Biomedical subjects

Bruno Giraudeau

Publications and source records attributed to Bruno Giraudeau.

40 records · Page 3Linked to original sources

PubMed2002

Simultaneous estimation of cyclosporin and mycophenolic acid areas under the curve in stable renal transplant patients using a limited sampling strategy.

OBJECTIVES: Area under the curve (AUC)-based monitoring of cyclosporin (CsA) could help to optimise therapeutic drug monitoring in certain transplant patients in addition to trough concentration monitoring. It is the method of choice for mycophenolic acid (MPA). The objective of this study was to develop a limited sampling strategy for simultaneous estimation of CsA and MPA AUCs in long-term renal transplant patients. METHODS: Twenty kidney transplant patients treated with CsA and mycophenolate mofetil were included in a pharmacokinetic study more than 6 months after transplantation. Multilinear regression analyses were performed to develop a model enabling the estimation of both drugs' AUCs using a limited number of samples. Dose-normalised data were used throughout the analysis. RESULTS: Trough concentrations of MPA were poorly correlated with AUC, either used alone (r2 = 0.232) or together with other concentrations. Several models for CsA AUC estimation met the predefined criteria (r2>0.9, P<0.05). The AUC of MPA was best estimated by a three-concentration model (AUC=0.58 C20 min+ 0.97 C1 h + 6.64 C3 h + 3.48; r2 = 0.946). These sampling times also applied to CsA AUC (AUC = 1.17 C20 min + 0.68 C1 h + 5.36 C3 h + 4.24; r = 0.985). AUCs estimated using these models in our patients using the jack-knife procedure were found to be precise and unbiased as compared with reference trapezoidal AUCs. CONCLUSION: We were able to develop a multilinear regression model for simultaneous estimation of both CsA and MPA AUCs using only three blood samples taken up to 3 h post-dosing.

Adult↗

PubMed2002

Frequency of adverse drug reactions in children: a prospective study.

AIMS: To assess the frequency of adverse drug reactions (ADRs) in children in France. METHODS: In a prospective study over a period of 1 week, we evaluated the incidence of ADRs (1) as a cause of admission to a regional children's hospital; (2) occurring during hospitalization in a regional children's hospital; and (3) as a cause of consultation with private paediatricians. RESULTS: Four out of 260 children were admitted to the regional children's hospital for ADRs (1.53% [0.42, 3.89]) and six developed ADRs during hospitalization (2.64% [0.97, 5.66]), 4/428 attended the Accident and Emergency Department for ADRs (0.93% [0.25, 2.37]) and 8/1192 consulted a private paediatrician for ADRs (0.67% [0.29, 1.31]). CONCLUSIONS: Our results are in agreement with the incidence of ADRs in children found in others countries.

Child↗

PubMed2002

Amoxicillin/clavulanic acid is ineffective at preventing otitis media in children with presumed viral upper respiratory infection: a randomized, double-blind equivalence, placebo-controlled trial.

AIMS: To assess the equivalence of amoxicillin/clavulanic acid and placebo in the prevention of acute otitis media in children at high risk of acute otitis media who develop upper respiratory tract infection. METHODS: This was a multicentre, equivalence, randomized, double-blind trial of two parallel groups comparing 5 days of amoxicillin/clavulanic acid 75 mg kg-1 day-1 (i.e. 25 mg kg-1 every 8 h) and placebo. The main outcome measure was acute otitis media occurring within 8-12 days of initiating treatment. RESULTS: Two hundred and three infants, aged 3 months-3 years with upper respiratory tract infection over 36 h and a history of recurrent acute otitis media were included over 8.5 months. Two children were lost to follow-up. Patient characteristics were similar in both groups. In the intention to treat analysis the frequency of acute otitis media was 16.2% (16/99) in the placebo group and 9.6% (10/104) in the amoxicillin/clavulanic acid group (P = 0.288). The difference between acute otitis media rates was 6.6% (one-sided 95% confidence interval of 14.3%). The occurrence of side-effects was similar in the amoxicillin/clavulanic acid and placebo groups. CONCLUSIONS: The difference in effectiveness between antibiotic and placebo was not greater than 14.3%, and we calculated that 94 children would need to be exposed to antibiotics to avoid six cases of acute otitis media. In view of the risk of development of resistance due to frequent exposure to antibiotics, our study supports the need for reduction in the administration of antibiotics in upper respiratory tract infection even in children at high risk of acute otitis media.

Acute Disease↗

PubMed2002

The risk of hypertension in men: direct and indirect effects of chronic smoking.

OBJECTIVES: To assess the risk of hypertension associated with smoking status. DESIGN: A population-based cross-sectional study in 12 417 men screened for a routine medical and biological check-up provided by their medical insurance at the 'Institut inter-Régional pour la Santé' (IRSA, Regional Institute for Health), a group of 10 medical centres in Western and Central France. MAIN OUTCOME MEASURES: The prevalence and the relative risk of hypertension associated with smoking status. RESULTS: Overall, the prevalence of hypertension was higher in former smokers than in never smokers (13.5 versus 8.8%, P < 0.001). The risk of hypertension was higher [odds ratio (OR) 1.31 (1.13-1.52), P < 0.001] in former smokers than in never smokers, independently of age and alcohol intake. Both current and former smokers were at risk for systolic hypertension, especially those subjects aged 60 years and above. The risk of hypertension was associated with the number of cigarettes smoked [OR per 10 cigarettes smoked daily: 1.13 (1.05-1.21), P < 0.001] and the duration of smoking cessation [OR 0.99 (0.98-1.00), P = 0.01]. When body mass index was entered into the model, the risk of hypertension in former smokers was no longer significant; however, current smokers remained at risk for systolic hypertension. CONCLUSIONS: Former smokers are at risk for hypertension, probably because of the higher prevalence of overweight and obese subjects in this group. Current smokers are also at risk for systolic hypertension, especially in those subjects aged 60 years or older. However, this risk is independent of body mass index.

Adult↗