RESUMO
Pediatric R-Tx patients are at high risk of developing EBV primary infection. Although high DNA replication is a risk factor for PTLD, some patients develop PTLD with low viral load. In this retrospective single-center study including all pediatric patients having received R-Tx (2003-2012 period), we aimed to identify risk factors for uncontrolled reactions to EBV (defined as the presence of a viral load >10 000 copies/mL or PTLD). A Cox proportional hazard model was performed. A total of 117 patients underwent R-Tx at a mean age of 9.7 ± 5.3 years, 46 of them being seronegative for EBV at the time of R-Tx. During follow-up, 54 patients displayed positive EBV viral load, 22 of whom presenting with primary infection. An uncontrolled reaction to EBV was observed in 24 patients, whilst 4 patients developed PTLD. Univariate and multivariate analyses suggested the following risk factors for an uncontrolled reaction: age below 5 years, graft from a deceased donor, ≥5 HLA mismatches, EBV-seronegative status at the time of R-Tx, and a secondary post-Tx loss of anti-EBNA. Monitoring anti-EBNA after R-Tx may contribute to the early identification of patients at risk for uncontrolled reaction.
Assuntos
Infecções por Vírus Epstein-Barr/etiologia , Transplante de Rim , Complicações Pós-Operatórias/etiologia , Adolescente , Criança , Pré-Escolar , Infecções por Vírus Epstein-Barr/epidemiologia , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Estimativa de Kaplan-Meier , Masculino , Avaliação de Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/epidemiologia , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Fatores de RiscoRESUMO
BACKGROUND: The operating theatre, anaesthesia induction and separation from parents create fear and anxiety in children. Anxiety leads to adverse behavioral changes appearing and sometimes persisting during the postoperative period. Our aim was to compare the effects of midazolam (0.3 mg kg-1: MDZ) for premedication with age-appropriate tablet game apps (TAB) on children anxiety during and after ambulatory surgery. METHODS: A randomized controlled trial was conducted from May 16th, 2013 to March 25th, 2014 at the Children Hospital of Lyon. The primary outcome of this study was the change in m-YPAS score at the time of anaesthetic mask induction. Anxiety was also assessed in the waiting surgical area, at the time of separation with parents and when back in the ambulatory surgery ward. RESULTS: One hundred and eighteen patients aged four-11 yr were recruited, 60 in the TAB Group and 58 in the MDZ Group. Main endpoint was missing for three patients from the MDZ Group. At the time of mask induction, there was no significant difference between MDZ and TAB Group for the m-YPAS score (40.5 (18.6) vs 41.8 (20.7), P = 0.99). There was no significant correlation between m-YPAS score and its evolution over the four period of time between subjects. CONCLUSIONS: We were not able to show whether TAB is superior to MDZ to blunt anxiety in children undergoing ambulatory surgery. TAB is a non-pharmacological tool which has the capacity in reducing perioperative stress without any sedative effect in this population. CLINICAL TRIAL REGISTRATION: NCT 02192710.
Assuntos
Procedimentos Cirúrgicos Ambulatórios , Ansiolíticos/uso terapêutico , Midazolam/uso terapêutico , Pais/psicologia , Medicação Pré-Anestésica , Jogos de Vídeo , Criança , Pré-Escolar , Computadores de Mão , Feminino , Humanos , MasculinoRESUMO
BACKGROUND: The aim of the study was to determine whether the introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety levels of children undergoing major surgery. Secondary objectives were to determine whether the level of understanding of participants and other risk factors influence STAIC-S (State-Trait Anxiety Inventory for Children-State subscale) score in children. METHODS: We performed a randomized controlled parallel-group trial comparing preoperative anxiety between two groups of children aged >6 and <17 yr. Before surgery, the intervention group received a comic information leaflet at home in addition to routine information given by the anaesthetist at least 1 day before surgery. The control group received the routine information only. The outcome measure was the difference between STAIC-S scores measured before any intervention and after the anaesthetist's visit. A multiple regression analysis was performed to explore the influence of the level of education, the anxiety of parents, and the childrens' intelligence quotient on STAIC-S scores. RESULTS: One hundred and fifteen children were randomized between April 2009 and April 2013. An intention-to-treat analysis on data from 111 patients showed a significant reduction (P=0.002) in STAIC-S in the intervention group (n=54, mean=-2.2) compared with the control group (n=57, mean=0.90). The multiple regression analysis did not show any influence on STAIC-S scores of the level of education, parental anxiety, or the intelligence quotient of the children. CONCLUSIONS: A paediatric anaesthesia comic information leaflet was a cheap and effective means of reducing preoperative anxiety, measured by STAIC-S, in children. CLINICAL TRIALS REGISTRATION: NCT 00841022.
