RESUMEN

A sociedade está cada vez mais exigente e em busca de excelência quando o assunto é estética facial. O sorriso tem grande impacto na harmonia da face e, atualmente, os pacientes estão mais conscientes sobre a influência da gengiva na beleza do sorriso. A exposição da gengiva em excesso, conhecida como sorriso gengival, afeta a estética, podendo interferir na autoestima e nas relações sociais dos pacientes. Existem diversos procedimentos descritos para solucionar o problema e, para o planejamento do caso e escolha do método, é preciso determinar a etiologia e levar em consideração o desejo do paciente. A injeção da proteína botulínica é uma alternativa minimamente invasiva que está sedo cada vez mais utilizada para a correção do sorriso gengival. Com isso, o objetivo do presente trabalho monográfico foi realizar uma revisão de literatura sobre o uso da toxina botulínica na correção do sorriso gengival, analisando técnicas de injeção, identificando o efeito imediato e a longo prazo da toxina nos músculos elevadores do lábio superior, além de avaliar a relevância desse método na correção do sorriso gengival, sozinho ou em conjunto com outros procedimentos. Foi realizada uma revisão de literatura nas bases de dados PubMed e Scielo, buscando artigos dos anos de 2013 até 2022, utilizando os descritores "botulinum toxin", "botox", "gummy smile", "gingival display" e "gingival exposure". Essa revisão analisa 15 artigos que discorrem sobre o método, durabilidade e eficácia da aplicação de proteína botulínica para correção do sorriso gengival. Algumas variantes diferenciam as técnicas de aplicação, como a marca do produto e recomendações do fabricante, classificação do sorriso e extensão da exposição gengival. Com base na revisão de literatura, pôde-se concluir que, apesar de ser transitório, esse procedimento se mostrou eficaz, tanto ao ser realizado como método principal, quanto como coadjuvante no tratamento. Além de ser comprovadamente seguro, rápido, minimamente invasivo e ser o tratamento de preferência entre os pacientes, com alto índice de satisfação, são raras as complicações relacionadas a aplicação da proteína botulínica para esse fim.

Society is becoming increasingly demanding, seeking excellence in facial aesthetics. The smile greatly impacts facial harmony, and nowadays, patients are more aware of the influence of the gums on smile beauty. Excessive gum exposure, known as gummy smile, affects aesthetics and can interfere with patients' self-esteem and social relationships. There are various procedures described to address this issue, and for case planning and method selection, it is necessary to determine the etiology and take into account the patient's desires. The injection of botulinum protein is a minimally invasive alternative that is increasingly being used for gummy smile correction. Thus, the aim of this monographic work was to conduct a literature review on the use of botulinum toxin in gummy smile correction, analyzing injection techniques, identifying the immediate and long-term effects of the toxin on the upper lip elevator muscles, and evaluating the relevance of this method in gummy smile correction, either alone or in conjunction with other procedures. A literature review was conducted in the PubMed and Scielo databases, seeking articles from 2013 to 2022, using the descriptors "botulinum toxin", "botox", "gummy smile", "gingival display", and "gingival exposure". This review analyzes 15 articles that discuss the method, durability, and effectiveness of botulinum toxin application for gummy smile correction. Some variations differentiate the application techniques, such as the product brand and manufacturer's recommendations, smile classification, and extent of gum exposure. Based on the literature review, it was possible to conclude that, despite being temporary, this procedure proved to be effective, both when performed as the main method and as an adjunct in treatment. In addition to being proven safe, fast, minimally invasive, and the preferred treatment among patients, with a high satisfaction rate, complications related to botulinum toxin application for this purpose are rare.

Asunto(s)

RESUMEN

INTRODUCTION: Biological disease-modifying antirheumatic drugs (bDMARD) have improved the clinical course and quality of life of patients with rheumatoid arthritis (RA). However, some patients failed to respond or have an insufficient response to bDMARD early in the course of the treatment. OBJECTIVES: To determine the percentage of RA patients who need to switch due to ineffectiveness in the first year of treatment and to identify specific baseline features as possible predictors of switch due to ineffectiveness in the first year of treatment. MATERIALS AND METHODS: An observational retrospective study was conducted with patients with RA that started their first bDMARD. Demographic data, disease characteristics, disease activity data scores, laboratory parameters and treatment at baseline were collected. The proportion of patients who failed to respond and who switched to another bDMARD in the first year of treatment was calculated. RESULTS: A total of 437 (364 females, 83.3%) patients with RA were included. The majority of these patients started an anti-TNF-α agent (n=315, 72.1%). Forty-eight (11.0%) patients failed to respond to the bDMARD in the first year of treatment. There were significantly more current or former smokers (p=0.030), with a history of depression (p=0.003) and positive for RF at baseline (p=0.014) in the switch group. In the multivariate analysis, anti-TNF-α agents use (OR 8.3, 95% CI 2.4-28.8, p=0.001), tobacco exposure (OR 2.3, 95% CI 1.1-4.8, p=0.02) and history of depression (OR 3.1, 95% CI 1.3-7.7) seem to predict the need to switch in the first year of treatment due to ineffectiveness. DISCUSSION AND CONCLUSION: In our study, tobacco exposure and depression appear to be modifiable risk factors associated with early switching due to ineffectiveness. Addressing these factors in daily clinical practice is crucial to enhance the overall response to therapy and improve the well-being of patients.

