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1.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-38750931

RESUMO

The 2024 Interamerican Society of Cardiology (SIAC) guidelines on cardiorespiratory rehabilitation (CRR) in pediatric patients with congenital heart disease aim to gather and evaluate all relevant evidence available on the topic to unify criteria and promote the implementation of CRR programs in this population in Latin America and other parts of the world. Currently, there is no unified CRR model for the pediatric population. Consequently, our goal was to create these CRR guidelines adapted to the characteristics of congenital heart disease and the physiology of this population, as well as to the realities of Latin America. These guidelines are designed to serve as a support for health care workers involved in the care of this patient group who wish to implement a CRR program in their workplace. The guidelines include an easily reproducible program model that can be implemented in any center. The members of this Task Force were selected by the SIAC on behalf of health care workers dedicated to the care of pediatric patients with congenital heart disease. To draft the document, the selected experts performed a thorough review of the published evidence.

3.
NPJ Digit Med ; 7(1): 125, 2024 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-38744955

RESUMO

Scientific research of artificial intelligence (AI) in dermatology has increased exponentially. The objective of this study was to perform a systematic review and meta-analysis to evaluate the performance of AI algorithms for skin cancer classification in comparison to clinicians with different levels of expertise. Based on PRISMA guidelines, 3 electronic databases (PubMed, Embase, and Cochrane Library) were screened for relevant articles up to August 2022. The quality of the studies was assessed using QUADAS-2. A meta-analysis of sensitivity and specificity was performed for the accuracy of AI and clinicians. Fifty-three studies were included in the systematic review, and 19 met the inclusion criteria for the meta-analysis. Considering all studies and all subgroups of clinicians, we found a sensitivity (Sn) and specificity (Sp) of 87.0% and 77.1% for AI algorithms, respectively, and a Sn of 79.78% and Sp of 73.6% for all clinicians (overall); differences were statistically significant for both Sn and Sp. The difference between AI performance (Sn 92.5%, Sp 66.5%) vs. generalists (Sn 64.6%, Sp 72.8%), was greater, when compared with expert clinicians. Performance between AI algorithms (Sn 86.3%, Sp 78.4%) vs expert dermatologists (Sn 84.2%, Sp 74.4%) was clinically comparable. Limitations of AI algorithms in clinical practice should be considered, and future studies should focus on real-world settings, and towards AI-assistance.

4.
Am J Manag Care ; 30(6 Spec No.): SP464-SP467, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38820188

RESUMO

OBJECTIVES: To show the procalcitonin (PCT) test demand from an emergency department (ED) over several years, to decrease PCT measurement via a computerized algorithm based on C-reactive protein (CRP) value, and to evaluate the subsequent economic savings. STUDY DESIGN: A cross-sectional study was performed from January 1, 2018, to May 31, 2019, to evaluate an intervention to avoid PCT measurement in the ED of Hospital Universitario San Juan in Alicante in Spain, when CRP values are low. METHODS: A PCT result of at least 1.5 ng/mL was agreed upon with ED providers in our study as the value for clinical decision-making, with values less than 1.5 ng/mL considered negative. We retrospectively reviewed all PCT and CRP values for ED patients and calculated the diagnostic indicators for PCT at 4 different CRP cutoffs using the PCT quantification as the gold standard. From July 1, 2019, to April 30, 2021, the agreed-upon strategy was implemented, and we counted the PCT tests avoided and calculated the savings. RESULTS: PCT was not measured when CRP values were less than the selected CRP cutoff of 0.8 mg/dL, at which false-negative results were 1% and the 99th percentile of PCT was 1.5 ng/mL. In the postintervention period, 1091 PCT values were not measured and $11,553.69 was saved. CONCLUSIONS: An intervention to decrease PCT measurement in the ED designed by the clinical laboratory staff in consensus with requesting clinicians and based on CRP values decreased PCT testing and generated significant economic savings.