Assuntos
Ansiedade , Pais , Anestesia , Criança , HumanosRESUMO
BACKGROUND: Cow's milk protein allergy (CMPA) represents one of the leading causes of food allergy in infants and young children. The immune reaction may be IgE mediated, non-IgE mediated, or mixed. IgE-mediated cow's milk protein allergy is revealed by immediate and acute symptoms which can be severe. The aim of this study is to report a one centre experience in the real life of testing children with IgE-mediated CMPA and try to identify predictive factor for follow-up challenges. METHOD: Retrospective and monocentric study between September 1997 and February 2008. 178 infants diagnosed with IgE-mediated CMPA during breastfeeding weaning were included. Initial factors such as age, sex, skin prick tests (SPTs), specific IgE (sIgE), atopic dermatitis and types of reaction were noted. Between 12 and 24 months all infants have undergone at least one evaluation including SPT. RESULTS: At the food challenge, 138 (75.8%) infants were found tolerant. Results of the skin prick test (SPT) were statistically different according to the food challenge result (2.2mm vs. 5.1mm, p<0.0001). It was the same result for sIgE for CM 2.0ku/l vs. 11.5ku/l - p<0.0001 and for casein 1.0ku/l vs. 16.0ku/l - p=0.0014. CONCLUSION: This study confirms the practical interest of both SPT and sIgE in the evaluation of tolerance induction in IgE-mediated CMPA, but with no corresponding results. Sensitivity, specificity and probability curves of success for cow's milk challenge can be determined and have clinical utility.
Assuntos
Tolerância Imunológica/imunologia , Imunoglobulina E/imunologia , Hipersensibilidade a Leite/diagnóstico , Hipersensibilidade a Leite/imunologia , Testes Cutâneos , Pré-Escolar , Estudos de Coortes , Feminino , Humanos , Imunoglobulina E/sangue , Lactente , Masculino , Estudos RetrospectivosRESUMO
Endocrine disrupting chemicals (EDCs) may impact children's health, with medicines as a possible exposure source. Objective: to assess the potential impact of substances in paediatric medications and essential oils on children as EDC. It is a systematic review of five databases including Medline following the PECOT approach. The review focused on publications about children exposed to medication (active ingredients or excipients of interest) and having developed clinical signs of endocrine dysfunction. Out of 946 studies identified, 28 studies were included. They revealed that parabens, lavender essential oils and anti-epileptics are the most identified pharmaceutical products. The reported outcomes relate to puberty, thyroid disorders, obesity and growth. The evidence indicates potential risks, but the overall quality of available data is limited. This systematic review exposes a lack of robust evidence linking paediatric medication exposure to EDC, predominantly relying on case reports. It cautions about potential conflicts of interest.