Asunto(s)

RESUMEN

PURPOSE: The "Impact of scalp pruritus in dermatological consultations in Spain: The SCALP-PR trial" was initiated to address the common yet often insufficiently examined issue of scalp pruritus in dermatology. This condition leads to an uncontrollable urge to scratch, affecting the patients' quality of life and potentially causing scalp damage. This study aimed to explore the prevalence, patient profile, underlying conditions, and therapeutic approaches for scalp pruritus in Spain, and to assess the safety and efficacy profile, as well as the tolerability of a non-pharmacologic treatment. METHODS: From 2021 through 2022, 75 dermatologists enrolled a total of 359 patients in a study on scalp pruritus, approved by the Bellvitge University Hospital Research Ethics Committee, Barcelona, Spain. This evidence-based research combined a meta-analysis with observational study techniques focused on real-world evidence to examine the therapeutic impact on quality of life (QoL). Utilizing the Dermatology Life Quality Index (DLQI) for QoL assessments, the study evaluated the effectiveness of the topical product over 15 days. Data collection was conducted via an eCRF and analyzed with statistical methods to provide reliable insights into the management of scalp pruritus. RESULTS: The prevalence of scalp pruritus in Spain was found to be 6.9%, predominantly among women with a mean age of 52.5 years. The leading causes identified were seborrheic dermatitis and pruritus of undetermined etiology or sensitive scalp. Stress was noted as a key factor, with corticosteroids and hygienic measures being common therapies. The topical product demonstrated significant reductions in pruritus and scratching in more than 90% of patients after 15 days. Improvements were also seen in dermatological quality of life, with 87.1% of patients showing enhancements in DLQI scores. The product was well-received thanks to its cosmetic properties, with high ratings in texture, ease of application, and fragrance. CONCLUSION: The topical product studied is a safe, effective, and cosmetically appealing treatment, improving scalp pruritus in various etiologies for most patients. The results highlight the need for patient-center treatments in dermatology, providing important insights for clinical practice and future research.

RESUMEN

INTRODUCTION AND OBJECTIVE: Patients with congenital diaphragmatic hernia (CDH) can have up to 40 times more frequency of muskuloskeletal deformities and decreased perception of physical activity tan their pairs. The objective of this study is to evaluate the safety and efficacy of an individualized exercise program in late adolescents and young adults with repaired CDH, as well as a description of their basal status. MATERIAL AND METHODS: Non randomized prospective trial of 13 patients with repaired CDH between 1997-2005. An initial physical exploration and a pre-post assessment of bioimpedance (BIA), dynamometry, maximal inspiratory and expiratory pressure (MIP/MEP), 6-minute walk test (6MWT), physical activity level (IPAQ) and quality of life (QoL) was made. The training program last for 4 weeks. For the statistical analysis, the Student's t test for paired samples and Wilcoxon test were used. RESULTS: 77% (n=10) were male with a mean age of 19.23±2.13 years. In baseline BIA, 62% (n=8) had truncal sarcopenia that improved in -0.43±0.58, and P=.016. MIP, MEP, 6MWT and QoL tests increased by -7.27±8.26 cmH2O, P=.008; -11.91±10.20 cmH2O, P=.002; -70.63±17.88 m, P=.001; -42,19±26.79, P=.00 respectively. The IPAQ did not change significantly (P=0.86), however the time dedicated to muscle strengthening increased. No adverse effects were reported. CONCLUSIONS: A personalized rehabilitation program is safe and could improve the respiratory muscle strength and truncal sarcopenia as well as the submaximal effort capacity in late adolescents and young adults with repaired CDH.

RESUMEN

Objective Multiple systematic reviews (SR) have been performed on the effects of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), often providing conflicting findings. This overview and network meta-analysis (NMA) aimed to summarize SR findings on the efficacy and safety of PCSK9i and provide an updated NMA. Materials and methods MEDLINE (Pubmed), Scopus, Cochrane, Epistemonikos and Google Scholar were searched from inception to September 21, 2023 for SRs of randomized controlled trials (RCTs) and from January 1, 2020 to September 21, 2023 for additional RCTs. Double-independent study selection, data extraction and quality assessment were performed. Qualitative analysis was performed for SRs and a frequentist random-effects model NMA was performed for RCTs. Results Totally, 86 SRs and 76 RCTs were included. Alirocumab (77/86 [90%]) and evolocumab (73/86 [85%]) were mostly analyzed. Associations from SRs (35/42 [83%]) and the updated NMA indicated PCSK9i benefit on major adverse cardiovascular events (MACEs). Reductions were also noted for cerebrovascular events (47/66 [71%]), coronary revascularization (29/33 [88%]) and myocardial infarction (41/63 [65%]). Alirocumab was associated with reductions on all-cause mortality (RR=0.82, 95%CI [0.72,0.94]). Data on any CV event reduction were conflicting (7/16 [44%]). Inclisiran appeared effective only on MACEs (RR=0.76, 95%CI [0.61,0.94]). No reductions in heart failure were observed (0/16). No increases were identified between PCSK9i and any (0/35) or serious adverse events (0/52). However, PCSK9i were associated with injection-site reactions (20/28 [71%]). Conclusion PCSK9i appeared to be effective in CV outcomes and their clinical application was generally safe. (AU)

Objetivo Las revisiones sistemáticas (RS) sobre los efectos de los inhibidores de la proproteína convertasa subtilisina/kexina tipo 9 (PCSK9i), presentan resultados contradictorios. Esta revisión general y metaanálisis en red (MER) tiene como objetivo resumir los hallazgos sobre la eficacia y seguridad de los PCSK9i. Materiales y métodos Se realizaron búsquedas en MEDLINE (PubMed), Scopus, Cochrane, Epistemonikos y Google Scholar desde sus inicios hasta el 21 de septiembre de 2023 para las RS de ensayos controlados aleatorios (ECA) y desde el 1 de enero de 2020 hasta 21 de septiembre de 2023 para los ECA adicionales. La selección de estudios, extracción de datos y evaluación de calidad se llevaron a cabo de manera doble e independiente. Se realizó un análisis cualitativo de las SR y un modelo de efectos aleatorios frecuentistas MER para los ECA. Resultados En total, se incluyeron 86 SR y 76 RCT. Alirocumab (77/86 [90%]) y evolocumab (73/86 [85%]) fueron los más analizados. Se reconocieron beneficios de los PCSK9i en eventos cardiovasculares adversos mayores (ECVAM), reducción de eventos cerebrovasculares (47/66 [71%]), revascularización coronaria (29/33 [88%]) e infartos de miocardio (41/63 [65%]). Alirocumab redujo la mortalidad por todas las causas (RR: 0,82; IC del 95%: 0,72-0,94). Los resultados sobre la reducción de cualquier evento cardiovascular (CV) fueron contradictorios (7/16 [44%]). Inclisiran pareció ser efectivo solo en la reducción de ECVAM (RR: 0,76; IC del 95%: 0,61-0,94). No se observaron reducciones en insuficiencia cardíaca (0/16) o relación con eventos adversos serios (0/52). Sin embargo, se asociaron con reacciones en el lugar de la inyección (20/28 [71%]). (AU)

