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Urien S.,University of Paris Descartes | Urien S.,French Institute of Health and Medical Research | Firtion G.,Groupe Hospitalier Cochin Saint Vincent Of Paul | Anderson S.T.,Brighton and Sussex Medical School | And 17 more authors.
British Journal of Clinical Pharmacology | Year: 2011

AIMS: Because of immature hepatic metabolism, lopinavir could present specific pharmacokinetics in the first weeks of life. We aimed at determining the optimal dosing regimen in neonates and infants weighing 1 to 10.5kg. METHODS: Lopinavir/ritonavir (LPV/r) pharmacokinetics were studied in 96 infants using a population approach. RESULTS: A one-compartment model described LPV/r pharmacokinetics. Normalized to a 70kg adult using allometry, clearance (CL/F) and distribution volume (V/F) estimates were 5.87lh -170kg -1 and 91.7l70kg -1. The relative bioavailabilty, F, increased with post-menstrual age (PMA) and reached 50% of the adult value at 39.7 weeks. CONCLUSIONS: Size and PMA explained some CL/F and V/F variability in neonates/infants. Based upon trough concentration limitations, suggested LPV/r dosing regimens were 40mg12h -1, 80mg12h -1 and 120mg12h -1 in the 1-2kg, 2-6kg and 6-10kg group, respectively. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.


Lada O.,French Institute of Health and Medical Research | Gervais A.,Service des Maladies Infectieuses et Tropicales | Branger M.,Laboratoire Of Virologie | Peytavin G.,Service de pharmacie clinique | And 8 more authors.
Liver International | Year: 2012

Aim: To evaluate the early virological response (EVR) to combined tenofovir-lamivudine or emtricitabine regimen in HBV/HIV-co-infected patients and the long-term efficacy of tenofovir. Methods: In this retrospective monocentric study, among the 166 HIV/HBV-co-infected patients regularly followed from 2003 to 2008 at Bichat Claude Bernard Hospital, 61 patients had received, either de novo combination therapy with tenofovir and lamivudine or emtricitabine (group I, n = 15) or add-on tenofovir to lamivudine therapy (group II, n = 46). The HBV polymerase region was sequenced and analysed for all patients with available samples. Results: All 15 group I patients achieved EVR vs 32 (82%) of group II patients (P = 0.15). Seven adherent group II patients met criteria for primary non-response, but achieved delayed response (DR) to therapy. In these seven patients, when compared with the 39 group II patients, there was a trend to longer duration of lamivudine pre-treatment and to higher rate of lamivudine-resistant mutants; and HBV genotype-G proportion was higher (P = 0.026). No virological breakthrough occurred after a median of 46 months follow up. Conclusion: In these HBV/HIV-co-infected patients, first-line HBV therapy with tenofovir and emtricitabine or lamivudine was associated with EVR. However, DR to tenofovir was observed in 15% of patients who added tenofovir to lamivudine therapy, of whom four of seven (57%) had genotype G-HBV infection. No resistance was evidenced after 46 months of therapy even in patients with DR to tenofovir. At last, a good renal safety profile of TDF was observed after a median follow-up of 4 years of therapy. © 2011 John Wiley & Sons A/S.


Lacrosse D.,Service danesthesiologie | Dincq A.-S.,Service danesthesiologie | Antoine A.,Service danesthesiologie | Michel C.,Service de pharmacie clinique | And 2 more authors.
Nutrition Clinique et Metabolisme | Year: 2011

