Comparison of quality of life after radical treatment in prostate cancer: radical prostatectomy versus external radiotherapy.

OBJECTIVE: To assess and compare the functional and quality of life results in patients treated with curative intent for localized prostate cancer during 2015 in our hospital. METHOD: 77 patients treated by radical prostatectomy or external radiotherapy with androgen deprivation were prospective enrolled. Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire at 3-year follow-up and Spanish Questionnaire on Quality of Life in Patients with Prostate Cancer (CAVIPRES-30) at diagnosis and at 3-year follow-up were registered. RESULTS: 68 patients were included, 39 patients treated by radical prostatectomy and 29 received external radiotherapy with androgen deprivation. Among the operated patients, 61.5% were dry and 17.9% use three or more daily pads, compared to 72.4% and 6.8%, respectively, in the radiotherapy group. 48.7% of prostatectomized patients reported very poor or no capacity to have a sufficiently rigid erection, compared to 69% of the radiated group. After surgery, 43.6% considered bad or very bad quality-of-life, compared to 68.9% in the radiotherapy group. In the comparison of the data of the pre- and post-treatment questionnaire can be seen that the patients had a superior perception before the procedure. CONCLUSIONS: Patients treated by surgery have a better perception of quality-of-life compared to those treated by radiotherapy.

OBJETIVO: Determinar y comparar los resultados funcionales y de calidad de vida de pacientes con cáncer de próstata tratados con intención curativa durante el año 2015 en nuestro centro. MÉTODO: Se incluyeron 77 pacientes sometidos a prostatectomía radical (PR) o radioterapia externa con terapia de deprivación androgénica (TDA). Se realizaron el Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) tras 3 años de seguimiento y el Cuestionario Español de Calidad de Vida en Pacientes con Cáncer de Próstata (CAVIPRES-30) al diagnóstico y a los 3 años. RESULTADOS: Se incluyeron 68 pacientes, 39 con PR y 29 con radioterapia más TDA. De los pacientes intervenidos, el 61.5% están secos y el 17.9% usan tres o más compresas, diarias frente al 72.4% y el 6.8%, respectivamente, en el grupo de radioterapia. El 48.7% de los prostatectomizados refieren erecciones muy malas o ninguna, frente al 69% de los radiados. Tras la cirugía, el 43.6% refieren mala o muy mala calidad de vida, frente al 68.9% de los radiados. En la comparación de los datos del cuestionario pre- y postratamiento, los pacientes tenían una percepción superior antes del procedimiento. CONCLUSIONES: Los pacientes tratados mediante cirugía tienen una mejor percepción de su calidad de vida relacionada con la salud que los radiados.

Prioritisation of pesticides and target organ systems for dietary cumulative risk assessment based on the 2019-2021 monitoring cycle.

Aiming at accelerating the implementation of cumulative risk assessment to pesticide residues, this report describes a two-step prioritisation analysis, on individual pesticides and on target organ systems, that allows to identify (i) low-priority substances expected to have a marginal contribution to cumulative risk, and (ii) high priority organ systems to be addressed in future cumulative risk assessments. The analysis encompassed 350 substances and 36 raw primary commodities of plant origin surveyed in the monitoring cycle 2019-2021, carried out in 30 population groups, covering 3 age classes, and 17 EU countries. Probabilistic exposure calculations, for chronic and acute effects, were executed on the occurrence and consumption data by a two-dimensional procedure, modelling variability and uncertainty. In the first step, the prioritisation method adopted allowed to reduce the number of substances by about 80%. These substances were in turn grouped based on their capacity to cause toxicological effects on common organ systems and, as second step, probabilistic combined exposure calculations were carried out for 16 target organ systems. This step allowed to identify the organ systems that need further assessment, reducing their initial number by about 70%. The organ systems would need to be prioritised as follows: reproductive and developmental toxicity, liver, kidney, male reproductive system, and haematopoietic system and haematology. The sources of uncertainty stemming from the modelling procedure and from methodological assumptions were discussed and their impact qualitatively assessed. Overall, it was concluded that the risk estimates for the different organ systems were more likely to be overestimated than underestimated.

