The effects of psilocybin on cognition and emotional processing in healthy adults and adults with depression: a systematic literature review.

INTRODUCTION: Psilocybin, a naturally occurring serotonergic agonist in some mushroom species, has shown promise as a novel, fast-acting pharmacotherapy seeking to overcome the limitations of conventional first-line antidepressants. Studying psilocybin effects on cognition and emotional processing may help to clarify the mechanisms underlying the therapeutic potential of psilocybin and may also support studies with people suffering from depression. Thus, this review aims to provide a comprehensive overview of the current literature regarding the effects of psilocybin on these two key areas in both healthy and depressed populations. METHOD: A systematic search was performed on 29 January 2024, in the PubMed, EBSCOhost, Web of Science and SCOPUS databases. After duplicates removal, study selection was conducted considering pre-specified criteria. Data extraction was then performed. The quality assessment of the studies was carried out using the Cochrane Collaboration tools for randomized (RoB 2.0) and non-randomized (ROBINS-I) controlled trials. RESULTS: Twenty articles were included, with 18 targeting healthy adults and two adults with depression. Results point to impairments within attentional and inhibitory processes, and improvements in the domains of creativity and social cognition in healthy individuals. In the population with depression, only cognitive flexibility and emotional recognition were affected, both being enhanced. The comparison of outcomes from both populations proved limited. CONCLUSIONS: Psilocybin acutely alters several cognitive domains, with a localized rather than global focus, in a dose- and time-dependent manner. However, the significant methodological constraints call for further research, in the context of depression and with standardized protocols, with longitudinal studies also imperative.

Frequency of gastroschisis and omphalocele and possible influence of maternal folic acid supplementation. A narrative review.

There is an increase in the worldwide prevalence of congenital abdominal wall defects (CAWD), with gastroschisis (GS) and omphalocele (OC) being the most common. It is widely accepted that folic acid supplementation (FAS) in the maternal diet decreases the incidence of anomalies such as neural tube defects, but there is controversy regarding the possible beneficial role for other congenital malformations. Several epidemiological studies raise controversy regarding a possible relationship between vitamin supplementation with the occurrence of abdominal wall malformations. The aim of the present study is to obtain an updated review of the global frequency of CAWD in neonates and the relationship with FAS in the mothers. For this we have carried out a systematic search of epidemiological studies in different article databases between 2011 and 2022. The analysis of 25 studies conducted in different countries where cases of OC and/or GS are registered directly or together with other congenital defects shows that 60% inquire into the relationship of FAS with the incidence of CAWD. Half of them proposes a beneficial effect of FAS and the other half find no association, concluding that there is no unanimous evidence that FAS in the maternal diet decreases the incidence of CAWD. However, it seems that an influential factor to take into account is the nutritional habits of the mothers.

Monocyte distribution width (MDW) and DECAF: two simple tools to determine the prognosis of severe COPD exacerbation.

Monocyte distribution width (MDW) has been associated with inflammation and poor prognosis in various acute diseases. Chronic obstructive pulmonary disease (COPD) exacerbations (ECOPD) are associated with mortality. The objective of this study was to evaluate the utility of the MDW as a predictor of ECOPD prognosis. This retrospective study included patient admissions for ECOPD. Demographic, clinical and biochemical information; intensive care unit (ICU) admissions; and mortality during admission were recorded. A total of 474 admissions were included. MDW was positively correlated with the DECAF score (r = 0.184, p < 0.001) and C-reactive protein (mg/dL) (r = 0.571, p < 0.001), and positively associated with C-RP (OR 1.115 95% CI 1.076-1.155, p < 0.001), death (OR 9.831 95% CI 2.981- 32.417, p < 0.001) and ICU admission (OR 11.204 95% CI 3.173-39.562, p < 0.001). High MDW values were independent risk factors for mortality (HR 3.647, CI 95% 1.313-10.136, p = 0.013), ICU admission (HR 2.550, CI 95% 1.131-5.753, p = 0.024), or either mortality or ICU admission (HR 3.084, CI 95% 1.624-5.858, p = 0.001). In ROC analysis, a combined MDW-DECAF score had better diagnostic power (AUC 0.777 95% IC 0.708-0.845, p < 0.001) than DECAF (p = 0.023), MDW (p = 0.026) or C-RP (p = 0.002) alone. MDW is associated with ECOPD severity and predicts mortality and ICU admission with a diagnostic accuracy similar to that of DECAF and C-RP. The MDW- DECAF score has better diagnostic accuracy than MDW or DECAF alone in identifying mortality or ICU admission.

