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1.
J Pediatr Gastroenterol Nutr ; 68(2): 237-243, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30256267

RESUMO

OBJECTIVE: The aim of this prospective cross sectional study was to assess the prevalence of sleep disturbance in children with inflammatory bowel disease (IBD), including the relationships between sleep, inflammatory markers, and disease activity of pediatric patients with IBD. METHODS: Pediatric patients with IBD and parents were enrolled in the study. Patients completed the Pittsburgh Sleep Quality Index (PSQI), the Pediatric Daytime Sleepiness Scale, and the Adolescent Sleep Wake Scale (ASWS) surveys. Parents completed the Child Sleep Habits Questionnaire (CSHQ). Disease activity for Crohn disease (CD) was determined by the Pediatric Crohn Disease Activity Index and the Pediatric Ulcerative Colitis Activity Index was used to define disease activity in ulcerative colitis (UC)/indeterminate colitis patients. RESULTS: Fifty-three pediatric patients with IBD (38 CD, 12 UC, and 3 indeterminate colitis) participated in the study. The significant correlations between the CSHQ and Pediatric Crohn Disease Activity Index (P = 0.002) and the PSQI and Pediatric Ulcerative Colitis Activity Index (P = 0.04) were found. Youth with UC and indeterminate colitis significantly reported more sleep disturbance than patients with CD, (P = 0.03, 0.05, and 0.04; PSQI, Pediatric Daytime Sleepiness Scale, ASWS, respectively). Patients self-reported significantly more sleep disturbance than was observed by parents (P < 0.0001). This study showed the significant correlations between CSHQ score compared to erythrocyte sedimentation rate and albumin (P = 0.001 and 0.03, respectively). CONCLUSIONS: Results suggest that increased disease activity is associated with adverse effects on sleep quality. Based on the results of this study, pediatric patients with IBD should be screened for sleep disturbance.


Assuntos
Colite Ulcerativa/complicações , Doença de Crohn/complicações , Doenças Inflamatórias Intestinais/complicações , Índice de Gravidade de Doença , Transtornos do Sono-Vigília/epidemiologia , Adolescente , Criança , Pré-Escolar , Colite Ulcerativa/fisiopatologia , Doença de Crohn/fisiopatologia , Estudos Transversais , Feminino , Humanos , Doenças Inflamatórias Intestinais/fisiopatologia , Masculino , Prevalência , Estudos Prospectivos , Sono , Transtornos do Sono-Vigília/etiologia , Inquéritos e Questionários
2.
Dig Dis Sci ; 64(2): 493-502, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30390234

RESUMO

BACKGROUND: In gastroesophageal reflux disease (GERD), the frequency of heartburn symptoms and erosive esophagitis (EE) increases with age in children and adolescents. Proton pump inhibitor, dexlansoprazole, is approved for healing EE of all grades, maintenance of healed EE, relief of heartburn, and treatment of symptomatic non-erosive GERD in patients ≥ 12 years. AIM: To assess safety and efficacy of dexlansoprazole dual delayed-release capsule in healing of EE and maintenance of healed EE in adolescents. METHODS: A multicenter, phase 2, 36-week study was conducted in 62 adolescents (12-17 years) with endoscopically confirmed EE. Patients received dexlansoprazole 60 mg once daily (QD) during open-label healing phase. Those with confirmed healing at week 8 were randomized to dexlansoprazole 30 mg QD or placebo during 16-week, double-blind maintenance phase, with subsequent treatment-free follow-up of ≥ 12 weeks. Primary endpoints were treatment-emergent adverse events (TEAEs) in ≥ 5% of patients during treatment. Secondary endpoints included percentages of patients with healing of EE and with maintenance of healed EE. RESULTS: 88% of patients achieved EE healing, and 61.3% reported a TEAE [headache (12.9%), oropharyngeal pain (8.1%), diarrhea (6.5%), and nasopharyngitis (6.5%)]. During maintenance phase, healing was maintained in 82% and 58% of dexlansoprazole and placebo groups, respectively. 72.0% of dexlansoprazole-treated patients reported TEAEs, which included headache (24.0%), abdominal pain (12.0%), nasopharyngitis (12.0%), pharyngitis (12.0%), sinusitis (12.0%), bronchitis (8.0%), upper respiratory tract infection (8.0%), and insomnia (8.0%); 61.5% experienced a TEAE with placebo. CONCLUSIONS: Dexlansoprazole is safe and efficacious for healing EE and maintenance of healed EE in adolescents.


