Assuntos

Antineoplásicos , Complexos de Coordenação , Neoplasias , Elementos de Transição , Antineoplásicos/química , Antineoplásicos/farmacologia , Humanos , Complexos de Coordenação/química , Complexos de Coordenação/farmacologia , Elementos de Transição/química , Neoplasias/tratamento farmacológico

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.

RESUMO

BACKGROUND: Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. METHODS: We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis. RESULTS: The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (Pinteraction<0.05 for both instrumental variable and propensity-weighted analyses). CONCLUSIONS: In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.

Assuntos

Estenose da Valva Aórtica , Dispositivos de Proteção Embólica , Sistema de Registros , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/mortalidade , Masculino , Feminino , Idoso de 80 Anos ou mais , Idoso , Fatores de Risco , Resultado do Tratamento , Medição de Risco , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Fatores de Tempo , Estados Unidos/epidemiologia , Mortalidade Hospitalar , Embolia Intracraniana/prevenção & controle , Embolia Intracraniana/etiologia , Embolia Intracraniana/mortalidade , Avaliação da Deficiência , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/diagnóstico , Fatores de Proteção , Estudos Retrospectivos

RESUMO

Background: Dengue virus (DENV) and Chikungunya virus (CHIKV) pose significant public health threats in Brazil, where favorable conditions facilitated the proliferation of Aedes mosquitoes. Since the mid-1980s, Brazil has experienced annual outbreaks of DENV, with recent increases in confirmed cases. In addition, CHIKV, which was first reported in 2014, has spread across the country. The concurrent presence of these viruses has triggered public health alerts in endemic regions, underscoring the complexity of managing vector-borne diseases. Case Presentation: This report details a case of simultaneous DENV and CHIKV infections. A 77-year-old female patient who has diabetes and arrhythmia exhibited symptoms including fever, myalgia, and severe arthralgia. Laboratory tests confirmed the coinfection through RNA detection. The patient received supportive care, showed gradual improvement, and was eventually discharged. Conclusions: Coinfection with DENV and CHIKV cases reported here developed with mild outcomes. However, one of the patients did not recover from the arthralgia after presenting diagnostic challenges, which underscores the need for accurate differentiation to manage symptoms effectively. The reported cases, amidst increasing DENV outbreaks, highlight the urgency for preparedness in the healthcare system. The Ribeirão Preto region's endemicity for DENV, coupled with the rising incidence of CHIKV, emphasizes the evolving landscape of arbovirus transmission. Studies on Aedes mosquitoes suggest potential implications for human infection dynamics, warranting further investigation into arbovirus transmission efficacy and coinfection dynamics.

RESUMO

Maca (Lepidium meyenii), a biennial herbaceous plant indigenous to the Andes Mountains, has a rich history of traditional use for its purported health benefits. Maca's chemical composition varies due to ecotypes, growth conditions, and post-harvest processing, contributing to its intricate phytochemical profile, including, macamides, macaenes, and glucosinolates, among other components. This review provides an in-depth revision and analysis of Maca's diverse bioactive metabolites, focusing on the pharmacological properties registered in pre-clinical and clinical studies. Maca is generally safe, with rare adverse effects, supported by preclinical studies revealing low toxicity and good human tolerance. Preclinical investigations highlight the benefits attributed to Maca compounds, including neuroprotection, anti-inflammatory properties, immunoregulation, and antioxidant effects. Maca has also shown potential for enhancing fertility, combating fatigue, and exhibiting potential antitumor properties. Maca's versatility extends to metabolic regulation, gastrointestinal health, cardio protection, antihypertensive activity, photoprotection, muscle growth, hepatoprotection, proangiogenic effects, antithrombotic properties, and antiallergic activity. Clinical studies, primarily focused on sexual health, indicate improved sexual desire, erectile function, and subjective wellbeing in men. Maca also shows promise in alleviating menopausal symptoms in women and enhancing physical performance. Further research is essential to uncover the mechanisms and clinical applications of Maca's unique bioactive metabolites, solidifying its place as a subject of growing scientific interest.

