Abstract:
OBJECTIVES:To evaluate the safety of lansoprazole in children between 1 and 11 years of age. METHODS:In a phase I/II, open-label, multicenter (11 sites) study, children with symptomatic gastroesophageal reflux disease (GERD), erosive esophagitis (> or = grade 2), and/or esophageal pH < 4 for > 4.2% of the 24-hour period were assigned, on the basis of body weight, to lansoprazole 15 mg (< or = 30 kg) or 30 mg (> 30 kg) once daily for 8 to 12 weeks. At the discretion of the investigator, the dosage of lansoprazole was increased up to 60 mg daily in children who continued to be symptomatic after 2 weeks of treatment. Safety for all study participants was monitored by adverse event reports and laboratory evaluations. RESULTS:Sixty-six children were enrolled in the study and were included in the safety analysis. Throughout the treatment period, no child discontinued therapy because of an adverse event and no clinically significant changes in laboratory values were observed. Three of the 32 children (9%) who received lansoprazole 15 mg once daily (mean exposure 50.3 days) and 6 of the 34 children (18%) who received the 30 mg once-daily dose (mean exposure 49.4 days) experienced one or more treatment-related adverse events before any dose increase. The three children in the lansoprazole 15 mg treatment group were treated with doses of 0.6 mg to 1.2 mg/kg/day; those in the lansoprazole 30 mg treatment group were treated with doses of 0.7 mg to 0.9 mg/kg/day. Only one child experienced a new treatment-related adverse event after an increase in lansoprazole dose to 1.3 mg/kg/day. Treatment-related events experienced by two or more children were: constipation (lansoprazole 15 mg QD, two children; lansoprazole 30 mg QD, one child), and headache (lansoprazole 30 mg QD, two children). Mean fasting serum gastrin levels were significantly increased from 58.0 pg/mL at baseline to 112.4 pg/mL at week 2 and 121.9 pg/mL at the final visit (P < or = 0.001 for each comparison). However, the median fasting serum gastrin levels at the week 2 and the final visit were within the normal range (25-111 pg/mL). CONCLUSION:Lansoprazole, when administered on the basis of body weight in children between 1 and 11 years of age, is safe and well-tolerated.
journal_name
J Pediatr Gastroenterol Nutrjournal_title
Journal of pediatric gastroenterology and nutritionauthors
Tolia V,Fitzgerald J,Hassall E,Huang B,Pilmer B,Kane R 3rddoi
10.1097/00005176-200211004-00002subject
Has Abstractpub_date
2002-01-01 00:00:00pages
S300-7eissn
0277-2116issn
1536-4801journal_volume
35 Suppl 4pub_type
临床试验,杂志文章,多中心研究abstract::As pediatric liver transplantation comes of age, experts gathered to discuss current paradigms and define gaps in knowledge warranting research to further improve patient and graft outcomes. Identified areas ripe for collaborative research include understanding the molecular and cellular mechanisms of tolerance and th...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 共识发展会议,杂志文章
doi:10.1097/MPG.0000000000001564
更新日期:2017-09-01 00:00:00
abstract:OBJECTIVES:We evaluated the response to infliximab in pediatric patients with ulcerative colitis (UC) and their long-term follow-up. We expanded our previous study of 14 patients and furthermore evaluated the success of weaning patients from infliximab. PATIENTS AND METHODS:We reviewed the charts of 27 pediatric patie...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/MPG.0b013e31802e98d4
更新日期:2007-03-01 00:00:00
abstract::Acarboxy prothrombin was detected in the plasma of 48 of 128 umbilical cord plasma samples and in all of 65 patients receiving coumadin. None was found in 20 normal adults. Although the prevalence was the same in blacks, whites, and neonates of mixed origin, levels were significantly higher in blacks. There was a nega...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/00005176-198406000-00025
更新日期:1984-06-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Breast milk contains several bioactive factors including human milk oligosaccharides (HMOs) and microbes that shape the infant gut microbiota. HMO profile is determined by secretor status; however, their influence on milk microbiota is still uncovered. This study is aimed to determine the impa...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/MPG.0000000000002216
更新日期:2019-02-01 00:00:00
abstract::We assessed the effect of pH on volatilization of short-chain fatty acids during lyophilization. Acetic, propionic, valeric, and butyric acids were added to a fecal homogenate in amounts sufficient to raise the energy density by 18-27%. Fecal homogenate samples were either acidified (pH 2.8-3.2), alkalinized (pH 7.9-8...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:
更新日期:1987-11-01 00:00:00
abstract:OBJECTIVE:Selected infants with short bowel syndrome (SBS) and progressive intestinal failure associated liver disease (IFALD) may benefit from isolated liver transplantation (iLTx). The aim of the study is to identify risk factors for unfavourable outcome in iLTx. PATIENTS AND METHODS:A retrospective review of medica...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/mpg.0b013e31818c6099
更新日期:2009-03-01 00:00:00