Assuntos
Disruptores Endócrinos , Disruptores Endócrinos/toxicidade , Humanos , Criança , Óleos Voláteis/toxicidade , Parabenos/toxicidade , Anticonvulsivantes/toxicidade , Anticonvulsivantes/efeitos adversos , Lavandula , Óleos de PlantasRESUMO
BACKGROUND: Arterial hypotension induced by general anesthesia is commonly identified as a risk factor of morbidity, especially neurological, after cardiac or noncardiac surgery in adults and children. Intraoperative hypotension is observed with sevoflurane anesthesia in children, in particular in neonates, infants younger than 6 months, and preterm babies. Ephedrine is commonly used to treat intraoperative hypotension. It is an attractive therapeutic, due to its dual action on receptors alpha and beta and its possible peripheral intravenous infusion. There are few data in the literature on the use of ephedrine in the context of pediatric anesthesia. The actual recommended dose of ephedrine (0.1 to 0.2 mg/Kg) frequently leads to a therapeutic failure in neonates and infants up to 6 months of age. The use of higher doses would probably lead to a better correction of hypotension in this population. The objective of our project is to determine the optimal dose of ephedrine for the treatment of hypotension after induction of general anesthesia with sevoflurane, in neonates and infants up to 6 months of age. METHODS: The ephedrine study is a prospective, randomized, open-label, controlled, dose-escalation trial. The dose escalation consists of 6 successive cohorts of 20 subjects. The doses studied are 0.6, 0.8, 1, 1.2, and 1.4 mg/kg. The dose chosen as the reference is 0.1 mg/kg, the actual recommended dose. Neonates and infants younger than 6 months, males and females, including preterm babies who undergo a surgery with general anesthesia inducted with sevoflurane were eligible. Parents of the subject were informed. Then, the subjects were randomized if presenting a decrease in mean blood pressure superior to 20% of their initial mean blood pressure (before induction of anesthesia), despite a vascular filling with sodium chloride 0.9%. The primary outcome is the success of the therapy defined as an mBP superior to 80% of the baseline mBP (prior to anesthesia) within 10 min post ephedrine administration. The subjects were followed-up for 3 days postanesthesia. DISCUSSION: This study is the first randomized, controlled trial intending to determine the optimal dose of ephedrine to treat hypotension in neonates and infants below 6 months old. TRIAL REGISTRATION: ClinicalTrials.gov NCT02384876 . Registered on March 2015.
Assuntos
Efedrina , Hipotensão , Adulto , Anestesia Geral/efeitos adversos , Pressão Sanguínea , Criança , Efedrina/efeitos adversos , Feminino , Humanos , Hipotensão/induzido quimicamente , Hipotensão/diagnóstico , Hipotensão/tratamento farmacológico , Lactente , Recém-Nascido , Masculino , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Vasoconstritores/efeitos adversosRESUMO
OBJECTIVES: The aim of this study was to systematically evaluate adverse drug reactions (ADRs) in children consulting at the pediatric emergency unit during a 6-month period. METHOD: The regional pharmacovigilance center (CRPV) and the department of clinical pharmacology prospectively and systematically recorded all potential ADRs among patients younger than 18 years of age in the pediatric emergency unit reported at the daily staff meetings. All cases were then screened and validated by the CRPV. For validated cases, preventability, seriousness, and off-label use were evaluated. RESULTS: During the study period, from 1 March to 1 September 2005, 90 children presented potential adverse drug events. ADRs were confirmed in 43 patients, 19 females and 24 males. Thirty-four patients (79%) were under the age of 5. According to the European definition, 14 patients (33%) had serious ADRs. One anaphylactic shock after amoxicillin injection; antimalarial prophylaxis misuse leading to convulsive status epilepticus, convulsion, and coma after hepatitis B and MMR vaccines were deemed life-threatening. Three ADRs were considered avoidable. Antibiotics and vaccines were the most common possible cause of ADRs (76%). Skin reactions (n=27), fever (n=8), and gastric disorders (n=5) were the most common clinical manifestations. CONCLUSIONS: Because ADRs were reported by clinicians on a voluntary basis, serious ADRs were probably reported more systematically. Compared to a similar period without active monitoring, active drug monitoring of ADRs doubled the number of confirmed cases 43 vs 17, p<0.001. Close collaboration between the pharmacovigilance center, pharmacologists, and clinicians is necessary and seems feasible for improving the monitoring of ADRs in children.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Monitoramento de Medicamentos , Pré-Escolar , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Serviço Hospitalar de Emergência , Feminino , Humanos , Masculino , Estudos Prospectivos , Vacinas/efeitos adversosRESUMO
