Utilisation du fondaparinux 2,5mg pour la prévention des évènements thromboemboliques veineux en médecine générale. ArchiMed Ville

International audienceOBJECTIVE:To evaluate the mean duration of treatment course with fondaparinux 2.5 mg (ARIXTRA(®)) in the setting of ambulatory general medicine, with respect to its indication in thromboprophylaxis for medically ill patients and to describe the population treated.METHODS:Observational, prospective, national, multicenter, pharmaco-epidemiological study, performed in France, at the request of the Transparency Commission (a division of the French Health Regulatory Authority). The general practitioners had to include the first three adult patients, considered as patients at high risk of venous thromboembolic events and immobilized for acute medical illness, treated with initiation of thromboprophylaxis by fondaparinux 2.5 mg.RESULTS:Two hundred and seventeen general practitioners included 840 patients. The mean age of patients was 63.6±18.1 years, and 63% of patients (n=520/831) were females. The real total administration duration of the treatment by fondaparinux 2.5 mg was known for 797 patients and was 15.8±12.4 days on average (range: 1-90 days, median: 10 days). In 40% of patients, the duration ranged from 6 to 14 days [duration consistent with the summary of product characteristics (SmPC)]. Among the 834 patients analyzed, 569 (68%) suffered from at least one acute illness and had at least one risk factor for venous thromboembolism (VTE). The indication did fully comply with the summary of product characteristics of fondaparinux 2.5 mg in 52% of the patients (n=434/834 patients).CONCLUSION:The results of the ArchiMed study support that the thromboprophylaxis treatment with fondaparinux 2.5 mg in ambulatory general medicine, and the associated medical conditions were usually consistent with the SmPC or guidelines. However, a difference was found for the duration and the initial indication, in situations that may be regarded as presenting a risk by the prescriber

Assessment of allergen sensitization in a general population-based survey (European Community Respiratory Health Survey I).

PURPOSE: Exposed to a common environment, the IgE-mediated immune response differs, for instance, among sensitized subjects, some of them reacting toward one allergen (monosensitized) whereas others are sensitized to a wide array of allergens (polysensitized). However, a better phenotypic characterization is needed for epidemiologic studies. Using the data collected during the ECRHS I (European Community Respiratory Health Survey), several assessments of skin prick tests and serum-specific IgE to identify mono- and polysensitized patients were compared. METHODS: Subjects took part in the ECRHS-I. The CAP-System was used for serum allergen-specific lgE, and allergen-coated Phazet was used for prick tests. Four allergens (Dermatophogoides pteronyssinus, cat, timothy grass, and Cladosprium) were measured using IgE and nine (the same ones plus olive pollen, birch, Alternoria, Parietaria, and ragweed) were skin tested. One to two local allergens were also tested, depending on countries. RESULTS: Prevalence of sensitization in 11,355 subjects (34.0 [27.9-40.1] years, 49.9% men) ranged from 32.3% (four specific IgE, 19.3% mono- and 13.0% polysensitized) to 41.8% (four specific IgE combined to nine prick tests, 19.6% mono- and 22.2% polysensitized). Concordance between four specific IgE and four prick tests was weak (weighted K 0.65 [0.64-0.66]). Concordance between seven and nine prick tests was high (weighted K 0.99 [0.98-1.00]). Local allergens induced small changes in the prevalence of sensitization, and reclassified some subjects from mono- to polysensitized. CONCLUSIONS: Skin tests or serum-specific IgE may be chosen to identify allergenic sensitivity, mono- and polysensitized subjects without being strictly interchangeable

Polymorphisms of MAMLD1 gene in hypospadias

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Le cancer des organes génitaux externes de l’homme dans le département de l’Hérault: résultats de 30 ans d’enregistrement du registre des tumeurs de l’Hérault (1987–2016)