Increased blood draws for ultrasensitive ctDNA and CTCs detection in early breast cancer patients.

Early breast cancer patients often experience relapse due to residual disease after treatment. Liquid biopsy is a methodology capable of detecting tumor components in blood, but low concentrations at early stages pose challenges. To detect them, next-generation sequencing has promise but entails complex processes. Exploring larger blood volumes could overcome detection limitations. Herein, a total of 282 high-volume plasma and blood-cell samples were collected for dual ctDNA/CTCs detection using a single droplet-digital PCR assay per patient. ctDNA and/or CTCs were detected in 100% of pre-treatment samples. On the other hand, post-treatment positive samples exhibited a minimum variant allele frequency of 0.003% for ctDNA and minimum cell number of 0.069 CTCs/mL of blood, surpassing previous investigations. Accurate prediction of residual disease before surgery was achieved in patients without a complete pathological response. A model utilizing ctDNA dynamics achieved an area under the ROC curve of 0.92 for predicting response. We detected disease recurrence in blood in the three patients who experienced a relapse, anticipating clinical relapse by 34.61, 9.10, and 7.59 months. This methodology provides an easily implemented alternative for ultrasensitive residual disease detection in early breast cancer patients.

Pharmacokinetics and Safety of Lurbinectedin Administrated with Itraconazole in Cancer Patients: A Drug-Drug Interaction Study.

This open-label, two-part, phase Ib drug-drug interaction study investigated whether the pharmacokinetic (PK) and safety profiles of lurbinectedin (LRB), a marine-derived drug, are affected by co-administration of itraconazole (ITZ), a strong CYP3A4 inhibitor, in adult patients with advanced solid tumors. In Part A, three patients were sequentially assigned to Sequence 1 (LRB 0.8 mg/m2, 1-h intravenous [IV] + ITZ 200 mg/day oral in Cycle 1 [C1] and LRB alone 3.2 mg/m2, 1 h, IV in Cycle 2 [C2]). In Part B, 11 patients were randomized (1:1) to receive either Sequence 1 (LRB at 0.9 mg/m2 + ITZ in C1 and LRB alone in C2) or Sequence 2 (LRB alone in C1 and LRB + ITZ in C2). Eleven patients were evaluable for PK analysis: three in Part A and eight in Part B (four per sequence). The systemic total exposure of LRB increased with ITZ co-administration: 15% for Cmax, area under the curve (AUC) 2.4-fold for AUC0-t and 2.7-fold for AUC0-∞. Co-administration with ITZ produced statistically significant modifications in the unbound plasma LRB PK parameters. The LRB safety profile was consistent with the toxicities described in previous studies. Co-administration with multiple doses of ITZ significantly altered LRB systemic exposure. Hence, to avoid LRB overexposure when co-administered with strong CYP3A4 inhibitors, an LRB dose reduction proportional to CL reduction should be applied.

Effectiveness and safety of azathioprine for inflammatory pouch disorders: results from the RESERVO study of GETECCU.

Background: The usefulness of thiopurines has been poorly explored in pouchitis and other pouch disorders. Objective: To evaluate the effectiveness and safety of azathioprine as maintenance therapy in inflammatory pouch disorders. Design: This was a retrospective and multicentre study. Methods: We included patients diagnosed with inflammatory pouch disorders treated with azathioprine in monotherapy. Effectiveness was evaluated at 1 year and in the long term based on normalization of stool frequency, absence of pain, faecal urgency or fistula discharge (clinical remission), or any improvement in these symptoms (clinical response). Endoscopic response was evaluated using the Pouchitis Disease Activity Index (PDAI). Results: In all, 63 patients were included [54% males; median age, 49 (28-77) years]. The therapy was used to treat pouchitis (n = 37) or Crohn's disease of the pouch (n = 26). The rate of clinical response, remission and non-response at 12 months were 52%, 30% and 18%, respectively. After a median follow-up of 23 months (interquartile range 11-55), 19 patients (30%) were in clinical remission, and 45 (66%) stopped therapy. Endoscopic changes were evaluated in 19 cases. PDAI score decreased from 3 (range 2-4) to 1 (range 0-3). In all, 21 patients (33%) presented adverse events and 16 (25%) needed to stop therapy. Conclusion: Azathioprine may be effective in the long term for the treatment of inflammatory pouch disorders and could be included as a therapeutic option.

