Evaluación de riesgos de exposición a virus respiratorios y propuesta formativa en PRL en laboratorio de microbiología clínica

Tras una evaluación del riesgo de exposición a agentes biológicos del puesto de trabajo para detectar posibles situaciones de riesgo que requieran adoptar medidas preventivas, se plantea la formación del personal laboral en el correcto uso de equipos de protección individual como una medida adicional para la prevención de riesgos, teniendo en cuenta que la formación nunca debe utilizarse en sustitución de las medidas preventivas que debe adoptar el empresario en el cumplimiento de su deber general de prevención

First-Pass Reperfusion by Mechanical Thrombectomy in Acute M1 Occlusion: The Size of Retriever Matters

Introduction: Single-pass complete reperfusion using stent retrievers has been shown to improve functional outcome in patients with large vessel occlusion strokes. The aim of this study was to investigate the optimal size of stent retrievers to achieve one-pass complete reperfusion by mechanical thrombectomy.Methods: The study evaluated the results of aspiration-assisted mechanical thrombectomy of acute isolated occlusion of the middle cerebral artery in the M1 segment with a novel 5 × 40-mm stent retriever compared to the usual 4 × 20-mm device. Reperfusion status was quantified using the Thrombolysis In Cerebral Infarction (TICI) scale. We hypothesized that thrombectomy of M1 occlusions with 5 × 40-mm stent retriever yields higher rates of complete first-pass reperfusion (FP) (TICI ≥2c after one pass) and successful or modified FP (mFP) (TICI ≥2b after one pass) than thrombectomy with 4 × 20. We included isolated M1 occlusions treated with pRESET 5 × 40 (phenox) as first-choice device for thrombectomy and compared with M1 occlusions treated with pRESET 4 × 20. We excluded patients with additional occlusions or tandem stenosis or who received an intracranial stent or angioplasty as a part of the endovascular treatment.Results: One hundred thirteen patients were included in the 4 × 20 group and 57 patients in the 5 × 40 group. The 5 × 40 group achieved higher FP compared to 4 × 20 group [61.4% (35 of 57 patients) vs. 40.7% (46 of 113), respectively; adjusted odds ratio (OR) and 95% confidence interval (95% CI) = 2.20 (1.08–4.48), p = 0.030] and a higher mFP [68.4%, 39 of 57 patients vs. 48.7%, 55 of 113; adjusted OR (95% CI) = 2.11 (1.04–4.28), p = 0.037]. Frequency of successful reperfusion (TICI ≥2b) was similar in both groups (100 vs. 97.3%), but frequency of complete reperfusion (TICI ≥2c) was higher in the 5 × 40 group [82.5 vs. 61.9%, adjusted OR (95% CI) = 2.47 (1.01–6.04), p = 0.047]. Number of passes to achieve reperfusion was lower in the 5 × 40 group than in the 4 × 20 group [1.6 ± 1.1 vs. 2 ± 1.4, p = 0.033; adjusted incidence rate ratio (95% CI) = 0.84 (0.69–1.03), p = 0.096]. Modified Rankin scale at 90 days was similar in 5 × 40 and 4 × 20 groups.Conclusions: The size of stent retriever matters in acute M1 occlusions treated with aspiration-assisted mechanical thrombectomy. A longer stent retriever with a larger nominal diameter achieves a higher complete and successful FP and higher successful reperfusion compared to a shorter stent retriever

Risk factors for sexual and erectile dysfunction in HIV-infected men: the role of protease inhibitors

Objectives: To determine the prevalence of erectile dysfunction in a cohort of HIV-infected men in a stable clinical state, the effect of exposure to antiretroviral therapy on sexual dysfunction and to identify the risk factors.Design: This is a cross-sectional, observational study.Methods: HIV-infected men without hepatitis C virus coinfection were included if they were antiretroviral therapy-naive (naive group), on current treatment with an enhanced protease inhibitor (protease inhibitor group) or on current treatment with two to three nucleoside reverse transcriptase inhibitors along with one nonnucleoside reverse transcriptase inhibitor and never having received treatment with protease inhibitor (nonnucleoside reverse transcriptase inhibitor group). Erectile dysfunction was defined as an ejection fraction of 25 or less (International Index of Erectile Function-15).Results: Ninety patients were included, with an age of 42 +/- 8.2 years and CD4 cell count of 465 cells/microl [P25-75 361-676]: 18.9% in Centers for Disease Control and Prevention class C and 72.2% with undetectable viral load. Seventy-six patients (84.4%) were receiving antiretroviral therapy, 39 (43.3%) in the protease inhibitor group. The prevalence of lipodystrophy was 31.5%. Forty-seven (53.4%) patients had an erectile dysfunction. Multivariate logistic regression analysis confirmed that there was an independent association between the patients' age (per decade; odds ratio 2.2, 95% confidence interval 1.04-4.5, P = 0.04) and greater duration of exposure to protease inhibitor (per year; odds ratio 1.6, 95% confidence interval 1.12-2.4, P = 0.01). Older age, depression and lipodystrophy, combined with the duration of exposure to protease inhibitor, determined a lower score on various sexual dysfunction domains (P < 0.05).Conclusion: There is a high prevalence of erectile dysfunction in HIV-infected men, with age and the duration of exposure to protease inhibitor being the only identifiable risk factors