Assuntos
Dexlansoprazol/uso terapêutico , Esofagite Péptica/tratamento farmacológico , Refluxo Gastroesofágico/tratamento farmacológico , Inibidores da Bomba de Prótons/uso terapêutico , Dor Abdominal/induzido quimicamente , Adolescente , Criança , Preparações de Ação Retardada , Diarreia/induzido quimicamente , Método Duplo-Cego , Feminino , Cefaleia/induzido quimicamente , Humanos , Quimioterapia de Manutenção , Masculino , Nasofaringite/induzido quimicamente , Orofaringe , Dor/induzido quimicamente , Faringite/induzido quimicamente , Distúrbios do Início e da Manutenção do Sono/induzido quimicamente , Resultado do Tratamento
3.
Dig Dis Sci ; 62(11): 3059-3068, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-28916953

RESUMO

BACKGROUND: Proton pump inhibitors are commonly used to treat gastro-esophageal reflux disease (GERD) and nonerosive GERD (NERD) in adolescents and adults. Despite the efficacy of available medications, many patients have persisting symptoms, indicating a need for more effective agents. AIMS: To assess the safety and efficacy of dexlansoprazole dual delayed-release capsules in adolescents for treatment of symptomatic NERD. METHODS: A phase 2, open-label, multicenter study was conducted in adolescents aged 12-17 years. After a 21-day screening period, adolescents with endoscopically confirmed NERD received a daily dose of 30-mg dexlansoprazole for 4 weeks. The primary endpoint was treatment-emergent adverse events (TEAEs) experienced by ≥5% of patients. The secondary endpoint was the percentage of days with neither daytime nor nighttime heartburn. Heartburn symptoms and severity were recorded daily in patient electronic diaries and independently assessed by the investigator, along with patient-reported quality of life, at the beginning and end of the study. RESULTS: Diarrhea and headache were the only TEAEs reported by ≥5% of patients. Dexlansoprazole-treated patients (N = 104) reported a median 47.3% of days with neither daytime nor nighttime heartburn. Symptoms such as epigastric pain, acid regurgitation, and heartburn improved in severity for 73-80% of patients. Pediatric Gastroesophageal Symptom and Quality of Life Questionnaire-Adolescents-Short Form symptom and impact subscale scores (scaled 1-5) each decreased by an average of 0.7 units at week 4. CONCLUSIONS: Use of 30-mg dexlansoprazole in adolescent NERD was generally well tolerated and had beneficial effects on improving heartburn symptoms and quality of life. TRIAL REGISTRATION: This study has the ClinicalTrials.gov identifier NCT01642602.


Assuntos
Dexlansoprazol/uso terapêutico , Refluxo Gastroesofágico/tratamento farmacológico , Azia/tratamento farmacológico , Inibidores da Bomba de Prótons/uso terapêutico , Administração Oral , Adolescente , Idade de Início , Cápsulas , Criança , Preparações de Ação Retardada , Dexlansoprazol/administração & dosagem , Dexlansoprazol/efeitos adversos , Europa (Continente) , Feminino , Refluxo Gastroesofágico/diagnóstico , Azia/diagnóstico , Humanos , América Latina , Masculino , América do Norte , Inibidores da Bomba de Prótons/administração & dosagem , Inibidores da Bomba de Prótons/efeitos adversos , Qualidade de Vida , Indução de Remissão , Índice de Gravidade de Doença , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento
4.
Cureus ; 13(12): e20181, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35004005

