Roseline MAZET - Academia.edu (original) (raw)

Papers by Roseline MAZET

Emerging Microbes & Infections

European Journal of Pharmaceutical Sciences

Emerging Microbes & Infections, 2022

ABSTRACT In order to optimise the operational implementation of mass vaccination policies, it is ... more ABSTRACT In order to optimise the operational implementation of mass vaccination policies, it is critical to consider not only the supply of vaccines as well as each element of the vaccination process. This study, which was conducted in a vaccination center clearly shows how the choice of a syringe reference used during the COVID-19 vaccination campaign influences the number of vaccine doses available. The results appear to be closely related to the type of vaccine used (COMIRNATY® and SPIKEVAX®). In this context, the choice of the right reference of syringe has major economic and organisational consequences on a global scale.

European Journal of Hospital Pharmacy, 2021

Objectives Automation of parenteral nutrition (PN) preparation is nowadays a recommended practice... more Objectives Automation of parenteral nutrition (PN) preparation is nowadays a recommended practice in order to reduce human errors and thus improve the safety and accuracy of the finished product. Other benefits of automation may include full documentation of preparation and a reduction in personnel requirements or staff injuries. The market of automation compounding presents different automated compounding devices (ACDs). The aim of this study is to compare the technical characteristics of ACDs by carrying out four specific challenges. Methods Three ACDs: Two piston pumps with ACD 1: MediMix Multi 4120R (Impromediform) and ACD 2: Mibmix Compounder C12 (Hemedis), and one peristaltic pump ACD 3: ExactaMix Compounder EM2400 (Baxter) were assessed in a pharmaceutical manufacturing unit within a controlled atmosphere area, under horizontal laminar flow hood (LFH) according to four tests: volumetric accuracy, flush volume, smoke test, and a production test with three configurations of PN bags. For this test, a PN bag was considered accepted when all quality controls (weight, molar concentration of sodium, potassium and calcium) were fulfilled. Results The maximum relative biases found for the different ACDs were heterogeneous. ACD 1 had the best volumetric accuracy with respect to supplier specifications and for extreme volumes (0.2 mL). Evaluation of the flushing volume allowed the validation of 50 mL volumes for ACD 1 and ACD 3. The smoke test was only conclusive for ACD 1 under a horizontal LFH. The percentage of PN bags accepted were 98.8% for ACD 1, 70% for ACD 2%, and 95.5% for ACD 3. Conclusion This study compared three ACDs according to four relevant and specific tests. Based on the data acquired, we conclude that ACD 1 is the most accurate, has the lowest flushing volume, is suitable for use in a LFH, and achieves the best results in the production test.

Clinical pharmacy, 2017

Background Lung transplant recipients require multidisciplinary care because of the complexity of... more Background Lung transplant recipients require multidisciplinary care because of the complexity of therapeutic management. Clinical pharmacists are able to detect drug related problems (DRPs) and provide recommendations to physicians. The potential significance of pharmacists’ interventions (PIs) has never been studied by a multidimensional approach in lung transplantation (LT). Purpose We aimed to assess the clinical, economic and organisational impact of PIs on immunosuppressive management among lung transplant outpatients. Material and methods In our centre, PIs are comprehensively and prospectively collected on Act-IP database, a free access website observatory created by the French Society of Clinical Pharmacy (SFPC) from 2009 onward. Each PI includes patient features, a description of the DRP and the PI according to the SFPC classification. A retrospective analysis of the PIs was performed from 1 January 2009 to 31 December 2015 by an expert committee including a clinical pharmacist, pharmacovigilant and pneumologist. The impact of accepted PIs was assessed according to the validated multidimensional ‘CLEO’ scale, which includes three dimensions: CLinical (harmful, null, minor, moderate, major, lethal, non-determined), Economic (cost increase, no change, cost decrease, not determined) and Organisational impacts (unfavourable, null, favourable, not determined). Results Among the 1568 PIs performed over the 7 year period, 713 (45.5%) were related to immunosuppressive therapy for which the physician’s acceptance rate was 94.0%. The expert committee considered the clinical impact of PIs as major, moderate and minor in 9.6%, 67.0% and 22.8%, respectively. Major clinical impact was mainly related to drug–drug interactions between immunosuppressants and antifungals (56.0%). Wrong dose was the main cause of moderate clinical impact (75.0%). While 41.6% of PIs led to a cost increase due to dose increase or adding of drug monitoring, 44.8% of PIs helped a cost decrease due to dose decrease or drug discontinuation (44.8%). Most PIs did not have an organisational impact for healthcare professionals (99.1%). Conclusion This is the first study which has evaluated the clinical, economic and organisational impacts of PIs in lung transplant outpatients. Our findings show that clinical pharmacists play a key role in optimising immunosuppressive therapy management in LT. As experts in drug therapy, clinical pharmacists are able to detect and resolve DRPs to improve patient care. No conflict of interest

