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Biomedical subjects

E Autret

Publications and source records attributed to E Autret.

At least 19 recordsLinked to original sources

Five vs. ten days of antibiotic therapy for acute otitis media in young children.

BACKGROUND: Many publications in recent years have argued in favor of shortened therapy for acute otitis media. However, doubt persists regarding children younger than 2 years, and some authors therefore restrict short course therapy to children older than 2 years. METHODS: In a prospective, comparative, double blind, randomized, multicenter trial we compared cefpodoxime-proxetil, 8 mg/kg/day in two divided doses for 10 days, with an identical 5-day regimen followed by a 5-day placebo period. RESULTS: Between October, 1996, and April, 1997, 450 children (mean age, 14.3 months) were enrolled, 227 in the 5-day group and 223 in the 10-day group. In the per protocol analysis clinical success was obtained on Days 12 to 14 after the beginning of treatment (main analysis) in 175 (84.1%) of the 208 children receiving the 5-day regimen and 194 (92.4%) of the 210 children receiving the 10-day regimen (P = 0.009). The superiority of the standard regimen was more marked among children cared for outside their homes (92.5% vs. 81.5%). Clinical success persisted on Days 28 to 42 among 134 (85.4%) of the 157 assessable patients in the 5-day group and 144 (83.7%) of the 172 assessable patients in the 10-day group (P = 0.68). CONCLUSIONS: The 10-day regimen resulted in a higher success rate at the conclusion of therapy, but there were no differences between the two study groups 4 to 6 weeks after enrollment in the study protocol.

Acute Disease↗

-Skin eruption after the first dose of antitubercular quadri-therapy: consideration of pyrazinamide-.

UNLABELLED: We report a rash after the first dose of antituberculosis polytherapy which raises questions concerning procedures to be followed. CASE REPORT: An 8-year-old child presented with a pruritic rash 1.5 hours after the first dose of isoniazide, rifampicine, pyrazinamide and ethambutol was simultaneously administered, which did not recur after successive re-administration of isoniazide and rifampicine. Pyrazinamide, which was re-administered last, induced a recurrence. Slower pyrazinamide re-administration allowed continuation of treatment. CONCLUSION: A protocol for re-administration of the four drugs is suggested.

Antibiotics, Antitubercular↗

[Eruption after the 1st dose of standard antitubercular chemotherapy. Thoughts on pyrazinamide].

UNLABELLED: We report 3 cases of rash after the first dose of antituberculosis polytherapy, thus raising questions concerning the procedures to be followed. CASE REPORT: Three patients developed a pruritic rash 1 hour after the first dose of isoniazide, rifampicine, pyrazinamide and ethambutol given simultaneously. The eruption did not recur after readministration of isoniazide and rifampicine successively. Pyrazinamide, which was readministered last (at the full dose in one case and at progressive doses in the two others), induced a recurrence in two of them. Pyrazinamide was definitively withdrawn in one patient with recurrence and slower pyrazinamide readministration allowed continuation of treatment in the other two patients. CONCLUSION: Since pyrazinamide appeared to be responsible for rash following the first administration of antituberculosis polytherapy, a protocol for readministration of the 4 drugs is suggested. If the responsibility of pyrazinamide is confirmed it should be readministered very slowly.

Aged↗

Evaluation of ibuprofen versus aspirin and paracetamol on efficacy and comfort in children with fever.

OBJECTIVE: We compared efficacy and impact on the comfort of ibuprofen (7.5 mg/kg per dose), aspirin (10 mg/kg/dose) and paracetamol (10 mg/kg per dose) on children with fever aged 6-24 months in an open, randomised study with three parallel groups. METHODS: The main criterion for efficacy was area under the curve (AUC) of percentage temperature reduction. Comfort was assessed on scores depending on general behaviour and degree of relief. General behaviour was assessed on a verbal scale and on a visual analogue scale (VAS) and the degree of relief was assessed in relation to baseline on a verbal scale. RESULTS: The efficacy of ibuprofen was better than that of aspirin or paracetamol. In spite of more adverse events, the comfort scores were significantly in favour of ibuprofen 6 h after the first dose of treatment.

Acetaminophen↗

Study of the use of vitamin K in neonates in France.

OBJECTIVE: Because of the risk of haemorrhagic disease of the newborn as a result of a deficit in vitamin K, it is generally agreed that newborns should receive vitamin K. However, there is no consensus concerning the route of administration, dose, number of doses, or dose frequency. METHODS: We studied patterns of vitamin K administration in all maternity hospitals in France in order to establish the range of practices and policies. Six hundred and forty questionnaires were analysed. Vitamin K was given systematically to all neonates in 619 maternity hospitals (96.7%), not given to any neonates in 2 (0.3%), and only to certain newborns in 19 (3%). A similar protocol was used for all newborns in 299 (47%) of the maternity hospitals, and the treatment protocol differed according to the neonatal clinical picture in 336 maternity hospitals (53%). RESULTS: The route of administration agreed with the recommendation that healthy newborns receive formula milk. In contrast, infants receiving breast milk were given IM vitamin K in only 19% of the maternity hospitals studied and regular weekly doses were prescribed in only 56%. In premature infants, IM doses were prescribed in only 46% of cases and repeat weekly doses in 34%. The dose generally prescribed (5 mg p.o. or IM) was not the recommended dose.

Administration, Oral↗

[Does stopping of oral feeding favour the occurrence of auriculoventricular block in premature infants treated with diphemanil?].