The Determination of Total Testosterone and Free Testosterone (RIA) are not Applicable to the Evaluation of Gonadal Function in HIV-Infected Males

Introduction: Hypogonadism is common in human immunodeficiency virus (HIV)-infected men; the high concentration of sex hormone binding globulin (SHBG) in this population, induces a "false increase" in total testosterone (TT) values.Aims: To validate the determination of TT and measured free testosterone (FT [radioimmunoassay {RIA}]) for hypogonadism diagnosis in an HIV-infected population using calculated free testosterone (CFT) as reference method; and also to determine the prevalence and identify the risks factors of hypogonadism.Methods: Cross-sectional, observational study. Ninety HIV-infected males (42 ± 8.2 years), not HCV coinfected, antiretroviral therapy (ART)-naive (14 patients), on current ART with enhanced protease inhibitor (PI) (39 patients), or patients on PI-naive ART (NN) (37 patients).Main outcome measures: CFT was calculated by determining TT, SHBG, and albumin (Vermeulen's formula); hypogonadism was defined as CFT <0.22 nmol/L (reference range for young healthy males in our laboratory); sensitivity of TT and FT (RIA) for hypogonadism diagnosis was calculated.Results: Twelve patients (13.3%, 95% confidence interval [CI] 7.8-21.9) by CFT presented hypogonadism. TT and FT (RIA) presented a sensitivity of less than 30% in the diagnosis of hypogonadism. Logistic regression multivariate analysis confirmed an independent association between hypogonadism, the patient's age per decade, odds ratio (OR) 6.9 (CI 1.9-24.8; P = 0.003), and longer duration of HIV infection per decade, OR 13.1 (CI 1.3-130.6; P = 0.02). Hypogonadism was associated with erectile dysfunction.Conclusions: TT and FT (RIA) are not useful in the differential diagnosis of hypogonadism in HIV-infected males. There is a significant prevalence of hypogonadism in HIV-infected males, with the patient's age and duration of the disease being the only identifiable risk factors

Clinical Efficacy and Safety of Fanhdi^®, a Plasma-Derived VWF/Factor VIII Concentrate, in von Willebrand Disease in Spain: A Retrospective Study

Objective: To evaluate the efficacy and safety of a plasma-derived factor VIII concentrate containing von Willebrand Factor (pdVWF/FVIII) in standard clinical practice in von Willebrand Disease (VWD) patients. Methods: A retrospective, multicentric, observational study of VWD patients treated with Fanhdi®, a pdVWF/FVIII concentrate, from January 2011 to December 2017 was conducted at 14 centers in Spain. Efficacy and safety were evaluated for acute bleeding episodes, for prevention of bleeding in surgeries, and for secondary long-term prophylaxis. Results: Seventy-two eligible patients, type 1, 2, 3 VWD (25%/38.9%/36.1%) were treated for spontaneous and traumatic bleeding (140 episodes, n = 41 patients), to prevent surgical bleeding (69 episodes, n = 43 patients); and for secondary long-term prophylaxis (18 programs, n = 13 patients). Replacement therapy with pdVWF/FVIII showed an excellent to good clinical efficacy in 96.7% of the bleeding episodes, 100% during surgical procedures and 100% during prophylaxis. No adverse events (AEs), nor serious AEs related to the product were observed. Conclusions: Fanhdi® was effective, safe and well tolerated in the management of bleeding episodes, the prevention of bleeding during surgeries, and for secondary long-term prophylaxis in VWD patientsThe author(s) disclosed receipt of the followingfinancial support forthe research, authorship, and/or publication of this article: This workwas supported by Grifols, manufacturer of the pdVWF/FVIII,Fanhdi

Clinical Efficacy and Safety of Fanhdi ®, a Plasma-Derived VWF/Factor VIII Concentrate, in von Willebrand Disease in Spain : A Retrospective Study