L'inflammation ophtalmique necessite un traitement rapide et efficace afin de limiter ses eff... more L'inflammation ophtalmique necessite un traitement rapide et efficace afin de limiter ses effets nefastes pour l'œil et la vision. La prise en charge therapeutique consiste dans 90 % des cas en l'administration d'anti-inflammatoires (AI) par voie topique. Leur penetration oculaire et leur biodisponibilite etant faibles, 1 a 5 % de la dose instillee traverse la cornee, la frequence des instillations est importante pour les patients. Parmi les AIS et AINS disponibles dans l'arsenal therapeutique, la dexamethasone (DXM) est une des molecules les plus puissantes et efficaces, apparaissant comme une reference. L'acetate de DXM (DXMa) est un derive lipophile, potentiellement interessant pour une utilisation topique ophtalmique, mais non commercialisee a ce jour. Cet ester serait mieux absorbe et moins enclin a provoquer une hypertension oculaire que les autres formes de DXM. Cependant, l'acetate de DXM presente un inconvenient majeur, sa tres faible solubilite ...

BMJ Open, 2020

ObjectivesLung transplant (LT) recipients require multidisciplinary care because of the complexit... more ObjectivesLung transplant (LT) recipients require multidisciplinary care because of the complexity of therapeutic management. Pharmacists are able to detect drug-related problems and provide recommendations to physicians through pharmacists’ interventions (PIs). We aimed at assessing the clinical impact of PIs on therapeutic management in LT outpatients.DesignData were collected prospectively from an LT recipients cohort during 7 years. A multidisciplinary committee assessed retrospectively the clinical impact of accepted PIs.SettingFrench University Hospital.ParticipantsLT outpatients followed from 2009 to 2015.Primary outcome measuresClinical impact of PIs performed by pharmacists using the CLEO tool and the Pareto chart.Results1449 PIs led to a change in patient therapeutic management and were mainly related to wrong dosage (39.6%) and untreated indication (19.6%). The clinical impact of PIs was ‘avoids fatality’, ‘major’ and ‘moderate’, in 0.1%, 7.0% and 57.9%, respectively. Imm...

Pharmaceutics, 2020

We previously developed two optimized formulations of dexamethasone acetate (DXMa) hydrogels by m... more We previously developed two optimized formulations of dexamethasone acetate (DXMa) hydrogels by means of special cubic mixture designs for topical ocular administration. These gels were elaborated with hydroxypropyl-β-CD (HPβCD) and hydroxypropyl-γ-CD (HPγCD) and commercial hydrogels in order to enhance DXMa water solubility and finally DXMa’s ocular bioavailability and transcorneal penetration. The main objective of this study was to characterize them and to evaluate in vitro, ex vivo, and in vivo their safety, biopermanence, and transcorneal permeation. Gels A and B are Newtonian fluids and display a viscosity of 13.2 mPa.s and 18.6 mPa.s, respectively, which increases their ocular retention, according to the in vivo biopermanence study by PET/CT. These hydrogels could act as corneal absorption promoters as they allow a higher transcorneal permeation of DXMa through porcine excised cornea, compared to DEXAFREE® and MAXIDEX®. Cytotoxicity assays showed no cytotoxic effects on human...