Los desafíos de la nueva variante ómicron para la salud pública: una revisión de la literatura actual / The challenges of the new omicron variant for public health: a review of the current literature

RESUMEN Introducción: Tras la pandemia del coronavirus del síndrome respiratorio agudo grave tipo 2 (SARS-Cov-2), múltiples variantes dentro de la estructura molecular del virus se han venido presentando, las cuales pueden condicionar mayores tasas de contagio, aumento de la morbimortalidad, disminución en la efectividad de las vacunas y manejos farmacológicos. La variante Ómicron, clasificada como variante preocupante (VOC), ha demostrado hasta ahora tener mayor transmisibilidad y una respuesta diferente frente a la vacunación y los esquemas terapéuticos ya instaurados. Objetivo: Describir la variante Ómicron y su impacto sobre la transmisibilidad y mortalidad. Métodos: Revisión de la literatura, en las bases de datos PubMed y Scopus, incluyendo estudios empíricos en inglés y español. De la bibliografía obtenida se utilizaron y analizaron detalladamente 49 artículos. Resultados: Los resultados obtenidos nos permiten identificar los diferentes aspectos de la variante Ómicron, desde su estructura molecular, transmisibilidad hasta su manejo actual y la efectividad de las vacunas contra la misma. Conclusiones: En la actualidad, la variante Ómicron ha constituido un desafío para el sistema de salud por su alta transmisibilidad. Sin embargo, los esfuerzos terapéuticos han demostrado un impacto en severidad y curso de la enfermedad.

ABSTRACT Introduction: Since the pandemic of severe acute respiratory syndrome type 2 coronavi-rus (SARS-Cov-2), multiple variants within the molecular structure of the virus have been appearing, which may lead to higher infection rates, increased morbidity, and mortality, decreased effectiveness of vaccines and pharmacological management. The Omicron variant, classified as variant of concern (VOC) has so far shown higher transmissibility and a different response to vaccination and therapeutic regimens. Objective: To describe the Omicron variant and its impact on transmissibility and mortality. Methods: Literature review in PubMed and Scopus databases, including empirical studies in English and Spanish. From the bibliography obtained, 49 articles were used and analyzed in detail. Results: The results obtained allow us to identify the different aspects of the Omicron variant, from its molecular structure, transmissibility to its current management and the effectiveness of vaccines against it. Conclusions: Currently, the Omicron variant has constituted a challenge for the health system due to its high transmissibility. However, therapeutic efforts have shown an impact on the severity and course of the disease.

Assessment of Clinical Parameters of Dental Anxiety during Noninvasive Treatments in Dentistry.

Dental anxiety is a matter of interest for the dentist since an anxious patient is a potential source of complications in the dental office. The main objectives of this study are to describe the correlation between dental anxiety levels and the values of physiological parameters related to dental anxiety and to study the evolution of blood pressure and heart rate over time during noninvasive dental treatments, i.e., not requiring local anesthesia. A descriptive, longitudinal, and prospective observational study was designed. The study population consisted of 200 patients who attended a university clinic for dental treatment without local anesthesia. The patients were asked to complete the Corah Dental Anxiety Scale. Afterward, blood pressure and heart rate were measured by means of a digital sphygmomanometer. Blood pressure and heart rate were taken throughout the procedure on four occasions. Most of the patients showed mild dental anxiety (5 [IQR: 3] points on Corah Dental Anxiety Scale). Significant but weak correlations were found between the level of dental anxiety and heart rate (Spearman rho: 0.166 and 0.176; p = 0.019 and 0.013; 3 min before and after treatment, respectively), as well as between the level of dental anxiety and the duration of treatment (Spearman rho: 0.191 3 min; p = 0.007). As for the evolution of physiological parameters, all patients showed a progressive decrease in values at different time points during treatment. When the types of treatment were evaluated separately, it was observed that there were statistically significant differences between them with respect to the level of dental anxiety (p = 0.006).