abstract::When conventional treatment with upright positioning and thickened feedings fails to control vomiting associated with gastroesophageal reflux (GER) of infancy, malnutrition and growth failure may result. If this occurs, fundoplication is usually recommended. In this study, 12 infants with growth failure associated wit...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/00005176-198302010-00007
更新日期:1983-01-01 00:00:00
abstract:OBJECTIVES:The transfer of exogenous genetic material to cells within the gastrointestinal (GI) tract has many potential therapeutic applications. An attractive feature of the GI tract for gene transfer is its accessibility through the orogastric route. In this study, we evaluated the stability of recombinant adeno-ass...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/01.mpg.0000228118.59853.ba
更新日期:2006-08-01 00:00:00
abstract::Three children were observed to have extensive liver injury following protracted seizures. Two recovered with supportive care and one died from central nervous system complications. When first measured, the levels of aminotransferases were minimally elevated, but they increased to 250 to 8,000 times normal within 12 t...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/00005176-198911000-00004
更新日期:1989-11-01 00:00:00
abstract::A 14-year-old black male with sickle cell anemia developed a duodenal ulcer that masqueraded as sickle cell-related abdominal pain crisis on multiple occasions. Malingering and poor therapeutic compliance aggravated the ulcer in this patient, who ultimately succumbed to a catastrophic bleed. Duodenal ulcer appears to ...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章,评审
doi:10.1097/00005176-199001000-00023
更新日期:1990-01-01 00:00:00
abstract::An infant boy with severe portal hypertension developed failure to thrive and malabsorption. Clinical findings and ultrasonography suggested the presence of an arteriovenous shunt, and hepatic angiography confirmed the diagnosis and outlined the anatomy of the vascular malformation, which was an intrahepatic arteriopo...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/00005176-198705000-00027
更新日期:1987-05-01 00:00:00
abstract::The objective of this study was to evaluate the accuracy of an indirect immunofluorescence (IIF) test for serodiagnosis of Helicobacter pylori infection in children and to determine how the test is affected by the presence of antibodies against Campylobacter jejuni. We studied 65 consecutive children (two with endosco...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/00005176-199304000-00004
更新日期:1993-04-01 00:00:00
abstract::A 20-year-old male patient with cystic fibrosis (CF) is described, who acutely developed hypoalbuminemia concurrently with giardiasis. Hypoalbuminemia could not be explained by the usual causes seen in patients with CF, but resolved with quinacrine therapy. Subsequently, asymptomatic giardiasis was sought but not foun...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/00005176-198504000-00030
更新日期:1985-04-01 00:00:00
abstract:OBJECTIVE:The aim of the study is to analyze the impact of physical activity and eating behaviors on precursors of cardiovascular disease-including overweight/obesity, hypertension, low high-density lipoprotein, and impaired glucose tolerance-in pediatric liver transplant (LT) recipients and matched controls. METHOD:C...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/MPG.0000000000002150
更新日期:2019-01-01 00:00:00
abstract:BACKGROUND:Population-based studies on the prevalence of encopresis in children are scarce and generally outdated. Prevalence estimates based on clinical studies are unreliable because parents tend to be reticent to seek medical help for this problem. Professional help is necessary, however, because encopresis can lead...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/01.mpg.0000149964.77418.27
更新日期:2005-03-01 00:00:00
abstract::The incidence of inflammatory bowel disease (IBD) is steadily on the rise in Western and in developing countries paralleling the increase of westernized diets, characterized by high protein and fat as well as excessive sugar intake, with less vegetables and fiber. Furthermore, nutrition is involved in several aspects ...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章,评审
doi:10.1097/MPG.0000000000001785
更新日期:2018-03-01 00:00:00
abstract::To further evaluate the nature of malnutrition, define at-risk groups, and confirm the efficacy of nutritional supplementation on body composition in cystic fibrosis (CF), we have conducted longitudinal and cross-sectional studies of total body potassium (TBK) in 161 unselected CF subjects aged 1 month to 17 years. TB...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/00005176-198908000-00012
更新日期:1989-08-01 00:00:00
abstract::Eosinophilic gastroenteropathy (EG) is an uncommon, idiopathic disease in children that is characterized by eosinophilic inflammation of the intestine. Over a 7-year period 17 infants and children with EG were evaluated; the retrospective review of their clinical data constitutes the basis of this report. A scale deve...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/00005176-198805000-00011
更新日期:1988-05-01 00:00:00