Assuntos
Algoritmos , Proteína C-Reativa , Serviço Hospitalar de Emergência , Pró-Calcitonina , Humanos , Pró-Calcitonina/sangue , Serviço Hospitalar de Emergência/estatística & dados numéricos , Estudos Transversais , Proteína C-Reativa/análise , Estudos Retrospectivos , Espanha , Masculino , Feminino , Pessoa de Meia-Idade , Adulto , Biomarcadores/sangue
5.
Food Chem ; 453: 139607, 2024 Sep 30.
Artigo em Inglês | MEDLINE | ID: mdl-38761725

RESUMO

The positive impact of use SEGs ("Shoot from vines - Enological - Granule") in winemaking for wines of the same variety has been extensively demonstrated, but their combination with different SEGs varieties and micro-oxygenation (MOX) remains unstudied. In this study, Tempranillo wines were in contact along 35 days with two doses of Tempranillo and Cabernet Sauvignon SEGs (12 and 24 g/L) and two fixed doses of MOX (LOTR, 6.24 mg/L·month, and HOTR, 11.91 mg/L·month). Chemical composition and sensory profiles were analyzed after SEGs-MOX treatments. Results indicated a greater impact of MOX on volatile composition when Cabernet Sauvignon SEGs were used, with similar results for CS12-HOTR and CS24-LOTR wines. Phenolic compounds showed a total concentration decrease in all treated wines, though trans-resveratrol increased in all cases, particularly with the highest MOX dose. In sensory evaluation, MOX accelerated the integration of characteristic SEGs aromas into the wine, reducing the required bottle time for round them.


Assuntos
Odorantes , Paladar , Vitis , Compostos Orgânicos Voláteis , Vinho , Vinho/análise , Vitis/química , Odorantes/análise , Compostos Orgânicos Voláteis/química , Humanos , Manipulação de Alimentos , Fenóis/química , Fenóis/análise , Masculino , Feminino , Adulto , Oxigênio/química , Oxigênio/análise
7.
Vision Res ; 217: 108378, 2024 04.
Artigo em Inglês | MEDLINE | ID: mdl-38458004

RESUMO

Human photoreceptors consist of cones, rods, and melanopsin-expressing intrinsically photosensitive retinal ganglion cells (ipRGCs). First studied in circadian regulation and pupillary control, ipRGCs project to a variety of brain centers suggesting a broader involvement beyond non-visual functions. IpRGC responses are stable, long-lasting, and with a particular codification of photoreceptor signals. In comparison with the transient and adaptive nature of cone and rod signals, ipRGCs' signaling might provide an ecological advantage to different attributes of color vision. Previous studies have indicated melanopsin's influence on visual responses yet its contribution to color perception in humans remains debated. We summarized evidence and hypotheses (from physiology, psychophysics, and natural image statistics) about direct and indirect involvement of ipRGCs in human color vision, by first briefly assessing the current knowledge about the role of melanopsin and ipRGCs in vision and codification of spectral signals. We then approached the question about melanopsin activation eliciting a color percept, discussing studies using the silent substitution method. Finally, we explore various avenues through which ipRGCs might impact color perception indirectly, such as through involvement in peripheral color matching, post-receptoral pathways, color constancy, long-term chromatic adaptation, and chromatic induction. While there is consensus about the role of ipRGCs in brightness perception, confirming its direct contribution to human color perception requires further investigation. We proposed potential approaches for future research, emphasizing the need for empirical validation and methodological thoroughness to elucidate the exact role of ipRGCs in human color vision.