RESUMO

This work aimed to show which treatments showed efficacy against coronavirus disease 2019 (COVID-19); therefore, the results of 37 clinical trials started in 2020 and completed in 2021 are reviewed and discussed here. These were selected from databases, excluding vaccines, computational studies, in silico, in vitro, and those with hyperimmune sera from recovered patients. We found 34 drugs, one vitamin, and one herbal remedy with pharmacological activity against symptomatic COVID-19. They reduced mortality, disease progression, or recovery time. For each treatment, the identifier and type of trial, the severity of the disease, the sponsor, the country where the trial was conducted, and the trial results are presented. The drugs were classified according to their mechanism of action. Several drugs that reduced mortality also reduced inflammation in the most severe cases. These include some that are not considered anti-inflammatory, such as Aviptadil, pyridostigmine bromide, anakinra, imatinib, baricitinib, and bevacizumab, as well as the combination of ivermectin, aspirin, dexamethasone, and enoxaparin. Nigella sativa seeds with honey have also been reported to have therapeutic activity. On the other hand, tofacitinib, novaferon with ritonavir, and lopinavir were also effective, as well as in combination with antiviral therapies such as danoprevir with ritonavir. The natural products colchicine and Vitamin D3 were only effective in patients with mild-to-moderate COVID-19, as was hydroxychloroquine. Drug repositioning has been the main tool in the search for effective therapies by expanding the pharmacological options available to patients.

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El objetivo del presente trabajo fue conocer qué tratamientos mostraron efectividad contra COVID-19, para lo cual se revisan y discuten los resultados de 37 estudios clínicos iniciados durante 2020 y concluidos en 2021. Estos fueron seleccionados de bases de datos, excluyendo vacunas, estudios computacionales, in silico, in vitro y con sueros hiperinmunes de pacientes recuperados. Se documentaron 34 fármacos, una vitamina y un remedio herbolario, con actividad farmacológica ante COVID-19 sintomático. Estos redujeron la mortalidad, el progreso de la enfermedad, o el tiempo de recuperación. Para cada tratamiento se presenta identificador y tipo de estudio, la gravedad de la enfermedad, patrocinador, país donde se realizó, así como sus resultados. Los fármacos se clasificaron de acuerdo con su mecanismo de acción. Varios fármacos que redujeron la mortalidad también disminuyeron la inflamación en los casos más graves. Esto incluyendo algunos no considerados antiinflamatorios, como el aviptadil, el bromuro de piridostigmina, el anakinra, el imatinib, el baricitinib y el bevacizumab, así como la combinación de ivermectina, aspirina, dexametasona y enoxaparina. También se reportaron con actividad terapéutica las semillas de Nigella sativa con miel. Además, resultaron efectivos el tofacitinib, el novaferón con ritonavir y lopinavir, así como los antivirales en terapias combinadas como el danoprevir con ritonavir. Los productos naturales colchicina y vitamina D3, solo tuvieron actividad en los pacientes en estado leve a moderado de la COVID-19, así como la hidroxicloroquina. El reposicionamiento de fármacos fue la principal herramienta para buscar terapias efectivas ampliando las opciones farmacológicas accesibles a los pacientes.

Assuntos

Produtos Biológicos , COVID-19 , Humanos , Ritonavir/uso terapêutico , Antivirais/uso terapêutico , Antivirais/farmacologia , SARS-CoV-2 , Pandemias

RESUMO

Abstract This work aimed to show which treatments showed efficacy against coronavirus disease 2019 (COVID-19); therefore, the results of 37 clinical trials started in 2020 and completed in 2021 are reviewed and discussed here. These were selected from databases, excluding vaccines, computational studies, in silico, in vitro, and those with hyperimmune sera from recovered patients. We found 34 drugs, one vitamin, and one herbal remedy with pharmacological activity against symptomatic COVID-19. They reduced mortality, disease progression, or recovery time. For each treatment, the identifier and type of trial, the severity of the disease, the sponsor, the country where the trial was conducted, and the trial results are presented. The drugs were classified according to their mechanism of action. Several drugs that reduced mortality also reduced inflammation in the most severe cases. These include some that are not considered anti-inflammatory, such as Aviptadil, pyridostigmine bromide, anakinra, imatinib, baricitinib, and bevacizumab, as well as the combination of ivermectin, aspirin, dexamethasone, and enoxaparin. Nigella sativa seeds with honey have also been reported to have therapeutic activity. On the other hand, tofacitinib, novaferon with ritonavir, and lopinavir were also effective, as well as in combination with antiviral therapies such as danoprevir with ritonavir. The natural products colchicine and Vitamin D3 were only effective in patients with mild-to-moderate COVID-19, as was hydroxychloroquine. Drug repositioning has been the main tool in the search for effective therapies by expanding the pharmacological options available to patients.