BACKGROUND: Bradycardia in preterm infants may require anticholinergic therapy (diphemanil methylsulphate). Such treatment may cause prolongation of QT interval and auriculoventricular block. CASE REPORTS: Three premature infants born before 34 weeks of gestational age were given 6-8 mg/kg/d diphemanil because they suffered from bradycardiac episodes. Aggravation and/or persistence of bradycardia required withdrawal of gavage feeding: heart block occurred within a few hours which subsided after cessation of diphemanil and oral refeeding. Diphemanil at progressive dosage was later introduced safely in two of these infants. CONCLUSION: The short interval of time between the oral feeding withdrawal and occurrence of heart block justified therapy be stopped or transiently reduced whenever oral feeding must be interrupted.

Administration, Oral↗

[Syncope with long QT interval in a 39 day-old infant treated with cisapride].

UNLABELLED: Cardiotoxicity of cisapride may increase when this drug is associated with ranitidine. CASE REPORT: A 37-day old term infant, treated with cisapride (1.2 mg/kg/d) and ranitidine for regurgitations, was hospitalized for malaise. A prolonged QT interval (with isolate ventricular extrasystoles), noted at admission, disappeared rapidly after cisapride withdrawal. Linkage to cisapride was probable, promoted by high dosage and cisapride metabolism inhibition by ranitidine, but its plasma concentration was not measured. CONCLUSION: This case report stresses the problem of cisapride dosage in infants and the question of an interaction between cisapride and ranitidine.

Anti-Ulcer Agents↗

[Isotretinoin (Roaccutane) in women of childbearing age: failure of following prescription guidelines].

BACKGROUND: Despite prominent warnings, pregnancies continue to be reported in women exposed to isotretinoin. PATIENTS AND METHODS: We report results of the analysis of 318 questions asked to pharacovigilance structures in France from 1987 to 1995 because of an exposition to isotretinoin during the risk period and of a prospective inquiry concerning isotretinoin prescription in women conducted among pharmacists. RESULTS: These 318 pregnancies began during the month after Roaccutane withdrawal (n = 104, 33 p. 100), during Roaccutane treatment (n = 163, 51 p. 100) or before Roaccutane treatment (n = 51, 16 p. 100). Of the 267 women with pregnancies conceived during treatment with isotretinoin (n = 104) or during the month after its discontinuation (n = 163), contraception was not prescribed in 28 (15 p. 100) or prescribed but with poor compliance in 109 (60 p. 100). Pregnancy was terminated voluntarily in 199 women (81 p. 100). In the 173 women who were interviewed in pharmacies, 49 (28 p. 100) did not use contraception and among them contraception was prescribed in only 59 p. 100. Only 14 p. 100 had received full information about isotretinoin and pregnancy. The teratogenic effects of isotretinoin were known by 98 p. 100 of the women and the need of contraception during treatment and for one month after discontinuation by 70 p. 100. DISCUSSION: Insufficient compliance with warnings is the main reason for pregnancies in women receiving isotretinoin therapy. A pregnancy prevention program is needed before prescription to ensure comprehension and to obtain informed consent of patients.

Abnormalities, Drug-Induced↗

Aseptic meningitis following mumps vaccine. A retrospective survey by the French Regional Pharmacovigilance centres and by Pasteur-Mérieux Sérums & Vaccins.

Since 1989 many case series and observational studies of aseptic meningitis (AM) associated with the use of live attenuated mumps vaccines containing the Urabe AM9 strain have been reported worldwide. The aim of this retrospective reported AM in France following mumps vaccination with monovalent or multivalent vaccines containing the Urabe strain. Fifty-four cases of AM were reported to the Regional Pharmacovigilance centres or to the manufacturer from the time each vaccine was launched up until June 1992. Twenty cases were temporally associated with the administration of a monovalent mumps vaccine and 34 with a trivalent measles, mumps and rubella vaccine (MMR). A mumps virus was isolated in four cases in the cerebrospinal fluid and an Urabe-like strain was characterized twice by polymerase chain reaction (PCR). A probable mumps origin was assumed in 17 other cases where the patients presented with other clinical or biological signs of mumps infection. The clinical outcome of AM, known in 87% of the population, was always favourable. The global incidence of mumps vaccine-associated AM was 0.82/100,000 doses, which is significantly lower than the incidence in the unvaccinated population. Even considering that the actual incidence of AM is much higher when assessed by active surveillance studies, the risk/benefit ratio of mumps vaccine remains in favour of vaccination.

Journal Article↗

Plasma concentrations and pharmacokinetics of idebenone and its metabolites following single and repeated doses in young patients with mitochondrial encephalomyopathy.

OBJECTIVE: The pharmacokinetics and tolerance of idebenone after single or repeated doses have been studied in young patients with mitochondrial encephalomyopathy. RESULTS: No significant adverse effects were noted. In 3 out of 7 patients idebenone induced overall stimulation and improvement in arousal. Plasma concentrations of idebenone and its main metabolites were determined and the pharmacokinetic parameters of idebenone after single and repeated doses were estimated. During the single dose study, the mean plasma concentrations of idebenone and its main metabolites and mean pharmacokinetic parameters were comparable to published results (Cmax = 452.2 ng.ml-1, tmax = 2.3 h, AUC = 26 micrograms. ml-1.h, t1/2 beta = 16.5 h). During the repeated doses study, no significant difference was found between mean residual plasma concentrations of idebenone on Day 2 (47 ng.ml-1) and Day 5 (70.6 ng.ml-1), and mean t1/2 beta of idebenone after the single and after repeated dose studies, i.e., there was no evidence of accumulation. Although idebenone did not appear to accumulate during this study, the coadministration of anticonvulsants, often prescribed during mitochondrial encephalomyopathy, can affect its pharmacokinetics.

Adolescent↗