Assuntos
Visão de Cores , Células Ganglionares da Retina , Humanos , Células Ganglionares da Retina/fisiologia , Células Fotorreceptoras Retinianas Cones/fisiologia , Percepção Visual , Opsinas de Bastonetes/fisiologia , Psicofísica , Luz
8.
Clin Biochem ; 126: 110730, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38387751

RESUMO

OBJECTIVES: Our objective was to shorten the screen for multiple myeloma (MM), through reflex testing. DESIGN AND METHODS: The clinical laboratory in the public University Hospital of San Juan (Alicante, Spain), serves 234,551 inhabitants. Through an intervention agreed with general practitioners, the Laboratory Information System (LIS) automatically registered serum immunoglobulins (Ig) when serum total proteins (STP) > 80 g/L for the first time in primary care patients. When concomitantly one Ig presented a value above and one below its reference interval, the LIS automatically registered a serum protein electrophoresis (SPEP). When a monoclonal peak in SPEP, immunofixation electrophoresis (IFE) for the typification of monoclonal bands (MB) was performed. If MB were present, a comment in the report explained the intervention. The number of additionally registered Ig, SPEP, IFE, and new diagnosis of MM were counted. The number of days elapsed from the report of elevated STP result to the final MM diagnosis was also counted as median and interquartile range (IQR), and compared to a pre intervention period. RESULTS: 2071 cases of hyperproteinemia were identified, and had 91 a monoclonal peak, confirmed by IFE. In 35 patients it was a new finding, and 9 were diagnosed with MM, 3 Waldestrom macroglobulinemia, 2 lymphoplasmacytic lymphoma and 21 monoclonal gammopathy of undetermined significance. The number of days elapsed from hyperproteinemia to diagnosis was lower in the intervention period (21.5 vs 119.4) (P < 0.01). As our results show, in addition to shortening the time to diagnosis, an increased rate of detection of plasma cell disorders was observed when using our algorithm. CONCLUSIONS: The above laboratory interventions agreed with clinicians, making use of laboratory technology resulted in early identification of MM.


Assuntos
Gamopatia Monoclonal de Significância Indeterminada , Mieloma Múltiplo , Paraproteinemias , Humanos , Mieloma Múltiplo/diagnóstico , Paraproteinemias/diagnóstico , Reflexo , Atenção Primária à Saúde
9.
Prim Health Care Res Dev ; 25: e6, 2024 Jan 17.
Artigo em Inglês | MEDLINE | ID: mdl-38229558

RESUMO

BACKGROUND: Rheumatoid arthritis (RA) is a chronic progressive autoimmune inflammatory disease with significant morbidity and mortality. The course of the disease can be modified if diagnosis is early and treatment appropriate. AIM: In this study, we aimed to evaluate a new strategy for early identification of RA patients in primary care settings (the 'diagnostic bottleneck') based on serological biomarkers and to manage inappropriate rheumatoid factor (RF) laboratory test requests. METHOD: A two-arm study was carried out. The first arm corresponded to a retrospective observational descriptive study of patients referred for RF testing from primary care using the current laboratory workflow. The second arm included the following prospective interventions: cancelation of RF requests corresponding to patients with previous negative results for RF over a one-year period; and automatic reflex testing antibodies against cyclic citrullinated proteins (anti-CCP) for patients displaying RF values >30 IU/ml. Outcomes from both arms were then compared. FINDINGS: As double positivity for RF and anti-CCP notably increases the positive likelihood ratio of RA. The intervention enabled a reduction of 2813 tests in 22 months. Moreover, the frequency of unnecessary referrals was reduced from 22% to 8.2%, while that of missed patients decreased slightly (from 21% to 16%), with the number of patients diagnosed per RF request remaining unchanged. In terms of costs, we saved 19.4 RF tests per anti-CCP test added.We developed a simple and cost-effective strategy for reducing the time to diagnosis of RA that can improve patients' quality of life. This approach was supported by primary and specialised care.


