Farmacovigilancia de las vacunas frente a la COVID-19 en farmacias comunitarias IV. Segunda dosis / Pharmacovigilance of COVID-19 vaccines in community pharmacies IV. Second dose

OBJETIVO: conocer tipo y frecuencia de sospechas de reacciones adversas (RA) experimentadas por la población general con la segunda dosis de la vacuna frente a COVID-19 y la repercusión sobre su actividad diaria.MÉTODOS: se describen detalladamente en el protocolo del Proyecto. Procedimiento: Seguimiento de los participantes incorporados al estudio tras la 2ª dosis, registrándose las nuevas sospechas de RA experimentadas. Resultados10 farmacias de la provincia de Pontevedra y 2 de Ourense incorporaron vacunados. Tras la 2ª dosis se redujeron en 88 (11,3 %): 43 habían recibido COVID-19 Vaccine Janssen® (JA), 39 se habían contagiado entre dosis, 1 no quiso vacunarse por RA de la 1ª dosis y con 5 no se pudo contactar. Quedaron 693 participantes, 441 (63,6 %) mujeres y 252 (36,4 %) hombres. Media de edad 57,8 (DE=18,0) (rango=18-97). 416 (60,0 %) recibieron Comirnaty® Pfizer- BioNtech (CO), 177 (25,5 %) Vaxzevria® (VZ) y 100 (14,5 %) Spikevax® Moderna (SP). 175 (25,2 %) utilizaron medicamentos como profilaxis de posibles RA. 145 (82,9 %) paracetamol.312 (45,0 %) vacunados, 218 mujeres (49,4 %) y 94 (37,1 %) hombres (p<0,01) refirieron al menos una reacción adversa: 183 (43,9 %) CO, 66 (37,3 %) VZ y 63 (63,0 %) SP. El número de reacciones adversas manifestadas por los encuestados fue de 971, con un máximo de 11 por vacunado, resultando las más prevalentes, que afectaron a >10 % de estos: dolor en punto de inyección 197 (28,4 %), cansancio/fatiga 141 (20,3 %), dolor muscular 111 (16,0 %), cefalea 95 (13,7 %) y fiebre 84 (12,1 %). (AU)

Farmacovigilancia de las vacunas frente a la COVID-19 en farmacias comunitarias V. Comparativa entre dosis / Pharmacovigilance of COVID-19 vaccines in community pharmacies V. Dose comparisons

OBJETIVO: conocer si hubo diferencias entre las dos dosis de la vacuna frente a COVID-19 en cuanto a tipo, frecuencia de sospechas de reacciones adversas (RA) y repercusión sobre la actividad diaria.MÉTODOS: se describen detalladamente en el protocolo del Proyecto. En esta comunicación se presentan las comparaciones estadísticas entre dosis y las relaciones con datos sociodemográficos de los encuestados.RESULTADOS: 10 farmacias de la provincia de Pontevedra y 2 de Ourense incorporaron 781 sujetos, que se redujeron a 693 tras la 2ª dosis. El número de vacunados que refirieron al menos una RA fue 495 (63,4 %) con la 1ª dosis y 312 (45,0 %) con la 2ª, p<0,05. El número de RA disminuyó con la segunda dosis, de 1.419 (1,8 DE=2,2 por vacunado), a 971 (1,2 DE=2,1 por vacunado), p<0,05. 227 encuestados sufrieron RA con las dos dosis, 266 que tuvieron RA con la 1ª no tuvieron con la 2ª, y 85 sin RA con la 1ª, sí tuvieron con la 2ª. Sexo y número de vacunados con RA: sin diferencias significativas entre sexos con la 1ª dosis. Sí con la 2ª, 218 (43,9 %) mujeres y 94 (37,1 %) hombres, p<0,05.No se encontraron diferencias significativas entre sexos con ninguna de las dos dosis en cuanto a la necesidad de atención profesional a causa de las RA ni en su repercusión sobre la actividad diaria de los vacunados. Edad y número de vacunados con RA: se encontró relación significativa inversa. 1ª dosis, media de edad de vacunados con RA 52,3 (DE=17,3) años; sin RA 64,5 (DE=16,5) años. 2ª dosis, media de edad vacunados con RA 51,1 (DE=17,5); sin RA 63,6 (DE=16,5), p<0,05. (AU)

Shaping the mitochondrial inner membrane in health and disease.