OBJECTIVE: To describe pain assessment, the pattern of analgesic and sedative drug use, and adverse drug reactions in a neonatal intensive care unit (NICU) during the postsurgery phase. METHOD: Demographic characteristics, pain scores, and drug use were extracted and analyzed from electronic patient medical files for infants after surgery, admitted consecutively between January 2012 and June 2013. RESULT: One hundred and sixty-eight infants were included. Acute (DAN score) and prolonged (EDIN score) pain assessment scores were used in 79% and 64% of infants, respectively, on the 1st day. This percentage decreased over the 7 days following surgery. The weekly average scores postsurgery were 2/15 (±2.2) for the EDIN score and 1.6/10 (±2.0) for the DAN score. The rates of pain control were 88% for the EDIN and 72% for the DAN. The most prescribed opiate drug was fentanyl (98 patients; 58%) with an average dose of 1.8 (±0.6) µg/kg/h. Midazolam was used in 95 patients (56%), with an average dose of 35 (±14) µg/kg/h. A bolus was administered in 7% (±7.4) of the total dose for fentanyl and 8% (±9.3) for midazolam. Similar doses were used in term and preterm neonates. Of 118 patients receiving fentanyl and/or midazolam, 40% presented urinary retention, 28% a weaning syndrome. Paracetamol (155 patients; 92%) and nalbuphine (55 patients; 33%) were the other medications most often prescribed. CONCLUSION: The off-label use of fentanyl and midazolam was necessary to treat pain after surgery. Pain assessment should be conducted for all neonates in order to optimize their treatment. Research on analgesic and sedative medicine in vulnerable neonates seems necessary to standardize practices and reduce adverse drug reactions.
Assuntos
Analgésicos Opioides/administração & dosagem , Uso de Medicamentos/estatística & dados numéricos , Hipnóticos e Sedativos/administração & dosagem , Unidades de Terapia Intensiva Neonatal , Dor Pós-Operatória/tratamento farmacológico , Acetaminofen/administração & dosagem , Acetaminofen/efeitos adversos , Analgésicos não Narcóticos/administração & dosagem , Analgésicos não Narcóticos/efeitos adversos , Analgésicos Opioides/efeitos adversos , Estudos de Coortes , Feminino , Fentanila/administração & dosagem , Fentanila/efeitos adversos , França , Hospitais Universitários , Humanos , Hipnóticos e Sedativos/efeitos adversos , Lactente , Recém-Nascido , Masculino , Midazolam/administração & dosagem , Midazolam/efeitos adversos , Morfina/administração & dosagem , Morfina/efeitos adversos , Nalbufina/administração & dosagem , Nalbufina/efeitos adversos , Uso Off-Label , Medição da Dor , Estudos Retrospectivos , Síndrome de Abstinência a Substâncias/etiologia , Sufentanil/administração & dosagem , Sufentanil/efeitos adversos , Retenção Urinária/etiologiaRESUMO
AIM: Recent US recommendations indicate a target blood pressure (BP) of 130/80mmHg for patients with type 2 diabetes (T2D). Our aim was to characterize the association between risk of cardiovascular events and differences in BP decreases in randomized trials of a T2D population. METHODS: A systematic search was made for randomized clinical trials assessing the effects of antihypertensive treatments in T2D patients on mortality, and fatal and non-fatal cardiovascular events, using a meta-regression technique to explore the influence of BP decreases on treatment effects. RESULTS: A total of 88,503 patients from 44 randomized trials were included. There was no significant association between BP decreases and risk of all-cause or cardiovascular mortality, cardiovascular events or myocardial infarction. However, stroke risk was influenced by BP decreases: compared with no reduction, a 10-mmHg reduction in systolic BP was associated with a relative odds ratio (OR) decrease of 33% (OR: 0.67, 95% CI: 0.54-0.82), and a 5-mmHg diastolic BP reduction was associated with a relative OR decrease of 38% (OR: 0.62, 95% CI: 0.50-0.76). Restricting the analysis to double-blind studies did not change the results for diastolic BP. CONCLUSION: A reduction in BP lowers the risk of stroke, but does not appear to affect the risk of other cardiovascular events in a T2D population.