International audienceAim: The objective of this study is to present the history of cancers of the external genital organs of male in Hérault using data from the Hérault tumor register (RTH) over a period of 30 years.Patients and methods: Using the RTH database, we studied the development of testicular germ cell tumors (TGCT) and penile cancer (PC) over 30 years, from 1987 to 2016. We analyzed the incidence and mortality data for these tumors. We compared these results to French, European and global data.Results: In 30 years of registration we have recorded 725 cases of TGCT and 175 cases of PC. The age standardized incidence rate (ASR) of TGCT has doubled between 1987 and 2016 (4.2 per 100,000 in 1987 and 9.3 per 100,000 in 2016). It was multiplied by 2.63 in the population of patients aged 30 to 44. There is a decrease of the mortality rate with a ASR of 0.8 deaths per 100,000 in 1987, and 0.4/100 000 in 2016. The PC incidence ASR was stable between 1987 and 2016 (0.4-0.9/100,000). Mortality is stable with a ASR between 0.1 and 0.3 deaths per 100,000 between 1987 and 2016.Conclusion: The incidence of TGCT has increased sharply in the Hérault over the past 30 years, while a decrease in mortality has been observed. The proportion of seminomas is increasing; it has gone from 53 % to 60 % in 30 years in the Hérault. The incidence and mortality of PC shows a stability in the Hérault over the past 30 years

The CONSORT statement checklist in allergen-specific immunotherapy: A GA 2LEN paper

The methodology of randomized clinical trials is essential for the critical assessment and registration of therapeutic interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement was developed to alleviate the problems arising from the inadequate reporting of randomized controlled trials. The present article reflects on the items that we believe should be included in the CONSORT checklist in the context of conducting and reporting trials in allergen-specific immunotherapy. Only randomized, blinded (in particular blinding of patients, health care providers, and outcome assessors), placebo-controlled Phase III studies in this article. Our analysis focuses on the definition of patients' inclusion and exclusion criteria, allergen standardization, primary, secondary and exploratory outcomes, reporting of adverse events and analysis. © 2009 John Wiley & Sons A/S

Opportunistic infections and AIDS malignancies early after initiating combination antiretroviral therapy in high-income countries

Background: There is little information on the incidence of AIDS-defining events which have been reported in the literature to be associated with immune reconstitution inflammatory syndrome (IRIS) after combined antiretroviral therapy (cART) initiation. These events include tuberculosis, mycobacterium avium complex (MAC), cytomegalovirus (CMV) retinitis, progressive multifocal leukoencephalopathy (PML), herpes simplex virus (HSV), Kaposi sarcoma, non-Hodgkin lymphoma (NHL), cryptococcosis and candidiasis. Methods: We identified individuals in the HIV-CAUSAL Collaboration, which includes data from six European countries and the US, who were HIV-positive between 1996 and 2013, antiretroviral therapy naive, aged at least 18 years, hadCD4+ cell count and HIV-RNA measurements and had been AIDS-free for at least 1 month between those measurements and the start of follow-up. For each AIDS-defining event, we estimated the hazard ratio for no cART versus less than 3 and at least 3 months since cART initiation, adjusting for time-varying CD4+ cell count and HIV-RNA via inverse probability weighting. Results: Out of 96 562 eligible individuals (78% men) with median (interquantile range) follow-up of 31 [13,65] months, 55 144 initiated cART. The number of cases varied between 898 for tuberculosis and 113 for PML. Compared with non-cART initiation, the hazard ratio (95% confidence intervals) up to 3 months after cART initiation were 1.21 (0.90-1.63) for tuberculosis, 2.61 (1.05-6.49) for MAC, 1.17 (0.34-4.08) for CMV retinitis, 1.18 (0.62-2.26) for PML, 1.21 (0.83-1.75) for HSV, 1.18 (0.87-1.58) for Kaposi sarcoma, 1.56 (0.82-2.95) for NHL, 1.11 (0.56-2.18) for cryptococcosis and 0.77 (0.40-1.49) for candidiasis. Conclusion: With the potential exception of mycobacterial infections, unmasking IRIS does not appear to be a common complication of cART initiation in high-income countries. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins