ABSTRACT
OBJETIVO: Evaluar la seguridad renal del tratamiento con polietilenglicol 3350 con electrolitos durante 1, 3 y 6 meses, la tolerancia digestiva y la dosis de eficacia. PACIENTES Y MÉTODOS: Fueron evaluados 3 grupos de 30 pacientes sanos, 2-10 años (media 6,2) con estreñimiento funcional (criterios de Roma III), con 1, 3 y 6 meses de tratamiento. La eficacia fue evaluada por el número de deposiciones/semana y la consistencia de las heces (escala de Bristol). La natriuria y la osmolaridad urinaria se midieron al inicio, 1, 3 y 6 meses. Los principios inmediatos en heces (análisis de reflexión de infrarrojos [FENIR]) y un test de hidrógeno espirado fueron efectuados en el grupo de un mes de tratamiento. RESULTADOS: La dosis efectiva fue de 0,37 g/kg/día (rango 0,18-0,8). El número de deposiciones/semana en la inclusión (2,4 ± 0,64) muestra diferencia significativa (p < 0,001) vs. (6,21 ± 1,5) tras el tratamiento. También se demostró una diferencia significativa en la puntuación en la escala de Bristol (1,9 ± 0,75 vs. 4,9 ± 1,1 [p < 0,001]). La ingesta media de sodio fue de 112 mg (5 mg/kg/día [rango de 4-12 mg/kg/día]). Los valores de sodio y osmolaridad en orina fueron normales en todos los grupos sin diferencia estadística con respecto a controles (90 niños sanos sin tratamiento). Los valores de FENIR fueron normales en todos los pacientes. La prueba de aliento con hidrógeno fue normal, con una media de 7 ppm. CONCLUSIÓN: No se observaron parámetros bioquímicos renales adversos ni alteraciones digestivas. La tolerancia y la eficacia demostraron ser óptimas. El polietilenglicol 3350 con electrolitos puede ser recomendado con seguridad para el tratamiento del estreñimiento funcional en los niños a corto y largo plazo
OBJECTIVE: To assess the renal safety of treatment with polyethylene glycol 3350 with electrolytes at 1, 3 and 6 months, its gastrointestinal tolerance and dose effectiveness. PATIENTS AND METHODS: Three groups of 30 healthy patient aged 2-10 years (mean 6.2 years) who suffered functional constipation (Rome III criteria) with 1, 3 and 6 months of treatment were evaluated. Efficacy was evaluated by the change in the number of stools per week and stool consistency (Bristol scale). Urine screens, sodium and osmolality, were performed at the beginning and after 1, 3 and 6 months of treatment. Stool sample NIRA (near-infrared reflectance analysis) and hydrogen breath test analysis samples were performed on the one-month treatment group. RESULTS: The mean dose was 0.37 g/kg/day (range 0.18 to 0.8) titrated according to age, weigh tand response. The number of stools per week during treatment (2.4±0.64) showed a significant difference (P<0.001) vs (6.21±1.5) after treatment. There was also a significant difference in the Bristol scale score (1.9±0.75 vs 4.9±1.1 [P<0.001]). The mean sodium intake was 112 mg (5 mg/kg/day [range 4-12 mg/kg/day]). The values of sodium and urine osmolality were normal in all groups with no statistical difference compared to normal control values (90 healthy children without treatment). NIRA values were normal in all patients. The hydrogen breath test was normal with a median of 7 ppm. CONCLUSION: There were no adverse renal biochemical parameters or gastrointestinal disorders. Tolerance and efficacy was shown to be optimal. Polyethylene glycol 3350 with electrolytes can be safely recommended for the treatment of functional constipation in children in the short and long term
Subject(s)
Humans , Male , Female , Child , Polyethylene Glycols/therapeutic use , Constipation/drug therapy , Patient Safety , Laxatives/therapeutic use , Time , Case-Control Studies , Kidney Function Tests , Drug ToleranceABSTRACT
OBJECTIVE: To assess the renal safety of treatment with polyethylene glycol 3350 with electrolytes at 1, 3 and 6 months, its gastrointestinal tolerance and dose effectiveness. PATIENTS AND METHODS: Three groups of 30 healthy patient aged 2-10 years (mean 6.2 years) who suffered functional constipation (Rome III criteria) with 1, 3 and 6 months of treatment were evaluated. Efficacy was evaluated by the change in the number of stools per week and stool consistency (Bristol scale). Urine screens, sodium and osmolality, were performed at the beginning and after 1, 3 and 6 months of treatment. Stool sample NIRA (near-infrared reflectance analysis) and hydrogen breath test analysis samples were performed on the one-month treatment group. RESULTS: The mean dose was 0.37g/kg/day (range 0.18 to 0.8) titrated according to age, weight and response. The number of stools per week during treatment (2.4±0.64) showed a significant difference (P<.001) vs (6.21±1.5) after treatment. There was also a significant difference in the Bristol scale score (1.9±0.75 vs 4.9±1.1 [P<.001]). The mean sodium intake was 112mg (5mg/kg/day [range 4-12mg/kg/day]). The values of sodium and urine osmolality were normal in all groups with no statistical difference compared to normal control values (90 healthy children without treatment). NIRA values were normal in all patients. The hydrogen breath test was normal with a median of 7ppm. CONCLUSION: There were no adverse renal biochemical parameters or gastrointestinal disorders. Tolerance and efficacy was shown to be optimal. Polyethylene glycol 3350 with electrolytes can be safely recommended for the treatment of functional constipation in children in the short and long term.