Assuntos
Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Doenças Cardiovasculares/mortalidade , Diabetes Mellitus Tipo 2/complicações , Angiopatias Diabéticas/epidemiologia , Angiopatias Diabéticas/mortalidade , Angiopatias Diabéticas/prevenção & controle , Humanos , Hipertensão/complicações , Hipertensão/tratamento farmacológico , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Análise de Regressão , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidadeRESUMO
T lymphoblastic lymphoma (T-LBL) is a rare type of lymphoma with a good prognosis with a remission rate of 85%. Patients can be completely cured or can relapse during or after a 2-year treatment. Relapses usually occur early after the remission of the acute phase. The median time of relapse is equal to 1 year, after the occurrence of complete remission (range 0.2-5.9 years) (Uyttebroeck et al., 2008). It can be assumed that patients may be treated longer than necessary with undue toxicity.The aim of our model was to investigate whether the duration of the maintenance therapy could be reduced without increasing the risk of relapses and to determine the minimum treatment duration that could be tested in a future clinical trial.We developed a mathematical model of virtual patients with T-LBL in order to obtain a proportion of virtual relapses close to the one observed in the real population of patients from the EuroLB database. Our simulations reproduced a 2-year follow-up required to study the onset of the disease, the treatment of the acute phase and the maintenance treatment phase.
Assuntos
Simulação por Computador , Progressão da Doença , Modelos Teóricos , Leucemia-Linfoma Linfoblástico de Células T Precursoras/terapia , HumanosRESUMO
BACKGROUND: Several studies have given frequencies of pain in children with cerebral palsy, but comparing the findings is difficult. We aimed to estimate the prevalence of pain in non-ambulatory children with cerebral palsy and describe their characteristics by presence or absence of pain. METHODS: Data were extracted from an ongoing longitudinal national cohort following non-ambulatory children with severe cerebral palsy aged 3 to 10years over 10years. We described and compared data for the first 240 children at inclusion by presence or absence of pain. Pain was assessed by a visual analog scale and the Douleur Enfant San Salvadour scales and by investigator interview. RESULTS: Overall, 65 children experienced pain, for a prevalence of 27.1% (95% confidence interval 22-33%). All children experiencing pain had orthopaedic pain and 45.6% had pain from another origin. The main pain sites were hips (43.4%) and feet (26.9%). Joint mobilisation was the source of pain for 58.3% of children experiencing pain, and sitting was identified as painful for 10.3%. Pain was greater with scoliosis (43.1% vs 24.1% with and without pain; P=0.006) and spasticity treatment (32.3% vs 17.2%; P=0.020). CONCLUSION: Children with cerebral palsy frequently experience pain and also early pain, mostly articular and orthopedic. The assessment of pain should be systematic because of its high prevalence. Interventions to prevent scoliosis, hip luxation, and foot deformities and to reduce spasticity, such as the use of analgesics before joint mobilization exercises, may reduce the prevalence of this pain.