Archives of Cardiovascular Diseases Supplements, 2020

Conclusion LSCI is useful in assessing the cutaneous microcirculation compared to LDI. Additional... more Conclusion LSCI is useful in assessing the cutaneous microcirculation compared to LDI. Additional testing is required such as skin microvascular reactivity to iontophoresis of acetylcholine and sodium nitroprusside and pressure ulcers for wound healing monitoring. Disclosure of interest The authors have not supplied their declaration of competing interest.

Pharmaceutics, 2020

Ocular inflammation is one of the most common symptom of eye disorders and diseases. The therapeu... more Ocular inflammation is one of the most common symptom of eye disorders and diseases. The therapeutic management of this inflammation must be rapid and effective in order to avoid deleterious effects for the eye and the vision. Steroidal (SAID) and non-steroidal (NSAID) anti-inflammatory drugs and immunosuppressive agents have been shown to be effective in treating inflammation of the ocular surface of the eye by topical administration. However, it is well established that the anatomical and physiological ocular barriers are limiting factors for drug penetration. In addition, such drugs are generally characterized by a very low aqueous solubility, resulting in low bioavailability as only 1% to 5% of the applied drug permeates the cornea. The present review gives an updated insight on the conventional formulations used in the treatment of ocular inflammation, i.e., ointments, eye drops, solutions, suspensions, gels, and emulsions, based on the commercial products available on the US, ...

The Journal of Clinical Pharmacology, 2020

Digital skin ulcers are a severe complication of systemic sclerosis. The first-line treatment is ... more Digital skin ulcers are a severe complication of systemic sclerosis. The first-line treatment is intravenous iloprost, but it induces dose-limiting adverse effects. Local administration of treprostinil through skin iontophoresis may be a safe alternative. We conducted a 2-stage, randomized, placebo-controlled single-ascending-dose study in healthy volunteers and patients with systemic sclerosis-related digital ulcer. We further explored the effect of the procedure on skin blood flux. In a first group of healthy subjects, treprostinil and placebo iontophoresis were performed at 3 locations (ie, 6 skin sites): the sole of the foot, the leg, and the fingers. We used a 1-mg/mL hydrogel of treprostinil. We then randomly treated systemic sclerosis-related digital ulcers in a 3:1 ratio of treprostinil or placebo. We used concentrations from 0.1 to 1 mg/mL. All adverse events were recorded and rated according to the Common Terminology Criteria for Adverse Events (CTCAE), whereas skin microvascular blood flux was recorded with laser speckle contrast imaging. Among the 12 healthy volunteers, we observed 60 local adverse effects: burns, skin pain, erythema, and pruritus, graded 1 or 2 on the 5-point CTCAE scale. Treprostinil iontophoresis significantly increased skin blood flux on the leg (AUC 0-4 h at 88 460% ± 6436% versus 12 730% ± 3397% baseline flux.min respectively; P < .001) and on the sole of the foot (AUC 0-3 h at 20 124% ± 6119% versus 3142% ± 3036% baseline flux.min, respectively; P = .018) with a trend on the finger. Among 5 patients with systemic sclerosis-related digital ulcer, 2 resolutive local adverse effects were reported. Iontophoresis of treprostinil hydrogel was safe in systemic sclerosis patients with digital ulcer.

BMC Pediatrics, 2019

Background The use and optimal duration of treatment with nebulized hypertonic saline (HS) in inf... more Background The use and optimal duration of treatment with nebulized hypertonic saline (HS) in infants hospitalized for acute bronchiolitis is unclear. The objective was to compare the efficacy of 1 versus 3 days of nebulized 3% HS at 72 h of treatment. We conducted a blinded non-inferiority randomized controlled trial including infants aged less than 12 months old, hospitalized for a moderate bronchiolitis. Methods Nebulisations of 3% HS for 1 day were followed by either the continuation of 3% HS (HS3d group) or switched to 0.9% normal isotonic saline (HS1d group) for 2 days Randomization was performed according to a predefined list with a 1:1 ratio, obtained with a random generator number with blocks.. Main outcome was mean Wang clinical severity score (CSS) after 72 h of treatment. Results One hundred sixteen infants (HS1d n = 59 and HS3d n = 57), were included over two epidemic seasons from 2014 to 2016, but recruitement did not reach the planned sample size. The difference for t...

