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1.
Arq. bras. oftalmol ; Arq. bras. oftalmol;88(1): e2023, 2025. graf
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1568850

RESUMO

ABSTRACT A patient presented with corneoscleral thinning five months after the treatment of suspected ocular squamous surface neoplasia with mitomycin-C and interferon. For tectonic and aesthetic purposes, we decided to perform lamellar corneoscleral transplantation. The approach used established new tectonic support and corneal homeostasis. This technique might be an option in similar cases.

2.
Arq. bras. oftalmol ; Arq. bras. oftalmol;88(2): e2023, 2025. tab, graf
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1574013

RESUMO

ABSTRACT Purpose: To compare the outcomes of intravitreal dexamethasone implant used as either an adjuvant or a switching therapy for diabetic macular edema in patients with poor anatomic response after three consecutive monthly injections of ranibizumab. Methods: This retrospective study included patients with diabetic macular edema who received three consecutive doses of ranibizumab as initial therapy and demonstrated poor response. A single dose of intravitreal de xamethasone implant was administered to these patients. The patients were divided into two groups according to the treatment modalities: the adjuvant therapy group, consisting of patients who continued treatment with ranibizumab injection after receiving intravitreal dexamethasone implant, and the switch therapy group, consisting of patients who were switched from ranibizumab treatment to intravitreal dexamethasone implant as needed. The main outcome measurements were best corrected visual acuity and central retinal thickness at baseline and at 3, 6, 9, and 12 months of follow-up. Results: In this study that included 64 eyes of 64 patients, the best corrected visual acuity and central retinal thickness values did not significantly differ between the groups at baseline and at 6 months of follow-up (p>0.05). However, at 12 months, the best corrected visual acuity values in the adjuvant and switch therapy groups were 0.46 and 0.35 LogMAR, respectively (p=0.012), and the central retinal thickness values were 344.8 and 270.9, respectively (p=0.007). Conclusions: In a real-world setting, it seems more reasonable to use intravitreal dexamethasone implant as a switch therapy rather than an adjuvant therapy for diabetic macula edema refractory to ranibizumab despite three consecutive monthly injections of ranibizumab. Patients switched to intravitreal dexamethasone implant were found to have better anatomic and visual outcomes at 12 months than those who continued ranibizumab therapy despite their less-than-optimal responses.

3.
Rev. Enferm. UERJ (Online) ; 32: e80171, jan. -dez. 2024.
Artigo em Inglês, Espanhol, Português | LILACS-Express | LILACS | ID: biblio-1566275

RESUMO

Objetivo: analisar o empoderamento estrutural de enfermeiros em um hospital de alta complexidade. Métodos: estudo quantitativo, analítico e transversal, realizado com 93 enfermeiros, utilizando um questionário sociodemográfico e ocupacional e o Questionário de Condições de Eficácia no Trabalho II. Os dados foram coletados entre fevereiro e março de 2023. A análise dos dados deu-se por meio de estatística descritiva, teste de Kolgomorov-Smirnov, teste do qui-quadrado e regressão de Poisson. Resultados: os enfermeiros apresentaram nível moderado de empoderamento estrutural, com média de 20,67 (p<0,000). O componente mais pontuado foi a oportunidade (4,22 dp±0,80). Não foram encontradas diferenças significativas nos níveis de empoderamento estrutural relacionadas às unidades de trabalho (p-Valor 0,381), vínculo empregatício (p-Valor 0,352) e grau de instrução (p-Valor 0,839). O modelo de regressão de Poisson indica que tanto pode haver altos ou baixos níveis de empoderamento a depender do setor. Conclusão: os enfermeiros demonstraram possuir níveis moderados de empoderamento estrutural.


Objective: to analyze the structural empowerment of nurses in a high-complexity hospital. Methods: a quantitative, analytical, cross-sectional study was carried out with 93 nurses, using a sociodemographic and occupational questionnaire and the Questionnaire of Conditions of Effectiveness at Work II. The data was collected between February and March 2023. The data was analyzed using descriptive statistics, the Kolgomorov-Smirnov test, the chi-square test, and Poisson regression. Results: the nurses had a moderate structural empowerment level, with a mean of 20.67 (p<0.000). The highest scoring component was opportunity (4.22 sd±0.80). No significant differences were found in the structural empowerment levels related to work units (p-Value 0.381), employment relationship (p-Value 0.352) and education level (p-Value 0.839). The Poisson regression model indicates that there can be either high or low empowerment levels depending on the sector. Conclusion: nurses showed moderate structural empowerment levels.