Assuntos
Artrite Reumatoide , Fator Reumatoide , Humanos , Anticorpos Antiproteína Citrulinada , Artrite Reumatoide/diagnóstico , Autoanticorpos , Atenção Primária à Saúde , Estudos Prospectivos , Qualidade de Vida , Estudos Retrospectivos
10.
Clin Chem Lab Med ; 62(2): 234-248, 2024 Jan 26.
Artigo em Inglês | MEDLINE | ID: mdl-37503587

RESUMO

Magnesium is one of the most abundant cations in the body and acts as a cofactor in more than 600 biochemical reactions. Hypomagnesemia is a highly prevalent condition, especially in subjects with comorbid conditions, but has received less attention than other electrolyte disturbances. This review will discuss magnesium physiology, absorption, storage, distribution across the body, and kidney excretion. After reviewing the regulation of magnesium homeostasis, we will focus on the etiology and clinical presentation of hypomagnesemia. The role of laboratory medicine in hypomagnesemia will be the main purpose of this review, and we will discuss the laboratory tests and different samples and methods for its measurement. Although free magnesium is physiologically active, total serum magnesium is the most commonly used measurement in laboratory medicine and is apt for clinical purposes; however, it is not appropriately used, and many patients with hypomagnesemia remain undiagnosed and not treated. Using information technologies, laboratory medicine can largely improve the diagnosis and treatment of hypomagnesemia through the design and establishment of automatic demand management and result management interventions by acting in the first and last steps of the laboratory cycle, test requests, and actions taken after test results, to unmask patients with hypomagnesemia and improve the number of patients undergoing treatment.


Assuntos
Deficiência de Magnésio , Magnésio , Humanos , Deficiência de Magnésio/diagnóstico , Deficiência de Magnésio/terapia , Homeostase
11.
Clin Chem Lab Med ; 2023 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-38044692

RESUMO

Clinical Decision Support Systems (CDSS) have been implemented in almost all healthcare settings. Laboratory medicine (LM), is one of the most important structured health data stores, but efforts are still needed to clarify the use and scope of these tools, especially in the laboratory setting. The aim is to clarify CDSS concept in LM, in the last decade. There is no consensus on the definition of CDSS in LM. A theoretical definition of CDSS in LM should capture the aim of driving significant improvements in LM mission, prevention, diagnosis, monitoring, and disease treatment. We identified the types, workflow and data sources of CDSS. The main applications of CDSS in LM were diagnostic support and clinical management, patient safety, workflow improvements, and cost containment. Laboratory professionals, with their expertise in quality improvement and quality assurance, have a chance to be leaders in CDSS.

12.
Comput Struct Biotechnol J ; 22: 27-31, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37661968

RESUMO

Background: New tools for health information technology have been developed in recent times, such as Clinical Decision Support (CDS) systems, which are any digital solutions designed to help healthcare professionals when making clinical decisions. The study aimed to show how we have adopted a CDS system in the San Juan de Alicante Clinical Laboratory and facilitate the implementation of our protocol in other clinical laboratories. We have user experience and the motivation to improve healthcare tools. The improvement, measurement, and monitoring of interventions and laboratory tests has been our motto for years. Materials and methods: A descriptive research was conducted. All stages in the design of the project are as follows: 1. Set up a multidisciplinary workgroup. 2. Review patients' data. 3. Identify relevant data from main sources. 4. Design the likely outcomes. 5. Define a complete integration scenario. 6. Monitor and track the impact. To set up this protocol, two new software systems were implemented in our laboratory: AlinIQ CDS v8.2 as Rule Engine, and AlinIQ AIP Integrated Platform v1.6 as Business Intelligence (BI) tool. Results: Our protocol shows the workflow and actions that can be done with a CDS system and also how it could be integrated with other monitoring systems, as well as some examples of KPIs and their outcomes. Conclusions: CDS could be a great strategic asset for clinical laboratories to improve the integration of care, optimize the use of laboratory tests, and add more clinical value to physicians in the interpretation of results.