Asunto(s)

RESUMEN

La pandemia del COVID-19 ha llevado a los países a adoptar severas y prolongadas medidas que —junto con el alto número de contagios y muertes y la continua información negativa— ha afectado la salud mental de las personas. Este estudio analiza el impacto de la crisis sanitaria del COVID-19 en España explorando el rol moderador de la eficacia percibida de las medidas de contención en la relación que establece la percepción del riesgo del COVID-19 con el estrés y la depresión. Un total de 478 adultos residentes en España (un 66.9% mujeres; Medad = 36.30, DT = 15.32) completaron un cuestionario con escalas concebidas para medir el riesgo percibido del COVID-19, la eficacia percibida de las medidas de protección, el estrés y la depresión entre el 16 de mayo y el 6 de junio de 2021. Los resultados confirmaron el rol moderador de la eficacia percibida, la cual actuó como un factor protector del estrés y la depresión al disminuir el impacto negativo que la percepción de riesgo del COVID-19 tiene en ambas variables relacionadas con el distrés mental. La percepción que tienen los individuos sobre la efectividad de las medidas de protección parece ser un factor protector relevante en relación con la salud mental durante una pandemia. Se subraya la relevancia de intervenciones psicológicas y de políticas gubernamentales que mejoren la comunicación positiva del riesgo y la información adecuada sobre la eficacia de las medidas de protección.(AU)

The pandemic situation caused by COVID-19 led countries to adopt harsh and prolonged (over time) measures that—along with the high number of infections and deaths and continuous negative information—have affected the mental health of individuals. In this study, the impact on mental health of the COVID-19 health crisis in Spain was explored through the perceived efficacy of pandemic containment measures as a moderator of the relationship that COVID-19 perceived risk establishes with stress and depression. A questionnaire composed of scales conceived to measure COVID-19 perceived risk, perceived efficacy of COVID-19 prevention measures, stress, and depression was completed by 478 adults living in Spain (66.9% females, Mage= 36.30, SD= 15.32) between May 16, 2021, and June 6, 2021. The results confirmed the moderating role of per-ceived efficacy. Perceived efficacy acted as a protective factor for stress and depression by decreasing the negative impact that perceived risk had on both variables related to mentaldistress. Also, the perception that par-ticipants had about the effectiveness of prevention measures appeared to be a relevant protective factor regarding mental health during the pandem-ic. This study highlights the relevance of psychological interventions and government policies that improve positive risk communication and pro-vide adequate information regarding the effectiveness of health-prevention measures.(AU)

Asunto(s)

RESUMEN

INTRODUCTION: New generation helixone dialyzers has recently been developed as part of the ongoing effort to improve dialyzer hemocompatibility and avoid adverse reactions to synthetic dialyzers. This study aimed to assess the performance and albumin loss of this new dialyzer series in hemodiafiltration and compare it with the previous generation helixone series. MATERIAL AND METHODS: A prospective study was conducted in 19 patients. Each patient underwent eight dialysis sessions with the same routine dialysis parameters; only the dialyzer varied: FX60 CorDiax, FX CorAL 60, FX600 CorDiax, FX CorAL 600, FX80 CorDiax, FX CorAL 80, FX800 CorDiax, and FX CorAL 800. The reduction ratios (RR) of urea, creatinine, ß2-microglobulin, myoglobin, kappa-free immunoglobulin light chains (κFLC), prolactin, α1-microglobulin, α1-acid glycoprotein, lambda immunoglobulin light chains (λFLC), and albumin were compared intra-individually. Dialysate albumin loss was also measured. RESULTS: All treatments were well tolerated. The mean amount of replacement fluid ranged from 31 to 34 L. Comparison of dialysis treatments showed no differences between small molecules and even up to those the size of ß2-microglobulins. Little differences were found between myoglobin, κFLC, prolactin, α1-microglobulin, and λFLC RRs, and only FX80 CorDiax was slightly superior to the others. Mean dialysate albumin losses were similar, with less than 2.5 g lost in each dialyzer. The FX80 CorDiax showed slightly higher global removal scores than the other dialyzers evaluated, except for FX CorAL 800. CONCLUSION: The new generation helixone dialyzers series has been updated to minimise the risk of adverse reactions, while maintaining the effectiveness and albumin loss achieved by the previous most advanced helixone generation.

Asunto(s)

RESUMEN

BACKGROUND AND OBJECTIVES: Evidence on the long-term use of tolvaptan in autosomal dominant polycystic kidney disease (ADPKD) is limited. The aim was to evaluate the tolvaptan effectiveness and safety in real clinical setting. MATERIAL AND METHODS: A single-center observational study (2016-2022) involving ADPKD patients treated with tolvaptan was conducted. Annual change in serum creatinine (sCr) and estimated glomerular filtration rate (eGFR) before and after treatment initiation were evaluated. Change in total kidney volume (TKV), blood pressure (BP) and urinary albuminuria at 12, 24 and 36 months after initiation were also determined. Adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 were analyzed. RESULTS: A total of 22 patients were included. No significant differences pre- vs post tolvaptan treatment in annual rate of change in eGFR (-3.52ml/min/1.73m2 [-4.98%] vs -3.98ml/min/1.73m2 [-8.48%], p=0.121) and sCr (+0.06mg/dL [4.22%] vs +0.15mg/dL [7.77%], p=0.429) were observed. Tolvaptan improved urinary osmolality at 12 (p=0.019) and 24 months (p=0.008), but not at 36 months (p=0.11). There were no changes in TKV, BP control and urinary albuminuria at 12, 24 or 36 months. A worse response was shown in patients with rapid kidney function decline (p=0.042). A 36.4% of the patients developed grade III/IV AEs. A 22.7% discontinued treatment due to unacceptable toxicity. CONCLUSIONS: This study shows a modest benefit of tolvaptan in ADPKD patients, as well as safety concerns.