Subject(s)
Constipation/drug therapy , Polyethylene Glycols/therapeutic use , Potassium Chloride/therapeutic use , Sodium Bicarbonate/therapeutic use , Sodium Chloride/therapeutic use , Child , Child, Preschool , Cross-Sectional Studies , Drug Therapy, Combination , Humans , Longitudinal Studies , Polyethylene Glycols/adverse effects , Potassium Chloride/adverse effects , Prospective Studies , Retrospective Studies , Sodium Bicarbonate/adverse effects , Sodium Chloride/adverse effects , Time FactorsABSTRACT
Introducción: El objetivo del trabajo ha sido evaluar la seguridad del PEG 3350 con electrolitos (PEG+E) a nivel renal y digestivo. Objetivo secundario: valorar su eficacia y dosis de efectividad. Pacientes y métodos: Quince pacientes con estreñimiento funcional (criterios de Roma III) y función renal normal fueron evaluados. La mediana de edad fue de 6,2 años (r=2-9). Sobres pediátricos de PEG+E fueron administrados durante 4 semanas (4ST) La dosis media administrada fue de 0,44g/kg/día. La natruria y osmolaridad urinaria se midieron al inicio y a las 4ST. La determinación de principios inmediatos en heces mediante FENIR (análisis de reflexión de infrarrojos) y una prueba de hidrógeno espirado fueron efectuadas a las 4ST. La eficacia del tratamiento fue evaluada mediante el cambio en el número de deposiciones por semana y la consistencia de las heces (escala de Bristol). Resultados: A las 4ST el número de deposiciones por semana fue de 5,29±1,68 vs 2,46±0,71 al inicio (p<0,001). La puntuación de la escala de Bristol fue de 4,5±0,91 tras 4TS vs 2,47±1,24 al inicio (p<0,001). No se encontraron diferencias estadísticas entre los valores de sodio y osmolalidad en orina al inicio vs 4ST. Los valores de FENIR fueron normales en todos los pacientes. La prueba del aliento de hidrógeno fue normal con una mediana de 7ppm. Conclusiones: No se observaron efectos adversos renales ni alteraciones digestivas. El PEG+E puede ser recomendado para el tratamiento del estreñimiento funcional en los niños (AU)
Introduction: Polyethylene glycol 3350 plus electrolytes (PEG+E) efficacy has been validated in some studies, but not many have evaluated its safety in children. The aim of our study was to evaluate the safety; renal, malabsorption or excessive production of gas and efficacy of PEG+E treatment in our paediatric population. Patients and methods: Fifteen patients who suffered functional constipation (Rome III criteria) were evaluated. Median age was 6.2 years (r 2-9). All patients had normal renal function. PEG+E were administered for 4weeks (4WP). The mean dose was 0.44g/kg/day, titrated according to age, weight and response. Urine screens (sodium and osmolality) were performed at the beginning and 4WP. Stool sample NIRA (near-infrared reflectance analysis) and hydrogen breath test analysis samples were performed at 4WP. To analyse the efficacy of the treatment, the number of stools per week and stool form type (Bristol stool scale) were recorded. Results: The number of stools per week was higher after 4weeks (2.46±0.71 vs 5.29±1.68, P<0.001), as well as the stool form score (2.47±1.24 vs 4.5±0.91, P<0.001). No statistical differences were obtained between urine sodium and urine osmolality values at the beginning and 4WP. After 4WP the NIRA median values were normal in all patients [fat 4.45% (range (r) 3.6-7.09); nitrogen 0.78% (r 0.4-1); sugars 1.4% (r 0.47-2.35) and water 68% (r 59-74)]. Median breath hydrogen test was 7ppm (r 2-18). Conclusions: No adverse effects on biochemistry values or gastrointestinal disturbances were observed. PEG+E can be recommended for the treatment of functional constipation in children (AU)
Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Child , Constipation/drug therapy , Polyethylene Glycols/pharmacokinetics , Laxatives/pharmacokinetics , Risk FactorsABSTRACT
INTRODUCTION: Polyethylene glycol 3350 plus electrolytes (PEG+E) efficacy has been validated in some studies, but not many have evaluated its safety in children. The aim of our study was to evaluate the safety; renal, malabsorption or excessive production of gas and efficacy of PEG+E treatment in our paediatric population. PATIENTS AND METHODS: Fifteen patients who suffered functional constipation (Rome III criteria) were evaluated. Median age was 6.2 years (r 2-9). All patients had normal renal function. PEG+E were administered for 4 weeks (4WP). The mean dose was 0.44 g/kg/day, titrated according to age, weight and response. Urine screens (sodium and osmolality) were performed at the beginning and 4WP. Stool sample NIRA (near-infrared reflectance analysis) and hydrogen breath test analysis samples were performed at 4WP. To analyse the efficacy of the treatment, the number of stools per week and stool form type (Bristol stool scale) were recorded. RESULTS: The number of stools per week was higher after 4 weeks (2.46 ± 0.71 vs 5.29 ± 1.68, P<.001), as well as the stool form score (2.47 ± 1.24 vs 4.5 ± 0.91, P<.001). No statistical differences were obtained between urine sodium and urine osmolality values at the beginning and 4WP. After 4WP the NIRA median values were normal in all patients [fat 4.45% (range (r) 3.6-7.09); nitrogen 0.78% (r 0.4-1); sugars 1.4% (r 0.47-2.35) and water 68% (r 59-74)]. Median breath hydrogen test was 7 ppm (r 2-18). CONCLUSIONS: No adverse effects on biochemistry values or gastrointestinal disturbances were observed. PEG+E can be recommended for the treatment of functional constipation in children.
