Practice variation in timing of antenatal corticosteroid administration in early-onset fetal growth restriction: A secondary analysis of the Dutch STRIDER study.

INTRODUCTION: In early-onset fetal growth restriction the fetus fails to thrive in utero due to unmet fetal metabolic demands. This condition is linked to perinatal mortality and severe neonatal morbidity. Maternal administration of corticosteroids in high-risk pregnancies for preterm birth at a gestational age between 24 and 34 weeks has been shown to reduce perinatal mortality and morbidity. Practice variation exists in the timing of the administration of corticosteroids based on umbilical artery monitoring findings in early-onset fetal growth restriction. The aim of this study was to examine differences in neonatal outcomes when comparing different corticosteroid timing strategies. MATERIAL AND METHODS: This was a post-hoc analysis of the Dutch STRIDER trial. We examined neonatal outcomes when comparing institutional strategies of early (umbilical artery pulsatility index >95th centile) and late (umbilical artery shows absent or reversed end-diastolic flow) administration of corticosteroids. The primary outcomes were neonatal mortality and a composite of neonatal mortality and neonatal morbidity, defined as bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis or retinopathy of prematurity. We also analyzed predictors for adverse neonatal outcomes, including gestational age at delivery, birthweight, maternal hypertensive disorders, and time interval between corticosteroids and birth. RESULTS: A total of 120 patients matched our inclusion criteria. In 69 (57.5%) the early strategy was applied and in 51 (42.5%) patients the late strategy. Median gestational age at delivery was 28 4/7 (± 3, 3/7) weeks. Median birthweight was 708 (± 304) g. Composite primary outcome was found in 57 (47.5%) neonates. No significant differences were observed in the primary outcome between the two strategies (neonatal mortality adjusted odds ratio [OR] 1.22, 95% CI 0.44-3.38; composite primary outcome adjusted OR 1.05, 95% CI 0.42-2.64). Only gestational age at delivery was a significant predictor for improved neonatal outcome (adjusted OR 0.91, 95% CI 0.86-0.96). CONCLUSIONS: No significant differences in neonatal outcomes were observed when comparing early and late strategy of antenatal corticosteroid administration on neonatal outcomes in pregnancies complicated by early-onset fetal growth restriction. We found no apparent risk contribution of interval between corticosteroid administration and delivery in multivariate analysis. Gestational age at delivery was found to be an important predictor of neonatal outcome.

Traquioniquia, ¿de qué se trata? / Trachyonychia, what is it about?

La traquioniquia es una afección ungueal de diagnóstico clínico y buen pronóstico, pero se ha de tener en cuenta que bajo su apariencia pueden subyacer otras enfermedades. Antes de plantear su tratamiento, es necesario valorar cómo afecta a la calidad de vida de los pacientes, ya que tiende a la resolución espontánea. (AU)

Trachyonychia is a nail disorder with good prognosis which diagnosis is clinical but, under this condition could be other diseases. So, before treatment it is necessary to ascertain how it affects patient´s quality of life as spontaneous resolution is possible. (AU)

Breaking through the steroid stigma: a single-centre study on topical corticosteroid perception and adherence in dermatology patients and caregivers.

INTRODUCTION: Topical corticosteroid phobia is a common phenomenon that can result in poor treatment adherence and therapeutic failure. OBJECTIVES: This study aims to evaluate the prevalence and degree of topical corticosteroid phobia and its impact on treatment adherence in various dermatological conditions. Additionally, we explored the sources of information regarding topical corticosteroids. MATERIALS AND METHODS: A cross-sectional study was conducted among 300 participants with topical corticosteroid usage experience. Topical corticosteroid phobia was assessed with the topical corticosteroid phobia (TOPICOP) scale, and treatment adherence was measured with the Elaboration d'un outil d'evaluation de l'observance des traitements medicamenteux (ECOB) score. Information sources regarding topical corticosteroids were identified, and their level of trust was assessed. The data were collected via questionnaires in three languages, namely English, Malay and Mandarin. RESULTS: The study found that topical corticosteroid phobia was prevalent, with 98% of participants expressing a certain degree of phobia. The mean global TOPICOP score was 32.7 ± 6.7%. The mean score of each domain was 27.1 ± 17.2% for knowledge and belief, 35.7 ± 23.8% for fears and 40.8 ± 25.8% for behaviour. Patients/caregivers who have eczema, highly educated, severe disease, low tolerability to symptoms, previous adverse effects with topical corticosteroids and tend to traditional/non-steroidal alternative therapy usage had a significant association with topical corticosteroid phobia (p<0.05). Dermatologists were the most common and trusted source of information on topical corticosteroids. CONCLUSIONS: This study highlights the widespread topical corticosteroid phobia in dermatological practice. Dermatologists should take the lead in combating steroid phobia and provide patients with public awareness regarding topical corticosteroids to improve treatment adherence and therapeutic outcomes.

