BACKGROUND Bowel preparation in children can be challenging.AIM To describe the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid(SPMC) bowel preparation in children.METHODS Ph...BACKGROUND Bowel preparation in children can be challenging.AIM To describe the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid(SPMC) bowel preparation in children.METHODS Phase 3, randomized, assessor-blinded, multicenter study of low-volume, divided dose SPMC enrolled children 9-16 years undergoing elective colonoscopy. Participants 9-12 years were randomized 1:1:1 to SPMC ? dose × 2, SPMC 1 dose × 2, or polyethylene glycol(PEG). Participants 13-16 years were randomized 1:1 to SPMC 1 dose × 2 or PEG. PEG-based bowel preparations were administered per local protocol. Primary efficacy endpoint for quality of bowel preparation was responders(rating of ‘excellent' or ‘good') by modified Aronchick Scale. Secondary efficacy endpoint was participant's tolerability and satisfaction from a 7-item questionnaire. Safety assessments included adverse events(AEs) and laboratory evaluations.RESULTS 78 participants were randomized, 48 were 9-12 years, 30 were 13-16 years. For the primary efficacy endpoint in 9-12 years, 50.0%, 87.5%, and 81.3% were responders for SPMC ? dose × 2, SPMC 1 dose × 2, and PEG groups, respectively. Responder rates for 13-16 years were 81.3% for SPMC 1 dose × 2 and 85.7% for PEG. Overall, 43.8% of participants receiving SPMC 1 dose × 2 reported it was ‘very easy' or ‘easy' to drink, compared with 20.0% receiving PEG. Treatment-emergent AEs were reported by 45.5% of participants receiving SPMC 1 dose × 2 and 63.0% receiving PEG.CONCLUSION SPMC was an efficacious and safe for bowel preparation in children 9-16 years, with comparable efficacy to PEG. Tolerability for SPMC was higher compared to PEG.展开更多
AIM:To establish the frequency of hyperphosphate-mia following the administration of sodium phosphate laxatives in low-risk patients. METHODS:One hundred consecutive ASAⅠ-Ⅱindividuals aged 35-74 years,who were under...AIM:To establish the frequency of hyperphosphate-mia following the administration of sodium phosphate laxatives in low-risk patients. METHODS:One hundred consecutive ASAⅠ-Ⅱindividuals aged 35-74 years,who were undergoing colonic cleansing with oral sodium phosphate(OSP) before colonoscopy were recruited for this prospective study.Exclusion criteria:congestive heart failure, chronic kidney disease,diabetes,liver cirrhosis,intestinal obstruction,decreased bowel motility,increased bowel permeability,and hyperparathyroidism.The day before colonoscopy,all the participants entered a 24-h period of diet that consisted of 4 L of clear fluids with sugar or honey and 90 mL(60 g)of OSP in two 45-mL doses,5 h apart.Serum phosphate was measured before and after the administration of the laxative. RESULTS:The main demographic data(mean±SD) were:age,58.9±8.4 years;height,163.8±8.6 cm; weight,71±13 kg;body mass index,26±4;women, 66%.Serum phosphate increased from 3.74±0.56 to 5.58±1.1 mg/dL,which surpassed the normal value (2.5-4.5 mg/dL)in 87%of the patients.The highest serum phosphate was 9.6 mg/dL.Urea and creatinine remained within normal limits.Post-treatment OSP se-rum phosphate concentration correlated inversely with glomerular filtration rate(P<0.007,R 2=0.0755),total body water(P<0.001,R 2=0.156)and weight(P< 0.013,R 2=0.0635). CONCLUSION:In low-risk,well-hydrated patients, the standard dose of OSP-laxative-induced hyperphos-phatemia is related to body weight.展开更多
文摘BACKGROUND Bowel preparation in children can be challenging.AIM To describe the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid(SPMC) bowel preparation in children.METHODS Phase 3, randomized, assessor-blinded, multicenter study of low-volume, divided dose SPMC enrolled children 9-16 years undergoing elective colonoscopy. Participants 9-12 years were randomized 1:1:1 to SPMC ? dose × 2, SPMC 1 dose × 2, or polyethylene glycol(PEG). Participants 13-16 years were randomized 1:1 to SPMC 1 dose × 2 or PEG. PEG-based bowel preparations were administered per local protocol. Primary efficacy endpoint for quality of bowel preparation was responders(rating of ‘excellent' or ‘good') by modified Aronchick Scale. Secondary efficacy endpoint was participant's tolerability and satisfaction from a 7-item questionnaire. Safety assessments included adverse events(AEs) and laboratory evaluations.RESULTS 78 participants were randomized, 48 were 9-12 years, 30 were 13-16 years. For the primary efficacy endpoint in 9-12 years, 50.0%, 87.5%, and 81.3% were responders for SPMC ? dose × 2, SPMC 1 dose × 2, and PEG groups, respectively. Responder rates for 13-16 years were 81.3% for SPMC 1 dose × 2 and 85.7% for PEG. Overall, 43.8% of participants receiving SPMC 1 dose × 2 reported it was ‘very easy' or ‘easy' to drink, compared with 20.0% receiving PEG. Treatment-emergent AEs were reported by 45.5% of participants receiving SPMC 1 dose × 2 and 63.0% receiving PEG.CONCLUSION SPMC was an efficacious and safe for bowel preparation in children 9-16 years, with comparable efficacy to PEG. Tolerability for SPMC was higher compared to PEG.
文摘AIM:To establish the frequency of hyperphosphate-mia following the administration of sodium phosphate laxatives in low-risk patients. METHODS:One hundred consecutive ASAⅠ-Ⅱindividuals aged 35-74 years,who were undergoing colonic cleansing with oral sodium phosphate(OSP) before colonoscopy were recruited for this prospective study.Exclusion criteria:congestive heart failure, chronic kidney disease,diabetes,liver cirrhosis,intestinal obstruction,decreased bowel motility,increased bowel permeability,and hyperparathyroidism.The day before colonoscopy,all the participants entered a 24-h period of diet that consisted of 4 L of clear fluids with sugar or honey and 90 mL(60 g)of OSP in two 45-mL doses,5 h apart.Serum phosphate was measured before and after the administration of the laxative. RESULTS:The main demographic data(mean±SD) were:age,58.9±8.4 years;height,163.8±8.6 cm; weight,71±13 kg;body mass index,26±4;women, 66%.Serum phosphate increased from 3.74±0.56 to 5.58±1.1 mg/dL,which surpassed the normal value (2.5-4.5 mg/dL)in 87%of the patients.The highest serum phosphate was 9.6 mg/dL.Urea and creatinine remained within normal limits.Post-treatment OSP se-rum phosphate concentration correlated inversely with glomerular filtration rate(P<0.007,R 2=0.0755),total body water(P<0.001,R 2=0.156)and weight(P< 0.013,R 2=0.0635). CONCLUSION:In low-risk,well-hydrated patients, the standard dose of OSP-laxative-induced hyperphos-phatemia is related to body weight.
