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Biomedical subjects

E Autret

Publications and source records attributed to E Autret.

At least 127 records · Page 7Linked to original sources

[Comparison of plasma concentration and tolerance of a single dose of human calcitonin by intradermal and subcutaneous administration].

UNLABELLED: The aim of the study was to compare plasmatic levels of calcitonin obtained after intradermic (ID) and usual subcutaneous (SC) route of administration. PATIENTS METHOD: 6 volunteers between 18 and 40 years old received calcitonin 0.5 mg (Cibacalcin, Ciba-Geigy Laboratory) by ID and SC routes in a random order but at the same site of injection. Each administration was spaced by 8 days. Plasmatic levels were measured by R.I.A. before administration then 2 (M2), 7 (M7), 15 (M15), 30 (M30) minutes and 1 (H1), 2 (H2), 4 (H4), 8 (H8), 12 (H12) hours after each administration. RESULTS: Tmax were at 23.6 +/- 10 min and 16.2 +/- 7.5 min for SC and ID routes respectively. With ID route, Tmax was reached simultaneously or earlier (3 times). Cmax is significantly higher with ID route. Neither mean plasmatic levels at each plasmatic dosage nor mean areas under the curve between 0 to 1,440 min or between 0 to 480 min (this latest AUC calculate to minimize the importance of calcitonin basal level) were significantly different with ID and SC routes. 16 mild side effects (8 with each administration) were observed in 4 subjects. They appeared before 5 min. and were transient (1 hour) for cutaneous manifestations, and later between hours 3 and 7 for nausea and vomiting or asthenia. The mean lowering of calcemia was 0.29 +/- 0.21 and 0.18 +/- 0.11 mmol/l respectively for SC and ID route. In this study ID and SC routes for calcitonin administration are not different with regard to plasma levels and side effects.

Adolescent↗

[Are theophylline determinations useful to the clinician during treatment with a sustained-release form of theophylline?].

The aims of the study were the correlation between dosage and plasmatic levels of slow release theophylline and the reason for dosage adjustment. 64 pharmacokinetic studies were performed in 58 asthmatic children between 17 months and 16 years. Plasmatic levels of theophylline were performed by fluoroimmunology technique at H0 (before the dose) 2 (H2), 4 (H4), 6 (H6) and 8 (H8) hours after the dose of slow release theophylline. The best correlation between dose and plasmatic levels were observed at H4 and H6 for Armophylline and Euphylline respectively. Dosage adjustment were based both upon clinical state and plasmatic levels in 55 cases. In 9 cases the modification of dose were decided only because of plasmatic levels out the therapeutic range. The authors proposed a schema of dosage modifications based upon clinical state; plasmatic levels must be used as a guide for dose adjustment in patients clinically uncontrolled.

Adolescent↗

[Epidemiology of pediatric paracetamol poisoning (retrospective analysis of calls received by the Poison Control Center of Tours)].

The authors analysed 101 phone calls received in 3 years and 8 months at the Poison Control Center of Tours for paracetamol poisoning in children under 15 years of age. 70% of children were between 1 and 5 years old, 15% under 1 year and 15% over 5 years old. The kind of poisoning differ according to age: iatrogenic in 93% of cases under 1 year old (medication given by parents; error in dosage); accidental in 85% of cases between 1 and 5 years old and "willful" poisoning (43%) or accidental (36%) over 5 years old. The average quantity of ingested paracetamol was low (58mg/kg). The delay before phone call from an individual or a doctor was usually quite short. The neurologic or digestive signs were present in 12% of the children. The outcome was uneventful in all cases indicating that this form of poisoning is being in childrens.

Acetaminophen↗

[Local catastrophe and C.A.P.: apropos of 1 plant in Touraine].

Drinking water supply to a 200,000 inhabitant urban area had to be interrupted owing the pollution of the Loire river due to fire in a chemical plant in the vicinity of Tours. This event showed a regretful lack of information diffusion making the role of the Poison Control Center more difficult. Consequences related to acute toxicity were negligible but the evaluation of long-term risk is still pending.

Accidents↗

[Cholestatic hepatitis caused by ketoconazole].

The authors report a new Ketoconazole-induced hepatitis in which clinical, chemical and histological features show evidence of a cholestatic injury in a 62 yrs-old female recovering once therapy is stopped. In this case-report, delay of onset of the illness is very short for a 200 mg-a-day prescription and no feature leads towards an immune response. This, may be, means that Ketoconazole-induced hepatitis should be led by an idiosyncrasic mechanism. Even if fatal hepatitis are rare, prescriptors have to beware of this therapy.