Objetivo: analizar el empoderamiento estructural del enfermero en un hospital de alta complejidad. Métodos: estudio cuantitativo, analítico y transversal, realizado con 93 enfermeros, utilizando un cuestionario sociodemográfico y ocupacional y el Cuestionario de Condiciones de Efectividad en el Trabajo II. Los datos se recolectaron entre febrero y marzo de 2023. El análisis de los datos se realizó mediante estadística descriptiva, prueba de Kolgomorov-Smirnov, prueba de chi-cuadrado y regresión de Poisson. Resultados: los enfermeros presentaron un nivel moderado de empoderamiento estructural, la media fue de 20,67 (p<0,000). El componente con mayor puntaje fue oportunidad (4,22 DE±0,80). No se encontraron diferencias significativas en los niveles de empoderamiento estructural relacionados con las unidades de trabajo (valor p 0,381), la relación laboral (valor p 0,352) y el nivel de formación (valor p 0,839). El modelo de regresión de Poisson indica que pueden existir niveles altos o bajos de empoderamiento dependiendo del sector. Conclusión: los enfermeros demostraron niveles moderados de empoderamiento estructural.

4.
Artigo em Inglês | MEDLINE | ID: mdl-39411248

RESUMO

Elephantiasis, also known as lymphatic filariasis (LF), is a debilitating condition characterized by the thickening of the skin and muscles, primarily affecting the limbs, genitalia, and female breasts. Lymphatic filariasis is a major global health concern, affecting approximately 120 million people worldwide and having a significant impact on people's quality of life, mobility, and socio-economic status. Although LF is endemic in many parts of the world, including Africa, it is a neglected issue in Southern Africa, with little information available. According to the World Health Organisation, approximately 882.5 million people in 44 countries worldwide are at risk of contracting LF, making it the second most common vector-borne disease after malaria. The primary goal of this review was to assess the prevalence of elephantiasis in the Southern African Development Community (SADC) region. Lymphatic filariasis is endemic in four of the sixteen SADC countries, three countries have administered MDA to the population that required it and they are now under post-intervention surveillance, while LF is no longer a public health problem in Malawi. Global efforts to eliminate LF have been hampered by the non-availability of MDA in some SADC countries such as Angola, Mozambique, Zambia, and Zimbabwe. Despite the implementation of mass drug administration programs, a review of the literature reveals gaps in knowledge about LF prevalence cases in SADC countries. Each country faces unique challenges and successes in combating LF due to varying levels of available data and healthcare infrastructure. Some SADC countries continue to bear the burden of LF-related diseases, necessitating ongoing disease prevention and elimination efforts. This review emphasizes the importance of ongoing research, data collection, and novel policies to combat the spread of elephantiasis disease in the SADC region and beyond.

5.
Front Pharmacol ; 15: 1338546, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39224777

RESUMO

Introduction: Breast cancer (BC) is one of the leading causes of cancer and is the first cause of death from malignant tumors among women worldwide. New cancer therapies receive regulatory approval yearly and to avoid health disparities in society, the health systems are challenged to adapt their infrastructure, methodologies, and reimbursement policies to allow broad access to these treatments. In addition, listening to patients' voices about their therapy preferences is essential. We aim to investigate the administration route preferences [subcutaneous (SC) or intravenous (IV)] among patients diagnosed with HER2 positive BC and healthcare professionals (HCPs) and to investigate healthcare resources utilization (quality and quantity) for each route of administration (SC or IV) for treating those patients. Methods: We conducted a systematic literature review focused on clinical trials and observational and economic studies, using PubMed (MEDLINE), Cochrane Library, Virtual Health Library (VHL), Scientific Electronic Library Online (SciELO), and Latin American and Caribbean Health Sciences Literature (LILACS) databases based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. Results: The literature review included 25 studies in the analysis. Studies have reported that patients and HCPs prefer the SC route of administration to IV because it saves time in terms of chair time, administration, and preparation and is less painful. In addition, SC administration might be a more cost-saving option when analyzing direct and indirect costs. Discussion: As BC stands as a significant global health concern and the leading cause of cancer-related deaths in women worldwide, understanding and incorporating patient and HCPs preferences in the choice of administration route become paramount. The observed preference for SC administration not only aligns with the imperative of adapting health systems to facilitate broad access to new cancer therapies but also underscores the importance of considering patient experiences and economic implications in shaping treatment strategies. These insights are crucial for healthcare policymakers, clinicians, and stakeholders in optimizing healthcare resources and enhancing the overall quality of BC care.