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Resumen El objetivo del presente trabajo fue conocer qué tratamientos mostraron efectividad contra COVID-19, para lo cual se revisan y discuten los resultados de 37 estudios clínicos iniciados durante 2020 y concluidos en 2021. Estos fueron seleccionados de bases de datos, excluyendo vacunas, estudios computacionales, in silico, in vitro y con sueros hiperinmunes de pacientes recuperados. Se documentaron 34 fármacos, una vitamina y un remedio herbolario, con actividad farmacológica ante COVID-19 sintomático. Estos redujeron la mortalidad, el progreso de la enfermedad, o el tiempo de recuperación. Para cada tratamiento se presenta identificador y tipo de estudio, la gravedad de la enfermedad, patrocinador, país donde se realizó, así como sus resultados. Los fármacos se clasificaron de acuerdo con su mecanismo de acción. Varios fármacos que redujeron la mortalidad también disminuyeron la inflamación en los casos más graves. Esto incluyendo algunos no considerados antiinflamatorios, como el aviptadil, el bromuro de piridostigmina, el anakinra, el imatinib, el baricitinib y el bevacizumab, así como la combinación de ivermectina, aspirina, dexametasona y enoxaparina. También se reportaron con actividad terapéutica las semillas de Nigella sativa con miel. Además, resultaron efectivos el tofacitinib, el novaferón con ritonavir y lopinavir, así como los antivirales en terapias combinadas como el danoprevir con ritonavir. Los productos naturales colchicina y vitamina D3, solo tuvieron actividad en los pacientes en estado leve a moderado de la COVID-19, así como la hidroxicloroquina. El reposicionamiento de fármacos fue la principal herramienta para buscar terapias efectivas ampliando las opciones farmacológicas accesibles a los pacientes.

RESUMO

Background Psoriasis is a chronic inflammatory disease that presents as scaly patches on the skin that affects about 3% of the world's population. Adherence to treatment and discrimination against people are common problems, adversely impacts quality of life. Objectives The aim of this study was to investigate the use of medicinal plants as therapeutic adjuvants in the treatment of plaque psoriasis through a systematic review and meta-analysis. Methods A systematic review and meta-analysis of randomized controlled trials in patients with plaque psoriasis was carried out, comparing the efficacy of herbal treatments alone or in association with other therapies. The search was performed in the databases of The Cochrane Library, Lilacs, Medline via PubMed and Embase, only including studies published from 2016 to 2020.The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. A systematic review and meta-analysis of randomized controlled trials (RCT) in patients with plaque psoriasis was carried out, comparing the efficacy of herbal treatments alone or in association with other therapies. We comprehensively searched the MEDLINE, Embase, Lilacs and Cochrane Library databases, only including studies published from 2016 to 2020. The certainty of evidence was assessed using the GRADE approach. Results Out of 2,268 articles evaluated, only seven RCT were eligible for final analysis. Five of these studies evidenced low risk of bias and a high level of evidence. Limitations Few RCT of medicinal plants. Conclusion This meta-analysis indicates that medicinal plants may be used as topical or oral products, either alone or combined with other forms of treatment. These products have the potential to greatly improve the quality of life of the patient.