Reduction of disease activity, corticosteroids use, and healthcare resource utilisation in patients with systemic lupus erythematosus treated with belimumab in clinical practice settings: OBSErve Spain multicentre study / Reducción de la actividad de la enfermedad, el uso de corticosteroides y recursos sanitarios en pacientes con lupus eritematoso sistémico tratados con belimumab en práctica clínica real: estudio multicéntrico OBSErve España

Introduction and objectives: This OBSErve Spain study, a part of the international OBSErve programme, evaluated belimumab real-world use and effectiveness following 6 months of treatment in patients with active systemic lupus erythematosus (SLE) in clinical practice in Spain. Materials and methods: In this retrospective, observational study (GSK Study 200883), eligible patients with SLE receiving intravenous belimumab (10mg/kg) had their disease activity (physician assessed), SELENA-SLEDAI scores, corticosteroid use, and healthcare resource utilisation (HCRU), assessed after 6 months of treatment versus index (belimumab initiation) or 6 months pre-index. Results: Overall, 64 patients initiated belimumab, mainly due to ineffectiveness of previous treatments (78.1%) and to reduce corticosteroid use (57.8%). Following 6 months of treatment, 73.4% of patients achieved ≥20% overall clinical improvement, while only 3.1% of patients worsened. Mean (standard deviation, SD) SELENA-SLEDAI score decreased from 10.1 (6.2) at index to 4.5 (3.7) 6 months post-index. HCRU decreased from 6 months pre-index to 6 months post-index, with fewer hospitalisations (10.9% vs 4.7% patients) and ER visits (23.4% vs 9.4% patients). Mean (SD) corticosteroid dose decreased from 14.5 (12.5)mg/day at index to 6.4 (5.1)mg/day 6 months post-index. Conclusions: Patients with SLE receiving belimumab for 6 months in real-world clinical practice in Spain experienced clinical improvements and a reduction in HCRU and corticosteroid dose.(AU)

Introducción y objetivos: El estudio OBSErve España, que forma parte del programa internacional OBSErve, evaluó el uso y la eficacia de belimumab en la práctica clínica real española tras seis meses de tratamiento en pacientes con lupus eritematoso sistémico (LES) activo. Materiales y métodos: En este estudio observacional y retrospectivo (GSK Study 200883) fue evaluada la respuesta clínica, la actividad de la enfermedad (puntuación SELENA-SLEDAI), el uso de corticosteroides y los recursos sanitarios utilizados de los pacientes con LES que recibieron belimumab intravenoso (10mg/kg), al inicio y tras seis meses de tratamiento. Resultados: En total 64 pacientes iniciaron belimumab, principalmente por ineficacia de los tratamientos previos (78,1%) y para reducir los corticoides (57,8%). Después de seis meses de tratamiento, 73,4% de los pacientes lograron una mejoría clínica general de ≥20%, mientras que solo 3,1% de los pacientes empeoró. La puntuación media (desviación estándar, DE) de SELENA-SLEDAI disminuyó de 10,1 (6,2) a 4,5 (3,7). Los recursos sanitarios utilizados disminuyeron con menos hospitalizaciones (10,9 vs. 4,7%) y visitas a urgencias (23,4 vs. 9,4%). La dosis media (DE) de corticosteroides disminuyó de 14,5 (12,5mg/día) a 6,4 (5,1mg/día). Conclusiones: Los pacientes con LES que recibieron belimumab durante seis meses en la práctica clínica real en España experimentaron mejoras clínicas y una reducción de la dosis de corticosteroides y recursos sanitarios utilizados.(AU)

The adherence to and utility of the Global Initiative for Chronic Obstructive Lung Disease guidelines for treating COPD among pulmonary specialists: a retrospective analysis.

