Audit d'une nouvelle stratégie de prise en charge des hémorragies du post-partum: audit des hémorragies du post partum

International audienceLe but de ce travail était de réaliser un audit clinique des cas des hémorragies graves du post-partum en Basse-Normandie et d'en évaluer la prévalence avant et après la mise en place d'un protocole régional. En 2004, dans le cadre du réseau périnatal Bas-Normand, un protocole de prise en charge des hémorragies du post-partum a été diffusé dans l'ensemble des maternités. Une étude « avant-après » a été réalisée afin d'en mesurer l'impact : l'enquête SPHERE. Les hémorragies graves étaient définies par le recours à une transfusion sanguine, à une embolisation des artères utérines ou à une chirurgie d'hémostase, par un delta d'hémoglobine supérieur à 4g/dl ou par un décès maternel. Nous avons analysé les cas graves, sauf ceux définis par le delta d'hémoglobine, avant et après la mise en place du protocole. Les périodes d'étude étaient les années 2002 et 2005. L'audit a été réalisé par dix experts de la région (5 binômes, anesthésiste-réanimateur/gynécologue-obstétricien). Chaque dossier, attribué au hasard, a été évalué pour le suivi du protocole, pour la gravité de l'hémorragie et pour la qualité de la prise en charge. Le nombre d'hémorragies graves du post-partum est resté stable entre 2002 et 2005, respectivement 130 et 136 cas, ainsi que le nombre des naissances. Mais le nombre d'HPP sévères passées inaperçues est passé de 96 à 73. Le nombre d'HPP sévères auditées étaient de 34 cas en 2002 et de 63 en 2005. Le protocole était bien respecté dans l'ensemble de la région, la plupart des points audités étant suivis dans près de 90% des cas en 2005. Mais certaines pratiques ne sont pas encore systématiques, notamment la prise en charge active de la troisième phase du travail réalisée seulement dans 70,6% de cas. Les hémorragies étaient de gravité extrême dans 38,1% en 2005 contre 44,1% en 2002 (différence non statistiquement significative). La qualité de leur gestion a été améliorée, ainsi les prises en charge insuffisantes représentaient 12,7% en 2005 contre 32,3% en 2002 (p<0,020). L'originalité de ce travail réside dans le fait qu'il a été réalisé sur le plan médical à l'échelle d'un réseau de soins régional. Nous n'avons pas observé de diminution de la prévalence des hémorragies graves du post-partum en Basse-Normandie mais l'audit a montré que la qualité de la prise en charge avait progressé, certes encore insuffisamment. Seul le perfectionnement de nos pratiques favorisera la réduction du nombre d'hémorragies sévères du post-partum, une des solutions principales étant la formation médicale continue

Real versus sham proximal biofield therapy in the treatment of warts of the hands and feet in adults: study protocol for a randomized controlled trial (MAGNETIK study)

Abstract Background Despite the lack of scientific studies on biofield therapies, they are widely acclaimed by patients. The mechanisms of action are not explained by current allopathic medical approaches. Warts are common and contagious viral lesions that may be refractory to standard dermatologic treatments such as cryotherapy, laser therapy, and keratolytic ointments. Biofield therapies are efficient in various pathologies. Their ability to treat warts has never been demonstrated in a scientific study with a robust methodology. Patients with refractory warts often place their trust in these alternative therapies because of the poor results obtained from traditional medicine. We propose a prospective, randomized, single-blind, assessor-blind trial to evaluate the efficacy of treatment of warts by biofield therapy. Methods/design Subjects with warts on their feet or hands will be randomized into two groups: real biofield therapy versus sham therapy. The diagnosis will be made at the time of inclusion, and follow-up will take place in week 3. Comparison of pictures of the warts at baseline and after 3 weeks will be used as the primary outcome measure. The hypothesis is that the extent of the disappearance of the original wart in the group treated by real biofield therapy will be 70% and that it will be 30% in the group treated by sham therapy. Using 90% power and an alpha risk of 5%, 31 subjects are required in each group for a two-tailed proportion comparison test. Discussion To our knowledge, this is the first study to evaluate the efficacy of biofield therapy on warts. Therefore, the aim of this study is to extend knowledge of biofield therapy to another area of medicine such as dermatology and to propose complementary or alternative practices to improve patient well-being. The main strength of the study is that it is a randomized, single-blind, assessor-blind, placebo-controlled study. Trial registration ClinicalTrials.gov identifier: NCT02773719 . Registered on 22 April 2016

Pharmacokinetics and safety of daptomycin administered subcutaneously in healthy volunteers: a single-blinded randomized crossover trial