Mitochondria play central roles in cellular energetics, metabolism and signalling. Efficient respiration, mitochondrial quality control, apoptosis and inheritance of mitochondrial DNA depend on the proper architecture of the mitochondrial membranes and a dynamic remodelling of inner membrane cristae. Defects in mitochondrial architecture can result in severe human diseases affecting predominantly the nervous system and the heart. Inner membrane morphology is generated and maintained in particular by the mitochondrial contact site and cristae organizing system (MICOS), the F1 Fo -ATP synthase, the fusion protein OPA1/Mgm1 and the nonbilayer-forming phospholipids cardiolipin and phosphatidylethanolamine. These protein complexes and phospholipids are embedded in a network of functional interactions. They communicate with each other and additional factors, enabling them to balance different aspects of cristae biogenesis and to dynamically remodel the inner mitochondrial membrane. Genetic alterations disturbing these membrane-shaping factors can lead to human pathologies including fatal encephalopathy, dominant optic atrophy, Leigh syndrome, Parkinson's disease and Barth syndrome.

Biomechanical and functional properties of trophoblast cells exposed to Group B Streptococcus in vitro and the beneficial effects of uvaol treatment.

BACKGROUND: Group B streptococcus (GBS) is the main bacteria that infects pregnant women and can cause abortion and chorioamnionitis. The impact of GBS effects on human trophoblast cells remains largely elusive, and actions toward anti-inflammatory strategies in pregnancy are needed. A potent anti-inflammatory molecule, uvaol is a triterpene from olive oil and its functions in trophoblasts are unknown. We aimed to analyze biomechanical and functional effects of inactivated GBS in trophoblast cells, with the addition of uvaol to test potential benefits. METHODS: HTR-8/SVneo cells were treated with uvaol and incubated with inactivated GBS. Cell viability and death were analyzed. Cellular elasticity and topography were accessed by atomic force microscopy. Nitrite production was evaluated by Griess reaction. Nuclear translocation of NFkB p65 was detected by immunofluorescence and Th1/Th2 cytokines by bead-based multiplex assay. RESULTS: GBS at 108 CFU increased cell death, which was partially prevented by uvaol. Cell stiffness, cytoskeleton organization and morphology were changed by GBS, and uvaol partially restored these alterations. Nuclear translocation of NFkB p65 began 15 min after GBS incubation and uvaol inhibited this process. GBS decreased IL-4 secretion and increased IL-1ß, IFN-γ and IL-2, whereas uvaol reverted this. CONCLUSIONS: The increased inflammation and cell death caused by GBS correlated with biomechanical and cytoskeleton changes found in trophoblast cells, while uvaol was effective its protective role. GENERAL SIGNIFICANCE: Uvaol is a natural anti-inflammatory product efficient against GBS-induced inflammation and it has potential to be acquired through diet in order to prevent GBS deleterious effects in pregnancy.

Degradation of Chloramphenicol in Synthetic and Aquaculture Wastewater Using Electrooxidation.

Chloramphenicol (CAP) is a broad-spectrum antibiotic widely used in animal farming and aquaculture industries. Despite its ban in many countries around the world, it is still used in several developing countries, with harmful effects on the surrounding aquatic environment. In this study, an electrooxidation process using a Ti/PbO anode was used to investigate the degradation of CAP in both synthetic solution and real aquaculture wastewater. A central composite design was used to determine the optimum conditions for CAP removal. Current intensity and treatment time had the most impact on the CAP removal. These two factors accounted for ∼90% of CAP removal. The optimum conditions found in this study were current intensity of 0.65 A, treatment time of 34 min, and CAP initial concentration of 0.5 mg L. Under these conditions, 98.7% of CAP removal was achieved with an energy consumption of 4.65 kW h m. The antibiotic was not present in the aquaculture wastewater, which received 0.5 mg L of CAP and was treated (by electrooxidation) under the optimum conditions. A complete removal of CAP was obtained after 34 min of treatment. According to these results, electrooxidation presents an option for the removal of antibiotics, secondary compounds, and other organic and inorganic compounds from solution.