14.
Angew Chem Int Ed Engl ; 62(41): e202307884, 2023 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-37604782

RESUMO

Triangulenes are a class of open-shell triangular graphene flakes with total spin increasing with their size. In the last years, on-surface-synthesis strategies have permitted fabricating and engineering triangulenes of various sizes and structures with atomic precision. However, direct proof of the increasing total spin with their size remains elusive. In this work, we report the combined in-solution and on-surface synthesis of a large nitrogen-doped triangulene (aza-[5]-triangulene) on a Au(111) surface, and the detection of its high-spin ground state. Bond-resolved scanning tunneling microscopy images uncovered radical states distributed along the zigzag edges, which were detected as weak zero-bias resonances in scanning tunneling spectra. These spectral features reveal the partial Kondo screening of a high-spin state. Through a combination of several simulation tools, we find that the observed distribution of radical states is explained by a quintet ground state (S=2), instead of the quartet state (S=3/2) expected for the neutral species. This confirms that electron transfer to the metal substrate raises the spin of the ground state. We further provide a qualitative description of the change of (anti)aromaticity introduced by N-substitution, and its role in the charge stabilization on a surface, resulting in an S=2 aza-triangulene on Au(111).

15.
Clín. salud ; 34(2): 51-63, jul. 2023. tab
Artigo em Inglês | IBECS | ID: ibc-223205

RESUMO

Background: Perinatal depression is a major public health problem, with an estimated prevalence of approximately 15% during the first postpartum year. Despite the high prevalence of postpartum depression, there is no consensus regarding assessment and treatment in the Spanish context. The General Council of Psychology of Spain convened a working group of experts in the field, including both academics and healthcare professionals, to review and propose recommendations based on evidence and best practices that could be applied in the Spanish context. Method: A literature search was completed in various databases (e.g., Medline, PsychInfo) including a combination of terms related to peripartum depression (PPD) assessment and diagnosis, prevention, treatment, and cost-effectiveness. A narrative synthesis of the literature has been conducted together with a critical overview of PPD with a special focus on the Spanish context. Results: In this consensus report, developing questions including prevalence and assessment tools, comparative effectiveness of preventive and treatment interventions, and cost-effectiveness of PPD management have been analyzed. Conclusions: The General Council of Psychology of Spain network advocates the establishment of compulsory screening protocols in all the autonomous regions. Also, it is necessary to promote the inclusion in maternal education of programs for the promotion of mental well-being and selective/indicated prevention carried out by a psychology professional with specialized training in the area. This consensus document also promotes the presence of a psychology professional with specialized training in the area. (AU)


Antecedentes: La depresión perinatal es un importante problema de salud pública, con una prevalencia estimada de aproximadamente el 15% durante el primer año posparto. A pesar de la gran prevalencia de depresión posparto (DPP), no existe consenso sobre la evaluación y el tratamiento en el contexto español. El Consejo General de Psicología de España convocó a un grupo de trabajo de expertos en la materia, tanto académicos como profesionales sanitarios, para revisar y proponer recomendaciones basadas en evidencias y mejores prácticas que puedan aplicarse en el contexto español. Método: Se realizó una búsqueda bibliográfica en varias bases de datos (p. ej., Medline, PsychInfo) que incluía una combinación de términos relacionados con la evaluación y el diagnóstico de la DPP, prevención, tratamiento y coste-eficacia. Se ha realizado una síntesis narrativa de la literatura junto con una visión crítica de la DPP con un enfoque especial en el contexto español. Resultados: Las preguntas de desarrollo que incluyen prevalencia y herramientas de evaluación, la eficacia comparativa de las intervenciones preventivas y de tratamiento y la relación coste-efectividad de la gestión de la PPD se han analizado en este informe de consenso. Conclusiones: La red del Consejo General de Psicología de España aboga por el establecimiento de protocolos obligatorios de cribado en todas las Comunidades Autónomas. Asimismo, es necesario promover la inclusión en la educación materna de programas de promoción del bienestar mental y la prevención selectiva indicada llevadas a cabo por un profesional de la psicología con formación especializada en el área. (AU)


Assuntos
Humanos , Depressão Pós-Parto/tratamento farmacológico , Depressão Pós-Parto/economia , Depressão Pós-Parto/epidemiologia , Depressão Pós-Parto/prevenção & controle , Espanha , Prevalência
16.
Clin Chem Lab Med ; 61(10): 1677-1678, 2023 09 26.
Artigo em Inglês | MEDLINE | ID: mdl-37155580
17.
Foods ; 12(8)2023 Apr 14.
Artigo em Inglês | MEDLINE | ID: mdl-37107440