Assuntos

Plantas Medicinais , Psoríase , Humanos , Psoríase/diagnóstico , Psoríase/tratamento farmacológico

RESUMO

Santalum genus belongs to the family of Santalaceae, widespread in India, Australia, Hawaii, Sri Lanka, and Indonesia, and valued as traditional medicine, rituals and modern bioactivities. Sandalwood is reported to possess a plethora of bioactive compounds such as essential oil and its components (α-santalol and ß-santalol), phenolic compounds and fatty acids. These bioactives play important role in contributing towards biological activities and health-promoting effects in humans. Pre-clinical and clinical studies have shown the role of sandalwood extract as antioxidant, anti-inflammatory, antibacterial, antifungal, antiviral, neuroleptic, antihyperglycemic, antihyperlipidemic, and anticancer activities. Safety studies on sandalwood essential oil (EO) and its extracts have proven them as a safe ingredient to be utilized in health promotion. Phytoconstituents, bioactivities and traditional uses established sandalwood as one of the innovative materials for application in the pharma, food, and biomedical industry.

Assuntos

Óleos Voláteis , Santalum , Humanos , Santalum/química , Compostos Fitoquímicos/farmacologia , Extratos Vegetais/farmacologia

RESUMO

The term postbiotic was recently defined by an panel of scientists convened by the International Scientific Association of Probiotics and Prebiotics as "a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host." This definition focused on the progenitor microbial cell or cell fragments, not just metabolites, proteins or carbohydrates they might produce. Although such microbe-produced constituents may be functional ingredients of the preparation, they are not required to be present in a postbiotic according to this definition. In this context, terms previously used such as paraprobiotics, ghostbiotics, heat-inactivated probiotics, non-viable probiotics, cell fragments or cell lysates, among others, align with the term postbiotics as conceived by this definition. The applications of postbiotics to infant nutrition and pediatric and adult gastroenterology, mainly, are under development. Some applications for skin health are also underway. As postbiotics are composed of inanimate microorganisms, they cannot colonize the host. However, they can in theory modify the composition or functions of the host microbiota, although evidence for this is scarce. Clinical results are promising, but, overall, there is limited evidence for postbiotics in healthy populations. For example, postbiotics have been studied in fermented infant formulas. The regulation of the term postbiotic is still in its infancy, as no government or international agency around the world has yet incorporated this term in their regulation.

RESUMO

Aim: Although bulk fill composites have been widely used as restorative material, there is no consensus regarding the best clinical protocol in terms of composite technique and adhesive system. Therefore, this clinical trial evaluated the clinical performance of bulk fill composites for class I restorations under different protocols. Methods: A randomized clinical trial including 155 class I restorations was conducted using different adhesive systems: conventional technique (phosphoric acid + conventional three-step adhesive system) (Group 1, 2 and 3); or self-etching adhesive system (Groups 4, 5 and 6). Control groups 1 and 4 were restored with conventional composite; groups 2 and 5 with low viscosity bulk fill and conventional composite as occlusal coverage; groups 3 and 6 with high viscosity bulk fill. The FDI criteria was used for clinical evaluation at baseline and after 6 months. Results: All groups showed good clinical performance. At baseline, the adhesive system did not affect postoperative hypersensitivity. After 6 months, group 5 showed a significant reduction in color and translucency; group 6 a reduction in terms of anatomical form and for postoperative sensitivity and an improvement in patient satisfaction (p<0.05). Considering the same restorative technique, the use of the self-etching adhesive system showed a significant decrease in color and translucency (p<0.05). Conclusion: All groups showed favorable clinical performance, and promising results were found for the conventional adhesive system and high viscosity bulk fill protocol

Assuntos

Ácidos Fosfóricos , Adesivos , Resinas Compostas , Restauração Dentária Permanente , Estética Dentária , Estudos Clínicos como Assunto

RESUMO

Propolis has been used since ancient times for the treatment of skin diseases and, currently, its pharmacological potential for healing and repairing various types of wounds is widely cited in the literature. The healing properties of propolis are mainly attributed to its composition which is rich in phenolic compounds, and propolis has aroused the interest of the pharmaceutical industry as a low-cost product as compared with other treatments and medications; however, most of the published data refer to its effects in vitro and in vivo and, so far, few clinical studies have been carried out proving its therapeutic efficacy. In this article, we aimed to review clinical trail data published in Portuguese, Spanish, and English, in Scielo, PubMed, Google Scholar, Medline, and Lilacs between 1990 and 2021 on the clinical use of propolis for skin ulcers. The potential of propolis as an alternative healing treatment for skin wounds such as diabetic, venous, and surgical wounds, as well as wounds caused by burns, etc., is mainly due to its evidenced properties such as antimicrobial, anti-inflammatory, analgesic, and angiogenesis promoter effects. However, there is a need to standardize the type of administration and the concentration of propolis for each type of wound. Furthermore, further clinical studies are essential to add information about propolis safety and for obtaining the best possible therapeutic benefits from its use.