UDHEBRONTo evaluate the efficacy and safety of a plasma-derived factor VIII concentrate containing von Willebrand Factor (pdVWF/FVIII) in standard clinical practice in von Willebrand Disease (VWD) patients. A retrospective, multicentric, observational study of VWD patients treated with Fanhdi ®, a pdVWF/FVIII concentrate, from January 2011 to December 2017 was conducted at 14 centers in Spain. Efficacy and safety were evaluated for acute bleeding episodes, for prevention of bleeding in surgeries, and for secondary long-term prophylaxis. Seventy-two eligible patients, type 1, 2, 3 VWD (25%/38.9%/36.1%) were treated for spontaneous and traumatic bleeding (140 episodes, n = 41 patients), to prevent surgical bleeding (69 episodes, n = 43 patients); and for secondary long-term prophylaxis (18 programs, n = 13 patients). Replacement therapy with pdVWF/FVIII showed an excellent to good clinical efficacy in 96.7% of the bleeding episodes, 100% during surgical procedures and 100% during prophylaxis. No adverse events (AEs), nor serious AEs related to the product were observed. Fanhdi ® was effective, safe and well tolerated in the management of bleeding episodes, the prevention of bleeding during surgeries, and for secondary long-term prophylaxis in VWD patients

Amidase-responsive controlled release of antitumoral drug into intracellular media using gluconamide-capped mesoporous silica nanoparticles

MCM-41 silica nanoparticles were used as inorganic scaffolding to prepare a nanoscopic-capped hybrid material S1, which was able to release an entrapped cargo in the presence of certain enzymes, whereas in the absence of enzymes, a zero release system was obtained. S1 was prepared by loading nanoparticles with Safranine O dye and was then capped with a gluconamide derivative. In the absence of enzymes, the release of the dye from the aqueous suspensions of S1 was inhibited as a result of the steric hindrance imposed by the bulky gluconamide derivative, the polymerized gluconamide layer and the formation of a dense hydrogen-bonded network around the pore outlets. Upon the addition of amidase and pronase enzymes, delivery of Safranine O dye was observed due to the enzymatic hydrolysis of the amide bond in the anchored gluconamide derivative. S1 nanoparticles were not toxic for cells, as demonstrated by cell viability assays using HeLa and MCF-7 cell lines, and were associated with lysosomes, as shown by confocal microscopy. Finally, the S1¿CPT material loaded with the cytotoxic drug camptothecin and capped with the gluconamide derivative was prepared. The HeLa cells treated with S1¿CPT underwent cell death as a result of material internalization, and of the subsequent cellular enzyme-mediated hydrolysis and aperture of the molecular gate, which induced the release of the camptothecin cargo.We thank the Spanish Government (Project MAT2009-14564-C04 and SAF2010-15512) and the Generalitat Valenciana (Project PROMETEO/2009/016and/2010/005) for support. I. C. thanks the Universitat Politecnica de Valencia for her fellowship. L. M. thanks the Generalitat Valenciana for her post-doctoral VALi+d contract. E. A. and C. T. also thank the CIBER-BBN for contracts. We thank Eva Maria Lafuente Villarreal and Alberto Hernandez Cano from the Confocal Microscopy service of CIPF and the Electronic Microscopy service of UPV for their technical support.Candel Busquets, I.; Aznar Gimeno, E.; Mondragón Martínez, L.; De La Torre Paredes, C.; Martínez Mañez, R.; Sancenón Galarza, F.; Marcos Martínez, MD.... (2012). Amidase-responsive controlled release of antitumoral drug into intracellular media using gluconamide-capped mesoporous silica nanoparticles. Nanoscale. 4(22):7237-7245. https://doi.org/10.1039/c2nr32062bS7237724542

Oral fosfomycin for the treatment of lower urinary tract infections among kidney transplant recipients—Results of a Spanish multicenter cohort