RESUMO

Protein-based foods based on sweet lupine are gaining the attention of industry and consumers on account of their being one of the legumes with the highest content of proteins (28-48%). Our objective was to study the thermal properties of two lupine flours (Misak and Rumbo) and the influence of different amounts of lupine flour (0, 10, 20 and 30%) incorporations on the hydration and rheological properties of dough and bread quality. The thermograms of both lupine flours showed three peaks at 77-78 °C, 88-89 °C and 104-105 °C, corresponding to 2S, 7S and 11S globulins, respectively. For Misak flour, higher energy was needed to denature proteins in contrast to Rumbo flour, which may be due to its higher protein amount (50.7% vs. 34.2%). The water absorption of dough with 10% lupine flour was lower than the control, while higher values were obtained for dough with 20% and 30% lupine flour. In contrast, the hardness and adhesiveness of the dough were higher with 10 and 20% lupine flour, but for 30%, these values were lower than the control. However, no differences were observed for G', G″ and tan δ parameters between dough. In breads, the protein content increased ~46% with the maximum level of lupine flour, from 7.27% in wheat bread to 13.55% in bread with 30% Rumbo flour. Analyzing texture parameters, the chewiness and firmness increased with incorporations of lupine flour with respect to the control sample while the elasticity decreased, and no differences were observed for specific volume. It can be concluded that breads of good technological quality and high protein content could be obtained by the inclusion of lupine flours in wheat flour. Therefore, our study highlights the great technological aptitude and the high nutritional value of lupine flours as ingredients for the breadmaking food industry.

18.
Lab Med ; 54(5): 473-478, 2023 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-36655985

RESUMO

BACKGROUND: There are nonestablished protocols in use for first-line allergy screening based on IgE testing. These protocols attempt to address an unmet need for sustainability of clinical laboratories, at a time when demand is increasing. OBJECTIVE: To present a novel protocol for first-line allergy screening and to evaluate the implementation benefits for patients, the health care system, and payers. METHODS: We carried out an observational retrospective study analyzing 4359 interventions on primary care testing requests. Interventions included overriding redundant serum IgE (sIgE) testing for allergen mixes, extracts included in mixes, low-prevalence extracts, and milk and egg molecular components without previous positive results when exposed to extracts. We also added prevalent allergen testing. RESULTS: The strategy saved 683 tests from being performed unnecessarily. Test volume decline was primarily driven by the cancelation of 2186 egg and milk components tests; 561 tests were added for mixes, together with 942 allergen extracts tests. DISCUSSION: The results of this study show how the allergy laboratory plays a key role in actively managing demand for sIgE testing, leading to optimized diagnosis.


Assuntos
Hipersensibilidade , Humanos , Estudos Retrospectivos , Hipersensibilidade/diagnóstico , Alérgenos , Imunoglobulina E , Atenção Primária à Saúde
19.
Rev. argent. reumatolg. (En línea) ; 34(1): 3-15, ene. 2023. tab
Artigo em Espanhol | BINACIS, LILACS | ID: biblio-1449435

