Abstract:
:Most drugs that are currently prescribed in pediatrics have not been tested in children. Pediatric drug studies are stimulated in the USA by the pediatric exclusivity provision under the Food and Drug Administration Modernization Act (FDAMA) that grants patent extensions when pediatric labeling is provided. We investigated the effectiveness of these programs in stimulating drug research in children, thereby increasing the evidence for safe and effective drug use in the pediatric population. All drugs granted pediatric exclusivity under the FDAMA were analyzed by studying the relevant summaries of medical and clinical pharmacology reviews of the pediatric studies or, if these were unavailable, the labeling information as provided by the manufacturer. A systematic search of the literature was performed to identify drug utilization patterns in children. From July 1998 to August 2006, 135 drug entities were granted pediatric exclusivity. Most frequent drug groups were anti-depressants and mood stabilizers, ACE inhibitors, lipid-lowering preparations, HIV antivirals, and non-steroidal anti-inflammatory and anti-rheumatic drugs. The distribution of the different drugs closely matched the distribution of these drugs over the adult market, and not the drug utilization by children. Many drug studies in children have been performed since the introduction of the FDAMA. However, children infrequently use the drugs granted pediatric exclusivity. The priorities for pediatric drug research should be set by the need of the patients, not by market considerations.
journal_name
Eur J Pediatrjournal_title
European journal of pediatricsauthors
Boots I,Sukhai RN,Klein RH,Holl RA,Wit JM,Cohen AF,Burggraaf Jdoi
10.1007/s00431-006-0381-zsubject
Has Abstractpub_date
2007-08-01 00:00:00pages
849-55issue
8eissn
0340-6199issn
1432-1076journal_volume
166pub_type
杂志文章abstract:UNLABELLED:We investigated the histological and molecular characteristics of pulmonary alveolar proteinosis (PAP) in two siblings (a brother and sister) who did not exhibit respiratory distress at birth but who each developed symptoms during infancy. Histological analysis of lung specimens showed positive staining for ...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s004310051107
更新日期:1999-05-01 00:00:00
abstract:UNLABELLED:Delta1-pyrroline-5-carboxylate synthase (P5CS) catalyses the reduction of glutamate to Delta1-pyrroline-5-carboxylate, a critical step in the biosynthesis of proline, ornithine and arginine. Recently, we reported a newly recognised inborn error due to deficiency of P5CS in two sibs, one presenting at birth w...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-004-1545-3
更新日期:2005-01-01 00:00:00
abstract::Resting metabolic rate (RMR) and the thermic effect of a meal (TEM) were measured in a group of 26 prepubertal children divided into three groups: (1) children with both parents obese (n = 8, group OB2); (2) children with no obese parents and without familial history of obesity (n = 8, OB0); and (3) normal body weight...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF02072489
更新日期:1993-02-01 00:00:00
abstract::Vascularization of the arms has been studied by impedance plethysmography (rheography) in eight children with Poland syndrome, a common malformation characterized by unilateral hand anomaly and ipsilateral aplasia of the inferior head of the pectoralis major muscle. A marked decrease of the velocity of the systolic in...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF00496922
更新日期:1978-05-22 00:00:00
abstract::We updated our 2010 systematic review on the efficacy of probiotics in the treatment of constipation in children. The MEDLINE, EMBASE, and Cochrane Library databases; clinical trial registries; and reference lists of included studies were searched to February 2017 for randomized controlled trials (RCTs) performed in c...