RESUMO

Vitamin D is a hormone involved in the regulation of important biological processes such as signal transduction, immune response, metabolic regulation and also in the nervous and vascular systems. To date, coronavirus disease 2019 (COVID-19) infection does not have a specific treatment. However, various drugs have been proposed, including those that attenuate the intense inflammatory response, and recently, the use of vitamin D, in clinical trials, as part of the treatment of COVID-19 has provided promising results. It has been observed in some clinical studies that the use of cholecalciferol (vitamin D3) and its two metabolites the circulating form, calcidiol or calcifediol (25-hydroxycalciferol, 25-(OH)-D), and the active form, calcitriol (1,25-(OH)2-D), in different doses, improve the clinical manifestations, prognosis, and survival of patients infected with COVID-19 probably because of its anti-inflammatory, antiviral and lung-protective action. In relation to the central nervous system (CNS) it has been shown, in clinical studies, that vitamin D is beneficial in some neurological and psychiatric conditions because of its anti-inflammatory and antioxidant properties, modulation of neurotransmitters actions, and regulation of calcium homeostasis between other mechanisms. It has been shown that COVID-19 infection induces CNS complications such as headache, anosmia, ageusia, neuropathy, encephalitis, stroke, thrombosis, cerebral hemorrhages, cytotoxic lesions, and psychiatric conditions and it has been proposed that the use of dietary supplements, as vitamin and minerals, can be adjuvants in this disease. In this review, the evidence of the possible role of vitamin D, and its metabolites, as a protector against the neurological manifestations of COVID-19 was summarized.

Assuntos

Tratamento Farmacológico da COVID-19 , Vitamina D , Calcifediol/uso terapêutico , Colecalciferol , Humanos , Neuroproteção , Vitamina D/metabolismo , Vitamina D/farmacologia , Vitamina D/uso terapêutico , Vitaminas/farmacologia , Vitaminas/uso terapêutico

RESUMO

Cannabidiol (CBD), a major non-psychotropic component of cannabis, is receiving growing attention as a potential anticancer agent. CBD suppresses the development of cancer in both in vitro (cancer cell culture) and in vivo (xenografts in immunodeficient mice) models. For critical evaluation of the advances of CBD on its path from laboratory research to practical application, in this review, we wish to call the attention of scientists and clinicians to the following issues: (a) the biological effects of CBD in cancer and healthy cells; (b) the anticancer effects of CBD in animal models and clinical case reports; (c) CBD's interaction with conventional anticancer drugs; (d) CBD's potential in palliative care for cancer patients; (e) CBD's tolerability and reported side effects; (f) CBD delivery for anticancer treatment.

RESUMO

Extracellular vesicles (EVs) are lipid bilayer envelopes that encase several types of molecules. Their contents mostly reflect their cell origin and possible targets at other locations in the organism and can be modified in pathological conditions to interfere with intercellular communication, thus promoting disease establishment and development. These characteristics, in addition to their presence in virtually all body fluids, make such vesicles ideal for biomarker discovery in human diseases. Here, we describe the effect of different anticoagulants and the combination of two purification methods for isolation and characterization of circulating EVs from blood of chronic Chagas disease (CCD) patients. We illustrated this procedure by studying a population of patients with Chagas disease at the indeterminate chronic stage, in which the Trypanosoma cruzi is very scarce in circulation. EVs were harvested from blood collected without or with different anticoagulants. Protein and nanoparticle tracking analysis was used to measure EVs size and concentration. The EVs were purified by ultracentrifugation, followed by size-exclusion chromatography and characterized by chemiluminescent enzyme-linked immunosorbent assay and dot blot using antibodies that recognized parasite-derived EVs, such as hyperimmune sera, polyclonal and monoclonal antibodies against trans-sialidase and mucins. In parallel, antibodies against classical human EV markers CD9, CD63, CD81, and CD82, were also analyzed. The results showed that anticoagulants did not interfere with the analyzed parameters and circulating EVs from CCD patients contain T. cruzi antigens and classical human exosomal markers. Overall, our protocol is adequate for the isolation of the total circulating EVs and can serve as an important basis for further studies on biomarker discovery in Chagas' disease.

