decrease in sodium, chloride and osmolality and increase in magnesium in the SPS-MC group and a decrease in bicarbonate in the PEG-Asc+B group. Hyponatraemia and hypermagnesaemia without clinical signs were observed in 16 (14 SPS-MC) and 13 SPS-MC patients, respectively. Patients reported significantly fewer physical complaints and a significantly higher completion rate with SPS-MC. Patients receiving SPS-MC rated the intake as being easier and better tasting. In the event of a repeat colonoscopy, 59.7% of patients in the PEG-Asc+B and 93.6% of patients in the SPS-MC group would opt for the same preparation again. CONCLUSION: Despite electrolyte shifts, both SPS-MC and PEG-Asc+B appeared clinically safe. From a patient's perspective, a small-volume preparation formula such as SPS-MC is preferred, resulting in fewer physical complaints and greater ease of intake.


Asunto(s)
Ácido Ascórbico/administración & dosificación , Bisacodilo/administración & dosificación , Catárticos/administración & dosificación , Citratos/administración & dosificación , Ácido Cítrico/administración & dosificación , Colon/efectos de los fármacos , Colonoscopía , Compuestos Organometálicos/administración & dosificación , Picolinas/administración & dosificación , Polietilenglicoles/administración & dosificación , Irrigación Terapéutica/métodos , Administración Oral , Adulto , Anciano , Ácido Ascórbico/efectos adversos , Biomarcadores/sangre , Bisacodilo/efectos adversos , Catárticos/efectos adversos , Citratos/efectos adversos , Ácido Cítrico/efectos adversos , Colon/patología , Esquema de Medicación , Combinación de Medicamentos , Femenino , Transferencias de Fluidos Corporales/efectos de los fármacos , Humanos , Hiponatremia/sangre , Hiponatremia/inducido químicamente , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Países Bajos , Compuestos Organometálicos/efectos adversos , Satisfacción del Paciente , Soluciones Farmacéuticas , Picolinas/efectos adversos , Polietilenglicoles/efectos adversos , Irrigación Terapéutica/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Equilibrio Hidroelectrolítico/efectos de los fármacos
2.
Dis Colon Rectum ; 61(2): 239-249, 2018 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-29337780

RESUMEN

BACKGROUND: Because of its volume, adequate bowel preparation remains problematic in physically unfit patients. OBJECTIVE: This study aimed to compare a small-volume sodium picosulfate/magnesium citrate preparation with a 2-L ascorbic acid-enriched polyethylene glycol solution plus bisacodyl. DESIGN: This study has a noninferiority design, assuming that ascorbic acid-enriched polyethylene glycol solution plus bisacodyl is 70% efficacious in achieving an Ottawa score ≤7 and accepting a difference in success rate of <15% with a target enrollment of 146 patients per group. SETTING: This study was conducted in an outpatient department. PATIENTS: Patients referred for diagnostic colonoscopy were randomly assigned. Key exclusion criteria were severe kidney disease, ASA class ≥III, and hospital admission. INTERVENTION: Patients were randomly assigned to receive sodium picosulfate/magnesium citrate or ascorbic acid-enriched polyethylene glycol solution plus bisacodyl according to a split-dose regimen. Patients in the sodium picosulfate/magnesium citrate group received advice on the recommended 4-L fluid intake. Patients in the ascorbic acid-enriched polyethylene glycol solution plus bisacodyl group received 2 bisacodyl tablets 2 days before and advice on the additionally recommended 2-L fluid intake. MAIN OUTCOME MEASURES: To assess bowel-cleansing adequacy, the Ottawa, Aronchick, and Boston scores were used. Colonoscopy quality measures were obtained. Safety was assessed for a 30-day follow-up period. RESULTS: Overall, 341 patients (169 men, mean age 57.0 years; BMI 26.2 kg/m) were included. Comorbidities were present in 76.2% of patients, and 75.4% of patients used medication. An adequate Ottawa score was obtained in 81.4% and 75.8% of patients receiving ascorbic acid-enriched polyethylene glycol solution plus bisacodyl and sodium picosulfate/magnesium citrate (difference of 5.6% (95% CI, -3.5 to -14.6; p = 0.023)), showing noninferiority of the sodium picosulfate/magnesium citrate therapy. Ottawa segmental scores were lower for sodium picosulfate/magnesium citrate in the right and transverse colon. In both groups, successful ileocecal intubation was achieved in 95%. No medication-related adverse events were reported. LIMITATIONS: These results in a physically disabled ambulant population cannot be extrapolated to immobile, hospitalized patients. CONCLUSIONS: Sodium picosulfate/magnesium citrate proved to be noninferior to ascorbic acid-enriched polyethylene glycol solution plus bisacodyl in efficacy and safety. Timing of the colonoscopy and addition of bisacodyl to sodium picosulfate/magnesium citrate warrants further consideration. See Video Abstract at http://links.lww.com/DCR/A461.


Asunto(s)
Ácido Ascórbico/farmacología , Bisacodilo/farmacología , Catárticos/farmacología , Citratos/farmacología , Ácido Cítrico/farmacología , Neoplasias del Colon/diagnóstico por imagen , Colonoscopía/métodos , Compuestos Organometálicos/farmacología , Picolinas/farmacología , Polietilenglicoles/farmacología , Adulto , Anciano , Ácido Ascórbico/administración & dosificación , Concienciación , Bisacodilo/administración & dosificación , Catárticos/administración & dosificación , Catárticos/efectos adversos , Citratos/administración & dosificación , Ácido Cítrico/administración & dosificación , Personas con Discapacidad , Relación Dosis-Respuesta a Droga , Combinación de Medicamentos , Detección Precoz del Cáncer/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Compuestos Organometálicos/administración & dosificación , Cooperación del Paciente , Picolinas/administración & dosificación , Polietilenglicoles/administración & dosificación
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