International audienceBackground: Daptomycin stands as a key IV antibiotic in treating MRSA infections. However, patients facing challenges with difficult venous access require alternative administration routes. This study aimed to evaluate the pharmacokinetic (PK) profile and safety of subcutaneous (SC) daptomycin.Patients and methods: In a two-period, two-treatment, single-blind crossover Phase I trial (ClinicalTrials.gov NCT04434300), participants with no medical history received daptomycin (10 mg/kg) both IV and SC in a random order, with a minimum 2 week washout period together with matched placebo (NaCl 0.9%). Blood samples collected over 24 h facilitated PK comparison. Monte Carlo simulations assessed the PTA for various dosing regimens. Adverse events were graded according to Common Terminology Criteria for Adverse Events(CTCAE) v5.0.Results: Twelve participants (aged 30.9 ± 24.4 years; 9 male,75%) were included. SC daptomycin exhibited delayed (median Tmax 0.5 h for IV versus 4 h for SC) and lower peak concentration than IV (Cmax = 132.2 ± 16.0 μg/mL for IV versus 57.3 ± 8.6 μg/mL for SC; P < 0.001). SC AUC0-24 (937.3 ± 102.5 μg·h/mL) was significantly lower (P = 0.005) than IV AUC0-24 (1056.3 ± 123.5 μg·h/mL) but was deemed bioequivalent. PTA demonstrated target AUC0-24 attainment for 100% of simulated individuals, for both 8 and 10 mg/kg/24 h SC regimens. Adverse events (AEs) related to SC daptomycin were more frequent than for SC placebo (25 versus 13, P = 0.016). No serious AEs were reported.Conclusions: Single-dose SC daptomycin infusion proved to be safe, exhibiting a bioequivalent AUC0-24 compared with the IV route. The SC route emerges as a potential and effective alternative when IV administration is not possible

Astrobiology: Future Perspectives

Astrobiology, a new exciting interdisciplinary research field, seeks to unravel the origin and evolution of life wherever it might exist in the Universe. The current view of the origin of life on Earth is that it is strongly connected to the origin and evolution of our planet and, indeed, of the Universe as a whole. We are fortunate to be living in an era where centuries of speculation about the two ancient and fundamental problems: the origin of life and its prevalence in the Universe are being replaced by experimental science. The subject of Astrobiology can be approached from many different perspectives. This book is focused on abiogenic organic matter from the viewpoint of astronomy and planetary science and considers its potential relevance to the origins of life on Earth and elsewhere. Guided by the review papers in this book, the concluding chapter aims to identify key questions to motivate future research and stimulate astrobiological applications of current and future research facilities and space missions. Today’s rich array of new spacecraft, telescopes and dedicated scientists promises a steady flow of discoveries and insights that will ultimately lead us to the answers we seek

Bioavailability of dissolved and crushed single tablets of bictegravir, emtricitabine, tenofovir alafenamide in healthy adults: the SOLUBIC randomized crossover study

Abstract Background Crushing or dissolving bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) tablets is not recommended because there are no data supporting this practice. Methods A crossover, randomized trial in healthy adults (NCT04244448) investigated the bioavailability of two off-label uses of BIC/TAF/FTC (50/200/25 mg), dissolved in water or crushed in apple compote, compared with the solid tablet. Pharmacokinetic (PK) parameters were estimated from sequential intensive plasma antiretroviral concentrations over a 72 h period post dose. Bioequivalence was met if the 90% CIs of the geometric least-squares means ratios comparing BIC/TAF/FTC exposures (AUC and Cmax) from the experimental phases were within 80%–125% of the reference. Results Eighteen subjects participated in each of the three phases. Dissolved tablet Cmax geometric mean ratio (90% CI) for BIC/TAF/FTC was 105% (93–119)/97% (87–108)/96% (74–124), respectively. Dissolved tablet AUC geometric mean ratio (90% CI) for BIC/TAF/FTC was 111% (100–122)/100% (94 to 105)/99% (81 to 120), respectively. Crushed tablet Cmax geometric mean ratio (90%) CI for BIC/TAF/FTC was 110% (97 to 124)/70% (63–78)/66% (51–85), respectively. Crushed tablet AUC geometric mean ratio (90%) CI for BIC/TAF/FTC was 107% (96–118)/86% (82–91)/84% (69–103), respectively. Conclusions Crushing BIC/TAF/FTC tablets may lead to suboptimal emtricitabine and tenofovir alafenamide drug exposures. Dissolving BIC/TAF/FTC in water may be acceptable if the tablet cannot be swallowed whole

El Diario de Pontevedra : periódico liberal: Ano XXII Número 3968 - 1905 outubro 2

Numeración errónea en el original