6.
Biomedicines ; 12(9)2024 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-39335511

RESUMO

An increase in total drug (small molecules and biologics) approvals by the Food and Drug Administration (FDA) was seen in 2023 compared with the previous year. Cancer remained the disease most targeted by monoclonal antibodies (mAbs), followed by autoimmune conditions. Our data reveal the prevalence of approvals for biologics even during years when the total number of authorizations was low, such as in 2022. Over half the drugs that received the green light in 2023 benefited from expedited programs, as the incidence of many diseases increased. In addition, over half of the biologics approved received Orphan Drug Designation from the FDA. This narrative review delves into details of the most significant approvals in 2023, including mAbs, enzymes, and proteins, explaining their mechanisms of action, differences from previous drugs, placebo, and standards of care, and outcomes in clinical trials. Given the varying number of drugs authorized annually by the U.S. health authority, this review also examines the limits of external influences over the FDA's decisions and independence regarding drug approvals and withdrawals.

7.
Pharmaceutics ; 16(9)2024 Aug 29.
Artigo em Inglês | MEDLINE | ID: mdl-39339178

RESUMO

Despite the safety and convenience of oral administration, poorly water-soluble drugs compromise absorption and bioavailability. These drugs can exhibit low dissolution rates, variability between fed and fasted states, difficulty permeating the mucus layer, and P-glycoprotein efflux. Drug nanocrystals offer a promising strategy to address these challenges. This review focuses on the opportunities to develop orally administered nanocrystals based on pharmacokinetic outcomes. The impacts of the drug particle size, morphology, dissolution rate, crystalline state on oral bioavailability are discussed. The potential of the improved dissolution rate to eliminate food effects during absorption is also addressed. This review also explores whether permeation or dissolution drives nanocrystal absorption. Additionally, it addresses the functional roles of stabilizers. Drug nanocrystals may result in prolonged concentrations in the bloodstream in some cases. Therefore, nanocrystals represent a promising strategy to overcome the challenges of poorly water-soluble drugs, thus encouraging further investigation into unclear mechanisms during oral administration.

8.
Pharmaceutics ; 16(9)2024 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-39339234

RESUMO

Needle-free buccal anesthesia improves dental treatment outcomes for both patients and dentists. In this study, we report on an assessment of the enhancement effects of α-bisabolol on the in vitro transmucosal permeation of prilocaine hydrochloride (PCl) and lidocaine hydrochloride (LCl) from needleless buccal films. We also evaluated the mechanical properties of the film, which consisted of Methocel™ K100 LV as the film-forming polymer (3% m·m-1), PEG 400 as a cosolvent (15% m·m-1 based on drug loading), α-bisabolol (15 and 30% m·m-1 based on drug loading), and the drugs combined at a 1:1 ratio (15 mg·unit-1). The porcine esophageal epithelium was used as a membrane barrier, and artificial saliva was the release medium. After a 1 h experiment at 25 ± 2 °C, α-bisabolol significantly decreased, rather than enhanced, the permeation fluxes (five-fold), permeability coefficients (seven-fold), and retentions (two-fold) of both PCl and LCl through the epithelium, regardless of the concentration. Moreover, the resistance and flexibility of the films markedly decreased compared to those without α-bisabolol. Therefore, under the experimental conditions, using α-bisabolol as a buccal permeation enhancer for the hydrophilic local anesthetics PCl and LCl from buccal films is not feasible.

9.
BMC Public Health ; 24(1): 2593, 2024 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-39334112

RESUMO

PURPOSE: Although mental disorders are common in the workplace, they often go unnoticed. There is frequently a gap in the recognition and effective management of these disorders, leading to delayed recovery and worsening conditions. This study evaluates the level of Mental Health Literacy (MHL) among employees of the Finance and Planning Departments in the Federal District, Brazil, and proposes preventive measures and de-stigmatization strategies for mental health in the workplace. METHODS: MHL among active employees was assessed using the Mental Health Literacy Scale (MHLS), developed by O'Connor and Casey (2015) and validated for Brazilian Portuguese by Buta et al. (2024). The data analysis included descriptive and inferential statistics, with nonparametric tests used to compare MHL across different groups. RESULTS: The results showed that 27.6% of participants had adequate literacy, 67.9% had problematic levels, and 4.5% had inadequate levels. Women were observed to have higher literacy levels than men. Additionally, significant variations in literacy levels were noted among individuals with different health conditions; those diagnosed with cancer, depression, or other illnesses had higher literacy than those without diagnosed conditions. CONCLUSION: To address MHL challenges, educational actions such as awareness campaigns, training, and consultancy programs are essential.