Pharmaceutics, 2018

Dexamethasone acetate (DXMa) has proven its efficiency to treat corneal inflammation, without a g... more Dexamethasone acetate (DXMa) has proven its efficiency to treat corneal inflammation, without a great propensity to increase intraocular pressure. Unfortunately, its poor aqueous solubility, associated with a rapid precorneal elimination, results in a low drug bioavailability and a low penetration after topical ocular administration. The main objective of this study was to improve the apparent aqueous solubility of DXMa using cyclodextrins. First, hydroxypropyl-β-CD (HPβCD) and hydroxypropyl-γ-CD (HPγCD) were used to enhance DXMa concentration in aqueous solution. The β and γ HPCD derivatives allowed the increase of the DXMa amount in solution at 25 °C by a factor of 500 and 1500, respectively. Second, with the aim of improving the persistence of the complex solution after instillation in the eye, the formulations of DXMa-based CD solutions with marketed ophthalmic gels (CELLUVISC®, GEL-LARMES®, and VISMED®) were investigated and optimized by means of special cubic mixture designs, ...

Journal of the European Academy of Dermatology and Venereology, 2018

Médecine Nucléaire, 2017

Les progrès en radioimmunothérapie (RIT) doivent tenir compte des principes de base d'utilisation... more Les progrès en radioimmunothérapie (RIT) doivent tenir compte des principes de base d'utilisation des anticorps en thérapeutique humaine et notamment les conséquences possibles de l'immunisation contre les fractions murines des anticorps monoclonaux. Un test rapide pour la détection qualitative d'anticorps humains anti-souris (Quickline HAMA, Milenia Biotec Quick-test) fournit une alternative intéressante au test quantitatif jusque-là utilisé. Ce test peut être utilisé au chevet du patient pour l'évaluation du statut HAMA.

Clinical Chemistry and Laboratory Medicine (CCLM), 2017

Pratique Neurologique - FMC, 2016

L'electroencéphalogramme (EEG) de sommeil est déterminant dans l'exploration de certaines épileps... more L'electroencéphalogramme (EEG) de sommeil est déterminant dans l'exploration de certaines épilepsies en pédiatrie, en raison de la mauvaise qualité du tracé de l'EEG de veille ou de l'effet spécifique du sommeil sur les anomalies de l'EEG. Cependant, l'endormissement et le maintien de l'état endormi lors de la sieste peuvent être difficiles à obtenir malgré la mise en place de recommandations de principe ; il est possible alors de recourir à une prise médicamenteuse. Comme les benzodiazépines, l'hydroxyzine ou l'hydrate de chloral peuvent influencer la macrostructure du sommeil et donc affecter l'interprétation de l'examen ou nécessiter une surveillance particulière, certaines unités de neurophysiologie clinique recourent à la mélatonine en libération immédiate. Cette neurohormone physiologique permet d'induire le sommeil et a été expérimentée avec succès en prémédication de différentes explorations complémentaires nécessitant une immobilité prolongée. Cet article passe en revue les arguments, tirés de la littérature et basés sur notre expérience, démontrant que les données d'efficacité et de tolérance de l'utilisation de la mélatonine dans l'obtention du sommeil au cours de l'EEG de l'enfant semblent confirmer l'intérêt de cette utilisation. Toutefois, aucune étude randomisée versus placebo n'est actuellement disponible.

, … pour votre soutien, votre amitié et les bons moments passés ensemble. A Maxim, mon filleul, A... more , … pour votre soutien, votre amitié et les bons moments passés ensemble. A Maxim, mon filleul, Agathe et Hugues, mes neveux, pour vos sourires et vos beaux dessins. A Stéphane, pour ton soutien si précieux, tes sourires, ton amour et surtout l'immense bonheur que tu m'apportes tous les jours.