RESUMO

Introducción: conocer la seguridad de las drogas actualmente disponibles para el tratamiento de las enfermedades reumáticas es muy importante al momento de tomar decisiones terapéuticas objetivas e individualizadas en la consulta médica diaria. Asimismo, datos de la vida real amplían el conocimiento revelado por los ensayos clínicos. Objetivos: describir los eventos adversos (EA) reportados, estimar su frecuencia e identificar los factores relacionados con su desarrollo. Materiales y métodos: se utilizaron datos BIOBADASAR, un registro voluntario y prospectivo de seguimiento de EA de tratamientos biológicos y sintéticos dirigidos en pacientes con enfermedades reumáticas inmunomediadas. Los pacientes son seguidos hasta la muerte, pérdida de seguimiento o retiro del consentimiento informado. Para este análisis se extrajeron datos recopilados hasta el 31 de enero de 2023. Resultados: se incluyó un total de 6253 pacientes, los cuales aportaron 9533 ciclos de tratamiento, incluyendo 3647 (38,3%) ciclos sin drogas modificadoras de la enfermedad biológicas y sintéticas dirigidas (DME-b/sd) y 5886 (61,7%) con DME-b/sd. Dentro de estos últimos, los más utilizados fueron los inhibidores de TNF y abatacept. Se reportaron 5890 EA en un total de 2701 tratamientos (844 y 1857 sin y con DME-b/sd, respectivamente), con una incidencia de 53,9 eventos cada 1000 pacientes/año (IC 95% 51,9-55,9). La misma fue mayor en los ciclos con DME-b/sd (71,1 eventos cada 1000 pacientes/año, IC 95% 70,7-77,5 versus 33,7, IC 95% 31,5-36,1; p<0,001). Las infecciones, particularmente las de la vía aérea superior, fueron los EA más frecuentes en ambos grupos. El 10,9% fue serio y el 1,1% provocó la muerte del paciente. El 18,7% de los ciclos con DME-b/sd fue discontinuado a causa de un EA significativamente mayor a lo reportado en el otro grupo (11,5%; p<0,001). En el análisis ajustado, las DME-b/sd se asociaron a mayor riesgo de presentar al menos un EA (HR 1,82, IC 95% 1,64-1,96). De igual manera, la mayor edad, el mayor tiempo de evolución, el antecedente de enfermedad pulmonar obstructiva crónica, el diagnóstico de lupus eritematoso sistémico y el uso de corticoides se asociaron a mayor riesgo de EA. Conclusiones: la incidencia de EA fue significativamente superior durante los ciclos de tratamientos que incluían DME-b/sd.


Introduction: knowing the efficacy and safety of the drugs currently available for the treatment of rheumatic diseases is very important when making objective and individualized therapeutic decisions in daily medical consultation. Likewise, real-life data extends the knowledge revealed by clinical trials. Objectives: to describe the reported adverse events (AEs), estimate their frequency and identify factors associated to them. Materials and methods: BIOBADASAR data were used, which is a voluntary, prospective follow-up registry of AEs of biological and synthetic treatments in patients with immune-mediated rheumatic diseases. Patients are followed until death, loss of followup, or withdrawal of informed consent. To carry out this analysis, the data collected up to January 31, 2023 was extracted. Results: a total of 6253 patients were included, who contributed with 9533 treatment periods, including 3647 (38.3%) periods without b/ts-DMARDs and 5886 (61.7%) with b/ts-DMARDs. Among the latter, the most used were TNF inhibitors and abatacept. A total of 5890 AEs were reported in a total of 2701 treatments (844 and 1857 without and with b/ts-DMARDs, respectively), with an incidence of 53.9 events per 1000 patients/ year (95% CI 51.9-55.9). It was higher during the periods with b/ts-DMARDs (71.1 events per 1000 patients/year, 95% CI 70.7-77.5 vs 33.7, 95% CI 31.5-36.1, p<0.001). Infections, particularly those of the upper respiratory tract, were the most frequent AEs in both groups. 10.9% were severe and 1.1% were associated with the death of the patient. 18.7% of the periods with b/ts-DMARDs were discontinued due to an AE, significantly higher than that reported in the other group (11.5%; p<0.001). In the adjusted analysis, b/ts-DMARDs were associated with a higher risk of presenting at least one AE (HR 1.82, 95% CI 1.64-1.96). Similarly, older age, longer evolution time, history of chronic obstructive pulmonary disease, diagnosis of systemic lupus erythematosus, and use of corticosteroids were associated with a higher risk of AE. Conclusions: the incidence of AEs was significantly higher during those treatment periods that included DME-b/sd.


Assuntos
Terapia Biológica , Terapia de Alvo Molecular , Medicamentos Sintéticos
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