Asunto(s)

RESUMEN

Background: Music therapy is increasingly examined in randomized controlled trials (RCTs) and shows potential in treating post-traumatic stress disorder (PTSD).Objective: This systematic review and meta-analysis critically evaluates the current clinical evidence supporting the efficacy and acceptability of music therapy for PTSD.Method: RCTs comparing music therapy in addition to care as usual (CAU) versus either CAU alone or CAU combined with standard psychotherapy/pharmacotherapy for PTSD were retrieved from major English - and Chinese-language databases. Standardized mean differences (SMDs) for post-treatment PTSD symptom scores and risk differences (RDs) for retention rates upon treatment completion were calculated to assess the efficacy and acceptability of music therapy, respectively. The Cochrane risk of bias (RoB) tool 2.0 and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) were used to assess the RoB of included studies and certainty of the evidence, respectively.Results: Nine studies, incorporating 527 PTSD patients, were included, all with high RoB. The post-treatment PTSD symptom scores were significantly lower in the music therapy group than the inactive control group (SMD = -1.64, P < .001), but comparable between the music therapy group and the active control group (SMD = -0.28, P = .330). The retention rates did not differ significantly between the music therapy group and both control groups (RD = 0.03, P = .769; RD = 0.16, P = .829). The GRADE rated certainty level of evidence as low.Conclusions: Although meta-analytic findings suggest that music therapy is effective in reducing post-traumatic symptoms in individuals with PTSD, with its therapeutic effect comparable to that of standard psychotherapy, the low level of certainty limits its generalizability. More methodologically stringent studies are warranted to strengthen the clinical evidence for the efficacy and acceptability of music therapy for PTSD.

This systematic review critically appraised the existing methodologically rigorous evidence for the efficacy and acceptability of music therapy for post-traumatic stress disorder (PTSD).The post-treatment PTSD symptom scores were significantly lower in the music therapy group than the inactive control group and comparable between the music therapy group and the active control group.The post-treatment retention rates did not differ significantly between the music therapy group and both the inactive and active control groups.

Asunto(s)

RESUMEN

SUMMARY: The objective of this study was to observe the clinical efficacy of apatinib (AP) combined with 131I in the treatment of radioiodine-refractory differentiated thyroid cancer (RAIR-DTC) and the prognostic significance of MIP-1α after treatment, and to provide reference and guidance for future treatment and disease assessment of RAIR-DTC. One hundred and six patients with RAIR- DTC admitted to our hospital from January 2019 to October 2020 were selected for the study. All the patients were treated with TC surgery with 131I at our hospital, and 58 of them were subsequently transferred to AP treatment, which was considered as the research group; the other 48 patients were transferred to thyroid stimulating hormone (TSH) suppression treatment, which was considered as the control group. The clinical efficacy of the research group was better than that of the control group (P 0.05). After treatment, Tg, TL, maximum diameter of C/B lymph nodes, number of lymph nodes and number of calcified spots were lower in the research group than in the control group (P < 0.05). ROC analysis revealed that the predictive sensitivity of MIP-1α for prognosis of 3-year RAIR-DTC death in the research group of patients was 84.63 % and the specificity was 72.16 %. AP combined with 131I is effective in the treatment of RAIR-DTC and is worth using in the clinical practice. In addition, elevated levels of MIP-1α predicted a poor prognosis for patients with RAIR-DTC.

El objetivo de este estudio fue observar la eficacia clínica de apatinib (AP) combinado con 131I en el tratamiento del cáncer de tiroides diferenciado refractario al yodo radiactivo (RAIR-DTC) y la importancia pronóstica de MIP-1α después del tratamiento, y proporcionar referencia y orientación para futuros tratamientos y enfermedades. Evaluación de RAIR- DTC. Se seleccionaron para el estudio 106 pacientes con RAIR- DTC ingresados en nuestro hospital desde enero de 2019 hasta octubre de 2020. Todos los pacientes fueron tratados con cirugía CT con 131I, y 58 de ellos fueron trasladados posteriormente a tratamiento AP, los que fueron considerados como grupo de investigación; los otros 48 pacientes fueron transferidos a tratamiento de supresión de la hormona estimulante de la tiroides (TSH), que se consideró como grupo de control. La eficacia clínica del grupo de investigación fue mejor que la del grupo de control (P 0,05). Después del tratamiento, Tg, TL, diámetro máximo de los linfonodos C/B, número linfonodos y número de manchas calcificadas fueron menores en el grupo de investigación que en el grupo de control (P <0,05). El análisis ROC reveló que la sensibilidad predictiva de MIP-1α para el pronóstico de muerte por RAIR-DTC a 3 años en el grupo de pacientes de investigación fue del 84,63 % y la especificidad fue del 72,16 %. AP combinado con 131I es eficaz en el tratamiento del RAIR-DTC y vale la pena utilizarlo en la práctica clínica. Además, los niveles elevados de MIP-1α predijeron un mal pronóstico para los pacientes con RAIR- DTC.

Asunto(s)

RESUMEN

Tildrakizumab is an IL-23-inhibitor that has been approved to treat plaque psoriasis. However, few reports have become available on its efficacy profile in the real-world. Our objective was to study the mid-term efficacy of tildrakizumab in patients with moderate-to-severe psoriasis in the Spanish routine clinical practice setting. This was a retrospective multicenter study that included a total of 91 psoriatic patients on tildrakizumab. The mean Psoriasis Area and Severity Index (PASI) was 9.09 (SD, 5.30). The overall tildrakizumab survival rate was 93.47% for a mean treatment exposure of 30.18 weeks (SD, 16.57). No drug discontinuation was associated with drug tolerability, or adverse reactions. Absolute PASI ≤3 was reached by 91.3% and 96.5% of the patients on weeks 28 and 52, respectively. Response was not impacted by weight, age (>65), metabolic syndrome, presence of arthritis, or previous number of biological therapies used. Based on our own experience tildrakizumab is an effective strategy to treat plaque psoriasis and difficult-to-treat-areas.