Peer review of the pesticide risk assessment of the active substance lavandulylsenecioate.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance lavandulylsenecioateare reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council.The conclusions were reached on the basis of the evaluation of the representative uses evaluated as a pheromone comprising manual applications to control Planococcusficus (vine mealybug) populations by mating disruption in table grape, wine grape, raisins and any other crops where P. ficus may be a pest in Southern Europe. The reliable endpoints,appropriate for use in regulatory risk assessmentare presented. Missing information identified as being required by the regulatory framework is listed.Concerns are identified.

Involvement of the retinoic acid signaling pathway in sex differentiation and pubertal development in the European sea bass Dicentrarchus labrax.

Retinoic Acid (RA) is a vitamin A derivative present in many biological processes including embryogenesis, organ development and cell differentiation. The RA signaling pathway is essential for the onset of meiosis in tetrapods, although its role in fish reproduction needs further evidence. This study reports the expression profiles of several genes involved in this pathway during sex differentiation and the first reproductive season in European sea bass (Dicentrarchus labrax) gonads. The assessed genes are representative of several steps of the pathway including retinol transport, RA synthesis, nuclear receptors, RA transport and degradation. The study includes a synteny analysis of stra8, a tetrapod meiosis gatekeeper, in several taxa. The results show that, these genes were overexpressed during early gonad development and their expression decreased during meiosis progression in males and during vitellogenesis in females. Specifically, a decrease of cyp26a1, involved in RA degradation, together with an increase of aldh1a2 and aldh1a3, in charge of RA-synthesis, might ensure the availability of high RA levels at the time of meiosis in males and females. Moreover, the absence of stra8 in the European sea bass genome, as well as the conserved genomic neighbourhood found in other taxa, suggest a stra8 independent signaling for RA during meiosis. Taken together, our results might help to better understand the role of RA signaling in teleost gonad development.

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified.

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active substance. Therefore, residues of chromafenozide are not expected to occur in any plant or animal commodity and therefore a consumer risk assessment is not required. Nevertheless, the available information allowed EFSA to propose a marker residue definition and a limit of quantification (LOQ) for enforcement against potential illegal uses.

Modification of the existing maximum residue levels for aminopyralid in certain cereals.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wheat has been considered unnecessary. Adequate analytical methods for enforcement are available to control the residues of aminopyralid and its conjugates in plant matrices and on the commodities under assessment at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of aminopyralid according to the intended agricultural practices is unlikely to present a risk to consumer health.

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out.

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen-Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip-rooted celery. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration. Adequate analytical methods for enforcement are available to control the residues of aclonifen in high water commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the exposure to residues resulting from the use of aclonifen according to the reported agricultural practices is unlikely to present a risk to consumer health.

Modification of the existing maximum residue levels for lambda-cyhalothrin in celeries, fennel and rice.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda-cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the MRL review for further investigations of the toxicological properties of the compounds formed under sterilisation conditions has not yet been addressed. Adequate analytical enforcement methods are available to control the residues of lambda-cyhalothrin in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the uses of lambda-cyhalothrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The consumer risk assessment presented might need to be reconsidered in the light of the confirmatory data requested following the renewal of the approval and the review of the existing MRLs.

Peer review of the pesticide risk assessment of the active substance fenamiphos.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co-rapporteur Member State Cyprus for the pesticide active substance fenamiphos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of fenamiphos as a nematicide in fruiting vegetables (i.e. tomato, aubergine, cucumber, pepper and courgette), herbaceous ornamentals and in nursery stock (both perennial and herbaceous species). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Setting of an import tolerance for spiromesifen in coffee beans.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesifen and spiromesifen-enol (M01) on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each compound. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of spiromesifen according to the reported agricultural practices is unlikely to present a risk to consumer health.

Review of the existing maximum residue levels for hexythiazox according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance hexythiazox. To assess the occurrence of hexythiazox residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, an MRL proposal was derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified. In addition, EFSA identified some data gaps which are not expected to impact on the validity of the MRL derived but which might have an impact on national authorisations.

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance dazomet. To assess the occurrence of dazomet residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Review of the existing maximum residue levels for imidacloprid according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance imidacloprid. To assess the occurrence of imidacloprid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and/or European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible chronic/acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.