Effects of early-life stress followed by access to stevia or sucralose during adolescence on weight gain, glycemia, and anxiety-related behaviors in male and female rats.

Early-life stress and subsequent high-calorie diets during adolescence are known to be risk factors for developing metabolic and psychological disorders. Although non-nutritive sweeteners such as stevia and sucralose have been a useful alternative to reduce sugar consumption, the effects of prolonged consumption of these sweeteners on metabolism and behavior in adolescents remain unclear. Here, we evaluated the effects of early-stress followed by access to stevia or sucralose during adolescence on weight gain, glycemia, and anxiety-related behaviors in male and female rats. During postnatal days (PNDs) 1-21, pups were separated twice a day, for 180 min each time, from their dam nest while non-separated pups served as controls. The pups were weaned, separated by sex and randomly distributed into the stevia, sucralose and water conditions. During PNDs 26-50, two bottles containing water and stevia or sucralose were placed in the animal home-cages, and body weight and blood glucose measures were scored. On PNDs 50 and 51, behavioral measures were obtained in the open-field test. Results showed that male rats consuming stevia reduced body weight gain, blood glucose and increased locomotion. Early-stress led to low blood glucose and alterations in anxiety and locomotion-related behaviors in a sex-dependent manner. Moreover, sucralose access during adolescence reversed the effects of early-stress on anxiety-related behaviors in female rats. The results suggest that the consumption of stevia and sucralose could be an alternative for the replacement of sugar-sweetened beverages, especially in adolescents who have had adverse early-life experiences.

Evaluation of Genetic Variants Associated with the Risk of Thiopurine-Related Pancreatitis: A Case Control Study from ENEIDA Registry.

INTRODUCTION: Risk factors for developing pancreatitis due to thiopurines in patients with inflammatory bowel disease (IBD) are not clearly identified. Our aim was to evaluate the predictive pharmacogenetic risk of pancreatitis in IBD patients treated with thiopurines. METHODS: We conducted an observational pharmacogenetic study of acute pancreatitis events in a cohort study of IBD patients treated with thiopurines from the prospectively maintained ENEIDA registry biobank of GETECCU. Samples were obtained and the CASR, CEL, CFTR, CDLN2, CTRC, SPINK1, CPA1, and PRSS1 genes, selected based on their known association with pancreatitis, were fully sequenced. RESULTS: Ninety-five cases and 105 controls were enrolled; a total of 57% were women. Median age at pancreatitis diagnosis was 39 years. We identified 81 benign variants (50 in cases and 67 in controls) and a total of 35 distinct rare pathogenic and unknown significance variants (10 in CEL, 21 in CFTR, 1 in CDLN2, and 3 in CPA1). None of the cases or controls carried pancreatitis-predisposing variants within the CASR, CPA1, PRSS1, and SPINK1 genes, nor a pathogenic CFTR mutation. Four different variants of unknown significance were detected in the CDLN and CPA1 genes; one of them was in the CDLN gene in a single patient with pancreatitis and 3 in the CPA1 gene in 5 controls. After the analysis of the variants detected, no significant differences were observed between cases and controls. CONCLUSION: In patients with IBD, genes known to cause pancreatitis seem not to be involved in thiopurine-related pancreatitis onset.

Impact of a Moderate CYP3A4 Inducer (Bosentan) on Lurbinectedin Pharmacokinetics and Safety in Patients with Advanced Solid Tumors: An Open-Label, Two-Way, Crossover, Phase Ib Drug-Drug Interaction Study.

This open-label, two-way, crossover, phase Ib drug-drug interaction study investigated whether the pharmacokinetics (PKs) and safety profile of lurbinectedin (LRB) are affected by co-administration of a moderate CYP3A4 inducer (bosentan, BOS) in adult patients with advanced solid tumors. Eleven patients were randomly assigned to Sequence 1 (LRB + BOS in Cycle 1 [C1] and LRB alone in Cycle 2 [C2]) or Sequence 2 (LRB alone in C1 and LRB + BOS in C2), and finally, eight patients (four per sequence) were considered evaluable for PK assessment. LRB (3.2 mg/m2, 1 h [h], intravenous) was administered alone or combined with multiple BOS administration (125 mg/12 h oral; 5.5 days). Co-administration with BOS decreased the systemic total exposure (area under the curve, AUC) of LRB by 21% for AUC0-t and 20% for AUC0-∞ and increased clearance by 25%. Co-administration with BOS did not significantly modify the unbound plasma LRB PK parameters. BOS increased the conversion of LRB to its metabolite M1, with no changes on its metabolite M4. The LRB safety profile was consistent with the toxicities previously described for this drug. No differences in terms of toxicity were found between LRB with and without BOS. In summary, the magnitude of the observed changes precludes a clinically relevant effect of BOS co-administration on LRB exposure and its safety profile.