Asunto(s)

RESUMEN

Resumo Fundamento: Os ensaios clínicos demonstraram a segurança da Edoxabana, um anticoagulante oral não dependente de vitamina K (NOAC), e a sua eficácia na prevenção de acidente vascular cerebral e embolia sistémica em pacientes com fibrilação atrial não valvar (FANV) e também na prevenção e tratamento de tromboembolismo venoso. No entanto, pesquisas adicionais são necessárias para avaliar a segurança e a eficácia da Edoxabana em um cenário real na população brasileira. Objetivo: A fim de compreender os riscos e benefícios do uso da Edoxabana em cenários clínicos de rotina, o estudo EdoBRA está sendo conduzido para obter informações sobre a segurança e eficácia do uso da Edoxabana em pacientes não pré-selecionados com FANV no Brasil. Métodos: O estudo EdoBRA é um estudo multicêntrico, prospectivo e observacional, realizado em 36 centros no Brasil. São elegíveis para este estudo pacientes com FANV, ≥ 18 anos de idade, tratados com Edoxabana disponível comercialmente, que iniciaram o tratamento por pelo menos 14 dias e não mais do que 90 dias antes da data de inclusão no estudo, e que não estão participando de nenhum outro estudo de intervenção. Ao todo, 700 pacientes devem ser inscritos e acompanhados por um ano, com coletas de dados programadas para o período basal e 3, 6 e 12 meses após a inscrição no estudo. O objetivo primário de segurança é o sangramento clinicamente relevante (de acordo com critérios da Sociedade Internacional de Trombose e Hemostasia - ISTH), e o objetivo secundário de eficácia são desfechos cardiovasculares relevantes relacionados à FANV. Conclusão: O estudo observacional EdoBRA gerará informações adicionais relevantes sobre a Edoxabana enquanto NOAC em diversos aspectos do manejo de pacientes no atendimento clínico de rotina, como perfil de segurança e efetividade em pacientes com FANV no Brasil.

Abstract Background: Clinical trials showed the safety of Edoxaban, a non-vitamin K-dependent oral anticoagulant (NOAC), and its efficacy to prevent stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) patients and also to prevent and treat venous thromboembolism. However, additional research is needed to evaluate the safety and effectiveness of Edoxaban in a real-world scenario in the Brazilian population. Objective: In order to understand the risks and benefits of Edoxaban use in routine clinical settings, the EdoBRA study is being conducted to gain insight into the safety and effectiveness of Edoxaban use in non-preselected patients with NVAF in Brazil. Methods: The EdoBRA study is a multicenter, prospective, observational study conducted in 36 sites in Brazil. NVAF patients ≥ 18 years treated with commercially available Edoxaban who initiated treatment for at least 14 days and no longer than 90 days prior to enrollment, and who are not simultaneously participating in any interventional study are eligible for this study. Seven hundred patients are planned to be enrolled and one-year of follow up, with data collections expected at baseline and 3, 6, and 12 months after the study enrollment. The primary safety objective is ISTH Clinically Relevant Bleeding, and the secondary effectiveness objective focuses on relevant cardiovascular outcomes related to NVAF. Conclusion: EdoBRA observational study will generate relevant additional information about NOAC Edoxaban on various aspects of patient management in routine care, such as its safety and effectiveness profile in patients with NVAF in Brazil.

RESUMEN

Introducción. Los a corren un mayor riesgo de infección por influenza en comparación con la población general. La Organización Mundial la Salud y las recomendaciones del Comité Asesor de Vacunas de la Asociación Española de Pediatría contemplan la vacunación anual como la forma más eficaz de prevenir la enfermedad. Por lo tanto, el propósito de esta revisión fue actualizar la información sobre eficacia y seguridad en la vacuna antigripal en niños y adolescentes. Material y métodos. Una búsqueda en cuatro bases de datos electrónicas (Scopus, Cumulative Index to Nursing and Allied Health Literature, MedLine / PubMed, Google Scholar y Cochrane), así como una búsqueda manual para identificar investigaciones originales publicadas entre 2012 y 2022. Se adoptaron las directrices de análisis (PRISMAcR) como elemento de informe preferido para revisiones sistemáticas. Resultados. Se incluyeron siete artículos de investigación originales donde se identificaron dos temas de la vacunación antigripal en niños/adolescentes sanos y con patologías. La eficacia (entre un 30% y un 80% aproximadamente) varió en función de la vacuna utilizada y los subtipos circulantes. La mayoría de las reacciones adversas fueron de intensidad leve y el evento adverso local más común informado fue dolor en el sitio de la inyección. Conclusiones. Destacamos positivamente la seguridad de la vacunación antigripal pediátrica en los estudios analizados, por el contrario, con respecto a la eficacia de la vacunación antigripal, observamos una amplia variabilidad de resultados. Existe una clara necesidad de seguir realizando estudios de eficacia y seguridad en el niño. (AU)

Introduction. Children are at a higher risk of influenza infection compared to the general population. The World Organization Health and recommendations of the Vaccine Advisory Committee of the Spanish Association of Pediatrics contemplate annual vaccination as the most effective way to prevent the disease. Therefore, the purpose of this review was to update information on efficacy and safety in the anti -shed vaccine in children and adolescents. Material and methods. A search in four electronic databases (Scopus, Cumulative Index to Nursing and Allied Health Literature, Medline / Pubmed, Google Scholar and Cochrane), as well as a manual search to identify original research published between 2012 and 2022. The guidelines of ANALYSIS (PRISMACR) as a preferred report element for systematic reviews. Results. Seven original research articles were included where two issues of antigripal vaccination were identified in healthy children/adolescents and with pathologies. The efficacy (between approximately 30% and 80%) varied depending on the vaccine used and circulating subtypes. Most adverse reactions were mild intensity, and the most common local adverse event was pain in the injection site. Conclusions. We positively highlight the safety of pediatric flu vaccination in analyzed studies, on the contrary, with respect to the efficacy of flu vaccination, we observe a wide variability of results. There is a clear need to continue conducting efficacy and safety studies in the child. (AU)

Asunto(s)