BACKGROUND: Despite the evidence-based guidelines promoted by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), the overuse of prescription drugs to manage COPD, particularly inhaled corticosteroids (ICS), remains a persistent challenge. In this real-world study, we evaluated how patients with COPD were divided into ABCD groups based on the 2017 GOLD guidelines, determined the rate of adherence to the GOLD treatment recommendations, described the rate of ICS usage, and determined the rate of triple therapy (TT) prescription. METHODS: The charts of 2291 patients diagnosed with COPD were retrospectively analyzed, of which 1438 matched the eligibility criteria. RESULTS: The average patient age was 69.6 ± 10.9 years; 52% of patients were female. The average COPD assessment test (CAT) score was 18.3 ± 9.1. The ABCD breakdown was as follows: group A 19.5%, group B 64.1%, group C 1.8%, and group D 14.6%. All groups, except group D, showed discordance in COPD treatment relative to the proposed GOLD guidelines. Only 18.9% of group A and 26% of group B were treated in concordance with the guidelines. TT was primarily used in group D (63.3%) and overused in groups A (30.6%) and B (47.8%). ICS was overused in all groups, particularly in groups A (56.2%) and B (67.3%). CONCLUSION: Studies from the last decade have consistently revealed a lack of conformity between what physicians prescribe and what GOLD guidelines recommend. The excessive usage of ICS, which continues despite all the associated adverse effects and the attributable costs, is concerning. The awareness of GOLD guidelines among primary care physicians (PCPs) and respiratory specialists needs to be improved.

Topical Anesthetic versus Lidocaine Mixture for Pain Relief During Keloid Treatment: A Prospective, Split Study.

BACKGROUND: The most common typical symptoms of keloids can be pain and itchiness. Intralesional corticosteroid administration is generally the first-line conservative treatment. Minimizing pain during intralesional corticosteroid injections into keloids should be aimed, as the treatment is often painful. There has yet to be a report on which local anesthetic technique is superior in keloid treatment between topical anesthetic versus lidocaine mixture injection. METHODS: This was a single-center prospective study. The study included 100 patients with painful multiple/multifocal keloids aged 18 to 85 years and was performed between May 2021 and December 2022. Among multiple keloid lesions in a single patient, we assigned the keloids pretreated with topical cream application versus local injection. Then, subjects received 40 mg of intralesional corticosteroid injections into the keloids with a 26G needle to treat keloids. Patients rated the pain intensity of each lesion pretreated with two different anesthetic techniques on an 11-point numeric rating scale. A separate direct question of "Which technique would you recommend if you had to be injected again?" was given. RESULTS: One-hundred patients with painful multiple/multifocal keloids were included in the study. Data on pain intensity numeric rating scale (NRS) revealed that injection techniques relieved the pain statistically significantly more than topical creams. ( P <0.001) 63% of the participants (n=63) preferred the injection technique, while 25% preferred topical anesthetics. In total, 12% of patients responded that there was no difference between the two techniques. CONCLUSION: When comparing with topical lidocaine/prilocaine (EMLA) cream, a 1:1 mixture of 1% lidocaine and epinephrine significantly alleviated pain during and after the corticosteroid injection.

Prescription Patterns of New Use of Fixed-Dose Combination Inhalers in Patients with Chronic Obstructive Pulmonary Disease: Long-Acting ß2 Agonists Plus Long-Acting Muscarinic Antagonists versus Long-Acting ß2 Agonists Plus Inhaled Corticosteroids.

Background: The clinical guideline recommends use of long-acting ß2 agonists/long-acting muscarinic antagonists (LABA/LAMA) or long-acting ß2 agonists/inhaled corticosteroids (LABA/ICS) combination therapies for patients with severe chronic obstructive pulmonary disease (COPD). The fixed-dose combination (FDC) inhalers of LABA/LAMA and LABA/ICS were reimbursed in Taiwan in 2015 and in 2002, respectively. This study aimed to examine prescription patterns of new use of either FDC therapy in real-world practice. Methods: We identified COPD patients who initiated LABA/LAMA FDC or LABA/ICS FDC between 2015 and 2018 from a population-based Taiwanese database with 2 million, randomly sampled beneficiaries enrolled in a single-payer health insurance system. We compared number of LABA/LAMA FDC and LABA/ICS FDC initiators in each calendar year, from different hospital accreditation levels, and cared for by different physician specialties. We also compared baseline patient characteristics between LABA/LAMA FDC and LABA/ICS FDC initiators. Results: A total of 12,455 COPD patients who initiated LABA/LAMA FDC (n=4019) or LABA/ICS FDC (n=8436) were included. Number of LABA/LAMA FDC initiators increased apparently (n=336 in 2015 versus n=1436 in 2018), but number of LABA/ICS FDC initiators decreased obviously (n=2416 in 2015 versus n=1793 in 2018) over time. The preference of use of LABA/LAMA FDC varied across clinical environments. The proportions of LABA/LAMA FDC initiators were more than 30% in the setting of non-primary care clinics (eg, medical centers) and in the services of chest physicians; but were only less than 10% in primary care clinics and non-chest physicians' services (eg, family medicine physicians). LABA/LAMA FDC initiators appeared to be older, male, to have more comorbidities, and to utilize resources more frequently compared to LABA/ICS FDC initiators. Conclusion: This real-world study found evident temporal trends, variations in healthcare provider, and differences in patient characteristics among COPD patients who initiated LABA/LAMA FDC or LABA/ICS FDC.