Nasolacrimal sac foreign body extraction using vitreoretinal forceps in 28 dogs.

PURPOSE: To describe a novel technique of nasolacrimal foreign body extraction in dogs by using a 20G vitreoretinal forceps introduced through the superior lacrimal punctum. METHODS: A retrospective review of the medical records of dogs with dacryocystitis due to nasolacrimal foreign bodies between the years 2001 and 2022 was performed. We recorded the breed, age, affected eye, type and number of foreign bodies, concomitant diseases, and the use of imaging techniques. All animals underwent the same procedure of a 20G vitreoretinal forceps insertion through the upper canaliculus reaching the lacrimal sac and retrograde extraction of the foreign bodies. RESULTS: A total of 28 dogs were included, 16 males and 12 females, with a mean (±SD) age of 4.7 (±3.2) years. The most common breeds were Wire-Haired Dachshund (4/28; 14.29%) and Labrador Retriever (3/28; 10.71%). Additional imaging techniques were used, such as orbital ultrasound in 13 cases (13/28; 46.43%) and computed tomography in one case (1/28; 3.57%). The most common type of foreign body retrieved was grass awns, although seeds and plant debris were also found. Dacryocystitis resolved after removal of the foreign body and appropriate medical therapy was ensured in all cases in the 1-month postprocedure follow-up. CONCLUSION: Extraction of nasolacrimal foreign bodies with vitreoretinal forceps is a novel, noninvasive, and easily applicable technique that, although not successful in all cases, can be attempted before performing more aggressive surgery.

Hidden Diversity in Eigenmannia (Gymnotiformes: Sternopygidae) Populations from Upper Paraná and Paraguay Rivers.

Eigenmannia is a highly diverse genus within the Sternopygidae family, comprising 30 species. Due to its complex taxonomy, molecular analyses have been crucial for species delimitation within this group. Therefore, the present study presents a genetic analysis using sequences of the mitochondrial gene cytochrome c oxidase subunit 1 (COI) in specimens previously identified through alpha taxonomy as E. correntes (with unpublished data), E. virescens, and E. trilineata, originating from various locations within the Upper Paraná and Paraguay River basins in Brazil. The molecular data confirm the taxonomic complexity of the genus, as individuals morphologically identified as E. virescens and E. trilineata shared the same haplotype (H52). Furthermore, the results of the species delimitation tests suggest that specimens morphologically identified as E. virescens belong to the species E. trilineata. In addition, samples morphologically identified as E. correntes may correspond to more than one Operational Taxonomic Units (OTUs). Furthermore, the intraspecific Kimura-2-parameter (K2P) distances within the different studied populations are significant. This study has contributed valuable information about genetic diversity in Eigenmannia, emphasizing the importance of using integrative analyses to resolve taxonomic conflicts within the group. It also supports biogeographical studies and assists in biodiversity conservation efforts.

Hematological Composite Scores in Patients with Inflammatory Bowel Disease.

The neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), and the systemic immune-inflammatory index (SIRI, neutrophils × monocytes/lymphocytes) have been identified as potential inflammatory biomarkers. In this work we aimed to analyze whether the hematological composite scores differ between inflammatory bowel disease (IBD) patients and healthy controls, and if they are related to disease activity. A total of 197 IBD patients-130 Crohn's (CD) disease and 67 ulcerative colitis (UC)-and 208 age- and sex-matched healthy controls were enrolled. C-reactive protein and fecal calprotectin were assessed. Multivariable linear regression analysis was executed. After adjustment, NLR and PLR, but not SIRI and MLR, were significantly higher in IBD patients compared to controls. C-reactive protein and SIRI and NLR were correlated in IBD patients. However, fecal calprotectin was not related to any of these blood scores. Furthermore, disease activity parameters were not associated with any of the blood composite scores in both CD and UC patients. In conclusion, NLR and PLR, but not SIRI and MLR, are independently higher in IBD patients compared to controls. However, the four hematological scores are not related to disease activity in either CD or UC patients. Based on these results, blood-based inflammatory scores may not serve as subrogated biomarkers of disease activity in IBD.

Determination of tissue oxygen saturation by diffuse reflectance spectroscopy.