abstract::Thiopurines are used as a maintenance therapy in patients with ulcerative colitis (UC). For some patients the metabolism of thiopurines is unfavorable, leading to increased adverse effects, including hepatotoxicity. There are many reports in the adult literature concerning the manipulation of thiopurine metabolism wit...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/MPG.0000000000000344
更新日期:2014-07-01 00:00:00
abstract::Light and electron microscopy was applied to surgical resections and endoscopic biopsies from the ileum and colon of 15 children with Crohn's disease in order to investigate the involvement of neutrophils in the disease process. Clear evidence was found of neutrophil infiltration of the lamina propria and epithelium, ...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/00005176-198705000-00021
更新日期:1987-05-01 00:00:00
abstract::Somatic gene therapy represents a new approach for treating a variety of genetic and acquired diseases and has many potential applications in gastroenterology. Somatic gene therapy is based on the ability to transfer recombinant genes efficiently into somatic tissues, such as the liver or intestine, and achieve expres...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章,评审
doi:10.1097/00005176-199204000-00017
更新日期:1992-04-01 00:00:00
abstract:OBJECTIVES:Although randomized trials demonstrated the efficacy of infliximab for both pediatric Crohn disease and ulcerative colitis (UC), few patients in these studies exhibited colitis requiring hospitalization. The aims of this study were to determine the rate of subsequent infliximab failure and dose escalation in...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/MPG.0b013e3182a98df2
更新日期:2014-02-01 00:00:00
abstract::Studies of gastric emptying in infancy indicate that a receptor system in the duodenum regulating emptying exists operating in a manner qualitatively similar to the adult. Further investigation is needed to describe this system in more detail and evaluate how other factors including feeding volume, nutrient digestion,...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/00005176-198300201-00019
更新日期:1983-01-01 00:00:00
abstract:OBJECTIVES:The objective of this study was to determine if dietary gangliosides induce changes in the ganglioside content of intestinal mucosa, plasma and brain and to identify where GM3 and GD3 are localized in the enterocyte membrane. METHODS:Male 18-day-old Sprague-Dawley rats were fed a semipurified diet containin...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/01.mpg.0000157199.25923.64
更新日期:2005-04-01 00:00:00
abstract:OBJECTIVES:Congenital hepatic fibrosis (CHF) is an important cause of morbidity and mortality in patients with autosomal recessive polycystic kidney disease (ARPKD). The pathogenesis of CHF remains undefined. Several recent studies suggest that the renin-angiotensin system (RAS) is an important mediator of progressive ...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/MPG.0b013e3181cc80e4
更新日期:2010-06-01 00:00:00
abstract:OBJECTIVES:Although rare, carcinoid tumor of the appendix is the most common neoplasm of the gastrointestinal tract in children and adolescents. It is usually an incidental finding after a laparotomy for appendectomy, with a frequency of 2 to 5 cases per 1000 appendectomies. The experience with 14 cases of carcinoid re...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/00005176-200502000-00025
更新日期:2005-02-01 00:00:00
abstract::Pseudomembranous colitis secondary to C. difficile and its toxin(s) is a well-recognized disease in children and usually responds to treatment with oral vancomycin. There are well-documented reports of relapse in adults after initial successful treatment with vancomycin. This report documents relapse in a child who de...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:
更新日期:1986-03-01 00:00:00
abstract::Anti-tumor necrosis factor-alpha (TNF-α) blockade is so far the most effective therapy for extensive pediatric Crohn disease (CD), but loss of response is frequently encountered. We describe here the use of golimumab (Simponi) in 6 pediatric CD patients with antibody formation/loss of response to infliximab and adalim...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/MPG.0000000000001165
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND:Primary sclerosing cholangitis is a rare chronic cholestatic condition of unknown etiology, frequently associated with inflammatory bowel disease and characterized by diffuse fibrosing and inflammatory destruction of the intra- and/or extrahepatic biliary duct system. PATIENTS AND METHODS:The study involved...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/MPG.0b013e31816fee95
更新日期:2008-07-01 00:00:00
abstract:OBJECTIVES:The aim of the study was to summarize short-term effectiveness, safety, and cost of using infliximab biosimilar (IFX-B) drugs, (Inflectra [Hospira] and Remsima [NAAP]) compared to originator infliximab (IFX-O) (Remicade [MSD]) in biologic naive pediatric inflammatory bowel disease in the United Kingdom. MET...
journal_title:Journal of pediatric gastroenterology and nutrition
pub_type: 杂志文章
doi:10.1097/MPG.0000000000002011
更新日期:2018-10-01 00:00:00