The atypical subunit composition of respiratory complexes I and IV is associated with original extra structural domains in Euglena gracilis.

In mitochondrial oxidative phosphorylation, electron transfer from NADH or succinate to oxygen by a series of large protein complexes in the inner mitochondrial membrane (complexes I-IV) is coupled to the generation of an electrochemical proton gradient, the energy of which is utilized by complex V to generate ATP. In Euglena gracilis, a non-parasitic secondary green alga related to trypanosomes, these respiratory complexes totalize more than 40 Euglenozoa-specific subunits along with about 50 classical subunits described in other eukaryotes. In the present study the Euglena proton-pumping complexes I, III, and IV were purified from isolated mitochondria by a two-steps liquid chromatography approach. Their atypical subunit composition was further resolved and confirmed using a three-steps PAGE analysis coupled to mass spectrometry identification of peptides. The purified complexes were also observed by electron microscopy followed by single-particle analysis. Even if the overall structures of the three oxidases are similar to the structure of canonical enzymes (e.g. from mammals), additional atypical domains were observed in complexes I and IV: an extra domain located at the tip of the peripheral arm of complex I and a "helmet-like" domain on the top of the cytochrome c binding region in complex IV.

Prior exercise reduces fast-start duration and end-spurt magnitude during cycling time-trial.

We examined the pacing strategy and the magnitude of the end spurt during a 200-kJ cycling time trial performed 12-14 h after an exercise protocol designed to reduce muscle glycogen content. 9 physically-active men performed 5 familiarization sessions and 2 experimental 200-kJ time trials in either a control condition (CON) or after an exercise protocol performed the previous evening that was designed to induce muscle glycogen depletion (EP). Mean total time was faster and power output was higher in the CON than in the EP (P<0.01). A fast-start was maintained until the 50-kJ section in CON, but only the 25-kJ section for EP (P<0.05). The power outputs during the 50-, 150- and 200-kJ sections, and the magnitude of the end-spurt, were significantly higher for the CON than for the EP condition (P<0.05). There was no significant difference in the rating of perceived exertion (overall feeling and feeling in legs) between conditions. In conclusion, a protocol designed to decrease muscle glycogen stores reduced the duration of the fast-start and the magnitude of the end spurt during a 200-kJ cycling time trial, impairing the overall performance.

Hyperbaric oxygen treatment of chronic refractory radiation proctitis: a randomized and controlled double-blind crossover trial with long-term follow-up.

PURPOSE: Cancer patients who undergo radiotherapy remain at life-long risk of radiation-induced injury to normal tissues. We conducted a randomized, controlled, double-blind crossover trial with long-term follow-up to evaluate the effectiveness of hyperbaric oxygen for refractory radiation proctitis. METHODS AND MATERIALS: Patients with refractory radiation proctitis were randomized to hyperbaric oxygen at 2.0 atmospheres absolute (Group 1) or air at 1.1 atmospheres absolute (Group 2). The sham patients were subsequently crossed to Group 1. All patients were re-evaluated by an investigator who was unaware of the treatment allocation at 3 and 6 months and Years 1-5. The primary outcome measures were the late effects normal tissue-subjective, objective, management, analytic (SOMA-LENT) score and standardized clinical assessment. The secondary outcome was the change in quality of life. RESULTS: Of 226 patients assessed, 150 were entered in the study and 120 were evaluable. After the initial allocation, the mean SOMA-LENT score improved in both groups. For Group 1, the mean was lower (p = 0.0150) and the amount of improvement nearly twice as great (5.00 vs. 2.61, p = 0.0019). Similarly, Group 1 had a greater portion of responders per clinical assessment than did Group 2 (88.9% vs. 62.5%, respectively; p = 0.0009). Significance improved when the data were analyzed from an intention to treat perspective (p = 0.0006). Group 1 had a better result in the quality of life bowel bother subscale. These differences were abolished after the crossover. CONCLUSION: Hyperbaric oxygen therapy significantly improved the healing responses in patients with refractory radiation proctitis, generating an absolute risk reduction of 32% (number needed to treat of 3) between the groups after the initial allocation. Other medical management requirements were discontinued, and advanced interventions were largely avoided. Enhanced bowel-specific quality of life resulted.