Assuntos
Paralisia Cerebral/complicações , Artropatias/epidemiologia , Espasticidade Muscular/epidemiologia , Dor/epidemiologia , Escoliose/epidemiologia , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Articulação do Quadril , Humanos , Artropatias/etiologia , Estudos Longitudinais , Masculino , Espasticidade Muscular/etiologia , Dor/etiologia , Medição da Dor , Prevalência , Estudos Prospectivos , Escoliose/etiologiaRESUMO
The purpose of this study was to interview paediatric nurses on administration issues using extemporaneous capsules and marketed capsules and tablets in children younger than 6 years old, based on most frequently administered drugs in six participating wards. The 59 responding nurses estimated respectively at 7.7±1.7 and 7.3±1.8years the age from which children would properly swallow extemporaneous capsules and marketed solids, with 33% and 37% of nurses considering that children under 6 would not get their prescribed treatment using these dosage forms. Refusal of the child to take the solid was the first reason to explain administration failure (85% of nurses for extemporaneous capsules, 89% for marketed solids). Although type of formulation and requirement of chewing were factors influencing the age at which children would take solid from nurses' experience, size of conventional tablets was not among these factors. All respondents use to crush tablets in children unable to swallow whole solids; 37% of nurses systematically split the tablets to ease the swallowing in children able to swallow. Only 11 nurses had an information tool at their disposal to guide manipulation of solids, with 7 of them using it in their daily practice. Providing specific-ward questionnaires, this study gives factual information on administration practices, perceptions and issues faced by paediatric nurses.
Assuntos
Administração Oral , Atitude do Pessoal de Saúde , Enfermeiros Pediátricos/psicologia , Adulto , Fatores Etários , Cápsulas , Pré-Escolar , Humanos , Inquéritos e Questionários , ComprimidosRESUMO
Selecting the most appropriate dosage form, that ensures safe administration and adherence of medications, is a major issue for children. Marketed drugs, however, have rarely been tested for their use in children. There is a need for more data on drug formulations administered to children to identify unmet needs, and drive future paediatric research. We observed, over a 12-month follow-up, 117,665 oral drug administrations to 1998 hospitalized children. Nine-tenths belonged to five Anatomical Therapeutic Chemical classes: Alimentary tract & metabolism, Nervous system, Cardiovascular system, Anti-infectives for systemic use and Blood & blood forming organs, one third of drug doses administered to school-age children and adolescents were liquids, and extemporaneous capsules were commonly used in younger children. Our study shows that despite the advantages of solid dosage forms and recent evidence from randomized controlled trials showing their acceptability in infants, they are seldom used in paediatric practice.
Assuntos
Uso de Medicamentos/estatística & dados numéricos , Hospitais Pediátricos/estatística & dados numéricos , Administração Oral , Adolescente , Criança , Pré-Escolar , Formas de Dosagem , França , Humanos , Lactente , Recém-NascidoRESUMO
INTRODUCTION: The patient overload in pediatric healthcare facilities is caused in part by parents bringing their children in for consultations for fever. We conducted a survey in the Lyon metropolitan area to improve our understanding of parents' attitudes towards their children's fever. OBJECTIVE: To assess the frequency and characteristics of healthcare utilization and evaluate parents' knowledge and attitudes before consulting. METHODS: A random sample of families with at least one child under 6 years of age and living in the Lyon metropolitan area was surveyed by telephone, according to a closed questionnaire that was answered by the person usually responsible for the child's health. RESULTS: 202 families were questioned: 58.9% defined fever as a temperature over 38 degrees C, and 82% used rectal thermometers to measure temperature. Among 144 parents of children with an episode of fever within the previous 12 months, 73% called a physician during the episode, 44% of them immediately. Working-class parents called more frequently (90%) than parents who were professionals or managers (74%). Most parents (94%) administered medication to the child several times before calling the physician. Paracetamol and ibuprofen were mentioned most often. 93% of fever episodes led to consultations. DISCUSSION: Our results show that 59% of the sample defined fever as a temperature equal to 38 degrees C and that fever episodes lead commonly and quickly to physician visits, but that parents do use physical methods and drugs to reduce fever before calling a physician.