Assuntos
Letramento em Saúde , Humanos , Letramento em Saúde/estatística & dados numéricos , Masculino , Feminino , Adulto , Brasil , Pessoa de Meia-Idade , Saúde Mental , Adulto Jovem , Transtornos Mentais , Empregados do Governo/psicologia , Empregados do Governo/estatística & dados numéricos , Local de Trabalho/psicologia , Inquéritos e Questionários , Estudos Transversais
10.
Pharmacol Biochem Behav ; 244: 173850, 2024 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-39159761

RESUMO

RATIONALE: Although the mesocorticolimbic dopamine (DA) system is the main neurochemical substrate that regulates the addictive and reinforcing effects of ethanol (EtOH), other neurotransmitter systems, such as the acetylcholine (Ach) system, modulate DAergic function in the nucleus accumbens (nAcc). Previously, we reported that intra-nAcc administration of the nicotinic Ach receptor agonist cytisine increased oral EtOH self-administration. GABAB receptors in the nAcc are expressed in DAergic terminals, inhibit the regulation of DA release into the nAcc, and could modulate the effects of cytisine on oral EtOH self-administration. The present study assessed the effects of intra-nAcc administration of the GABAB receptor agonist baclofen (BCF) on the impacts of cytisine on oral EtOH self-administration. METHODS: Male Wistar rats were deprived of water for 23.30 h and then trained to press a lever to receive EtOH on an FR3 schedule until a stable response rate of 80 % was achieved. After this training, the rats received an intra-nAcc injection of the nAch receptor agonist cytisine, BCF, and cytisine or 2-hydroxysaclofen, BCF, and cytisine before they were given access to EtOH on an FR3 schedule. RESULTS: Intra-nAcc injections of cytisine increased oral EtOH self-administration; this effect was reduced by BCF, and 2-hydroxysaclofen blocked the effects of BCF. CONCLUSIONS: These findings suggest that the reinforcing effects of EtOH are modulated not only by the DA system but also by other neurotransmitter systems involved in regulating DA release from DAergic terminals.


Assuntos
Alcaloides , Azocinas , Baclofeno , Condicionamento Operante , Etanol , Agonistas dos Receptores de GABA-B , Agonistas Nicotínicos , Núcleo Accumbens , Quinolizinas , Ratos Wistar , Autoadministração , Animais , Masculino , Baclofeno/farmacologia , Baclofeno/administração & dosagem , Ratos , Alcaloides/farmacologia , Alcaloides/administração & dosagem , Azocinas/farmacologia , Azocinas/administração & dosagem , Quinolizinas/farmacologia , Quinolizinas/administração & dosagem , Agonistas dos Receptores de GABA-B/farmacologia , Agonistas dos Receptores de GABA-B/administração & dosagem , Núcleo Accumbens/efeitos dos fármacos , Núcleo Accumbens/metabolismo , Etanol/administração & dosagem , Etanol/farmacologia , Condicionamento Operante/efeitos dos fármacos , Agonistas Nicotínicos/farmacologia , Agonistas Nicotínicos/administração & dosagem , Administração Oral , Consumo de Bebidas Alcoólicas/tratamento farmacológico , Consumo de Bebidas Alcoólicas/psicologia , Alcaloides Quinolizidínicos
11.
Front Public Health ; 12: 1384561, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39086801

RESUMO

Introduction: The COVID-19 pandemic had a great impact on several public sectors worldwide, requiring the implementation of public policies in an organized way to contain and control the disease. Thus, this study aimed to analyze public policies to face the COVID-19 pandemic in the State of Paraná, Brazil. Methods: This was a cross-sectional, retrospective, quantitative survey carried out with data from March 2020 to March 2022 in the twenty-two municipalities that host the local health regions. Data collection was documentary, carried out from the municipal Portal da Transparência website, which is dedicated to making public all expenditures, and epidemiological bulletins released by the Health Department of the state of Paraná. The variables analyzed were New Cases and Deaths, Mortality and Lethality Coefficient, Incidence Rate, Vaccination Coverage, Number of Hospital and ICU beds exclusive to COVID-19, Settled Expenses destined for COVID-19 and coping measures, namely, the Declaration of Public Health Emergency, Curfew, Mandatory use of masks, Businesses closure, Teleworking of risk groups, and Suspension of activities with crowds and of classes. After collection, data underwent descriptive analysis, and subsequently, the correlation of variables was analyzed using the Spearman test. Multiple linear regression was applied using the variable selection method called best subset selection (BSS). The dependent variables listed were incidence rate, new cases and new deaths. Results: The results showed that coping measures, as well as the application of resources for the pandemic, were implemented heterogeneously in the municipalities studied, and the progression of the disease, the distribution of beds and vaccination occurred unevenly and may be a reflection of the limited Brazilian national governance. An important correlation was observed between the incidence rate and new deaths with vaccination coverage. In addition, the regression model showed that measures such as mandatory use of masks, closure of shops, suspension of classes, and curfew showed important correlations with the variables incidence rate, cases, and new deaths. Discussion: The study highlighted the importance of carrying out a robust analysis of public policies to face emergencies of global importance so that government entities are prepared for future crises of great repercussions, such as the COVID-19 pandemic.