Seismostratigraphy and thermal structure of Earth's core-mantle boundary region.

We used three-dimensional inverse scattering of core-reflected shear waves for large-scale, high-resolution exploration of Earth's deep interior (D'') and detected multiple, piecewise continuous interfaces in the lowermost layer (D'') beneath Central and North America. With thermodynamic properties of phase transitions in mantle silicates, we interpret the images and estimate in situ temperatures. A widespread wave-speed increase at 150 to 300 kilometers above the coremantle boundary is consistent with a transition from perovskite to postperovskite. Internal D'' stratification may be due to multiple phase-boundary crossings, and a deep wave-speed reduction may mark the base of a postperovskite lens about 2300 kilometers wide and 250 kilometers thick. The core-mantle boundary temperature is estimated at 3950 +/- 200 kelvin. Beneath Central America, a site of deep subduction, the D'' is relatively cold (DeltaT = 700 +/- 100 kelvin). Accounting for a factor-of-two uncertainty in thermal conductivity, core heat flux is 80 to 160 milliwatts per square meter (mW m(-2)) into the coldest D'' region and 35 to 70 mW m(-2) away from it. Combined with estimates from the central Pacific, this suggests a global average of 50 to 100 mW m(-2) and a total heat loss of 7.5 to 15 terawatts.

Donor-to-host transmission of bacterial and fungal infections in lung transplantation.

The purpose of this study was to evaluate the incidence and etiology of bacterial and fungal infection or contamination in lung allograft donors and to assess donor-to-host transmission of these infections. Recipients who survived more than 24 h and their respective donors were evaluated. The overall incidence of donor infection was 52% (103 out of 197 donors). Types of donor infection included isolated contamination of preservation fluids (n = 30, 29.1%), graft colonization (n = 65, 63.1%) and bacteremia (n = 8, 7.8%). Donor-to-host transmission of bacterial or fungal infection occurred in 15 lung allograft recipients, 7.6% of lung transplants performed. Among these cases, 2 were due to donor bacteremia and 13 to colonization of the graft. Twenty-five percent of donors with bacteremia and 14.1% of colonized grafts were responsible for transmitting infection. Excluding the five cases without an effective prophylactic regimen, prophylaxis failure occurred in 11 out of 197 procedures (5.58%). Donor-to-host transmission of infection is a frequent event after lung transplantation. Fatal consequences can be avoided with an appropriate prophylactic antibiotic regimen that must be modified according to the microorganisms isolated from cultures of samples obtained from donors, grafts, preservation fluids and recipients.

Radon concentrations in ground and drinking water in the state of Chihuahua, Mexico.

This paper reports (222)Rn concentrations in ground and drinking water of nine cities of Chihuahua State, Mexico. Fifty percent of the 114 sampled wells exhibited (222)Rn concentrations exceeding 11Bq/L, the maximum contaminant level (MCL) recommended by the USEPA. Furthermore, around 48% (123 samples) of the tap-water samples taken from 255 dwellings showed radon concentrations over the MCL. There is an apparent correlation between total dissolved solids and radon concentration in ground-water. The high levels of (222)Rn found may be entirely attributed to the nature of aquifer rocks.