RESUMO

BACKGROUND AND OBJECTIVES: Hospital readmission rate helps to highlight the effectiveness of post-discharge care. There remains a paucity of plausible age-based categorization especially for ages below one year for hospital readmission rates. METHODS: Data from the 2017 Healthcare Cost and Utilization Project National Readmissions Database was analyzed for ages 0-18 years. Logistic regression analysis was performed to identify predictors for unplanned early readmissions.  Results: We identified 5,529,389 inpatient pediatric encounters which were further divided into age group cohorts. The overall rate of readmissions was identified at 3.2%. Beyond infancy, the readmission rate was found to be 6.7%. Across all age groups, the major predictors of unplanned readmission were cancers, diseases affecting transplant recipients and sickle cell patients. It was determined that reflux, milk protein allergy, hepatitis and inflammatory bowel diseases were significant diagnoses leading to readmission. Anxiety, depression and suicidal ideation depicted higher readmission rates in those older than 13 years. Across ages one to four years, dehydration, asthma and bronchiolitis were negative predictors of unplanned readmission.  Conclusions: Thirty-day unplanned readmissions remain a problem leading to billions of taxpayer dollars lost per annum. Effective strategies for mandatory outpatient follow-up may help the financial aspect of care while also enhancing the quality of care.

5.
Pediatrics ; 144(2)2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31350360

RESUMO

In 2016, the American Academy of Pediatrics published a clinical practice guideline that more specifically defined apparent life-threatening events as brief resolved unexplained events (BRUEs) and provided evidence-based recommendations for the evaluation of infants who meet lower-risk criteria for a subsequent event or serious underlying disorder. The clinical practice guideline did not provide recommendations for infants meeting higher-risk criteria, an important and common population of patients. Therefore, we propose a tiered approach for clinical evaluation and management of higher-risk infants who have experienced a BRUE. Because of a vast array of potential causes, the initial evaluation prioritizes the diagnosis of time-sensitive conditions for which delayed diagnosis or treatment could impact outcomes, such as child maltreatment, feeding problems, cardiac arrhythmias, infections, and congenital abnormalities. The secondary evaluation addresses problems that are less sensitive to delayed diagnosis or treatment, such as dysphagia, intermittent partial airway obstruction, and epilepsy. The authors recommend a tailored, family-centered, multidisciplinary approach to evaluation and management of all higher-risk infants with a BRUE, whether accomplished during hospital admission or through coordinated outpatient care. The proposed framework was developed by using available evidence and expert consensus.


Assuntos
Diagnóstico Tardio/tendências , Hospitalização/tendências , Sintomas Inexplicáveis , Diagnóstico Tardio/prevenção & controle , Humanos , Recém-Nascido , Fatores de Risco
6.
SAGE Open Med Case Rep ; 6: 2050313X18781742, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29977558

RESUMO

Clostridium difficile infection is increasingly diagnosed in children with a wide clinical spectrum ranging from asymptomatic carriage to fulminant colitis. Symptomatic patients typically present with diarrhea, with or without blood, fever, and abdominal pain. Kawasaki disease, a vasculitis of unknown etiology, occurs primarily in young children. Establishing the diagnosis of Kawasaki disease can be challenging given the lack of a confirmatory diagnostic test or pathognomonic features as well as the appearance of symptoms over time rather than simultaneously. In addition, commonly occurring nonspecific associated symptoms, such as diarrhea and abdominal pain, may confound the clinical presentation. We present two cases of children with Kawasaki disease presenting with fever and Clostridium difficile colitis to illustrate the importance of keeping a high index of suspicion for Kawasaki disease.