Significance: Tissue oxygenation is a parameter that allows for determining the health status of human beings. In diabetic patients, it is particularly important to evaluate this parameter as an indicator of microcirculatory problems in the extremities. Aim: We aim to obtain tissue oxygen saturation from diffuse reflectance measurements. Approach: A computational algorithm to automate the methodology was implemented with the aim of establishing a medical diagnosis technique that is non-invasive and easy to apply and requires a short evaluation time. Tissue oxygen saturation measurements were performed on a group of volunteers to whom a vascular occlusion was applied. It was observed that, by increasing the applied pressure to the arm of each volunteer, the tissue oxygen saturation progressively decreased. Results: The results indicate that the developed technique is an effective method for monitoring changes in blood hemodynamics in patients with some type of pathology in which tissue oxygenation is compromised. In addition, the expected behavior of tissue oxygen saturation during a vascular occlusion was obtained. Conclusions: A methodology to obtain tissue oxygen saturation from diffuse reflectance measurements was successfully developed. It meets the necessary characteristics to be considered a technique for obtaining StO2 because it can be applied in vivo and non-invasively and does not require a high computational cost; thus it is fast and capable of providing an objective and quantifiable evaluation.

Comparative genomic analysis of Mycoplasma related to cell culture for infB gene-based loop-mediated isothermal amplification.

Mycoplasma contamination in cell culture affects the properties of cell lines. Gold standard detection by microbiological culture takes days and requires specialists. The polymerase chain reaction and loop-mediated isothermal amplification (LAMP) are fast molecular options, but LAMP only requires one heating block for DNA amplification. This study presents a comparative genomic analysis of Mycoplasma species to identify common target genes different from the rrsA gene, which encodes 16 S rRNA. The aim is to implement a LAMP assay to detect Mycoplasma species, reducing the time and specialized equipment required for detection. We performed a comparative genomic analysis through Mauve software and the GView server and selected infB and clpB genes as target candidates for designing LAMP primers. We evaluated both genes by multiple sequence alignment (MSA). The infB gene presented the best score MSA assessment with lower odd-log values (5,480,281) than other genes. We selected the infB gene to design LAMP primers specific to Mycoplasma spp. We used these primers to implement LAMP at 63 °C for 30 min, which showed 100% positive amplifications for detecting Mycoplasma spp. In conclusion, we present a methodology utilizing the infB gene-based LAMP assay to detect three of the six most prevalent Mycoplasma species in cell culture.

Estudio sobre la salud mental de una población de niños y niñas escolarizados desde la perspectiva epidemiológica / Study on the mental health of a population of school children from an epidemiological perspective

Resumen Se presentan resultados de una investigación empírica sobre problemas comportamentales en niños y niñas escolarizados entre 6 y 11 años. El objetivo principal es describir, desde la perspectiva epidemiológica, los problemas comportamentales de una muestra clínica (N = 395; edad: . = 7.92 y DE = 1.75) y de una muestra no clínica (N = 363; edad: . = 8.78 años y DE = 1.73). Son objetivos específicos el analizar las diferencias por sexo y variables sociodemográficas en ambos contextos: clínico y no clínico. No se efectuó un estudio comparativo entre ambas muestras. Se administró el formulario Child Behaviour Checklist (CBCL) y una encuesta sociodemográfica a los adultos responsables. El análisis cuantitativo se efectuó mediante estudios de frecuencia, distribución y asociaciones entre variables con el objetivo de describir a ambas muestras desde el punto de vista de los resultados del CBCL y de las variables sociodemográficas. Se estudiaron asociaciones entre los valores de las escalas de síndromes del CBCL y las variables sociodemográficas mediante el análisis de la varianza (ANOVA). Se obtuvieron asociaciones estadísticamente significativas entre la presencia de problemas comportamentales y las condiciones socioeconómicas de la familia: a mayor vulnerabilidad socioeconómica y educativa, mayor deterioro en la salud mental infantil. Este estudio se encontró con la dificultad de las restricciones sanitarias por la pandemia de COVID-19 para continuar el trabajo de campo. Interesa replicar el estudio y considerar el impacto de la pandemia y el presunto deterioro de las variables sociodemográficas. Se debe priorizar la continuidad de una indagación sostenida para un seguimiento de la salud mental infantil.