Chemical and Drug Induced Liver Injury↗

[Use of phenobarbital by the oral route in the acute and maintenance treatment of convulsions in children].

Early and long-lasting phenobarbital plasma levels were obtained by the following schedule in children presenting with convulsions who remained at risk for early relapse: a load dose of 15 mg/kg, followed 12 hours later by the administration of 5 mg/kg in children under 1 year of age and 3 mg/kg in older children; further maintenance doses were 3 mg/kg every 24 hours for 10 days in all children. No child presented with any convulsion in the period of time studied. The mean phenobarbital plasma levels were, from the 1st to the 88th hour, between the values considered as effective (12.6 and 22.3 mg/l). These values were always lower in children under 1 year of age, except for the 1st hour.

Administration, Oral↗

[Determination of drug posology in pediatrics].

The dosage of drugs which might be used in children must be determined to avoid empirical use, even when no application has been submitted for a paediatric licence. Toxicological evaluation and assessment of the effects on growth, an adapted pharmaceutical form and paediatric pharmacokinetic and adult clinical data are essential before conducting trials designed to determine the paediatric dosage. The dose used during preliminary studies is extrapolated from the adult dose expressed in relation to weight, tested in a dose-effect study, and then more accurately defined on the basis of pharmacokinetic data in different age groups. Obtaining consent from both parents for studies whose direct benefit is not always obvious, as well as the global cost of these studies, constitute drawbacks to paediatric drug development. Incentives to determine a paediatric dosage could consist of public participation in funding, prolongation of the patent, and granting an advantageous price for a specifically paediatric pharmaceutical form or indication.

Age Factors↗

[Does the placebo effect exist in newborn infants?].

Although comparison with a placebo is necessary to demonstrate the "true" effect of a drug, neonatologists are usually reluctant to use a placebo. The reason given is the lack of placebo effect in neonates. We studied heart and respiration rates and behaviour in normal neonates during heelstick for diagnosis of phenylketonuria. In this open randomized study we compared no treatment with an "analgesic" treatment consisting of water and sucrose. There was no difference in heart and respiration rates and behaviour between the two groups. These results do not demonstrate a "suggested" placebo effect and can in part be explained by the model and tools used to measure pain. The results do not support the non-use of placebo in drug evaluation trials in children.

Female↗

[Pentasa (mesalazine) and pregnancy].

We analysed the outcome of 11 pregnancies in women treated for inflammatory bowel disease with mesalazine (Pentasa) during part of or throughout pregnancy. There were 9 healthy babies, one spontaneous abortion (the woman had an uterine malformation) and one infant with multiple malformations (but the mother was not treated with mesalazine during organogenesis). Because of the relatively small number of pregnancies exposed to mesalazine (Pentasa) in this study, these data need to be confirmed by other studies.

Adult↗

[Children's participation in biomedical research. A planned survey of 541 parents].

BACKGROUND: We have interviewed the parents of children born at two maternity hospitals to evaluate the knowledge of parents concerning the French Huriet law and their consent to the participation of their child in a randomized therapeutic trial. METHODS: The inquiry was conducted between 15 February and 30 April 1991. Each couple of parents of whom the mother had given birth in one of the hospitals was sent an explanatory letter and a questionnaire on the second day after delivery. Parents who were unable to read adequately and those whose baby was ill were excluded from the study. The main questions were: age of parents, country of origin, education, profession, social insurance, frequency of medical consulting, their knowledge of the Huriet law, the source of that knowledge, their attitude to giving parental consent for their child to participate in a trial, the reasons for their consent or refusal. RESULTS: Five hundred and eighty two questionnaires were distributed but only 541 were used. 73% of the parents said they knew that drugs were tested on volunteers. 59% claimed to know of the Huriet law, through the media (75%), their practitionist (12%), their environment (8%). 21% of the parents would consent to one of their children participating in such trial; 74% would refuse. Both parents were in agreement in 79% of cases, 12% of them for consent. The main reasons for refusal were the risk for side-effects of the drug (75%), lack of proof for efficacy (49%), disagreement in principle (19%). The mothers who consented were older than those who refused. The members of the "consent" group were more highly educated. CONCLUSIONS: Law Huriet is still inadequately understood in France. Pediatricians should consider how best to provide parents and the media with better information before trying to obtain parental consent.

Adult↗