journal_title:European journal of pediatrics
pub_type: 杂志文章,评审
doi:10.1007/s00431-017-2972-2
更新日期:2017-09-01 00:00:00
abstract::Inflammatory bowel disease (IBD) is a cause of chronic intestinal inflammation in children. In a subset of patients affected by IBD, arthropathy may be the leading presenting sign. In the past years, remarkable advances in gastrointestinal endoscopy techniques have been achieved; recently, the development of capsule e...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-011-1505-7
更新日期:2011-10-01 00:00:00
abstract:UNLABELLED:A 9-year-old boy lost almost all his small bowel after an acute volvulus due to a congenital, but previously unsuspected malrotation. Survival using total parenteral nutrition is possible in these cases, but the medical burden is heavy. Small intestinal transplantation was performed for the first time in the...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-003-1294-8
更新日期:2003-11-01 00:00:00
abstract::Although thyroid medications are frequently prescribed during pregnancy, paediatricians treating the respective neonates often have no information about the underlying maternal thyroid disease, and inconsistencies in postnatal diagnostics may result. We analysed a cohort of 1819 mothers admitted for delivery in 1 year...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-018-3232-9
更新日期:2018-11-01 00:00:00
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journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s004310050942
更新日期:1998-10-01 00:00:00
abstract::This was a retrospective study documenting all pacemaker implantations (PMIs) secondary to postoperative atrioventricular block. A total of 26 patients were included between 2011 and 2020. The incidence rate was 1.8%, with a median follow-up time of 4.5 years. At the time of the initial PMI, the median weight was 5 kg...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-020-03739-9
更新日期:2020-12-01 00:00:00
abstract::A 22 years old female with the late-onset of argininosuccinic aciduria was successfully treated for 5 months with a mixture of essential amino acids and their keto-analogues. There was a marked change in plasma ammonia, plasma amino acids and argininosuccinic acid excretion. A long term anabolic response was reflected...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF00445607
更新日期:1978-07-19 00:00:00
abstract:UNLABELLED:A 14-year-old boy developed acute quadriplegia, associated with sensory impairment and bowel and urinary dysfunction. MRI of the cervical cord showed diffuse increased signal intensity on T2-weighted images with gadolinium-diethylenetriamine penta-acetic acid enhancement. Based on the clinical presentation a...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF02072107
更新日期:1995-05-01 00:00:00
abstract::The peak flow velocities in the middle cerebral artery were continuously recorded by transcranial Doppler sonography in 29 children. Arterial blood pressure and heart rates were measured every minute. The values observed during orthostasis and physical exercise were compared to baseline values obtained in the supine p...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF01958769
更新日期:1991-08-01 00:00:00
abstract:UNLABELLED:The aim of this study was to provide growth and sexual maturation reference data for Turkish children living in The Netherlands. We also compared these references with the reference data of children of Dutch origin and with Turkish reference data collected in Turkey and elsewhere in Europe. Cross-sectional g...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-003-1292-x
更新日期:2003-11-01 00:00:00
abstract::Piritramide is indicated for treatment of postoperative pain and analgosedation in the intensive care unit (ICU) setting. In an open prospective study the pharmacokinetics of piritramide were investigated in four groups: newborns (NB, age: 1-28 days) (n=8), infants 1 (IF1, age: 2-4 months) (n=7), infants 2 (IF2, age: ...
journal_title:European journal of pediatrics
pub_type: 临床试验,杂志文章
doi:10.1007/s00431-005-0021-z
更新日期:2006-04-01 00:00:00
abstract::Retraction Note to: Eur J Pediatr (1994) 153:668-671 DOI 10.1007/BF02190689. This article, "Adenosine triphosphate treatment for supraventricular tachycardia in infants", published in the European Journal of Pediatrics (1994) 153/9: 668-671, Springer-Verlag 1994, has been retracted at the request of the Publisher as i...
journal_title:European journal of pediatrics
pub_type: 撤回出版物
doi:10.1007/s00431-015-2640-3
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:The severity of childhood gastroenteritis is generally believed to be age-related rather than aetiology-related. Rotavirus-induced gastroenteritis is more severe than gastroenteritis caused by other enteric pathogens and is also age-related. We thus addressed the question of whether the increased severity of...
journal_title:European journal of pediatrics
pub_type: 杂志文章,多中心研究
doi:10.1007/s00431-006-0237-6
更新日期:2007-03-01 00:00:00
abstract::Twenty-eight children whose parents reported sleep apnoea were investigated. In 15 infants apnoeic periods during sleep could be confirmed during clinical observation. Ventilatory responses to CO2 were measured in all infants, in 23 during sleep in 5 only when awake. A very wide range of CO2 sensitivities was found. I...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF00496030
更新日期:1986-04-01 00:00:00
abstract::A five-year-old-girl with a history of recurrent hypoglycemia presented with acidosis, intractable vomiting, and abdominal tenderness; the diagnosis of acute pancreatitis was made by abdominal ultrasonography and supportive biochemical studies. Urinary organic acid analysis revealed metabolites suggestive of HMG-CoA l...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF00540255
更新日期:1984-09-01 00:00:00
abstract::Asymptomatic excretion of group B streptococcus (GBS) in breast milk may be an underrecognized cause of neonatal and recurrent infection. We report the case of late-onset and recurrent infection in newborn twins resulting from ingestion of maternal breast milk infected with GBS. Genetic analysis of isolates is equally...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-008-0903-y
更新日期:2009-09-01 00:00:00
abstract::Sweet syndrome, also referred to as acute febrile neutrophilic dermatosis, is characterized by tender, red inflammatory nodules or papules that occur in association with infection, malignancy, connective tissue disease, or following exposure to certain drugs. Although drug-induced Sweet syndrome is rare, granulocyte c...