7.
Artigo em Inglês | MEDLINE | ID: mdl-31119217

RESUMO

BACKGROUND: Brief Resolved Unexplained Events (BRUE) is defined as a sudden, brief and now resolved episode characterized by color change, altered respirations, change in tone, and altered level of responsiveness. This study aims to identify the characteristics of esophageal Multichannel Intraluminal Impedance-pH (MII-pH) monitoring in infants who have experienced a BRUE. METHODS: This study was a retrospective review of records of infants younger than 12 months who presented to the University of South Alabama Children's and Women's Hospital with an admission diagnosis of BRUE. Patients who underwent esophageal MII-pH monitoring between October 2015 and February 2017 and diagnosed with BRUE were initially included in this study. RESULTS: Fifty-three infants (preterm 25, term 28) who experienced a higher risk BRUE were included in our study. The mean age at diagnosis was 2.25 ± 2.07 months. Apnea (41/53; 77.4%) was the most common manifestation of BRUE. Non-acid reflux events were the most common findings in the MII-pH studies (66%). MII-pH results showed 6/53 (11%) acid reflux, 17/53 (32%) non-acid reflux and 12/53 (23%) both acid/nonacid reflux and 18/53 (34%) were normal. There were significant differences in the longest acid reflux episode and the Reflux Symptom Sensitivity Index (RSSI) of coughing/choking/gagging between preterm and term infants. The Reflux Symptom Index (RSI), RSSI and Reflux Symptom Association Probability (RSAP) were significantly correlated with each other in all symptoms (pain/fussiness, coughing/choking/gagging and vomiting). CONCLUSIONS: Among infants experiencing a higher risk BRUE, esophageal MII-pH monitoring revealed acid or nonacid reflux in 2/3 of patients.

8.
Ann Gastroenterol Dig Disord ; 1(1): 9-25, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-31119218

RESUMO

BACKGROUND: Pediatric patients with inflammatory bowel disease (IBD) are at risk for psychiatric symptoms that impact quality of life (QoL) and psychosocial functioning. Sleep disturbance has been reported to impose adverse effects on host defense mechanisms by affecting the magnitude and characteristics of the inflammatory response. The current study sought to assess the relationships among sleep disturbance, QoL, and psychosocial functioning in children with IBD. METHODS: Pediatric IBD patients completed multiple measures of sleep and daytime functioning as well as measures of QoL and psychosocial functioning. The parents completed complementary measures of sleep, QoL, and psychosocial functioning. The HRQOL results for subjects with IBD were compared to a healthy control group. RESULTS: Fifty-three children with pediatric IBD and their parents were enrolled in the study. QoL was positively associated with sleep quality, based on significant negative correlations between QoL and both sleep quality and daytime sleepiness scales (r = -0.62, -0.57; p value <0.001, respectively). Patients with CD reported significantly better QoL and psychosocial functioning than patients with UC. The QoL was similar between IBD patients and healthy controls. CONCLUSIONS: The present study suggests that a positive association exists between sleep functioning and QoL in pediatric patients with IBD. Patients with pediatric IBD should be screened for sleep disturbance, QoL and psychosocial functioning. Prevention and intervention strategies of sleep disturbance aimed at improving QoL and psychosocial functioning in children with IBD should be developed and evaluated.

9.
Eur J Gastroenterol Hepatol ; 30(2): 195-200, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29099422

RESUMO

INTRODUCTION: A brief resolved unexplained event (BRUE) describes an event associated with a change in muscle tone, color, respiration, and responsiveness that is unexplained after an appropriate examination. Some infants with higher risk BRUE may undergo endoscopy as part of their evaluation. OBJECTIVE: This retrospective study aimed to identify the endoscopic findings in infants who have experienced a higher risk BRUE. We also compared the characteristics, prenatal, natal, and postnatal risk factors between 23 infants who underwent endoscopic evaluation and 23 race-matched/sex-matched/term-matched/preterm-matched infants who did not undergo endoscopic evaluation. METHODS: This was a retrospective descriptive study. Infants were identified from a query of medical records using the ICD-10 code for BRUE (R68.13). RESULTS: Of 119 infants with BRUE, 23 infants with higher risk BRUE underwent an esophagogastroduodenoscopy and flexible sigmoidoscopy. Apnea (87%) was the most common presentation of BRUE. Most were female (57%) with a mean age at BRUE presentation of 2.73 months. We found 10 (43.5%) term infants and 13 (56.5%) preterm infants in our study. There were no significant differences in characteristics, prenatal, natal, and postnatal risk factors between the infants who underwent endoscopy and those who did not undergo endoscopy. The most common abnormal endoscopic finding was lymphonodular hyperplasia (LNH) associated with eosinophilia in the rectosigmoid colon. The proportion of females in the LNH group was significantly higher than the non-LNH group. CONCLUSION: Rectosigmoid LNH and eosinophilia, which are associated with milk soy protein intolerance (MSPI), were the most common findings on endoscopic evaluation. Although there is no proof of causation between MSPI and BRUE, MSPI should be considered in the differential diagnosis for higher risk BRUE.