In severely malnourished patients, preoperative nutritional support helps lessen the adverse impact of malnourishment on postoperative progress. An essential prerequisite is to identify this malnourishment. We wanted to find out whether pre-anaesthetic consultation (which is not compulsory in Belgium) was a tool that could be used to achieve these objectives of preoperative nutritional screening in patients undergoing abdominal surgery. Method: Our working method comprised of three phases. Having conducted a study to determine our situation, we integrated the NRS 2002 into our computerised consultation protocol and created a procedure used to link our consultation with the dietetics consultation on the same day. We then analysed the effectiveness of our actions. Results: We received 87.8% of patients undergoing elective abdominal surgery at the pre-anaesthetic consultation. Thanks to the computerisation of the NRS 2002, our nutritional screening rose from 60.8% to 86.1%. All patients at risk of malnutrition were referred to the dietetics service on the same day for a nutritional assessment and nutritional support if necessary. This procedure reduced the hospital re-admittance rate as much as possible. The average period of 13 to 15 days between the pre-anaesthetic consultation and the surgery was sufficient to put in place preoperative nutritional support. Conclusion: Pre-anaesthetic consultation has therefore become a tool used for preoperative nutritional screening and care. © 2011 Elsevier Masson SAS.


Bourget P.,Service de Pharmacie Clinique | Amin A.,Service de Pharmacie Clinique | Vidal F.,Service de Pharmacie Clinique | Merlette C.,Service de Pharmacie Clinique | And 3 more authors.
Journal de Pharmacie de Belgique | Year: 2013

In France, central IV admixture of chemotherapy (CT) treatments at the hospital is now required by law. We have previously shown that the shaping of Therapeutic Objects (TOs) could profit from an Analytical Quality Assurance (AQA), closely linked to the batch release, for the three key parameters: identity, purity, and initial concentration of the compound of interest. In the course of recent and diversified works, we showed the technical superiority of non-intrusive Raman Spectroscopy (RS) vs. any other analytical option and, especially for both HPLC and vibrational method using a UV/visible-FTIR coupling. An interconnected qualitative and economic assessment strongly helps to enrich these relevant works. The study compares in operational situation, the performance of three analytical methods used for the AQC of TOs. We used: a) a set of evaluation criteria, b) the depreciation tables of the machinery, c) the cost of disposables, d) the weight of equipment and technical installations, e) the basic accounting unit (unit of work) and its composite costs (€), which vary according to the technical options, the weight of both human resources and disposables; finally, different combinations are described. So, the unit of work can take 12 different values between 1 and 5.5 €, and we provide various recommendations. A qualitative evaluation grid constantly places the SR technology as superior or equal to the 2 other techniques currently available. Our results demonstrated: a) the major interest of the non-intrusive AQC performed by RS, especially when it is not possible to analyze a TO with existing methods e.g. elastomeric portable pumps, and b) the high potential for this technique to be a strong contributor to the security of the medication circuit, and to fight the iatrogenic effects of drugs especially in the hospital. It also contributes to the protection of all actors in healthcare and of their working environment.


In France, central IV admixture of chemotherapy (CT) treatments at the hospital is now required by law. We have previously shown that the shaping of Therapeutic Objects (TOs) could profit from an Analytical Quality Assurance (AQA), closely linked to the batch release, for the three key parameters: identity, purity, and initial concentration of the compound of interest. In the course of recent and diversified works, we showed the technical superiority of non-intrusive Raman Spectroscopy (RS) vs. any other analytical option and, especially for both HPLC and vibrational method using a UV/visible-FTIR coupling. An interconnected qualitative and economic assessment strongly helps to enrich these relevant works. The study compares in operational situation, the performance of three analytical methods used for the AQC of TOs. We used: a) a set of evaluation criteria, b) the depreciation tables of the machinery, c) the cost of disposables, d) the weight of equipment and technical installations, e) the basic accounting unit (unit of work) and its composite costs (€), which vary according to the technical options, the weight of both human resources and disposables; finally, different combinations are described. So, the unit of work can take 12 different values between 1 and 5.5 €, and we provide various recommendations. A qualitative evaluation grid constantly places the SR technology as superior or equal to the 2 other techniques currently available. Our results demonstrated: a) the major interest of the non-intrusive AQC performed by RS, especially when it is not possible to analyze a TO with existing methods e.g. elastomeric portable pumps, and b) the high potential for this technique to be a strong contributor to the security of the medication circuit, and to fight the iatrogenic effects of drugs especially in the hospital. It also contributes to the protection of all actors in healthcare and of their working environment.

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