Reducing the Risk of Mortality in Chronic Obstructive Pulmonary Disease With Pharmacotherapy: A Narrative Review.

In 2020, chronic obstructive pulmonary disease (COPD) was the fifth leading cause of death in the United States excluding COVID-19, and its mortality burden has been rising since the 1980s. Smoking cessation, long-term oxygen therapy, noninvasive ventilation, and lung volume reduction surgery have had a beneficial effect on mortality; however, until recently, the effects of pharmacologic therapies on all-cause mortality have been unclear. Inhaled pharmacologic treatments for patients with COPD include combinations of long-acting muscarinic receptor antagonists (LAMAs), long-acting-ß2-agonists (LABAs), and inhaled corticosteroids (ICS). The recent IMPACT and ETHOS clinical trials reported mortality benefits with ICS/LAMA/LABA triple therapy compared with LAMA/LABA dual therapy. In IMPACT, fluticasone furoate/umeclidinium/vilanterol therapy significantly reduced the risk of on-/off-treatment all-cause mortality vs umeclidinium/vilanterol (hazard ratio, 0.72; 95% CI, 0.53 to 0.99; P=.042). The ETHOS trial found a reduction in the risk of on-/off-treatment all-cause mortality in patients treated with budesonide/glycopyrrolate/formoterol vs glycopyrrolate/formoterol (hazard ratio, 0.51 [0.33 to 0.80]; nominal P=.0035). Both trials included populations of patients with symptomatic COPD at high risk of future exacerbations, and a post hoc analysis of the final retrieved vital status data suggested that the observed mortality benefits are conferred by the ICS component. In conclusion, triple therapy reduces the risk of mortality in patients with symptomatic COPD characterized by moderate or severe airflow obstruction and a recent history of moderate or severe exacerbations. This benefit is likely to be driven by reductions in exacerbations. Future research efforts should focus on improving the long-term prognosis of patients living with COPD.

Oral corticosteroids vs. exercises on treatment of frozen shoulder: a randomized, single-blinded study.

BACKGROUND: Many treatment strategies have been described for the management of frozen shoulder. However, to date no randomized controlled trial has directly compared the efficacy of exercise and oral corticosteroids. The aim of this study was to determine whether pain, range of motion (ROM), and function differ between patients with frozen shoulder randomized to treatment with exercise or oral corticosteroids. METHODS: This prospective, randomized, assessor-blinded trial was performed to compare the effectiveness of exercise and oral corticosteroids in patients with frozen shoulder. Overall, 33 patients with frozen shoulder were randomly assigned to receive either exercise (n = 17) or oral corticosteroids (n = 16). The exercise was applied 2 times per week for 6 weeks for 12 visits; patients in the oral corticosteroids group received prednisolone for 4 weeks. Participants were assessed at baseline, after 6 weeks and at the 12-week follow-up. The primary outcome was the Disabilities of the Arm, Shoulder and Hand and visual analog scale. Secondary outcomes were American Shoulder and Elbow Surgeons Standardized Shoulder Assessment, ROM, and Hospital Anxiety and Depression Scale. Repeated-measures analysis of covariance with baseline scores as the covariates was used to determine between-group differences. An intention-to-treat analysis was performed using the multiple imputation method to impute values for all missing data. RESULTS: Planned pairwise comparisons demonstrated significant improvements in pain relief and functional outcomes in both groups at the 6- and 12-week follow-ups compared to baseline. There were no significant time-by-group interactions between-group differences noted for the Disabilities of the Arm, Shoulder and Hand (F = 0.470, P = .93), visual analog scale (F = 0.006, P = .94), flexion ROM (F = 2.78, P = .1), internal rotation ROM (F = 3.440, P = .07) and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (F = 0.470, P = .49). The overall group-by-time interaction for the 2 × 3 mixed-model analysis of covariance using baseline scores as a covariate was significant for the abduction range (F = 4.460, P = .04) and external rotation ROM (F = 12.100, P = .002) in favor of the exercise group. CONCLUSIONS: The study demonstrated that while both groups achieved significant improvements at the 6-, and 12-week follow-ups, the exercise group was superior in terms of abduction and external rotation ROM. Additionally, even though both groups were improved, the effect sizes were larger in the exercise group. Considering the systemic side effects of oral corticosteroids, even at low doses, a well-planned exercise program that considers pain may be a good option for frozen shoulder.