Assuntos
Endoscopia Gastrointestinal , Eosinofilia/patologia , Mucosa Intestinal/patologia , Tecido Linfoide/patologia , Sintomas Inexplicáveis , Doenças do Colo Sigmoide/patologia , Obstrução das Vias Respiratórias/etiologia , Apneia/etiologia , Cianose/etiologia , Eosinofilia/diagnóstico por imagem , Feminino , Engasgo , Humanos , Hiperplasia/diagnóstico por imagem , Lactente , Recém-Nascido , Masculino , Estudos Retrospectivos , Fatores de Risco , Doenças do Colo Sigmoide/diagnóstico por imagem , Sigmoidoscopia
10.
SAGE Open Med ; 5: 2050312117745221, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29276590

RESUMO

BACKGROUND: Esophageal multichannel intraluminal impedance-pH monitoring has become one of the preferred tests to correlate observed reflux-like behaviors with esophageal reflux events. The Gastroesophageal reflux disease Assessment Symptom Questionnaire is a validated tool used to distinguish infants with gastroesophageal reflux disease from healthy children. The aim of this study was to determine whether the Gastroesophageal reflux disease Assessment Symptom Questionnaire composite symptom scores and individual symptom scores correlate with outcomes in esophageal multichannel intraluminal impedance-pH monitoring. METHODS: A total of 26 patients with gastroesophageal reflux disease-associated symptoms, aged 0-2 years, for whom both esophageal multichannel intraluminal impedance-pH monitoring and Gastroesophageal reflux disease Assessment Symptom Questionnaire survey results were available were included in the study. Gastroesophageal reflux disease Assessment Symptom Questionnaire score data were collected from a 7-day recall of parent's responses about the frequency and severity of gastroesophageal reflux disease symptoms, which determined the individual symptom scores. The composite symptom scores is the sum of all individual symptom scores. Multichannel intraluminal impedance-pH study results were compared to Gastroesophageal reflux disease Assessment Symptom Questionnaire data using Pearson correlation. RESULTS: Among 26 patients, a total number of 2817 (1700 acid and 1117 non-acid) reflux episodes and 845 clinical reflux behaviors were recorded. There were significant correlations between the reflux index and the individual symptom scores for coughing/gagging/choking (r2 = 0.2842, p = 0.005), the impedance score and individual symptom scores for coughing/gagging/choking (r2 = 0.2482, p = 0.009), the reflux symptom index for acid reflux-related coughing/gagging/choking and the individual symptom scores for coughing/gagging/choking (r2 = 0.1900, p = 0.026), the impedance score and individual symptom scores for vomiting (r2 = 0.1569, p = 0.045), and the impedance score and the composite symptom scores (r2 = 0.2916, p = 0.004). However, there were no significant correlations between fussiness, irritability, or abdominal pain-related multichannel intraluminal impedance-pH results and the individual symptom scores for abdominal pain. CONCLUSION: The impedance scores from multichannel intraluminal impedance-pH studies correlate with coughing/gagging/choking and vomiting in infants with gastroesophageal reflux disease. There are no significant correlations among the reflux index and impedance score versus the Gastroesophageal reflux disease Assessment Symptom Questionnaire scores for abdominal pain. We conclude that in infants with gastroesophageal reflux disease, multichannel intraluminal impedance-pH studies are more likely to demonstrate an association between gastroesophageal reflux disease and symptoms of coughing, gagging, or choking compared to an association between gastroesophageal reflux disease and pain in infants.