Assuntos
COVID-19 , Política Pública , COVID-19/epidemiologia , COVID-19/prevenção & controle , Humanos , Brasil/epidemiologia , Estudos Transversais , Estudos Retrospectivos , SARS-CoV-2 , Pandemias/prevenção & controle , Saúde Pública , Política de Saúde
12.
J Vet Pharmacol Ther ; 2024 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-39212299

RESUMO

The objective of this study was to assess the impact of the vehicle of administration and the prandial state of post weaning piglets on the indices of therapeutic efficacy for different broad-spectrum antibiotic/pathogen combinations. Pharmacokinetic data were retrieved from previous studies, in which we orally administered oxytetracycline (OTC), fosfomycin (FOS), or amoxicillin (AMX) according to the following treatments: dissolved in soft water to fasted or non-fasted piglets, dissolved in hard water to fasted or non-fasted piglets, and mixed with feed. Minimum inhibitory concentration (MIC) values for susceptible strains of bacteria causing swine diseases were obtained from the database of European Committee on Antimicrobial Susceptibility Testing (EUCAST) for each antibiotic. Pharmacokinetic/pharmacodynamic (PK/PD) indices of therapeutic efficacy-drug exposure over the dosing interval (fAUC/MIC) for OTC and FOS; time that free drug concentration remains above MIC (%fT>MIC) for AMX-were calculated for each antibiotic/pathogen combination under each treatment. After all OTC and in-feed FOS and AMX treatments, the indices of therapeutic efficacy were below the target value for all the study microorganisms. When FOS or AMX were delivered dissolved in soft or hard water, the indices were above the target value over which therapeutic efficacy would be expected for Escherichia coli treated with FOS and, Glaesserella parasuis, Pasteurella multocida, and Actinobacillus pleuropneumoniae treated with AMX. The prandial state of piglets showed no influence on the indices of therapeutic efficacy. Pharmacokinetic profiles of broad-spectrum antibiotics, specifically the ability to achieve target concentrations, may be largely reduced due to drug interactions with components present in feed or water resulting in a discrepancy with PK/PD principles of prudent and responsible use of antibiotics.

13.
Life (Basel) ; 14(8)2024 Aug 17.
Artigo em Inglês | MEDLINE | ID: mdl-39202764

RESUMO

Gentisic acid (2,5-dihydroxybenzoic acid) is primarily found naturally in plants and has demonstrated a significant range of biological activities; however, its efficacy and safety as a topical application ingredient are not yet well established. Thus, the compound's potential antioxidant and antimicrobial properties were evaluated for efficacy, while the cytotoxicity was evaluated for safety. The antioxidant activity, measured by the DPPH kinetic method, showed an Efficiency Concentration (EC50) of 0.09 with an antioxidant reducing power (ARP) of 11.1. The minimum inhibitory concentration (MIC) against Staphylococcus aureus was 4.15 mg/mL, Escherichia coli was 4.00 mg/mL, Candida albicans was 3.00 mg/mL, and Cutibacterium acnes was 3.60 mg/mL, and the MIC for C. acnes has remained unpublished until now. The substance showed low cytotoxicity by the neutral red uptake (NRU) methodology against HaCat, HDFa, and HepG2 cells at concentrations of up to 10.0, 7.3, and 4.0 mM, respectively, also representing unpublished data. This evidence demonstrates gentisic acid as a promising active substance for skin topical application in the cosmetic or pharmaceutical industry.

14.
J Pediatr ; 275: 114220, 2024 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-39097265

RESUMO

OBJECTIVE: To assess whether beta-lactam extended or continuous beta-lactam infusions (EI/CI) improve clinical outcomes in children with proven or suspected bacterial infections. STUDY DESIGN: We included observational and interventional studies that compared beta-lactam EI or CI with standard infusions in children less than 18 years old, and reported on mortality, hospital or intensive care unit length of stay, microbiological cure, and/or clinical cure. Data sources included PubMed, Medline, EBM Reviews, EMBASE, and CINAHL and were searched from January 1, 1980, to November 3, 2023. Thirteen studies (2945 patients) were included: 5 randomized control trials and 8 observational studies. Indications for antimicrobial therapies and clinical severity varied, ranging from cystic fibrosis exacerbation to critically ill children with bacteriemia. RESULTS: EI and CI were not associated with a reduction in mortality in randomized control trials (n = 1464; RR 0.93, 95% CI 0.71, 1.21), but were in observational studies (n = 833; RR 0.43, 95% CI 0.19, 0.96). We found no difference in hospital length of stay. Results for clinical and microbiological cures were heterogeneous and reported as narrative review. The included studies were highly heterogeneous, limiting the strength of our findings. The lack of shared definitions for clinical and microbiological cure outcomes precluded analysis. CONCLUSIONS: EI and CI were not consistently associated with reduced mortality or length of stay in children. Results were conflicting regarding clinical and microbiological cures. More well-designed studies targeting high-risk populations are necessary to determine the efficacy of these alternative dosing strategies.