A differential therapeutic consideration for use of corticosteroids according to established COVID-19 clinical phenotypes in critically ill patients / Una consideración terapéutica diferencial para el uso de corticoesteroides en COVID-19 según los diferentes fenotipos clínicos establecidos en pacientes críticos

bjective To determine if the use of corticosteroids was associated with Intensive Care Unit (ICU) mortality among whole population and pre-specified clinical phenotypes. Design A secondary analysis derived from multicenter, observational study. Setting Critical Care Units. Patients Adult critically ill patients with confirmed COVID-19 disease admitted to 63 ICUs in Spain. Interventions Corticosteroids vs. no corticosteroids. Main variables of interest Three phenotypes were derived by non-supervised clustering analysis from whole population and classified as (A: severe, B: critical and C: life-threatening). We performed a multivariate analysis after propensity optimal full matching (PS) for whole population and weighted Cox regression (HR) and Fine-Gray analysis (sHR) to assess the impact of corticosteroids on ICU mortality according to the whole population and distinctive patient clinical phenotypes. Results A total of 2017 patients were analyzed, 1171 (58%) with corticosteroids. After PS, corticosteroids were shown not to be associated with ICU mortality (OR: 1.0; 95% CI: 0.98–1.15). Corticosteroids were administered in 298/537 (55.5%) patients of “A” phenotype and their use was not associated with ICU mortality (HR=0.85 [0.55–1.33]). A total of 338/623 (54.2%) patients in “B” phenotype received corticosteroids. No effect of corticosteroids on ICU mortality was observed when HR was performed (0.72 [0.49–1.05]). Finally, 535/857 (62.4%) patients in “C” phenotype received corticosteroids. In this phenotype HR (0.75 [0.58–0.98]) and sHR (0.79 [0.63–0.98]) suggest a protective effect of corticosteroids on ICU mortality. Conclusion Our finding warns against the widespread use of corticosteroids in all critically ill patients with COVID-19 at moderate dose. Only patients with the highest inflammatory levels could benefit from steroid treatment (AU)

Objetivo Evaluar si el uso de corticoesteroides (CC) se asocia con la mortalidad en la unidad de cuidados intensivos (UCI) en la población global y dentro de los fenotipos clínicos predeterminados. Diseño Análisis secundario de estudio multicéntrico observacional. Ámbito UCI. Pacientes Pacientes adultos con COVID-19 confirmado ingresados en 63 UCI de España. Intervención Corticoides vs. no corticoides. Variables de interés principales A partir del análisis no supervisado de grupos, 3 fenotipos clínicos fueron derivados y clasificados como: A grave, B crítico y C potencialmente mortal. Se efectuó un análisis multivariado después de un propensity optimal full matching (PS) y una regresión ponderada de Cox (HR) y análisis de Fine-Gray (sHR) para evaluar el impacto del tratamiento con CC sobre la mortalidad en la población general y en cada fenotipo clínico. Resultados Un total de 2.017 pacientes fueron analizados, 1.171 (58%) con CC. Después del PS, el uso de CC no se relacionó significativamente con la mortalidad en UCI (OR: 1,0; IC 95%: 0,98-1,15). Los CC fueron administrados en 298/537 (55,5%) pacientes del fenotipo A y no se observó asociación significativa con la mortalidad (HR=0,85; 0,55-1,33). Un total de 338/623 (54,2%) pacientes del fenotipo B recibieron CC sin efecto significativo sobre la mortalidad (HR=0,72; 0,49-1,05). Por último, 535/857 (62,4%) pacientes del fenotipo C recibieron CC. En este fenotipo, se evidenció un efecto protector de los CC sobre la mortalidad HR (0,75; 0,58-0,98). Conclusión Nuestros hallazgos alertan sobre el uso indiscriminado de CC a dosis moderadas en todos los pacientes críticos con COVID-19. Solamente pacientes con elevado estado de inflamación podrían beneficiarse con el tratamiento con CC (AU)

Decision-making factors for the long-term topical treatment of mild-to-moderate plaque psoriasis: TEPPSO, a case-vignette study on clinical practice.