Assuntos

Doença de Chagas , Vesículas Extracelulares , Trypanosoma cruzi , Anticoagulantes , Biomarcadores/metabolismo , Vesículas Extracelulares/metabolismo , Humanos , Trypanosoma cruzi/metabolismo

RESUMO

A falta de medicamentos contendo bulas prevendo o tratamento de pacientes pediátricos representa um problema frequentemente observado em hospitais, principalmente nos setores de unidade de terapia intensiva (UTI) pediátrica e neonatais. Sabe-se que, para que um tratamento seja considerado seguro e eficaz, uma série de estudos clínicos são necessários, no entanto, relata-se um baixo número dessas pesquisas envolvendo crianças, principalmente devido a questões éticas que dificultam a condução das mesmas. Assim, poucos são os medicamentos que provam ser adequados para o tratamento desses pacientes, tornando necessário recorrer ao uso de medicamentos off-label e não licenciados. Os medicamentos são classificados como off-label quando seu uso se dá de maneira que difere de suas especificações aprovadas, por sua vez, produtos não licenciados são classificados desta forma por não possuírem aprovação para sua comercialização no país ou não possuírem comprovação de segurança e eficácia. O preparo de protocolos de estudo organizados, relato de informações aos pais e à criança de maneira clara e objetiva, aproximação entre pesquisadores e pais para o estabelecimento de uma relação de confiança e a condução das pesquisas em momentos de disponibilidade da família demonstram-se estratégias importantes para facilitar a realização dos ensaios clínicos.

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The lack of medicines containing drug information leaflets considering the treatment of pediatric patients is a problem frequently observed in hospitals, especially in the pediatric and neonatal intensive care unit (ICU) sectors. It is known that, for a treatment to be considered safe and effective, a series of clinical studies are necessary; however, a low number of these studies involving children are reported, mainly due to ethical issues that make conducting them difficult. Thus, few drugs prove to be suitable for treating these patients, making it necessary to resort to using off-label and unlicensed drugs. Drugs are classified as off-label when their use differs from their approved specifications, in turn, unlicensed products are classified in this way due to not having approval for marketing in the country or do not have proof of safety and efficacy. Preparation of organized study protocols, reporting information to parents and the child in a clear and objective way, bringing researchers and parents closer to establish a relationship of trust and conducting research at moments when the family is available are important strategies to facilitate conducting clinical trials.

Assuntos

Pediatria/normas , Uso Off-Label/normas , Padrões de Prática Médica/normas , Preparações Farmacêuticas/administração & dosagem , Uso de Medicamentos/normas