RESUMEN

Abstract Introduction Although the COVID-19 pandemic negatively impacted the mental health of vulnerable populations, such as adolescent mothers, very few studies have documented the prevalence of postpartum depression (PPD) in this population. Objective a) Determine the frequency of PPD (Edinburgh Postnatal Depression Scale [EPDS] ≥ 9) in adolescent mothers before (AM-BP) and during (AM-DP) the pandemic, b) Examine psychosocial factors (self-esteem, maternal efficacy, social support, depression and anxiety in pregnancy, planned and wanted pregnancy) in AM-BP and AM-DP, and c) Determine whether being an AM-DP was a significant factor for experiencing PPD (EPDS ≥ 9). Method Cross sectional study. Subjects: Forty-one AM-BP recruited at Health Centers and interviewed face to face and forty-one AM-DP surveyed online. Results PPD (EPDS ≥ 9) was 42% (p = .001) more frequent in AM-DP. The groups differed significantly in all psychosocial factors, with AM-DP faring worse. Unadjusted regressions showed that being an AM-DP, having lower maternal efficacy and self-esteem, greater dissatisfaction with social support, and depression and/or anxiety in pregnancy increased PPD (EPDS ≥ 9). Adjusted multiple analysis indicated that lower self-esteem was the only factor to maintain its association with PPD (EPDS ≥ 9; p = .017). Discussion and conclusion The pandemic negatively affected PPD (EPDS ≥ 9) and psychosocial factors in AM-DP, as compared to AM-BP, with self-esteem being the main factor associated with PPD (EPDS ≥ 9). In situations of extreme stress as happened in the pandemic, the mental health of adolescent mothers should be prioritized to prevent negative effects such as PPD. PPD preventive and treatment interventions should consider strengthening self-esteem.

Resumen Introducción La pandemia por COVID-19 tuvo un impacto negativo en la salud mental de poblaciones vulnerables, como las madres adolescentes, no obstante, escasos estudios documentaron la prevalencia de depresión posparto (DPP) en esta población. Objetivo a) Conocer la frecuencia de DPP (Escala Edinburgh para la Depresión Postnatal [EPDS] ≥ 9) en madres adolescentes antes de la pandemia (MA-AP) y durante la pandemia (MA-DP), b) Examinar algunos factores psicosociales (autoestima, eficacia materna, apoyo social, depresión y ansiedad en el embarazo, embarazo planeado y deseado) en MA-AP y MA-DP, y, c) Analizar si ser MA-DP, fue un factor significativo para experimentar DPP (EPDS ≥ 9). Método Estudio transversal. Participantes: 41 MA-AP captadas en Centros de Salud y 41 MA-DP encuestadas en línea. Resultados La DPP (EPDS ≥ 9) fue 42% (p = .001) más frecuente en las MA-DP. Los grupos difirieron significativamente en todos los factores psicosociales, en detrimento de las MA-DP. Las regresiones no ajustadas mostraron que ser MA-DP, tener menor eficacia materna y autoestima, mayor insatisfacción con el apoyo social, y depresión y/o ansiedad en el embarazo incrementaron la DPP (EPDS ≥ 9). El análisis múltiple ajustado indicó que una menor autoestima fue el único factor que mantuvo su asociación con DPP (EPDS ≥ 9; p = .017). Discusión y conclusión La pandemia tuvo un efecto negativo en la DPP (EPDS ≥ 9) y en factores psicosociales en MA-DP; la autoestima fue el principal factor asociado a la misma. Ante situaciones de estrés extremo, la salud mental de madres adolescentes debería ser prioritaria para prevenir efectos negativos como la DPP. Intervenciones preventivas y de tratamiento de DPP deben fortalecer la autoestima.

RESUMEN

La motivación orientada a la tarea se vincula con la tendencia de los estudiantes de Educación Física a asociarse con una mayor probabilidad de ser físicamente activos en el futuro y fuera de las clases de Educación Física, mientras que la motivación orientada al ego estaría vinculada a una menor probabilidad de desarrollar estilos de vida activos. Además, la literatura existente ha mostrado que la percepción de autoeficacia también sería una variable que determina la intención de ser activo. Así, el objetivo de esta investigación fue analizar las relaciones entre la orientación motivacional y la intención de ser activo, analizando el papel de la autoeficacia motriz en estas relaciones. Para ello, se desarrolló un modelo de ecuaciones estructurales en el que se evaluaron los efectos directos e indirectos entre las variables. Participaron en esta investigación 478 adolescentes con edades comprendidas entre los 13 y los 18 años (M=14.57; DT=1.15). Para la recogida de información se utilizaron elCuestionario Orientación al Ego y a la Tarea en el Deporte (TEOSQ), la Escala de Autoeficacia Motriz (MSES) y la Escala de Intención de Ser Físicamente Activo (MIFA). Los datos mostraron una relación positiva y directa entre la orientación a la tarea con la autoeficacia motriz y la intención de ser activo. Asimismo, los datos mostraron una relación positiva y directa entre la orientaciónal ego con la autoeficacia motora, pero no con la intención de ser activo. Asimismo, se observaron efectos indirectos y positivos entre la orientación a la tarea y al ego con la intención de ser activo. Por lo tanto, los resultados de este estudio muestran que podría ser necesario tener en cuenta la autoeficacia para comprender mejor las relaciones entre las orientaciones motivacionales y la intención de ser activo.(AU)

Task-oriented is linked to the tendency of Physical Education students to be associated with a higher likelihoodof being physically active in the future and outside of Physical Education classes, while ego-oriented motivation is linked to a lower likelihood of developing active lifestyles. However, existing literature has shown that self-efficacy perception is also a variable that determines the intention to be active. Thus, this research aimed to analyze the relationships between motivational orientationand the intention to be active, examining the role of motor self-efficacy in these relationships. To this end, astructural equation model was developed in which direct and indirect effects between the variables were evaluated. A total of 478 adolescents aged between 13 and 18 years old (M=14.57; SD=1.15) participated in this research. The Task and Ego Orientation in Sport Questionnaire (TEOSQ), the Motor Self-Efficacy Scale (MSES), and the Intention of Being Physically Active Scale (MIFA) were used to collect information. The data showed a positive and direct relationship between task orientation with motor self-efficacy and intention to be active. Likewise, the data showed a positive and direct relationship between ego orientation and motor self-efficacy, but not to be active. Additionally, indirect and positive effects were observed between task and ego orientation to be active. Therefore, the results of this study suggest that it might be necessary to consider self-efficacy to better understand the relationships between motivational orientations and intention to be active.(AU)