OBJECTIVES: Topical maintenance therapy strategy with regard to patients with mild-to-moderate plaque psoriasis (PP) continues to be heterogeneous and insufficiently investigated in real-life clinical practice. The objective of this study was to describe the initiation of long-term maintenance treatment and to identify clinical parameters influencing the therapeutic decision. METHODS: TEPPSO was a French and Belgian multicentre cross-sectional study based on completion of questionnaires and assessment of credible clinical scenarios of mild-to-moderate PP by physicians using the validated case-vignette method. RESULTS: Maintenance therapy was recommended by dermatologists (Ds) and by general practitioners (GPs) in 79.1% and 76.8% of cases, respectively. GPs recommended the use of a fixed-dose combination of corticosteroid and vitamin D analogues in only 14.8% of cases, whereas this therapy was recommended by French and Belgian Ds in 54.8% and 39.8% of cases, respectively. In a multivariate analysis, significant determinants of the therapeutic decision were skin lesions impacting quality of life (OR 1.9 [95% CI: 1.1; 3.2] P=0.01) for Ds, and patient corticophobia (OR 1.7 [95% CI: 1.1; 2.7] P=0.03) or the presence of skin pruritus (OR 1.8 [95% CI: 1.2; 1.8] P=0.004) for GPs, respectively. CONCLUSIONS: Maintenance treatment with topical agents in patients with mild-to-moderate PP was considered in more than two thirds of cases. Heterogeneity in the choice of topical agents was evidenced particularly between Ds and GPs. Our study is the first to identify significant clinical determinants affecting the therapeutic decision. Updated and validated clinical practice guidelines are needed to ensure uniform therapeutic choices.

Actualización del consenso chileno SOCHINEP-SER para el manejo de las sibilancias recurrentes del preescolar / Update of the chilean consensus SOCHINEP-SER for the management of recurrent wheezing in preschool children

Las sibilancias recurrentes del preescolar son un problema prevalente. 50% de todos los niños tiene al menos un episodio de sibilancias en los primeros 6 años. Sin embargo, solo 4 % de los menores de 4 años tiene diagnóstico de asma. Por este motivo es fundamental realizar una adecuada anamnesis y examen físico tendientes a descartar causas secundarias, lo que debe ser complementado con exámenes de laboratorio de acuerdo con la orientación clínica. En la actualidad se recomienda indicar tratamiento de mantención con corticoides inhalados en aquellos niños que tengan episodios repetidos de obstrucción bronquial y que tengan una alta probabilidad de respuesta favorable a esta terapia. Se ha demostrado que aquellos pacientes que tienen un recuento de eosinófilos en sangre > 300 células por mm3 o aquellos que presentan una prueba cutánea positiva o IgE específicas positivas para alérgenos inhalados, responderán adecuadamente al tratamiento con esteroides inhalados.

Recurrent wheezing in preschoolers has a high prevalence. 50% of all children have at least one wheezing episode in the first six years of life. However, only 4% of children under four years of age are diagnosed with asthma. Therefore, it is essential to carry out an adequate medical history and physical examination to rule out secondary causes, which must be complemented with laboratory tests in accordance with clinical guidance. It is recommended to indicate maintenance treatment with inhaled corticosteroids to those children who have repeated episodes of wheezing and who have a high probability of a good response to this therapy. It has been demonstrated that those patients who have blood eosinophil count > 300 cells per mm3 or those who have a positive skin test or positive specific IgE for inhaled allergens will have a good response to inhaled corticosteroids.

Corticosteroid safety in COVID-19 patients: a pharmacovigilance study / Seguridad de corticoesteroides en pacientes con COVID-19: un estudio de farmacovigilancia

The use of oral and intravenous corticosteroids as a treatment for SARS-CoV-2 infection has been shown to inhibit the exaggerated inflammatory response, reducing symptoms and days of hospitalization of patients. However, its use is controversial because not enough clinical studies have been made to verify the safety of the drugs. Objective: To assess the safety profile of corticosteroids treatment, at high and low doses, in suspected or confirmed patients with COVID-19, determining the most frequent side effects in patients, and assessing whether the administration of the drugs represents a greater benefit than the risk of presenting these effects. Methods: Ambispective study of active pharmacovigilance at a cohort of confirmed or suspected COVID-19 patients, treated with intravenous and oral corticosteroids. 366 patients were evaluated and divided into 3 groups: use of methylprednisolone (155 mg average) every 24 hours for 3 days, dexamethasone (6 mg) every 24 hours for 10 days, and a control group. Results: The distribution of the cases with hyperglycemia was 33 in high doses and 82 with low doses of corticosteroids and both high and low doses have a similar distribution in cases of infections. When evaluating the harshness and severity of hyperglycemia in the two groups with corticosteroids, it is observed that patients with high doses present more harsh (48%). In case of harshness and severity of infections it is observed that patients with high doses present more harsh (62%) and more severe (79%) cases than those who were administered low doses. (AU)