12.
World J Hepatol ; 9(23): 1008-1012, 2017 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-28878866

RESUMO

Autoimmune hepatitis (AIH) is a progressive liver disease that is often associated with extrahepatic autoimmune disorders. Evans syndrome (ES) is a rare autoimmune disorder, which is characterized by immune thrombocytopenia and autoimmune hemolytic anemia. Association of AIH with ES is rare, especially in children. We report a 3-year-old female with a past medical history of ES who presented with jaundice and significant transaminitis due to AIH type 1. She required multiple treatments with steroids as well as azathioprine, intravenous immunoglobulin and a course of rituximab.

13.
Pediatrics ; 137(5)2016 05.
Artigo em Inglês | MEDLINE | ID: mdl-27244835

RESUMO

This is the first clinical practice guideline from the American Academy of Pediatrics that specifically applies to patients who have experienced an apparent life-threatening event (ALTE). This clinical practice guideline has 3 objectives. First, it recommends the replacement of the term ALTE with a new term, brief resolved unexplained event (BRUE). Second, it provides an approach to patient evaluation that is based on the risk that the infant will have a repeat event or has a serious underlying disorder. Finally, it provides management recommendations, or key action statements, for lower-risk infants. The term BRUE is defined as an event occurring in an infant younger than 1 year when the observer reports a sudden, brief, and now resolved episode of ≥1 of the following: (1) cyanosis or pallor; (2) absent, decreased, or irregular breathing; (3) marked change in tone (hyper- or hypotonia); and (4) altered level of responsiveness. A BRUE is diagnosed only when there is no explanation for a qualifying event after conducting an appropriate history and physical examination. By using this definition and framework, infants younger than 1 year who present with a BRUE are categorized either as (1) a lower-risk patient on the basis of history and physical examination for whom evidence-based recommendations for evaluation and management are offered or (2) a higher-risk patient whose history and physical examination suggest the need for further investigation and treatment but for whom recommendations are not offered. This clinical practice guideline is intended to foster a patient- and family-centered approach to care, reduce unnecessary and costly medical interventions, improve patient outcomes, support implementation, and provide direction for future research. Each key action statement indicates a level of evidence, the benefit-harm relationship, and the strength of recommendation.


Assuntos
Apneia/diagnóstico , Cianose/diagnóstico , Hipotonia Muscular/diagnóstico , Terminologia como Assunto , Emergências , Humanos , Lactente , Fatores de Risco , Morte Súbita do Lactente/diagnóstico
14.
Clin Ther ; 27(4): 472-83, 2005 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-15922820

RESUMO

BACKGROUND: Gastroesophageal reflux disease (GERD), which is reflux that produces damage or troubling symptoms, afflicts approximately 7% of infants and children to the extent that administration of physician-directed pharmacotherapy is warranted. OBJECTIVE: This study was designed in conjunction with the US Food and Drug Administration (FDA) to assess the tolerability and effectiveness of nizatidine, in different doses and formulations, including a newly formulated premade oral solution, for pediatric GERD. METHODS: Children aged 5 days through 18 years were recruited to this 8-week, open-label, multiple-dose, randomized, parallel-group, multicenter study. The original study design specified that patients aged 5 days through 12 years at study start be given a nizatidine capsule dissolved in infant formula or apple juice depending on patient age ("extemporaneous solution"). Children 13 through 18 years old were to be given the "adult dose" of nizatidine capsules 150 mg BID regardless of body weight. All patients aged < 13 years were randomized in blocks of 4 between 2 dose levels (2.5 and 5 mg/kg per dose BID). A protocol amendment during the study added a newly formulated, more pediatric-appropriate, premade oral solution that was developed at the request of the FDA. This premade formulation ("oral solution") was to replace the extemporaneous solution mixed in infant formula or apple juice. Subsequently, an additional 44 children aged < 13 years old were enrolled in the study and randomized to receive the new nizatidine oral solution for 8 weeks at the same 2 dose levels as used for the extemporaneous solution. Outcome data at 4 and 8 weeks included adverse events (AEs) (severity, relation to study drug, and any relationship to study withdrawal) and effectiveness (investigators' assessment of changes in reflux symptoms and overall physical well-being, and parent/child assessment of change in antacid use). Formal statistical analyses were not planned, but post hoc chi-square analyses were performed. RESULTS: Of 214 children enrolled, 210 (98%) intent-to-treat (ITT) patients received > or = 1 dose; of these, 173 (82%) completed 8 weeks of study. At least 77% were compliant (ie, medicated on > or = 75% of days). Of the ITT patients, 37 did not complete 8 weeks due to insufficient response, AEs (regardless of relationship to study drug), or other reasons. Although 292 AEs occurred in 115 patients, 277 (95%) were mild to moderate and 15 (5%) were severe. Most of the AEs in these children studied during the winter were related to infectious illnesses. Only 4 serious AEs occurred; 3 were unrelated to study drug. The fourth AE--considered possibly related--was worsening sickle cell anemia 18 days after medication discontinuation. Approximately 30% of patients became asymptomatic after 8 weeks of treatment, regardless of dosing or formulation, and despite reduction of antacid use in half of the patients. No clear superiority of any dose or formulation was demonstrated. CONCLUSIONS: This large study, although limited by its open-label design and post hoc analyses, supports the tolerability and effectiveness of 8 weeks of treatment with nizatidine in children aged 5 days through 18 years. AE incidence and severity were as expected for children during the winter season. There was an overall improvement in symptoms and a decrease in antacid use. Formulation did not appear to alter tolerability or effectiveness assessments: the premade solution, extemporaneous solution, and capsule provided comparable symptomatic relief with no disproportionate adverse reactions.