A orientação para a tarefa está ligada à tendência dos estudantes de Educação Física para serem fisicamente activos no futuro bem como fora das aulas de Educação Física. Por outro lado, a orientação para o ego está mais relacionada com uma menor probabilidade de desenvolverem estilos de vida activos. No entanto, a literatura existente tem demonstrado que a perceção de auto-eficácia seria também uma variável que determina a intenção de ser ativo. Assim, o objetivodo presente estudo foi analisar as relações entre a orientação motivacional e a intenção de ser ativo, analisando o papel da auto-eficácia motora nestas relações. Para isso, foi desenvolvido um modelo de equações estruturais no qual foram avaliados os efeitos diretos e indiretos. Participaram nesta investigação 478 adolescentes com idades compreendidas entre os 13 e os 18 anos (M=14,57; DP=1,15). Para a recolha de informação foram utilizados o Task and Ego Orientation in Sport Questionnaire (TEOSQ), aMotor Self-Efficacy Scale (MSES) e a Intention ofBeing Physically Active Scale (MIFA). Os dados revelaram uma relação positiva e direta entre a orientação para a tarefa, a auto-eficácia motora e a intenção de ser ativo. Além disso, os dados revelaram uma relação positiva e direta entre a orientação para o ego e a auto-eficácia motora, mas não com a intenção de ser ativo. Da mesma forma, foram observados efeitos indirectos positivos entre a orientação para a tarefa e a orientação para o ego com a intenção de ser ativo. Portanto, os resultados deste estudo sugerem que pode ser necessário considerar a autoeficácia para entender as relações entre as orientações motivacionais e a intenção de ser ativo.(AU)

Asunto(s)

RESUMEN

Este estudio tuvo como objetivo evaluar y determinar la eficacia de un tratamiento transdiagnóstico breve en formato grupal para personas con trastornos emocionales leves y moderados y establecer correlaciones entre los cambios tras el tratamiento en las diferentes variables. Para ello, se usó un diseño experimental de grupo único (n=11) con medidas pre-post. Los participantes fueron evaluados antes y después de la intervención con las siguientes medidas: PHQ-15, PHQ-9, GAD-7, PSQW-A, RRS-B y CERQ-18. Se encontró que la terapia transdiagnóstica breve fue efectiva para reducir los síntomas depresivos (p =.005), síntomas ansiosos (p =.011) y preocupación (p = .020) con tamaños del efecto alto. Además, se encontraron correlaciones significativas positivas entre los cambios de las variables de síntomas depresivos y preocupación y entre los cambios en síntomas ansiosos y rumiación. Se concluyó que los tratamientos transdiagnóticos breves pueden ser una opción a tener en cuenta para los pacientes con trastornos emocionales leves y moderados en atención primaria debido a su eficacia en algunos síntomas y sus características. (AU)

This study aimed to evaluate and determine the efficacy of a brief transdiagnostic treatment in group format for people with mild and moderate emotional disorders, and to establish correlations between the changes after treatment in the different variables. We use a single experimental group (n=11) design with pre-post measures. Participants were assessed pre- and post-intervention with the following measures: PHQ-15, PHQ-9, GAD-7, PSQW-A, RRS-B, and CERQ-18. Brief transdiagnostic therapy was found to be effective in reducing depressive symptoms (p =.005), anxious symptoms (p=.011), and worry (p=.020) with high/moderate effect sizes. In addition, significant positive correlations were found between changes in depressive symptoms and worry variables, and between changes in anxious symptoms and rumination. In conclusion, brief transdiagnostic treatments can be a treatment to consider for patients with mild and moderate emotional disorders in primary care due to their efficacy in some symptoms and their characteristics. (AU)

Asunto(s)

RESUMEN

Este estudio tuvo como objetivo evaluar y determinar la eficacia de un tratamiento transdiagnóstico breve en formato grupal para personas con trastornos emocionales leves y moderados y establecer correlaciones entre los cambios tras el tratamiento en las diferentes variables. Para ello, se usó un diseño experimental de grupo único (n=11) con medidas pre-post. Los participantes fueron evaluados antes y después de la intervención con las siguientes medidas: PHQ-15, PHQ-9, GAD-7, PSQW-A, RRS-B y CERQ-18. Se encontró que la terapia transdiagnóstica breve fue efectiva para reducir los síntomas depresivos (p =.005), síntomas ansiosos (p =.011) y preocupación (p = .020) con tamaños del efecto alto. Además, se encontraron correlaciones significativas positivas entre los cambios de las variables de síntomas depresivos y preocupación y entre los cambios en síntomas ansiosos y rumiación. Se concluyó que los tratamientos transdiagnóticos breves pueden ser una opción a tener en cuenta para los pacientes con trastornos emocionales leves y moderados en atención primaria debido a su eficacia en algunos síntomas y sus características. (AU)

This study aimed to evaluate and determine the efficacy of a brief transdiagnostic treatment in group format for people with mild and moderate emotional disorders, and to establish correlations between the changes after treatment in the different variables. We use a single experimental group (n=11) design with pre-post measures. Participants were assessed pre- and post-intervention with the following measures: PHQ-15, PHQ-9, GAD-7, PSQW-A, RRS-B, and CERQ-18. Brief transdiagnostic therapy was found to be effective in reducing depressive symptoms (p =.005), anxious symptoms (p=.011), and worry (p=.020) with high/moderate effect sizes. In addition, significant positive correlations were found between changes in depressive symptoms and worry variables, and between changes in anxious symptoms and rumination. In conclusion, brief transdiagnostic treatments can be a treatment to consider for patients with mild and moderate emotional disorders in primary care due to their efficacy in some symptoms and their characteristics. (AU)

Asunto(s)