Abstract This article shows the results of an empirical research study on behavioral and emotional problems in schoolchildren between 6 and 11 years old. From an epidemiological perspective the goal is to describe the behavioral problems of a clinical sample (N= 395, age: . = 7.92 y SD = 1.75) and a non-clinical sample (N = 363, age: M = 8.78 años y DE = 1.73). The specific objectives are to analyze the differences by sex and possible sociodemographic variables in both clinical and non-clinical contexts. A comparative study between both samples is not carried out. We administered the Child Behavior Checklist (CBCL) and a sociodemographic survey to the responsible adults. The quantitative analysis was carried out through studies of frequency, distribution and associations among variables in order to describe both samples from the point of view of the CBCL results and of the sociodemographic variables. In order to identify the possible sociodemographic conditioning factors in the childhood and youth psychopathology, we studied the associations among the CBCL syndrome scale scores and the different sociodemographic variables through the analysis of variance (ANOVA). The results of the clinical sample show mental health deterioration in boys and girls compared to previous studies. The increase of the internalizing and externalizing syndrome scores is significant. The prejudices and gender stereotypes constitute obstacles to gain access to mental health services in childhood, especially for girls whose psychological conditions may often go unnoticed. In the non-clinical sample, the gender distribution is even and the total average of average scores is lower compared to studies performed in other populations in previous years. In both samples we observe a significant relation between the psychological and behavioral problems and the socio-economic conditions of the family. The higher the educational and socio-economic vulnerability, the higher the deterioration of the children's mental health. The simultaneous study from the epidemiological perspective in both samples is necessary to detect psychopathological problems in childhood. This study encountered some limitations: the difficulty to continue the field work due to sanitary restrictions because of the COVID-19 pandemic. We want to replicate the study in both samples considering the impact of the pandemic and the alleged deterioration of the sociodemographic variables and family conditions. Another limitation has been the socio-economic homogeneity of the clinical sample. It would be useful in the future to include clinical samples that belong to other socioeconomic sectors who receive mental health care from private medical insurances or medical insurances run by labor unions. The shortage of epidemiological studies on emotional and behavioral problems in children and the lack of research work on the right to receive mental health care in childhood, indicate the absence of this topic in the political agenda. This deficit prevents the implementation of efficient programs to prevent and early detect mental health problems in children, to extend clinical care proposals in the community and to train professionals so that the programs can have an accurate impact on the population. It is a priority to continue the sustained inquiry in both populations in order to ensure the follow-up of the mental health conditions. Also, it would be useful to extend and deepen the analysis incorporating the examination of other family problems such as violence situations, consumption of psychoactive drugs, suicides and other loss situation.

A model-based head-to-head comparison of single-agent lurbinectedin in the pivotal ATLANTIS Study.

Introduction: Lurbinectedin is a selective inhibitor of oncogenic transcription U.S. Food and Drug Administration (FDA)-approved for patients with relapsed small cell lung cancer (SCLC) as monotherapy at 3.2 mg/m2 every 3 weeks (q3wk). ATLANTIS was a phase 3 study in SCLC with lurbinectedin 2.0 mg/m2 plus doxorubicin 40 mg/m2 q3wk vs physician's choice, with overall survival (OS) as the primary endpoint and objective response rate (ORR) as the secondary endpoint. This work aimed to dissect the contribution of lurbinectedin and doxorubicin to antitumor effects in SCLC, and to predict the efficacy of single-agent lurbinectedin at 3.2 mg/m2 in ATLANTIS to allow for a head-to-head comparison with the control arm. Methods: The dataset included exposure and efficacy data from 387 patients with relapsed SCLC (ATLANTIS, n=288; study B-005, n=99). Patients in the ATLANTIS control arm (n=289) were used for comparison. Unbound plasma lurbinectedin area under the concentration-time curve (AUCu) and total plasma doxorubicin area under the concentration-time curve (AUCDOX) were used as exposure metrics. Univariate and multivariate analyses were conducted to determine the best predictors and predictive model for OS and ORR. OS baseline hazard was best described by a log-logistic distribution, with chemotherapy-free interval (CTFI), lactate dehydrogenase, albumin, brain metastases, neutrophils/lymphocytes ratio, AUCu, and the interaction between AUCu and AUCDOX as predictors. Effect of AUCu on ORR best fitted to a sigmoid-maximal response (Emax) logistic model, where Emax was dependent on CTFI. Results: Head-to-head comparisons with predicted 3.2 mg/m2 lurbinectedin resulted in a positive outcome in ATLANTIS, with hazard ratio (95% prediction intervals [95% PI]) for OS of 0.54 (0.41, 0.72), and odds ratio (95% PI) for ORR of 0.35 (0.25, 0.5). Conclusion: These results support the superiority of lurbinectedin monotherapy for relapsed SCLC over other approved therapies.