Complicaciones postoperatorias en el paciente trasplantado pulmonar: importancia de la infección nosocomial temprana / Postoperative complications in lung transplant recipients: importance of early nosocomial infection

Fundamento. Los pacientes sometidos a trasplante pulmonar presentan un elevado riesgo de complicaciones en el postoperatorio inicial, entre las que destaca la infección. El objetivo de este trabajo es estudiar la incidencia de dichas complicaciones. Pacientes y método. Un total de 63 pacientes sometidos a trasplante pulmonar entre 1991 y 1998 ingresados en el período postoperatorio en la unidad de cuidados intensivos (UCI).Se trata de un estudio retrospectivo en el que se analizan las complicaciones desarrolladas, así como diversas variables relacionadas con el paciente durante el período pre y peroperatorio y su asociación con la aparición temprana de infección. Resultados. La edad media fue de 44 años, se efectuó trasplante unipulmonar en 30 casos (48 per cent) y bipulmonar en 33 (52 per cent). La estancia media en la UCI fue de 17 días y los pacientes precisaron ventilación mecánica durante un promedio de 11 días. En 18 pacientes se produjo hemorragia perioperatoria grave; en 29 casos se diagnosticó una lesión de reimplantación y en 11 un rechazo agudo. Un total de 37 pacientes (59 per cent) desarrolló 61 episodios infecciosos, de los cuales 46 (75 per cent) eran de origen respiratorio. En 41 episodios (67 per cent) la aparición fue anterior al día 15 del postoperatorio, sin que se hallara ninguna relación significativa entre la aparición temprana de infección y diversos factores, como el tipo de trasplante, la duración de la ventilación mecánica o la colonización del injerto o del huésped, previa al acto quirúrgico. La mortalidad intra-UCI fue del 25 per cent (16 casos), pero tan sólo en 3 casos fue atribuida a la infección. Conclusiones. La infección fue una complicación frecuente en el postoperatorio inicial del trasplante pulmonar, siendo en la mayor parte de los casos de origen respiratorio. La infección fue más frecuente durante el período precoz y su presencia tuvo poca repercusión en la evolución de los pacientes durante su estancia en la UCI. (AU)

Nebulized amphotericin B prophylaxis for Aspergillus infection in lung transplantation: study of risk factors.

BACKGROUND: Aspergillus infection remains a major cause of morbidity and mortality after lung transplantation. Therefore, some strategies have been attempted, one of which is nebulized amphotericin B (nAB); however, the efficacy of this prophylaxis has not been shown clearly. The aim is to study whether nAB can protect against Aspergillus infection in lung transplant recipients. PATIENTS AND METHODS: A study of risk factors was conducted in 55 consecutive lung allograft recipients. Twenty-three potential risk factors were analyzed. In 44 (80%) patients, nAB was indicated as prophylaxis. Multivariate analysis using logistic regression was performed. RESULTS: Eighteen of the 55 patients (33%) developed infection due to Aspergillus spp. Multivariate analysis showed nAB to be a preventive factor (odds ratio: 0.13; 95% confidence interval [CI] 0.02-0.69; p < 0.05) and cytomegalovirus (CMV) disease was an independent risk factor for developing Aspergillus infection (odds ratio: 5.1; 95% CI 1.35-19.17; p < 0.05). Only 1 patient required withdrawal of the prophylaxis owing to bronchospasm. nAB was well-tolerated in the remaining patients with only a few, mild, easily controlled side effects. CONCLUSIONS: The present results show that nAB prophylaxis may be efficient and safe in preventing Aspergillus infection in lung-transplanted patients, and CMV disease increases the probability of Aspergillus infection.

I-123 uptake by mediastinal goiter after recombinant human thyroid-stimulating hormone administration.

Radioiodine scintigraphy is useful to confirm the presence of mediastinal thyroid tissue. However, the degree of iodine avidity of mediastinal goiters varies. Recombinant human thyroid-stimulating hormone given to stimulate iodine uptake by thyroid remnants and thyroid cancer metastases can now replace thyroid hormone withdrawal scanning of selected patients who have well-differentiated thyroid carcinoma. A case of mediastinal goiter visualized with I-123 after the administration of recombinant human thyroid-stimulating hormone is reported.