Assuntos
Refluxo Gastroesofágico/tratamento farmacológico , Antagonistas dos Receptores H2 da Histamina/uso terapêutico , Nizatidina/uso terapêutico , Adolescente , Adulto , Cápsulas , Química Farmacêutica , Criança , Pré-Escolar , Esquema de Medicação , Tolerância a Medicamentos , Feminino , Refluxo Gastroesofágico/fisiopatologia , Antagonistas dos Receptores H2 da Histamina/administração & dosagem , Antagonistas dos Receptores H2 da Histamina/efeitos adversos , Humanos , Lactente , Recém-Nascido , Masculino , Nizatidina/administração & dosagem , Nizatidina/efeitos adversos , Soluções
15.
Paediatr Drugs ; 4(12): 807-15, 2002.
Artigo em Inglês | MEDLINE | ID: mdl-12431133

RESUMO

Ulcerative colitis is a chronic relapsing inflammatory disorder of the colonic mucosa of unknown etiology. The inflammatory process involves the mucosa and submucosa in a continuous segment of bowel with rectal involvement in almost all cases. Since its etiology is unknown, therapy is directed at modulating the inflammatory response in order to control symptoms and to prevent relapses. 5-aminosalicylates and corticosteroids have been the most widely used therapeutic agents for treatment of ulcerative colitis. Recently, experience has been gained with the use of other immunomodulators, such as mercaptopurine, azathioprine, methotrexate, cyclosporine, and tacrolimus, in pediatric patients. Colectomy is indicated in patients with severe colitis who do not respond to intensive medical therapy. The care of children with ulcerative colitis not only involves control of symptoms from gastrointestinal and extraintestinal manifestations, but also optimizing growth and development. The complications of chronic inflammation and long-term medical therapy must be weighed against the risks and benefits of surgery for children and adolescents with this condition.


Assuntos
Colite Ulcerativa , Adolescente , Anti-Inflamatórios não Esteroides/uso terapêutico , Criança , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/fisiopatologia , Feminino , Humanos
16.
Clin Pediatr (Phila) ; 41(4): 225-9, 2002 May.
Artigo em Inglês | MEDLINE | ID: mdl-12041718

RESUMO

Polyethylene glycol (PEG) 3350 and lactulose were compared in an unblinded, randomized, crossover design for treatment of constipation in 37 children aged 2 to 16 years. Subjects received lactulose (1.3 g/kg/d divided twice daily up to 20 g) or PEG 3350 (10 g/m2/day) for 2 weeks. PEG 3350 significantly decreased the total colonic transit time compared to lactulose (47.6+/-2.7 vs 55.3+/-2.4 hours, mean +/- SE, PEG 3350 vs lactulose, respectively, p = 0.038). The stool frequency, form, and the ease of passage were similar for each laxative. Polyethylene glycol 3350 is an effective laxative for the treatment of chronic constipation in children.