RESUMEN

The last consensus statement of the Spanish Society of Neurology's Demyelinating Diseases Study Group on the treatment of multiple sclerosis (MS) was issued in 2016. Although many of the positions taken remain valid, there have been significant changes in the management and treatment of MS, both due to the approval of new drugs with different action mechanisms and due to the evolution of previously fixed concepts. This has enabled new approaches to specific situations such as pregnancy and vaccination, and the inclusion of new variables in clinical decision-making, such as the early use of high-efficacy disease-modifying therapies (DMT), consideration of the patient's perspective, and the use of such novel technologies as remote monitoring. In the light of these changes, this updated consensus statement, developed according to the Delphi method, seeks to reflect the new paradigm in the management of patients with MS, based on the available scientific evidence and the clinical expertise of the participants. The most significant recommendations are that immunomodulatory DMT be started in patients with radiologically isolated syndrome with persistent radiological activity, that patient perspectives be considered, and that the term "lines of therapy" no longer be used in the classification of DMTs (> 90% consensus). Following diagnosis of MS, the first DMT should be selected according to the presence/absence of factors of poor prognosis (whether epidemiological, clinical, radiological, or biomarkers) for the occurrence of new relapses or progression of disability; high-efficacy DMTs may be considered from disease onset.

Asunto(s)

RESUMEN

Asthma is one of the most common chronic diseases and is estimated to be severe in 3%-10% of affected patients. There is a need for additional biologic treatments that are highly efficacious across the spectrum of severe uncontrolled asthma. Currently available drugs inhibit 1 or 2 specific cytokines or IgE antibodies and thus only partially suppress the complex type 2 (T2) inflammatory cascade. Biologics targeting more upstream molecules in the pathophysiological pathway of asthma could treat asthma more effectively. Tezepelumab is a human monoclonal immunoglobulin G2λ antibody that targets the cytokine thymic stromal lymphopoietin (TSLP). It is the first marketed biologic against an epithelial cell–derived cytokine, preventing binding of TSLP to its receptor and reducing the immune stimuli that TSLP can trigger in different asthma endotypes. Tezepelumab reduces downstream biomarkers of inflammation, such as blood and airway eosinophils, FeNO, IgE, IL-5, and IL-13. Tezepelumab provides a clinical benefit in severe asthma, reducing the annualized asthma exacerbation rate in patients with either high or low levels of biomarkers of T2 inflammation, although the effect is greater among those with high levels. The drug has been shown to improve asthma control, quality of life, and lung function and reduce airway hyperresponsiveness. Therefore, tezepelumab can be used across the spectrum of patients with severe uncontrolled asthma, especially in T2-high patients. This review includes a positioning statement by the authors, all of whom are members of the SEAIC Asthma Committee (AU)

A asma é uma das doenças crônicas mais comuns e estima-se que seja grave em 3% a 10% dos pacientes afetados. Há necessidade de tratamentos biológicos adicionais que sejam altamente eficazes em todo o espectro da asma grave não controlada. Os medicamentos atualmente disponíveis inibem 1 ou 2 citocinas específicas ou anticorpos IgE e, portanto, suprimem apenas parcialmente a cascata inflamatória complexa tipo 2 (T2). Os produtos biológicos que visam moléculas mais a montante na via fisiopatológica da asma poderiam tratar a asma de forma mais eficaz. Tezepelumab é um anticorpo monoclonal humano imunoglobulina G2λ que tem como alvo a citocina linfopoietina estromal tímica (TSLP). É o primeiro produto biológico comercializado contra uma citocina derivada de células epiteliais, impedindo a ligação da TSLP ao seu receptor e reduzindo os estímulos imunológicos que a TSLP pode desencadear em diferentes endótipos de asma. Tezepelumabe reduz biomarcadores de inflamação a jusante, como eosinófilos no sangue e nas vias aéreas, FeNO, IgE, IL-5 e IL-13. O tezepelumab proporciona um benefício clínico na asma grave, reduzindo a taxa anualizada de exacerbação da asma em pacientes com níveis elevados ou baixos de biomarcadores de inflamação T2, embora o efeito seja maior entre aqueles com níveis elevados. Foi demonstrado que o medicamento melhora o controle da asma, a qualidade de vida e a função pulmonar e reduz a hiperresponsividade das vias aéreas. Portanto, o tezepelumabe pode ser usado em todo o espectro de pacientes com asma grave não controlada, especialmente em pacientes com T2 elevado. Esta revisão inclui uma declaração de posicionamento dos autores, todos membros do Comitê de Asma da SEAIC (AU)

Asunto(s)

RESUMEN

OBJECTIVE: Multiple systematic reviews (SR) have been performed on the effects of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), often providing conflicting findings. This overview and network meta-analysis (NMA) aimed to summarize SR findings on the efficacy and safety of PCSK9i and provide an updated NMA. MATERIALS AND METHODS: MEDLINE (Pubmed), Scopus, Cochrane, Epistemonikos and Google Scholar were searched from inception to September 21, 2023 for SRs of randomized controlled trials (RCTs) and from January 1, 2020 to September 21, 2023 for additional RCTs. Double-independent study selection, data extraction and quality assessment were performed. Qualitative analysis was performed for SRs and a frequentist random-effects model NMA was performed for RCTs. RESULTS: Totally, 86 SRs and 76 RCTs were included. Alirocumab (77/86 [90%]) and evolocumab (73/86 [85%]) were mostly analyzed. Associations from SRs (35/42 [83%]) and the updated NMA indicated PCSK9i benefit on major adverse cardiovascular events (MACEs). Reductions were also noted for cerebrovascular events (47/66 [71%]), coronary revascularization (29/33 [88%]) and myocardial infarction (41/63 [65%]). Alirocumab was associated with reductions on all-cause mortality (RR=0.82, 95%CI [0.72,0.94]). Data on any CV event reduction were conflicting (7/16 [44%]). Inclisiran appeared effective only on MACEs (RR=0.76, 95%CI [0.61,0.94]). No reductions in heart failure were observed (0/16). No increases were identified between PCSK9i and any (0/35) or serious adverse events (0/52). However, PCSK9i were associated with injection-site reactions (20/28 [71%]). CONCLUSION: PCSK9i appeared to be effective in CV outcomes and their clinical application was generally safe.

Asunto(s)