Assuntos
Febre/diagnóstico , Febre/terapia , Conhecimentos, Atitudes e Prática em Saúde , Pais , Adulto , Criança , Estudos Transversais , Feminino , França , Humanos , Entrevistas como Assunto , Masculino , Inquéritos e QuestionáriosRESUMO
Selecting the most appropriate oral formulation is very challenging when developing medicines for children and in routine practice. Research in pediatric pharmacology has focused on oral drug formulation, determining whether the active pharmaceutical ingredient can be successfully delivered to children. Pediatric expert committees (EMA, EuFPI) recommend that children's medicines be safe, well tolerated, easy to use (palatable and requiring minimal handling), transportable, easily produced, cost effective, commercially viable, with a minimal impact on children's life-style. Oral liquid drug formulations (OLFs: solutions, syrups, suspensions) are historically considered as the most appropriate oral formulation for children, since they are easy to swallow for younger infants and palatable for children. However, OLFs present numerous disadvantages, such as low stability, potentially toxic excipients for children, and low transportability. In the long-term, dose volume and frequency of administration might lead to non-compliance. Multiple preparation steps and volume calculations are also among risk factors for medicine errors in children. An alternative to OLFs is the conventional solid oral dosage form (OSF), such as tablets and capsules. These offer the advantages of greater stability, easy dose selection, improved transportability, and ease of storage. They also allow the modification of drug pharmacokinetic parameters, minimizing administration frequency. Finally, OSFs are less costly than OLFs, since they are easier to develop, manufacture, transport, store, and deliver. Controlled study results suggest that the use of OSFs in children would be associated with greater acceptability by children, greater preference on the part of caregivers, and higher drug compliance than OLFs. Recent controlled studies, confirming that OSFs with an acceptable size for children (mini-tablets), should shift the current paradigm of OLFs as the reference for children's oral medicine. We lack evidence on OSF acceptability in children and its influence on drug compliance, particularly with appropriate-size OSFs for children. Further investigation on oral formulation should investigate the utilisation of OSFs in young children. Few OSFs are licensed for children under 6 years of age.
Assuntos
Química Farmacêutica , Formas de Dosagem , Preferência do Paciente , Criança , Humanos , Adesão à MedicaçãoRESUMO
BACKGROUND/OBJECTIVE: To determine gastrointestinal (GI) responses and maximum tolerated dose of erythritol in young children given as a single oral dose in a 250-ml non-carbonated fruit-flavoured beverage in between meals. This is a multicentre double-blind study with sequential design for multiple dose groups and randomised crossover for comparators of placebo vs dose. SUBJECTS/METHODS: A total of 185 healthy young children aged 4-6 years were recruited at three clinical investigation centres after informed consent of both parents; 184 children completed the study. Children were included in one of the four dose groups (5, 15, 20 or 25 g erythritol) and exposed randomly to only one single dose vs an isosweet sucrose placebo. After consumption in the clinic and an observation period, GI symptoms and stooling patterns were recorded during the next 48 h. RESULTS: Statistically significantly more episodes of diarrhoea and/or severe GI symptoms were observed in the 20 and 25 g groups compared with placebo, but not in the 5 and 15 g groups. Stool consistency, as measured by Bristol stool scale, was lower in the 15-, 20- and 25 g groups for the first 24 -h period, but not at later time points. Incidences of nausea, vomiting, borborygmi, excess flatus and abdominal pain were not significantly different from the placebo controls at all doses of erythritol. CONCLUSIONS: Rapid ingestion of up to and including 15 g (6% w/v) of erythritol in a beverage in between meals by young children aged 4-6 years was well tolerated. The no observed effect level for diarrhoea and/or severe GI symptoms was 15 g (0.73 g/kg body weight (bw)). Children appeared not to be more sensitive to the GI effects of erythritol than published for adults on a g/kg bw basis.