Emerging Microbes & Infections

European Journal of Pharmaceutical Sciences

Emerging Microbes & Infections, 2022

ABSTRACT In order to optimise the operational implementation of mass vaccination policies, it is ... more ABSTRACT In order to optimise the operational implementation of mass vaccination policies, it is critical to consider not only the supply of vaccines as well as each element of the vaccination process. This study, which was conducted in a vaccination center clearly shows how the choice of a syringe reference used during the COVID-19 vaccination campaign influences the number of vaccine doses available. The results appear to be closely related to the type of vaccine used (COMIRNATY® and SPIKEVAX®). In this context, the choice of the right reference of syringe has major economic and organisational consequences on a global scale.

European Journal of Hospital Pharmacy, 2021

Objectives Automation of parenteral nutrition (PN) preparation is nowadays a recommended practice... more Objectives Automation of parenteral nutrition (PN) preparation is nowadays a recommended practice in order to reduce human errors and thus improve the safety and accuracy of the finished product. Other benefits of automation may include full documentation of preparation and a reduction in personnel requirements or staff injuries. The market of automation compounding presents different automated compounding devices (ACDs). The aim of this study is to compare the technical characteristics of ACDs by carrying out four specific challenges. Methods Three ACDs: Two piston pumps with ACD 1: MediMix Multi 4120R (Impromediform) and ACD 2: Mibmix Compounder C12 (Hemedis), and one peristaltic pump ACD 3: ExactaMix Compounder EM2400 (Baxter) were assessed in a pharmaceutical manufacturing unit within a controlled atmosphere area, under horizontal laminar flow hood (LFH) according to four tests: volumetric accuracy, flush volume, smoke test, and a production test with three configurations of PN bags. For this test, a PN bag was considered accepted when all quality controls (weight, molar concentration of sodium, potassium and calcium) were fulfilled. Results The maximum relative biases found for the different ACDs were heterogeneous. ACD 1 had the best volumetric accuracy with respect to supplier specifications and for extreme volumes (0.2 mL). Evaluation of the flushing volume allowed the validation of 50 mL volumes for ACD 1 and ACD 3. The smoke test was only conclusive for ACD 1 under a horizontal LFH. The percentage of PN bags accepted were 98.8% for ACD 1, 70% for ACD 2%, and 95.5% for ACD 3. Conclusion This study compared three ACDs according to four relevant and specific tests. Based on the data acquired, we conclude that ACD 1 is the most accurate, has the lowest flushing volume, is suitable for use in a LFH, and achieves the best results in the production test.

Clinical pharmacy, 2017

Background Lung transplant recipients require multidisciplinary care because of the complexity of... more Background Lung transplant recipients require multidisciplinary care because of the complexity of therapeutic management. Clinical pharmacists are able to detect drug related problems (DRPs) and provide recommendations to physicians. The potential significance of pharmacists’ interventions (PIs) has never been studied by a multidimensional approach in lung transplantation (LT). Purpose We aimed to assess the clinical, economic and organisational impact of PIs on immunosuppressive management among lung transplant outpatients. Material and methods In our centre, PIs are comprehensively and prospectively collected on Act-IP database, a free access website observatory created by the French Society of Clinical Pharmacy (SFPC) from 2009 onward. Each PI includes patient features, a description of the DRP and the PI according to the SFPC classification. A retrospective analysis of the PIs was performed from 1 January 2009 to 31 December 2015 by an expert committee including a clinical pharmacist, pharmacovigilant and pneumologist. The impact of accepted PIs was assessed according to the validated multidimensional ‘CLEO’ scale, which includes three dimensions: CLinical (harmful, null, minor, moderate, major, lethal, non-determined), Economic (cost increase, no change, cost decrease, not determined) and Organisational impacts (unfavourable, null, favourable, not determined). Results Among the 1568 PIs performed over the 7 year period, 713 (45.5%) were related to immunosuppressive therapy for which the physician’s acceptance rate was 94.0%. The expert committee considered the clinical impact of PIs as major, moderate and minor in 9.6%, 67.0% and 22.8%, respectively. Major clinical impact was mainly related to drug–drug interactions between immunosuppressants and antifungals (56.0%). Wrong dose was the main cause of moderate clinical impact (75.0%). While 41.6% of PIs led to a cost increase due to dose increase or adding of drug monitoring, 44.8% of PIs helped a cost decrease due to dose decrease or drug discontinuation (44.8%). Most PIs did not have an organisational impact for healthcare professionals (99.1%). Conclusion This is the first study which has evaluated the clinical, economic and organisational impacts of PIs in lung transplant outpatients. Our findings show that clinical pharmacists play a key role in optimising immunosuppressive therapy management in LT. As experts in drug therapy, clinical pharmacists are able to detect and resolve DRPs to improve patient care. No conflict of interest