El uso de corticoides orales e intravenosos como tratamiento para la infección por SARS-CoV-2 ha demostrado inhibir la respuesta inflamatoria exagerada, reduciendo los síntomas y los días de hospitalización de los pacientes. Sin embargo, su uso es controvertido porque no se han realizado suficientes estudios clínicos para verificar la seguridad de los medicamentos. Objetivo: Evaluar el perfil de seguridad del tratamiento con corticoides, a dosis altas y bajas, en pacientes con sospecha o confirmación de COVID-19, determinando los efectos secundarios más frecuentes en los pacientes, y valorando si la administración de los fármacos representa un mayor beneficio que el riesgo de presentar estos efectos. Métodos: Estudio ambispectivo de farmacovigilancia activa en una cohorte de pacientes confirmados o sospechosos de COVID-19, tratados con corticoides intravenosos y orales. Se evaluaron 366 pacientes y se dividieron en 3 grupos: uso de metilprednisolona (155 mg promedio) cada 24 horas por 3 días, dexametasona (6 mg) cada 24 horas por 10 días y un grupo control. Resultados: La distribución de los casos con hiperglucemia fue de 33 casos usando dosis altas y 82 con dosis bajas de corticoides, tanto las dosis altas como las bajas tienen la misma distribución en los casos de infecciones. Al evaluar la severidad y gravedad de la hiperglucemia en los dos grupos con corticoides, se observa que los pacientes con dosis altas presentan mayor gravedad (48%). En caso de severidad y gravedad de las infecciones se observa que los pacientes con dosis altas presentan casos más graves (62%) y más severos (79%) que los que recibieron dosis bajas. (AU)

Protocolo clínico ­ Manejo das exacerbações pulmonares agudas da fibrose cística / Clinical protocol ­ Management of acute pulmonary exacerbations of cystic fibrosis

A fibrose cística é uma desordem genética de caráter multissistêmico originada por variações no gene CFTR, que é responsável pela síntese da proteína homônima conhecida como "cystic fibrosis transmembrane conductance regulator", localizado no cromossomo 7. A manifestação predominante da doença é pulmonar, que se mantém como a principal causa de morbidade e mortalidade entre os indivíduos acometidos. As crises de exacerbação pulmonar se caracterizam por episódios de agravamento abrupto do quadro respiratório, demandando intervenção médica imediata, visto que tais episódios podem ocasionar danos irreversíveis e deterioração da função pulmonar, mesmo após a resolução dos sintomas agudos. O propósito do presente estudo foi a elaboração de um protocolo clínico direcionado ao manejo da exacerbação pulmonar aguda em pacientes portadores de fibrose cística, para ser implementado Hospital do Servidor Público Municipal. O protocolo proposto repousa sobre quatro pilares: continuidade ou intensificação do tratamento crônico em curso, emprego criterioso de corticosteroides em situações específicas, utilização de suporte ventilatório apropriado e seleção de terapêuticas antivirais e antimicrobianas. Palavras-chave: Fibrose cística. Exacerbação pulmonar. Antimicrobianos. Antivirais. Suporte ventilatório.

Corticoides inhalados para el asma: sigue la batalla de la talla baja / Inhaled corticosteroids for asthma: the battle of the smaller height continues

Conclusiones de los autores del estudio: el uso de corticoides inhalados para el tratamiento del asma en los seis primeros años de vida no parece influir en el contenido mineral óseo a esa edad, independientemente de la dosis acumulada administrada. En cambio, los autores han encontrado asociación con una menor talla a los 6 años, pero solo en aquellos pacientes que continúan con tratamiento durante el sexto año de vida y que han tenido una elevada dosis acumulada de corticoides inhalados previamente. Comentario de los revisores: el tratamiento de mantenimiento con corticoides inhalados hasta la edad de 6 años podría disminuir la talla, efecto más acusado cuanto mayor es la dosis total consumida. Aunque no queda claro si esta disminución es transitoria o permanente, parece prudente monitorizar de cerca el pronóstico de talla (AU)