Assuntos
Bebidas/efeitos adversos , Diarreia/etiologia , Dieta Redutora , Eritritol/efeitos adversos , Gastroenterite/etiologia , Adoçantes Calóricos/efeitos adversos , Lanches , Dor Abdominal/etiologia , Criança , Pré-Escolar , Estudos de Coortes , Estudos Cross-Over , Diarreia/epidemiologia , Diarreia/fisiopatologia , Diarreia/urina , Método Duplo-Cego , Eritritol/administração & dosagem , Eritritol/urina , Feminino , Gastroenterite/epidemiologia , Gastroenterite/fisiopatologia , Gastroenterite/urina , Humanos , Incidência , Masculino , Adoçantes Calóricos/administração & dosagem , Adoçantes Calóricos/metabolismo , Eliminação Renal , Índice de Gravidade de DoençaRESUMO
Internet is a tool allowing a wide distribution of information. Initially reserved to the field of scientific research, it develops currently in many sectors of the socio-economic life and saved the area of the health. Each day appear new services allowing the access to the information on the diagnostic and treatment of different pathologies. Patients and physicians share their knowledge and their information, through newsgroups and electronic mail. This paper presents the Internet and cancer resources to allow clinicians and researchers a rapid access to the relevant information.
Assuntos
Redes de Comunicação de Computadores , Oncologia , Neoplasias , Telemedicina , Difusão de Inovações , França , Humanos , Sistemas de InformaçãoRESUMO
The absolute benefit from antihypertensive therapy increases with the baseline risk. However, age is a major determinant of cardiovascular risk, so it is important to express therapeutic efficacy with indices for which age is not a confounder. With this aim we explored the expected gain in life expectancy without cardiovascular events according to age at the initiation of the treatment. The treatment effect estimated from the INDANA meta-analysis, was applied to the cardiovascular risk of a French hypertensive population, simulated from national vital statistics. The gain in life expectancy was estimated from the area between survival curves without events. The treatment effect varied according three different hypotheses: increasing, decreasing or constant effect. When assuming a constant treatment effect, our results show a 29 month gain without stroke for a man who began his treatment at 40 years, and 15 months if hypertension is screened and treatment initiated at 75 years. The gains without coronary heart disease are respectively of 11 and 6 months. The variation of treatment effect over time could have a major impact on the treatment benefit. The gain in life expectancy without events is a relevant decision tool, completing usefully the absolute benefit, since it takes into account the influence of age.
Assuntos
Anti-Hipertensivos/uso terapêutico , Hipertensão/tratamento farmacológico , Expectativa de Vida , Adulto , Fatores Etários , Idoso , Doença das Coronárias/prevenção & controle , Tomada de Decisões , Feminino , Humanos , Hipertensão/complicações , Masculino , Pessoa de Meia-Idade , Planejamento de Assistência ao Paciente , Fatores de Risco , Acidente Vascular Cerebral/prevenção & controleRESUMO
AIMS: To describe the rehabilitation of non-ambulatory children with cerebral palsy and to explore adjustability on their individual needs. MATERIAL AND METHOD: Data described are extracted from an on-going national cohort study, following during 10years 385 children with cerebral palsy, aged from 4 to 10, Gross Motor Function Classification System IV and V. We analysed data from the first 190 patients (mean age 6years 10months (SD 2.0), 111 boys), focusing on physiotherapy, ergotherapy, psychomotility and speech therapy in medico-social and liberal sectors. RESULTS: In medico-social sector, duration of paramedical care is significantly more important than in liberal sector (structure of care: median=4.25h/week, liberal sector: median=2.00h/week) (P<0.0001). More than 4 different types of care per week are given in medico-social sector, while in liberal sector children benefit from only 2 different types of care a week. In investigators opinion, rehabilitation in structures of care is 71.65% adapted as opposed to 18.75% in the liberal sector (P<0.001). Children level V have less time of rehabilitation than the others (P=0.0424). INTERPRETATION: Rehabilitation of children with cerebral palsy who are not able to walk, with an objective to improve quality of life, is truly multidisciplinary and suitable in medico-social sector.