[Reimplantation lesion in the postoperative period of lung transplantation. Incidence, predictive factors, prognosis and outcome. The Lung Transplantation Group of Vall d'Hebron University General Hospital]. / Lesión de reimplantación en el postoperatorio del trasplante pulmonar. Incidencia, factores predictivos, pronósticos y evolución. Grupo de Trasplante Pulmonar del Hospital General Universitari Vall d'Hebron.

BACKGROUND: Reimplantation disease (RD) is a postoperative complication in lung transplantation. It is defined as hypoxemia (PaO2/FiO2 ratio < 150 mmHg), radiologic infiltrates and decrease of lung compliance. The aim of the study was to analyze the incidence, predictive factors, prognosis and outcome of the patients with RD. PATIENTS AND METHOD: 49 patients submitted to lung transplantation (June 1991-December 1996) were admitted in our intensive care unit (ICU). Donor and recipient conditions, surgical parameters and outcome in ICU were analyzed. Mann-Whitney, Kruskall-Wallis, Fisher, Pearson and ANOVA-Friedman tests were used for statistical analysis according to the different variables. RESULTS: 49% of the patients (29/49) developed RD, which was influenced neither by lung disease, nor by the kind of transplantation or by ischemia time. All patients with a long surgical time developed RD, versus only 41% in those where surgery was undertaken in a shorter period of time, OR: 2.8 (1.5-5.7; p = 0.0016). The patients with RD improved showing a PaO2/FiO2 ratio of 176 and 235 mmHg at 24 and 48 h respectively (ANOVA, p < 0.00001). The patients with RD needed 14 days of mechanical ventilation versus 7 days in those without RD (p = 0.013). There were no statistically significant differences in stay and mortality in ICU. CONCLUSIONS: RD is a common complication in the postoperative phase of lung transplantation. It is present in almost all the patients with long surgical time. Almost all of them improve, with the same survival but a longer period of mechanical ventilation.

[Rectal atresia]. / Atresia retal.

The authors report a case of rectal atresia by diaphragm in a newborn four days old, male, with colon obstruction. Diagnosis was made by clinical characteristics, physical examination and radiographic features. After compensation of hydro-electrolytic disturbances, the patient was submitted to surgical treatment. Discharged one week from operation.

[Accessory perineal scrotum]. / Escroto acessório perineal.

Congenital anomalies of genital region frequently occur but congenital scrotal anomalies are not common and few cases have been reported in the literature. Among these reported anomalies the accessory scrotum is the lowest incidence principally when not associated with other congenital anomalies. The authors reports a case of accessory perineal scrotum without associated anomalies.

[Unilateral lung transplantation: the first 2 cases. Group of Lung Transplantation of the University General Hospital of the Vall d'Hebron]. / Trasplante unipulmonar: los dos primeros casos. Grupo de Trasplante Pulmonar del Hospital General Universitario de la Vall d'Hebron.

Since 1983 unilateral lung transplantation has become a clinical reality. The initial experience of the Hospital General Universitario de la Vall d'Hebron is presented with the description of the two first unipulmonary transplants. The first was a 20 year-old woman with idiopathic pulmonary fibrosis in whom a left unipulmonary transplant was carried out and who, at present is at home following the 23rd postoperative month. The second case was a 27 year-old man with pneumoconiosis who, at 12 months following the left lung transplantation, carries on a normal life. Among the complications observed, the presence of pneumonitis by cytomegalovirus in both patients is of note. Stenosis and partial dehiscence of the bronchial suture in the first patient and isolation of syncitial respiratory virus in the second patient were also observed. The effort and integration into a normal life style of the second patient is excellent. In contrast, the first patient presents an important postoperative functional deterioration secondary to her complications. The present study demonstrates that unipulmonary transplantations is a reality in Spain which must be considered by all respiratory disease specialists in their daily clinical practise.