journal_title:European journal of pediatrics
pub_type: 杂志文章,评审
doi:10.1007/s00431-010-1201-z
更新日期:2010-12-01 00:00:00
abstract::Twelve preterm infants, median gestational age 31.5 weeks, were entered into a randomised, placebo-controlled trial of bronchodilator therapy. Their postnatal age was a median of 17.5 months and all suffered from recurrent respiratory symptoms. The infants received either inhaled placebo or 40 micrograms of ipratropiu...
journal_title:European journal of pediatrics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF01955008
更新日期:1991-10-01 00:00:00
abstract:UNLABELLED:An 8-year-old boy with frequently recurring pancreatitis-like abdominal pain, Fredrickson type V dyslipidaemia, and significantly decreased post-heparin plasma lipoprotein lipase (LPL) activity is described. In order to exclude familial LPL deficiency, the complete LPL coding gene sequence was analysed revea...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF01957148
更新日期:1996-08-01 00:00:00
abstract::We compared epinephrine and dopamine as a first-line vasoactive drug in 40 neonates (enrolled in two gestational age strata ≤ 306/7 and ≥ 310/7 weeks) with fluid-refractory septic shock. Epinephrine or dopamine was initiated at 0.2 or 10 μg/kg/min, respectively. If shock persisted after 15 min, epinephrine or dopamine...
journal_title:European journal of pediatrics
pub_type: 杂志文章,随机对照试验
doi:10.1007/s00431-018-3195-x
更新日期:2018-09-01 00:00:00
abstract::Continuous negative extrathoracic pressure (CNEP) has been recently reintroduced as therapy for respiratory failure. To determine its effects on cardiac output a pilot study was performed in ten patients aged 2 months-3 years (median 4 months). All had chronic respiratory failure (seven with bronchopulmonary dysplasia...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF01954088
更新日期:1993-07-01 00:00:00
abstract::To access outcome following hypoxic ischemic encephalopathy (HIE), survivors without cerebral palsy were invited for formal developmental assessment. Children aged ≥ 42 months were assessed using the NEPSY-2, Movement Assessment Battery for Children 2 (Movement ABC-2), Behavior Rating Inventory of Executive Function, ...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-017-3028-3
更新日期:2018-01-01 00:00:00
abstract::Most reviews on weight status have focused on obesity, and little information on underweight children is available. This review aimed to examine the prevalence and trends of underweight status among Asian children and adolescent populations in the last two decades. A systematic review of publications between the years...
journal_title:European journal of pediatrics
pub_type: 杂志文章,评审
doi:10.1007/s00431-012-1685-9
更新日期:2012-05-01 00:00:00
abstract:OBJECTIVES:The aim of the 'Motorik-Modul' (MoMo Basiserhebung, www.motorik-modul.de ) was to establish prevalence measurements on physical fitness and physical activity in German children and adolescents and to identify differences between age groups and genders. A total of 4,529 children and adolescents between the ag...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-010-1391-4
更新日期:2011-09-01 00:00:00
abstract:UNLABELLED:In 135 women and 85 men who initially presented for tall stature, the outcome in treated (56 women and 33 men; cases) and untreated (controls) was investigated. At the time of height prediction, cases were significantly taller (P < or = 0.03) than the controls, they had higher target heights (P < 0.001) and ...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s004310050740
更新日期:1997-12-01 00:00:00
abstract::Comprehensive data on 30 patients with propionic acidaemia, diagnosed by selective screening for inborn errors of metabolism, are presented. The most valuable diagnostic metabolites found were methylcitric-, 3-hydroxypropionic-, and 2-methyl-3-oxovaleric acids. Hyperlysinaemia and hyperlysinuria are also characteristi...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF02138781
更新日期:1994-01-01 00:00:00