Assuntos
Constipação Intestinal/tratamento farmacológico , Lactulose/uso terapêutico , Polietilenoglicóis/uso terapêutico , Adolescente , Criança , Pré-Escolar , Doença Crônica , Estudos Cross-Over , Feminino , Humanos , Masculino , Resultado do Tratamento
17.
Clin Pediatr (Phila) ; 42(4): 341-5, 2003 May.
Artigo em Inglês | MEDLINE | ID: mdl-12800728

RESUMO

The causal relationship between lactose ingestion and gastrointestinal symptoms is questionable. The aim of this study was to assess symptoms associated with milk ingestion in children with lactose maldigestion. Thirty children (11 males) age 3 to 17 years with lactose maldigestion were studied. In a double-blind, crossover design, subjects ingested 240 mL daily of either lactose-hydrolyzed or lactose-containing milk for 14 days. Diaries were kept daily that recorded diet, medication use, and symptoms. There was a significant increase in abdominal pain experienced by study participants during the lactose ingestion period when compared to the lactose-free period. We conclude that ingestion of 12 g of lactose daily is associated with increased abdominal pain in susceptible children with lactose maldigestion. A trial of dietary lactose restriction may be beneficial in reducing abdominal pain in children with lactose maldigestion.


Assuntos
Dor Abdominal/etiologia , Intolerância à Lactose/complicações , Dor Abdominal/classificação , Adolescente , Criança , Pré-Escolar , Estudos Cross-Over , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Lactose/efeitos adversos , Intolerância à Lactose/diagnóstico , Intolerância à Lactose/dietoterapia , Masculino , Índice de Gravidade de Doença
19.
Pediatrics ; 131(5): e1684-95, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23629618

RESUMO

Recent comprehensive guidelines developed by the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition define the common entities of gastroesophageal reflux (GER) as the physiologic passage of gastric contents into the esophagus and gastroesophageal reflux disease (GERD) as reflux associated with troublesome symptoms or complications. The ability to distinguish between GER and GERD is increasingly important to implement best practices in the management of acid reflux in patients across all pediatric age groups, as children with GERD may benefit from further evaluation and treatment, whereas conservative recommendations are the only indicated therapy in those with uncomplicated physiologic reflux. This clinical report endorses the rigorously developed, well-referenced North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition guidelines and likewise emphasizes important concepts for the general pediatrician. A key issue is distinguishing between clinical manifestations of GER and GERD in term infants, children, and adolescents to identify patients who can be managed with conservative treatment by the pediatrician and to refer patients who require consultation with the gastroenterologist. Accordingly, the evidence basis presented by the guidelines for diagnostic approaches as well as treatments is discussed. Lifestyle changes are emphasized as first-line therapy in both GER and GERD, whereas medications are explicitly indicated only for patients with GERD. Surgical therapies are reserved for children with intractable symptoms or who are at risk for life-threatening complications of GERD. Recent black box warnings from the US Food and Drug Administration are discussed, and caution is underlined when using promoters of gastric emptying and motility. Finally, attention is paid to increasing evidence of inappropriate prescriptions for proton pump inhibitors in the pediatric population.


Assuntos
Fundoplicatura/métodos , Refluxo Gastroesofágico/diagnóstico , Refluxo Gastroesofágico/terapia , Guias de Prática Clínica como Assunto , Inibidores da Bomba de Prótons/uso terapêutico , Adolescente , Fatores Etários , Criança , Pré-Escolar , Dietoterapia/métodos , Gerenciamento Clínico , Monitoramento do pH Esofágico , Esofagoscopia/métodos , Feminino , Humanos , Lactente , Masculino , Prognóstico , Medição de Risco , Índice de Gravidade de Doença , Resultado do Tratamento
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