15.
Curr Oncol ; 31(8): 4443-4454, 2024 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-39195315

RESUMO

INTRODUCTION: Advancements in oncology have revolutionized cancer treatment, with new drugs being approved at different rates worldwide. Our objective was to evaluate the approval of new oncological drugs for solid tumors by the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Brazilian Health Regulatory Agency (ANVISA) since 2008. METHODS: Data were collected from public and online databases by searching for the date of submission, the date of the procedure, the date of approval, clinical indication, and drug characteristics. The distribution was tested using the Shapiro-Wilk, test and comparisons were made using the Mann-Whitney U test; the data are reported using median days and interquartile range (IQR1-IQR3). RESULTS: In total, 104 new oncologic drugs for the treatment of solid tumors were approved by the three agencies: 98 by the FDA, 90 by the EMA, and 68 by ANVISA. The cancer types with the highest number of first indications were lung cancer (n = 24), breast cancer (n = 15), and melanoma (n = 15). Most approvals were for oral medications (n = 63) and tyrosine-kinase inhibitors or other small-molecule inhibitors (n = 54). Time to approval after submission was as follows: the FDA-224 days (167-285); the EMA-364 days (330-418); and ANVISA-403 days (276-636) (p < 0.00001 for the FDA to the EMA and the FDA to ANVISA). The difference between submission dates among the agencies was as follows: EMA-FDA: 24 days (0-85); ANVISA-FDA: 255 (114-632); and ANVISA-EMA: 260 (109-645). The difference in approval dates between the agencies was as follows: EMA-FDA: 185 days (59-319); ANVISA-FDA: 558 (278-957); and ANVISA-EMA: 435 days (158-918). CONCLUSIONS: New oncologic drugs are submitted to the FDA and EMA for approval on similar dates; however, the longer appraisal period by the EMA pushes the approval date for Europe to approximately 6 months later. The same steps at ANVISA delay the approval by 1.5 years. Such procedures cause a significant difference in available medications between these regions.


Assuntos
Antineoplásicos , Aprovação de Drogas , Neoplasias , United States Food and Drug Administration , Humanos , Brasil , Estados Unidos , Europa (Continente) , Antineoplásicos/uso terapêutico , Neoplasias/tratamento farmacológico
16.
Ciênc. Saúde Colet. (Impr.) ; Ciênc. Saúde Colet. (Impr.);29(8): e05052024, ago. 2024. tab, graf
Artigo em Português | LILACS-Express | LILACS | ID: biblio-1569056

RESUMO

Resumo Objetivou-se analisar a atuação dos enfermeiros na gestão hospitalar frente à COVID-19. O estudo teve uma abordagem qualitativa, do tipo descritivo e exploratório. O cenário foi um hospital que se transformou totalmente para atendimento de pacientes com COVID-19. No momento da coleta de dados, dez enfermeiros estavam à frente da gestão dos serviços, e todos participaram da entrevista semiestruturada. Os dados, após análise temática, foram apresentados em três categorias representativas dos elementos da tríade de Donabedian, ou seja, estrutura, processo e resultado. A categoria 1 realçou a reconfiguração da estrutura hospitalar a partir da gestão de materiais e das pessoas; a categoria 2 abordou a reestruturação do processo de trabalho para alcance das metas com segurança e qualidade; e a categoria 3 focou nas experiências dos enfermeiros na descrição dos resultados alcançados e esperados. A análise evidenciou a importância do trabalho em equipe, do envolvimento e da adaptação do gestor diante dos desafios da doença nova e ameaçadora da vida, dos recursos escassos e da complexidade das relações humanas na crise. Na liderança transformacional esses enfermeiros incentivaram a mudança de comportamento, o crescimento profissional, e resiliência.