Transudative Malignancy: Uncommon and Real.

Light's criteria are the cornerstone to differentiate exudates from transudates. The traditional literature states that malignant pleural effusions are rarely transudative; therefore, cytology tends to be low yield and not a cost-effective decision. This case describes an 82-year-old female who developed a transudative pleural effusion despite having an underlying malignancy, highlighting the importance of integrating clinical judgment into pursuing thoracentesis with the cytological examination.

Early Postoperative Outcomes of Lung Transplant Recipients With Abdominal Adverse Events.

INTRODUCTION: Patients undergoing lung transplantation (LT) are at high risk of developing serious abdominal complications, which can lead to higher rates of morbidity and mortality. The aim of this study was to investigate the incidence and spectrum of these complications when they develop during the first 30 days after LT, as well as their possible association with possible risk factors. METHODS: A retrospective study of 552 patients undergoing LT between 01/02/2006 and 06/03/2021 was carried out. A descriptive and analytical evaluation of the patients who experienced complications and those who did not was performed comparatively. Data related to patient characteristics and the lung transplantation procedure were collected. RESULTS: Overall, 8.2% of patients developed severe abdominal complications during the first 30 days; paralytic ileus was the most frequent (31.1%), closely followed by visceral perforation (26.7%). The percentage of patients who required an invasive procedure to manage post-transplant complications was 57.8%. Surgical intervention was required in 39.8%. The variables that showed a significant relationship with the development of severe short-term abdominal complications in the univariate analysis were the time of surgery, the use of ECMO/ ECC and red blood cell transfusion during or after surgery. In the multivariate study, however, only duration of surgery remained significant (p=0.03). CONCLUSION: The incidence of severe short-term abdominal complications after LT period was 8%. The commonest complications were paralytic ileus and intestinal perforation. Most patients did not require surgery. The only risk factor found associated with these complications was the duration of the surgical intervention.

COVID-19 vaccination rate and willingness of an additional dose among inflammatory bowel disease patients receiving biologic therapy: Fearless and with desire / Tasa de vacunación y aceptación de la dosis adicional de la vacuna frente al COVID-19 en los pacientes con enfermedad inflamatoria intestinal que reciben terapia biológica: sin miedo y con ganas

Background: Vaccination against COVID-19 prevents its severe forms and associated mortality and offers a promising action to control this pandemic. In September 2021, an additional dose of vaccine was approved in patients with immunosuppression including IBD patients on biologic agents. We evaluated the vaccination rate and additional dose willingness in this group of at risk patients. Methods: A single-center, cross-sectional study was performed among IBD patients on biologic agents and eligible for an additional dose of the COVID-19 vaccine. IBD clinical characteristics and type of vaccine and date of administration were checked in medical records. Acceptance was evaluated after telephone or face-to-face surveys in IBD patients. Results: Out of a total of 344 patients, 269 patients (46.1% male; mean age 47±16 years; Crohn's disease 73.6%) were included. Only 15 (5.6%) patients refused the COVID-19 vaccine mainly (40%) for conviction (COVID-19 pandemic denial). 33.3% would re-consider after discussing with their doctor and/or receiving information on the adverse effects of the vaccine. Previous to the additional dose, the COVID-19 vaccination was present in 94.4% of patients (n=254). Adverse effects occurred in 53.9% of the cases, mainly pain in the arm (40%). Up to 94.1% of the patients agreed to an additional dose and 79.4% had already received the additional dose at the final time of the assessment. Conclusions: IBD patients on biological agents accept the vaccine as well as an additional dose if recommended. Physicians in charge of IBD units should provide information and confidence in the use of the vaccine in these IBD patients.(AU)