Preliminary results of this study were presented at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), held in Amsterdam, The Netherlands, from 13 to 16 April, 2019 (oral communication O‐0699).Oral fosfomycin may constitute an alternative for the treatment of lower urinary tract infections (UTIs) in kidney transplant recipients (KTRs), particularly in view of recent safety concerns with fluroquinolones. Specific data on the efficacy and safety of fosfomycin in KTR are scarce. We performed a retrospective study in 14 Spanish hospitals including KTRs treated with oral fosfomycin (calcium and trometamol salts) for posttransplant cystitis between January 2005 and December 2017. A total of 133 KTRs developed 143 episodes of cystitis. Most episodes (131 [91.6%]) were produced by gram‐negative bacilli (GNB), and 78 (54.5%) were categorized as multidrug resistant (including extended‐spectrum β‐lactamase‐producing Enterobacteriaceae [14%] or carbapenem‐resistant GNB [3.5%]). A median daily dose of 1.5 g of fosfomycin (interquartile range [IQR]: 1.5‐2) was administered for a median of 7 days (IQR: 3‐10). Clinical cure (remission of UTI‐attributable symptoms at the end of therapy) was achieved in 83.9% (120/143) episodes. Among those episodes with follow‐up urine culture, microbiological cure at month 1 was achieved in 70.2% (59/84) episodes. Percutaneous nephrostomy was associated with a lower probability of clinical cure (adjusted odds ratio: 10.50; 95% confidence interval: 0.98‐112.29; P = 0.052). In conclusion, fosfomycin is an effective orally available alternative for treating cystitis among KTRs.This study was supported by Plan Nacional de I+D+i 2013‐2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Ciencia, Innovación y Universidades, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016)—cofinanced by the European Development Regional Fund “A way to achieve Europe”; the Group for Study of Infection in Transplantation and the Immunocompromised Host (GESITRA‐IC) of the Spanish Society of Clinical Microbiology and Infectious Diseases (SEIMC); and the Spanish Network for Research in Renal Diseases (REDInREN RD16/0009). MFR holds a research contract “Miguel Servet” (CP 18/00073) from the Spanish Ministry of Science, Innovation and Universities, Instituto de Salud Carlos III

Real-world effectiveness of caplacizumab vs the standard of care in immune thrombotic thrombocytopenic purpura

Immune thrombotic thrombocytopenic purpura (iTTP) is a thrombotic microangiopathy caused by anti-ADAMTS13 antibodies. Caplacizumab is approved for adults with an acute episode of iTTP in conjunction with plasma exchange (PEX) and immunosuppression. The objective of this study was to analyze and compare the safety and efficacy of caplacizumab vs the standard of care and assess the effect of the concomitant use of rituximab. A retrospective study from the Spanish TTP Registry of patients treated with caplacizumab vs those who did not receive it was conducted. A total of 155 patients with iTTP (77 caplacizumab, 78 no caplacizumab) were included. Patients initially treated with caplacizumab had fewer exacerbations (4.5% vs 20.5%; P <.05) and less refractoriness (4.5% vs 14.1%; P <.05) than those who were not treated. Time to clinical response was shorter when caplacizumab was used as initial treatment vs caplacizumab used after refractoriness or exacerbation. The multivariate analysis showed that its use in the first 3 days after PEX was associated with a lower number of PEX (odds ratio, 7.5; CI, 2.3-12.7; P <.05) and days of hospitalization (odds ratio, 11.2; CI, 5.6-16.9; P <.001) compared with standard therapy. There was no difference in time to clinical remission in patients treated with caplacizumab compared with the use of rituximab. No severe adverse event was described in the caplacizumab group. In summary, caplacizumab reduced exacerbations and refractoriness compared with standard of care regimens. When administered within the first 3 days after PEX, it also provided a faster clinical response, reducing hospitalization time and the need for PEX

Real-world effectiveness of caplacizumab vs the standard of care in immune thrombotic thrombocytopenic purpura

Immune thrombotic thrombocytopenic purpura (iTTP) is a thrombotic microangiopathy caused by anti-ADAMTS13 antibodies. Caplacizumab is approved for adults with an acute episode of iTTP in conjunction with plasma exchange (PEX) and immunosuppression. The objective of this study was to analyze and compare the safety and efficacy of caplacizumab vs the standard of care and assess the effect of the concomitant use of rituximab. A retrospective study from the Spanish TTP Registry of patients treated with caplacizumab vs those who did not receive it was conducted. A total of 155 patients with iTTP (77 caplacizumab, 78 no caplacizumab) were included. Patients initially treated with caplacizumab had fewer exacerbations (4.5% vs 20.5%; P < .05) and less refractoriness (4.5% vs 14.1%; P < .05) than those who were not treated. Time to clinical response was shorter when caplacizumab was used as initial treatment vs caplacizumab used after refractoriness or exacerbation. The multivariate analysis showed that its use in the first 3 days after PEX was associated with a lower number of PEX (odds ratio, 7.5; CI, 2.3-12.7; P < .05) and days of hospitalization (odds ratio, 11.2; CI, 5.6-16.9; P < .001) compared with standard therapy. There was no difference in time to clinical remission in patients treated with caplacizumab compared with the use of rituximab. No severe adverse event was described in the caplacizumab group. In summary, caplacizumab reduced exacerbations and refractoriness compared with standard of care regimens. When administered within the first 3 days after PEX, it also provided a faster clinical response, reducing hospitalization time and the need for PEX