Abstract This study aimed to analyze the role of nurses in hospital management in the face of COVID-19. The study had a qualitative, descriptive, and exploratory approach. The setting was a hospital that was completely transformed to care for patients with COVID-19. At the time of data collection, ten nurses managed the services, and all participated in the semi-structured interview. After thematic analysis, the data were presented in three categories, representing the elements of Donabedian's triad: structure, process, and result. Category 1 highlighted the hospital structure reconfiguration based on material and people management; category 2 addressed the work process restructuring to achieve goals with safety and quality; and category 3 focused on nurses' experiences in describing the results achieved and expected. The analysis highlighted the importance of teamwork, involvement, and adaptation of managers in the face of the challenges of a new and life-threatening disease, scarce resources, and the complexity of human relationships in the crisis. In transformational leadership, these nurses encouraged behavior change, professional growth, and resilience.

17.
Radiol Bras ; 57: e20230129, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38993967

RESUMO

Objective: To study the effect of antenatal corticosteroid administration on fetal hemodynamics using longitudinal analysis of Doppler waveforms in the umbilical artery (UA) and middle cerebral artery (MCA). Materials and Methods: This was a retrospective study that included 30 fetuses at risk for preterm birth. Twenty-eight pregnant women were treated with betamethasone for fetal lung maturation. Doppler examinations of the UA and MCA were performed once before and three or eight times after corticosteroid administration. We used a Bayesian hierarchical linear model. Reference ranges were constructed, and associations between variables (gestational age and pre-eclampsia) were tested. Results: The mean maternal age, gestational age at betamethasone administration, and gestational age at delivery were 32.6 ± 5.89 years, 30.2 ± 2.59 weeks, and 32.9 ± 3.42 weeks, respectively. On UA Doppler, there was a significant decrease in the pulsatility index (PI) after corticosteroid administration, with a mean of 0.1147 (credibility interval: 0.03687-0.191) in three observations and a median of 0.1437 (credibility interval: 0.02509-0.2627) in eight observations. However, there was no significant change in the Doppler MCA PI, regardless of gestational age and the presence or absence of pre-eclampsia. Conclusion: Although antenatal corticosteroid administration induced a significant decrease in the Doppler UA PI, we observed no change in the cerebral vasculature.


Objetivo: Estudar o efeito da administração antenatal de corticosteroides na hemodinâmica fetal mediante análise longitudinal do Doppler na artéria umbilical (AU) e artéria cerebral média (ACM). Materiais e Métodos: Este foi um estudo retrospectivo que incluiu 30 fetos com risco de nascimento pré-termo. Vinte e oito gestantes foram tratadas com betametasona para maturação pulmonar fetal. Os exames de Doppler da AU e da ACM foram realizados uma vez antes e depois da administração de corticosteroides, num total de três ou oito observações. Utilizamos o modelo linear hierárquico com abordagem Bayesiana. Foram construídos os intervalos de referência e testadas associações entre variáveis (idade gestacional e pré-eclâmpsia). Resultados: A média ± desvio-padrão da idade materna, idade gestacional na administração de betametasona e idade gestacional no parto foram 32,6 ± 5,89 anos, 30,2 ± 2,59 semanas e 32,9 ± 3,42 semanas, respectivamente. No Doppler da AU, verificou-se diminuição significativa do índice de pulsatilidade (IP) com a terapêutica com corticosteroides (média: 0,1147 [0,03687-0,191]; em três observações) (mediana: 0,1437 [0,02509-0,2627]; em oito observações). No entanto, não foi observada alteração significativa no IP do Doppler da ACM, independentemente da idade gestacional e do diagnóstico de pré-eclâmpsia. Conclusão: Os corticosteroides pré-natais induziram diminuição significativa no IP do Doppler da AU, mas não houve alteração na vasculatura cerebral.

18.
Cir Cir ; 92(4): 525-531, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39079247

RESUMO

OBJECTIVE: The number of participants in sports or some form of recreation globally has led to an increase in the incidence of anterior cruciate ligament (ACL) injuries and the number of surgeries performed. Although it does not belong to risky surgical interventions, this operation is accompanied by complications that slow down post-operative rehabilitation. The objective is to analyze the effects of intra-articular (IA) injection of tranexamic acid (TXA) on the reduction of post-operative drained blood volume, pain intensity, and incidence of hemarthrosis after ACL reconstruction. METHODS: This prospective research included 124 patients undergoing ACL reconstruction surgery, randomly divided into two groups. The TXA group received IA TXA, whereas an equal amount of placebo was administered using the same route in the control group. RESULTS: The research has shown that IA injection of TXA effectively reduces post-operative blood loss (TXA group 71.29 ± 40.76 vs. control group 154.35 ± 81.45), reducing the intensity of post-operative pain (p < 0.001) and the incidence of hemarthrosis. CONCLUSION: The application of TXA significantly reduced post-operative bleeding and pain intensity, which accelerated the post-operative period.