Antecedentes: La vacunación frente al COVID-19 constituye una acción prometedora para controlar esta pandemia. En septiembre de 2021, se aprobó una dosis adicional de vacuna en pacientes con inmunosupresión, incluidos los pacientes con enfermedad inflamatoria intestinal (EII) que reciben agentes biológicos. En este estudio se evaluó la tasa de vacunación y la disposición de recibir la dosis adicional de vacuna en este grupo de pacientes de riesgo. Métodos: Se realizó un estudio transversal unicéntrico con pacientes afectos de EII con tratamiento biológico y elegibles para una dosis adicional de la vacuna COVID-19. Se evaluó la aceptación y los efectos adversos de la vacuna mediante encuesta telefónica o presencial y se recopiló en las historias clínicas las características de la EII, el tipo de vacuna recibida y la fecha de administración. Resultados: De un total de 344 pacientes, 269 (46,1% varones; edad media 47±16 años; enfermedad de Crohn n=198) fueron incluidos. Solo 15 (5,6%) pacientes rechazaron la vacuna frente al COVID-19, el 40% por convicción (negación de la pandemia COVID-19). Antes de la dosis adicional, la vacuna COVID-19 se había administrado en el 94,4% de los pacientes (n=254). En el 53,9% de los casos presentaron efectos adversos, principalmente dolor en el brazo (40%). Hasta el 94,1% de los pacientes refería la aceptación de una dosis adicional de la vacuna y el 79,1% ya había recibido esta dosis adicional en el momento de la evaluación final. Conclusiones: Los pacientes con EII que reciben agentes biológicos aceptan la vacuna frente al COVID-19, así como una dosis adicional si se les recomienda. Los médicos responsables de las unidades de EII deben proporcionar información y confianza en el uso de la vacuna en estos pacientes.(AU)

Investigación en fisuras faciales: quo vadis España? / Investigation in facial fissures: quo vadis Spain?

Las fisuras orofaciales representan un grupo heterogéneo de malformaciones congénitas que afectan a distintas estructuras de la cavidad oral y de la cara. Globalmente, los bebés con estos trastornos presentan una mayor morbilidad y mortalidad a lo largo de su vida en comparación con individuos no afectados. Por ello, los avances en la investigación biomédica resultan ineludibles. Así, el objetivo general de este trabajo fue llevar a cabo una revisión bibliográfica para analizar narrativamente los 10 principales estudios primarios sobre fisuras orofaciales llevados a cabo en España, publicados del 2018 hasta la actualidad. Según esto, a nivel institucional, destaca la Universidad Complutense de Madrid (UCM) con cuatro artículos publicados por el grupo de investigación UCM 920202. También sobresale la Universidad Rey Juan Carlos de Madrid, con tres artículos relacionados con diferentes aspectos de la personalidad y la calidad de vida de los pacientes fisurados, así como otras muchas variables cognitivo-emocionales. En relación con la Universidad de Valencia, encontramos dos artículos llevados a cabo en amplias muestras de pacientes con fisuras. Por último, en Barcelona resulta destacable un estudio observacional sobre problemas otorrinolaringológicos en pacientes operados de fisura palatina. En conclusión, si bien en los últimos años se han publicado varios artículos sobre distintos aspectos relacionados con las fisuras, aún queda mucho trabajo por hacer. España debería seguir potenciando proyectos con líneas de trabajo centradas en estas alteraciones del desarrollo craneofacial. Se necesitan estudios amplios, multicéntricos y colaborativos, para ahondar en los mecanismos etiológicos y, en última instancia, en las posibles herramientas para su prevención. Del mismo modo, se necesitan ayudas para dilucidar mejor las cuestiones relacionadas con los tratamientos en todas las dimensiones de la salud, preferentemente a partir de ensayos clínicos controlados aleatorizados, que faciliten la traslación de conocimientos y su accesibilidad universal dentro del sistema sanitario público español.

SUMMARY: Orofacial clefts represent a heterogeneous group of congenital malformations affecting different structures of the oral cavity and face. Overall, infants with these disorders have a higher lifetime morbidity and mortality compared to unaffected individuals. Therefore, advances in biomedical research are unavoidable. Thus, the overall objective of this work was to conduct a literature review to narratively analyse the 10 main primary studies on orofacial clefts carried out in Spain, published from 2018 to date. According to this review, at an institutional level, the Complutense University of Madrid (UCM) is notable with 4 articles published by the UCM 920202 research group. The Rey Juan Carlos University of Madrid also stands out, with three papers related to different aspects of the personality and quality of life of cleft patients, as well as many other cognitive-emotional variables. In relation to the University of Valencia, we found two studies carried out on large samples of cleft patients. Finally, in Barcelona, an observational study on otorhinolaryngological problems in cleft palate patients is noteworthy. In conclusion, although several studies have been published in recent years on different aspects related to clefts, there is still much work to be done. Spain should craniofacial development. Large, multicenter and collaborative studies are needed to delve deeper into the aetiological mechanisms and, ultimately, into the possible tools for their prevention. Similarly, support is needed to better elucidate questions related to treatments in all dimensions of health, preferably randomised controlled clinical trials, which facilitate the transfer of knowledge and its universal accessibility within the Spanish public health system.