RESUMO

RESUMEN Objetivo: La pandemia ocasionada por el Covid-19 ha significado un gran desafío para la investigación en salud por la necesidad de dar una respuesta oportuna y efectiva a esta situación de crisis. Es importante proveer una visión panorámica sobre las principales barreras y facilitadores encontrados en la conducción de estudios en ciencias de la salud durante la crisis del Covid-19, así como también de las iniciativas en investigación sugeridas por autoridades en salud de investigación a nivel global, regional o local. Materiales y métodos: Se desarrolló una revisión sistemática de alcance. Se hizo una búsqueda de la literatura en Medline, Cochrane library, Lilacs y Google Scholar. Se incluyeron estudios de investigación originales, artículos de revisión, de opinión y editoriales disponibles en texto completo, publicados entre enero de 2020 y mayo de 2021 en español, inglés o portugués. Se hizo selección de los documentos y extracción de los datos por dos autores de manera independiente. Las barreras y facilitadores identificados fueron descritos y organizados en cuatro categorías a partir de la literatura: socioculturales, administrativos, organizacionales y metodológicos. Asimismo, se incluyeron documentos y comunicados oficiales de autoridades en salud e investigación a nivel global, regional y local. Los resultados se presentan de manera narrativa y en tablas. Resultados: Se seleccionaron 26 documentos para el análisis y síntesis de la información. Las barreras mencionadas más frecuentemente en la literatura incluyen las dificultades en cuanto al acceso a los participantes, a los trámites asociados a los comités de ética; así como el riesgo biológico para los investigadores y la falta de coordinación inter e intrainstitucional. Por su parte, los facilitadores identificados incluyen la adopción de soluciones virtuales, el trabajo cooperativo entre los actores de la investigación y la flexibilidad en el proceso de obtención del consentimiento informado. Frente a las iniciativas difundidas por las autoridades en salud e investigación, se identificaron cuatro estrategias relacionadas con la priorización de preguntas de investigación, el fomento de la cooperación y la inclusión en la investigación, la lucha contra la infodemia y el fortalecimiento de la calidad metodológica de los estudios. Conclusiones: Para la investigación en el contexto de la pandemia representa un desafío continuar con la cooperación e interoperabilidad entre las instituciones, los países y las disciplinas, con el fin de facilitar los procesos investigativos en el futuro; del mismo modo, cobra importancia mantener la ciencia abierta y la financiación de estudios cooperativos cuando surjan otras prioridades. Asimismo, es evidente la necesidad de desarrollar y sostener mecanismos que gestionen la información de manera eficiente para la toma de decisiones. Se requiere evaluar de manera continua los efectos que ha dejado esta pandemia en la práctica de la investigación en ciencias de la salud para comprender de manera integral lo que debemos aprender como sociedad a partir de las crisis.

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ABSTRACT Objective: The COVID-19 pandemic has imposed a great challenge on health research because of the pressing need to respond promptly and effectively to this crisis situation. It is important to offer a high level perspective of the main barriers and facilitators found when conducting health science studies during the COVID-19 crisis and to discuss the research initiatives suggested by global, regional or local health research authorities. Materials and methods: A systematic scoping review was carried out. A literature search was conducted in the Medline, Cochrane Library, Lilacs and Google Scholar databases. Original research studies, review and opinion articles and editorials available in full text published in Spanish, English or Portuguese between January 2020 and May 2021 were included. Two authors working independently selected the papers and collected the data. The barriers and facilitators identified were described and organized in four categories according to the literature: sociocultural, administrative, organizational and methodological. Official documents and communications from global, regional and local health and research authorities were also included. Results are presented in narrative and table form. Results: Overall, 26 documents were selected for data analysis and synthesis. The barriers most frequently mentioned in the literature include issues with access to participants, ethics committees paperwork, biological risk for the researchers, and lack of inter and intra-institutional coordination. On the other hand, the facilitators identified include the adoption of on-line solutions, cooperative work among research actors, and a more flexible informed consent process. Regarding the initiatives disseminated by health and research authorities, four strategies were identified: prioritization of research questions, cooperation and inclusion promotion, fight against infodemia, and strengthening of the methodological quality of the studies. Conclusions: Continued cooperation and interoperability among institutions, countries and disciplines to facilitate future research processes is a challenge in the context of the pandemic; similarly, it is now important to maintain open science and funding of cooperative studies when other priorities emerge. Likewise, there is an evident need to develop and sustain efficient information management systems to help with decision-making. Ongoing review of the effects of the pandemic on health research practice is needed in order to gain comprehensive insights of what we need to learn as a society from this crisis.

Assuntos

Humanos , COVID-19 , Pesquisa Qualitativa , Ciências da Saúde

RESUMO

Baicalin is one of the bioactive flavonoid glycosides isolated from the dried root of Scutellaria baicalensis Georgi, Lamiaceae, with antiviral properties. In recent years, the antiviral activity of baicalin has been widely investigated to explore its molecular mechanism of action. In this mini-review, the molecular mechanisms of action of baicalin as an antiviral agent are evaluated, which included three categories: the inhibition or stimulation of JAK/STAT, TLRs, and NF-κB pathways; up or down modulation of the expression levels of IFN, IL, SOCS1/3, PKR protein, Mx1 protein, and AP-1 protein; and inhibition of cell apoptosis caused by virus infection. In addition, clinical studies of baicalin are also discussed. This literature search suggested that baicalin can serve as a potential candidate for the development of a novel broad-spectrum antiviral drug. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s43450-021-00182-1.