OBJETIVO: El mayor número de participantes en deportes o alguna forma de recreación en todo el mundo ha llevado a un aumento en la incidencia de lesiones del ligamento cruzado anterior (LCA) y de las cirugías realizadas. Aunque no es una intervención quirúrgica de riesgo, esta operación va acompañada de complicaciones que ralentizan la rehabilitación posoperatoria. El objetivo es analizar los efectos de la inyección intraarticular de ácido tranexámico (TXA) sobre la reducción del volumen sanguíneo drenado posoperatorio, la intensidad del dolor y la incidencia de hemartrosis tras la reconstrucción del LCA. MÉTODO: Esta investigación prospectiva incluyó 124 pacientes sometidos a cirugía de reconstrucción del LCA, divididos aleatoriamente en dos grupos: uno recibió TXA intraarticular y otro (grupo de control) una cantidad igual de placebo por la misma vía. RESULTADOS: La investigación ha demostrado que la inyección intraarticular de TXA reduce efectivamente la pérdida de sangre posoperatoria (grupo TXA 71.29 ± 40.76 vs. grupo control 154.35 ± 81.45), reduciendo la intensidad del dolor posoperatorio (p < 0.001) y la incidencia de hemartrosis. CONCLUSIONES: La aplicación de TXA redujo significativamente el sangrado posoperatorio y la intensidad del dolor, lo que aceleró el posoperatorio.


Assuntos
Reconstrução do Ligamento Cruzado Anterior , Antifibrinolíticos , Dor Pós-Operatória , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/uso terapêutico , Ácido Tranexâmico/administração & dosagem , Reconstrução do Ligamento Cruzado Anterior/métodos , Antifibrinolíticos/uso terapêutico , Antifibrinolíticos/administração & dosagem , Feminino , Masculino , Estudos Prospectivos , Injeções Intra-Articulares , Adulto , Dor Pós-Operatória/prevenção & controle , Dor Pós-Operatória/tratamento farmacológico , Adulto Jovem , Hemorragia Pós-Operatória/prevenção & controle , Hemartrose/prevenção & controle , Hemartrose/etiologia , Lesões do Ligamento Cruzado Anterior/cirurgia , Método Duplo-Cego , Adolescente , Perda Sanguínea Cirúrgica/prevenção & controle
19.
Artigo em Inglês | MEDLINE | ID: mdl-38876507

RESUMO

OBJECTIVE: To explore opioid prescribing patterns for cancer pain in Latin America (LA). METHODS: A systematic review was conducted adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Relevant databases, including MEDLINE, EMBASE, PubMed, LILACS and Scielo, were searched from inception to June 2023. Empirical studies of opioid prescription patterns in adult palliative care patients with cancer pain were included. Methodological quality was assessed using the Effective Public Health Practice Project tool. Data were analysed using narrative synthesis. Descriptive statistical analyses were conducted using SPSS V.28 (IBM). Categorical variables were summarised using frequencies and percentages and continuous variables as means or medians. RESULTS: Seventeen studies from six countries were included. Ten were observational, while seven were experimental, including five randomised controlled trials (RCT) and two non-RCT. Most were low or moderate methodological quality. Out of 7809 patients, morphine (54%) and tramadol (18%) were the most prescribed opioids. The median of morphine equivalent daily dose was 26 mg (IQR 26-41). CONCLUSION: Latin America shows lower opioid consumption rates compared with high-income countries for control pain management (CPM). More rigorous research on CPM in LA is needed. Additionally, a comprehensive review of opioid prescription patterns, including non-cancer diagnoses, is necessary.

20.
Pharmaceuticals (Basel) ; 17(6)2024 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-38931415

RESUMO

Cannabis sativa is a plant of the Cannabaceae family, whose molecular composition is known for its vast pharmacological properties. Cannabinoids are the molecules responsible for Cannabis sativa potential effects, especially tetrahydrocannabinol and cannabidiol. Scientific development has shown interest in the potential of cannabidiol in various health conditions, as it has demonstrated lower adverse events and great pharmacological potential, especially when administered topically. The present study aims to carry out a scoping review, focusing on the use of cannabidiol, in vivo models, for topical administration. Thus, the methodological approach used by the Joanna Briggs Institute was applied, and the studies were selected based on previously established inclusion criteria. Even though more information regarding the dose to achieve pharmacological potential is still needed, cannabidiol demonstrated potential in treating and preventing different conditions, such as glaucoma, atopic dermatitis, epidermolysis bullosa, and pyoderma gangrenosum.

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