Subject(s)
Constipation/drug therapy , Electrolytes/therapeutic use , Polyethylene Glycols/therapeutic use , Child , Child, Preschool , Electrolytes/adverse effects , Female , Humans , Male , Polyethylene Glycols/adverse effects , Prospective StudiesABSTRACT
BACKGROUND: Transplant recipients treated with calcineurin inhibitors (CNIs) frequently show hyperkalemia, metabolic acidosis, and hypomagnesemia which could be deleterious for some patients. Conversion to inhibitors of mammalian target of rapamycin (mTOR) could improve these electrolytic disturbances. OBJECTIVE: To evaluate the potassium and magnesium changes due to converting patients from CNIs to mTOR inhibitors. METHODS: Retrospective review of 138 renal transplant patients who were converted from CNIs to mTOR inhibitors over a 6-month observation period. The following parameters were determined: potassium, sodium, chloride, magnesium, urea, glucose, and creatinine in blood and urine. We also analyzed plasma bicarbonate and calculated plasma and urine anion gap and plasma osmolarity. RESULTS: One month after conversion, a decrease was observed in serum creatinine (1.75±0.68 vs 1.61±0.61 mg/dL; P=.01), plasma potassium (4.60±0.52 vs 4.39±0.53 mEq/L; P<.001), calculated plasma osmolarity (308.7±8.5 vs 307.4±8.4 mOsm/L; P<.036), fractional excretion of sodium (1.55±0.69 vs 1.29±0.65%; P<.003), and fractional excretion of magnesium (7.15±4.08 vs 15.84±3.64%; P<.001), with an increase in serum magnesium (1.77±0.24 vs 1.95±0.29 mg/dL; P<.001). At 3 and 6 months, these differences remained unchanged. The transtubular potassium gradient did not change. CONCLUSIONS: We observed a decrease in serum magnesium due to renal magnesium wasting before switching from CNIs to mTOR inhibitors. After conversion, an increase in serum magnesium was observed together with a drop in the fractional excretion of this cation. A decrease in plasma potassium levels, plasma osmolarity, and fractional excretion of sodium consistent with minor aldosterone resistance was also detected after changing the immunosuppressive treatment.
Subject(s)
Calcineurin Inhibitors , Homeostasis , Potassium/blood , TOR Serine-Threonine Kinases/antagonists & inhibitors , Humans , Retrospective StudiesABSTRACT
BACKGROUND: In kidney transplanted children, it is difficult to obtain blood levels of mycophenolic acid between 2 and 4 microg/mL, when mycophenolate mofetil doses up to 30 mg/kg/d are given two or three times a day. We proposed that using mycophenolic acid, instead of the salt mycophenolate mofetil, may help us to reach target levels. AIM: We sought to describe the pharmacokinetics of mycophenolic acid in eight kidney transplanted children over a period of 1.2 +/- 0.8 years. PATIENTS AND METHODS: Eight patients (5 boys and 3 girls) aged 7.0 +/- 1.8 years received cadaveric kidney transplantations. Induction with basiliximab was followed by cyclosporine (n = 4) or tacrolimus (n = 4), tapered steroids (withdrawal at 12 months in six cases and maintained at 0.15 mg/kg/d in two cases), and mycophenolate mofetil (25 to 30 mg/kg/d two or three times a day). For 1.0 +/- 0.3 years mycophenolic acid levels were between 0.8 +/- 0.3 microg/mL. When mycophenolic acid sodium tablets were available, all patients were switched to this drug. RESULTS: After the conversion, blood levels obtained at 8 +/- 3 days were 1.5 to 5.0 microg/mL (median, 3.2), which were far closer to the target 2 to 4 microg/mL. No gastrointestinal disorders were observed with the follow-up of 72 +/- 18 days. CONCLUSION: Mycophenolic acid sodium reaches therapeutic levels whereas mycophenolate mofetil does not. If mycophenolic acid were available in syrup form, it could be used in patients under 5 years of age. It is necessary to follow these patients to rule out enzymatic induction.