L'inflammation ophtalmique necessite un traitement rapide et efficace afin de limiter ses eff... more L'inflammation ophtalmique necessite un traitement rapide et efficace afin de limiter ses effets nefastes pour l'œil et la vision. La prise en charge therapeutique consiste dans 90 % des cas en l'administration d'anti-inflammatoires (AI) par voie topique. Leur penetration oculaire et leur biodisponibilite etant faibles, 1 a 5 % de la dose instillee traverse la cornee, la frequence des instillations est importante pour les patients. Parmi les AIS et AINS disponibles dans l'arsenal therapeutique, la dexamethasone (DXM) est une des molecules les plus puissantes et efficaces, apparaissant comme une reference. L'acetate de DXM (DXMa) est un derive lipophile, potentiellement interessant pour une utilisation topique ophtalmique, mais non commercialisee a ce jour. Cet ester serait mieux absorbe et moins enclin a provoquer une hypertension oculaire que les autres formes de DXM. Cependant, l'acetate de DXM presente un inconvenient majeur, sa tres faible solubilite ...

BMJ Open, 2020

ObjectivesLung transplant (LT) recipients require multidisciplinary care because of the complexit... more ObjectivesLung transplant (LT) recipients require multidisciplinary care because of the complexity of therapeutic management. Pharmacists are able to detect drug-related problems and provide recommendations to physicians through pharmacists’ interventions (PIs). We aimed at assessing the clinical impact of PIs on therapeutic management in LT outpatients.DesignData were collected prospectively from an LT recipients cohort during 7 years. A multidisciplinary committee assessed retrospectively the clinical impact of accepted PIs.SettingFrench University Hospital.ParticipantsLT outpatients followed from 2009 to 2015.Primary outcome measuresClinical impact of PIs performed by pharmacists using the CLEO tool and the Pareto chart.Results1449 PIs led to a change in patient therapeutic management and were mainly related to wrong dosage (39.6%) and untreated indication (19.6%). The clinical impact of PIs was ‘avoids fatality’, ‘major’ and ‘moderate’, in 0.1%, 7.0% and 57.9%, respectively. Imm...

Pharmaceutics, 2020

We previously developed two optimized formulations of dexamethasone acetate (DXMa) hydrogels by m... more We previously developed two optimized formulations of dexamethasone acetate (DXMa) hydrogels by means of special cubic mixture designs for topical ocular administration. These gels were elaborated with hydroxypropyl-β-CD (HPβCD) and hydroxypropyl-γ-CD (HPγCD) and commercial hydrogels in order to enhance DXMa water solubility and finally DXMa’s ocular bioavailability and transcorneal penetration. The main objective of this study was to characterize them and to evaluate in vitro, ex vivo, and in vivo their safety, biopermanence, and transcorneal permeation. Gels A and B are Newtonian fluids and display a viscosity of 13.2 mPa.s and 18.6 mPa.s, respectively, which increases their ocular retention, according to the in vivo biopermanence study by PET/CT. These hydrogels could act as corneal absorption promoters as they allow a higher transcorneal permeation of DXMa through porcine excised cornea, compared to DEXAFREE® and MAXIDEX®. Cytotoxicity assays showed no cytotoxic effects on human...