RESUMO

BACKGROUND: The blockade of the progression or onset of pathological events is essential for the homeostasis of an organism. Some common pathological mechanisms involving a wide range of diseases are the uncontrolled inflammatory reactions that promote fibrosis, oxidative reactions, and other alterations. Natural plant compounds (NPCs) are bioactive elements obtained from natural sources that can regulate physiological processes. Inflammation is recognized as an important factor in the development and evolution of chronic renal damage. Consequently, any compound able to modulate inflammation or inflammation-related processes can be thought of as a renal protective agent and/or a potential treatment tool for controlling renal damage. The objective of this research was to review the beneficial effects of bioactive natural compounds on kidney damage to reveal their efficacy as demonstrated in clinical studies. METHODS: This systematic review is based on relevant studies focused on the impact of NPCs with therapeutic potential for kidney disease treatment in humans. RESULTS: Clinical studies have evaluated NPCs as a different way to treat or prevent renal damage and appear to show some benefits in improving OS, inflammation, and antioxidant capacity, therefore making them promising therapeutic tools to reduce or prevent the onset and progression of KD pathogenesis. CONCLUSIONS: This review shows the promising clinical properties of NPC in KD therapy. However, more robust clinical trials are needed to establish their safety and therapeutic effects in the area of renal damage.

Assuntos

Nefropatias/tratamento farmacológico , Extratos Vegetais/farmacologia , Substâncias Protetoras/farmacologia , Antioxidantes/farmacologia , Berberina/farmacologia , Beta vulgaris , Betalaínas/farmacologia , Produtos Biológicos/farmacologia , Catequina/farmacologia , Curcumina/farmacologia , Dissulfetos/farmacologia , Flavonoides/farmacologia , Humanos , Isotiocianatos/farmacologia , Rim/efeitos dos fármacos , Rim/patologia , Punica granatum , Resveratrol/farmacologia , Ácidos Sulfínicos/farmacologia , Sulfóxidos/farmacologia , Xantofilas/farmacologia

RESUMO

INTRODUCTION: The substitution of reference drugs for similar, new or existing drugs in the market is a dilemma present in daily dental procedures. In order to decide whether or not to adopt a new drug in relation to the reference, a clinical trial can provide the necessary evidence. METHODS: A total of 179 healthy volunteers (18-25 years) requiring extraction of mandibular third molars completed the study. Subjects were randomized into 4 groups: right, left, Arteek-SP and Septanest. Allocations consisted of 4% Articaine hydrochloride with 1:10000 epinephrine. The primary aim of this randomized controlled trial was to determine whether the test drug Arteek-SP was noninferior by a margin of 10% in the proportion of patients with total absence of pain, compared to the reference drug Septanest in the extraction of mandibular third molars using inferior alveolar nerve blocks. Secondary outcomes included, hemodynamic parameters, volume (mL), pain scores assessed during one visit and reported postoperative discomfort assessed during 8 days. Noninferiority was declared if total absence of pain for both groups was equal to 0.9, with a significance level of 5% (P < 0.05) and power at 90% (ß = 0.1) at 95% confidence level. RESULTS: Arteek-SP was applied during the first surgery to 90 volunteers (50.28%) and Septanest was applied to 89 subjects (49.72%). Less than 10% difference was identified, in the proportion of patients with total absence of tooth pain P < 0.05 and in the gum P < 0.1, at 95% CI, when Arteek-SP was applied first in comparison with Septanest, establishing noninferiority. CONCLUSION: The clinical performance of the test drug Arteek-SP is noninferior to the reference drug Septanest. They can be considered interchangeable in terms of cost or convenience. REGISTRATION: ClinicalTrials.org, number NCT4166890.