Authors' conclusions: The use of inhaled corticosteroids (IC) for the treatment of asthma from 0 to 6 years of age is associated with shorter height at 6 years of life, but only in patients who continue treatment in the sixth year of life with IC and who have been exposed to a higher cumulative dose of IC.Reviewers' commentary: in children under 6 years of age, the maintenance treatment of choice is IC. Although they offer good clinical control of the disease, they could have an immediate decrease in height, more pronounced in those with a higher dose consumed, without being clear if this effect is transient or permanent. (AU)

Inclusão de nova apresentação de omalizumabe (150 mg/mL) solução injetável em seringa preenchida para tratamento da asma alérgica grave não controlada apesar do uso de corticoide inalatório (CI) associado a um beta2- agonista de longa ação (LABA) / Inclusion of new presentation of omalizumab (150 mg/mL) solution for injection in pre-filled syringe for treatment of severe allergic asthma that is uncontrolled despite use of inhaled corticosteroids (ICS) associated with a beta2- long-acting agonist (LABA)

INTRODUÇÃO: A asma é uma doença inflamatória crônica das vias aéreas inferiores que se caracteriza por aumento da responsividade dessas vias a diferentes estímulos, com consequente obstrução ao fluxo aéreo, de forma recorrente e reversível. A OMS estima que cerca de 235 milhões de pessoas sofrem de asma. No Brasil, a asma foi a 3ª causa de internação hospitalar pelo SUS em 2008, com cerca de 300.000 hospitalizações naquele ano. Em 2013, ocorreram 129.728 internações e 2.047 mortes. Já em 2018, o número de internações foi de aproximadamente 87.000. De acordo com o PCDT de asma, do Ministério da Saúde, o omalizumabe é uma terapia inespecífica anti-IgE indicada exclusivamente para adultos e crianças com pelo menos 6 anos de idade com asma alérgica, moderada a grave (etapas IV e V), cujos sintomas são inadequadamente controlados apesar do uso de corticoide inalatório associado a um beta-2 agonista de longa ação. RECOMENDAÇÃO PRELIMINAR: Os membros do Plenário, presentes na 111ª Reunião Ordinária da Conitec, no dia 03 de agosto de 2022, deliberaram por unanimidade que a matéria fosse disponibilizada em consulta pública com recomendação preliminar favorável à inclusão da nova apresentação de omalizumabe (150 mg/mL) solução injetável em seringa preenchida, ao SUS, para tratamento da asma alérgica grave não controlada apesar do uso de corticoide inalatório (CI) associado a um beta2-agonista de longa ação (LABA). A matéria foi disponibilizada em consulta pública. CONSULTA PÚBLICA: Foram recebidas 14 contribuições, sendo nove pelo formulário de experiência e opinião e cinco pelo formulário técnico-científico. Os nove respondentes do formulário de experiência e opinião apresentaram-se favoráveis à recomendação inicial da Conitec. Os participantes mencionaram a facilidade de administração do omalizumabe em seringa preenchida, a melhora na qualidade de vida e a necessidade de incorporação dessa apresentação do medicamento no SUS. Os benefícios desse formato de administração foram mencionados como uma facilidade do medicamento. No formulário para contribuições técnico-científicas quatro não apresentaram argumentação técnica sobre as evidências, mas argumentação de cunho pessoal acerca do uso da tecnologia, três foram positivas à incorporação. A contribuição enviada pela empresa fabricante do omalizumabe teceu comentários sobre as justificativas científicas e sobre o impacto orçamentário apresentadas na apreciação inicial da matéria, reforçando que não haverá ônus ao Ministério da Saúde na incorporação da nova apresentação de omalizumabe. RECOMENDAÇÃO FINAL DA CONITEC: Os membros do Plenário presentes na 113ª Reunião Ordinária da Conitec, realizada no dia 06 de outubro de 2022, deliberaram por unanimidade, recomendar a incorporação da nova apresentação de omalizumabe (150 mg/mL) solução injetável em seringa preenchida, ao SUS, para tratamento da asma alérgica grave não controlada apesar do uso de corticoide inalatório (CI) associado a um beta2-agonista de longa ação (LABA). Não foram adicionadas evidências, durante a Consulta Pública, que alterassem a recomendação preliminar da Comissão. Foi assinado o Registro de Deliberação nº 774/2022. DECISÃO: Incorporar, no âmbito do Sistema Único de Saúde - SUS, a nova apresentação de omalizumabe (150 mg/mL), solução injetável em seringa preenchida, para tratamento da asma alérgica grave não controlada apesar do uso de corticoide inalatório (CI) associado a um beta2- agonista de longa ação (LABA), conforme a Portaria nº 143, publicada no Diário Oficial da União nº 214, seção1, página 92, em 11 de novembro de 2022.