Archives of Cardiovascular Diseases Supplements, 2020

Conclusion LSCI is useful in assessing the cutaneous microcirculation compared to LDI. Additional... more Conclusion LSCI is useful in assessing the cutaneous microcirculation compared to LDI. Additional testing is required such as skin microvascular reactivity to iontophoresis of acetylcholine and sodium nitroprusside and pressure ulcers for wound healing monitoring. Disclosure of interest The authors have not supplied their declaration of competing interest.

Pharmaceutics, 2020

Ocular inflammation is one of the most common symptom of eye disorders and diseases. The therapeu... more Ocular inflammation is one of the most common symptom of eye disorders and diseases. The therapeutic management of this inflammation must be rapid and effective in order to avoid deleterious effects for the eye and the vision. Steroidal (SAID) and non-steroidal (NSAID) anti-inflammatory drugs and immunosuppressive agents have been shown to be effective in treating inflammation of the ocular surface of the eye by topical administration. However, it is well established that the anatomical and physiological ocular barriers are limiting factors for drug penetration. In addition, such drugs are generally characterized by a very low aqueous solubility, resulting in low bioavailability as only 1% to 5% of the applied drug permeates the cornea. The present review gives an updated insight on the conventional formulations used in the treatment of ocular inflammation, i.e., ointments, eye drops, solutions, suspensions, gels, and emulsions, based on the commercial products available on the US, ...

The Journal of Clinical Pharmacology, 2020

Digital skin ulcers are a severe complication of systemic sclerosis. The first-line treatment is ... more Digital skin ulcers are a severe complication of systemic sclerosis. The first-line treatment is intravenous iloprost, but it induces dose-limiting adverse effects. Local administration of treprostinil through skin iontophoresis may be a safe alternative. We conducted a 2-stage, randomized, placebo-controlled single-ascending-dose study in healthy volunteers and patients with systemic sclerosis-related digital ulcer. We further explored the effect of the procedure on skin blood flux. In a first group of healthy subjects, treprostinil and placebo iontophoresis were performed at 3 locations (ie, 6 skin sites): the sole of the foot, the leg, and the fingers. We used a 1-mg/mL hydrogel of treprostinil. We then randomly treated systemic sclerosis-related digital ulcers in a 3:1 ratio of treprostinil or placebo. We used concentrations from 0.1 to 1 mg/mL. All adverse events were recorded and rated according to the Common Terminology Criteria for Adverse Events (CTCAE), whereas skin microvascular blood flux was recorded with laser speckle contrast imaging. Among the 12 healthy volunteers, we observed 60 local adverse effects: burns, skin pain, erythema, and pruritus, graded 1 or 2 on the 5-point CTCAE scale. Treprostinil iontophoresis significantly increased skin blood flux on the leg (AUC 0-4 h at 88 460% ± 6436% versus 12 730% ± 3397% baseline flux.min respectively; P < .001) and on the sole of the foot (AUC 0-3 h at 20 124% ± 6119% versus 3142% ± 3036% baseline flux.min, respectively; P = .018) with a trend on the finger. Among 5 patients with systemic sclerosis-related digital ulcer, 2 resolutive local adverse effects were reported. Iontophoresis of treprostinil hydrogel was safe in systemic sclerosis patients with digital ulcer.

BMC Pediatrics, 2019

Background The use and optimal duration of treatment with nebulized hypertonic saline (HS) in inf... more Background The use and optimal duration of treatment with nebulized hypertonic saline (HS) in infants hospitalized for acute bronchiolitis is unclear. The objective was to compare the efficacy of 1 versus 3 days of nebulized 3% HS at 72 h of treatment. We conducted a blinded non-inferiority randomized controlled trial including infants aged less than 12 months old, hospitalized for a moderate bronchiolitis. Methods Nebulisations of 3% HS for 1 day were followed by either the continuation of 3% HS (HS3d group) or switched to 0.9% normal isotonic saline (HS1d group) for 2 days Randomization was performed according to a predefined list with a 1:1 ratio, obtained with a random generator number with blocks.. Main outcome was mean Wang clinical severity score (CSS) after 72 h of treatment. Results One hundred sixteen infants (HS1d n = 59 and HS3d n = 57), were included over two epidemic seasons from 2014 to 2016, but recruitement did not reach the planned sample size. The difference for t...

Pharmaceutics, 2018

Dexamethasone acetate (DXMa) has proven its efficiency to treat corneal inflammation, without a g... more Dexamethasone acetate (DXMa) has proven its efficiency to treat corneal inflammation, without a great propensity to increase intraocular pressure. Unfortunately, its poor aqueous solubility, associated with a rapid precorneal elimination, results in a low drug bioavailability and a low penetration after topical ocular administration. The main objective of this study was to improve the apparent aqueous solubility of DXMa using cyclodextrins. First, hydroxypropyl-β-CD (HPβCD) and hydroxypropyl-γ-CD (HPγCD) were used to enhance DXMa concentration in aqueous solution. The β and γ HPCD derivatives allowed the increase of the DXMa amount in solution at 25 °C by a factor of 500 and 1500, respectively. Second, with the aim of improving the persistence of the complex solution after instillation in the eye, the formulations of DXMa-based CD solutions with marketed ophthalmic gels (CELLUVISC®, GEL-LARMES®, and VISMED®) were investigated and optimized by means of special cubic mixture designs, ...

Journal of the European Academy of Dermatology and Venereology, 2018

Médecine Nucléaire, 2017

Les progrès en radioimmunothérapie (RIT) doivent tenir compte des principes de base d'utilisation... more Les progrès en radioimmunothérapie (RIT) doivent tenir compte des principes de base d'utilisation des anticorps en thérapeutique humaine et notamment les conséquences possibles de l'immunisation contre les fractions murines des anticorps monoclonaux. Un test rapide pour la détection qualitative d'anticorps humains anti-souris (Quickline HAMA, Milenia Biotec Quick-test) fournit une alternative intéressante au test quantitatif jusque-là utilisé. Ce test peut être utilisé au chevet du patient pour l'évaluation du statut HAMA.

Clinical Chemistry and Laboratory Medicine (CCLM), 2017

Pratique Neurologique - FMC, 2016

L'electroencéphalogramme (EEG) de sommeil est déterminant dans l'exploration de certaines épileps... more L'electroencéphalogramme (EEG) de sommeil est déterminant dans l'exploration de certaines épilepsies en pédiatrie, en raison de la mauvaise qualité du tracé de l'EEG de veille ou de l'effet spécifique du sommeil sur les anomalies de l'EEG. Cependant, l'endormissement et le maintien de l'état endormi lors de la sieste peuvent être difficiles à obtenir malgré la mise en place de recommandations de principe ; il est possible alors de recourir à une prise médicamenteuse. Comme les benzodiazépines, l'hydroxyzine ou l'hydrate de chloral peuvent influencer la macrostructure du sommeil et donc affecter l'interprétation de l'examen ou nécessiter une surveillance particulière, certaines unités de neurophysiologie clinique recourent à la mélatonine en libération immédiate. Cette neurohormone physiologique permet d'induire le sommeil et a été expérimentée avec succès en prémédication de différentes explorations complémentaires nécessitant une immobilité prolongée. Cet article passe en revue les arguments, tirés de la littérature et basés sur notre expérience, démontrant que les données d'efficacité et de tolérance de l'utilisation de la mélatonine dans l'obtention du sommeil au cours de l'EEG de l'enfant semblent confirmer l'intérêt de cette utilisation. Toutefois, aucune étude randomisée versus placebo n'est actuellement disponible.

, … pour votre soutien, votre amitié et les bons moments passés ensemble. A Maxim, mon filleul, A... more , … pour votre soutien, votre amitié et les bons moments passés ensemble. A Maxim, mon filleul, Agathe et Hugues, mes neveux, pour vos sourires et vos beaux dessins. A Stéphane, pour ton soutien si précieux, tes sourires, ton amour et surtout l'immense bonheur que tu m'apportes tous les jours.