ABSTRACT
Abstract Background: Systemic sclerosis (SSc) Is a clinically complex and challenging disease, that leads to skin fibrosis. Its most frequent complication is interstitial lung disease (ILD), which leads to a worse prognosis. In this situation, cyclophosphamide is considered the gold standard for its treatment, despite the controversies regarding its efficacy and toxicity. However, studies using rituximab (RTX) have shown that this drug may be a promising therapeutic option. Objectives: This paper objective was to analyze the scientific evidence on the RTX effects on SSc. Methods: A systematic review (SR) was performed including clinical trials (CTs) on the use of RTX in SSc, published up to May 2020. The studies were identified through systematic searches in bibliographic databases using a predefined search strategy. The following databases were used: PUBMED, SCOPUS, SCIELO, LILACS, SCIENCE DIRECT, WEB OF SCIENCE, COCHRANE, WHOLIS, PAHO and EMBASE. Also, a manual search was performed. The methodological quality of the studies was determined using Jadad scale, Risk of Bias Tool (RoB 2.0) and Risk of Bias in Non-Randomized Studies - of Interventions tool (ROBINS-I). A meta-analysis of the randomized CTs was performed, using Review Manager. Results: Ten CTs were included in this SR. Of these, three were randomized and seven were non-randomized. Five showed a statistically significant improvement in forced vital capacity (FVC) at some time during follow-up. Regarding the skin, eight studies showed statistically significant improvements according toa the modified Rodnan skin score. The meta-analysis found positive effects of RTX in SSc, with a statistical significance for lung disease. Conclusion: Rituximab is a promising strategy for the SSc-associated ILD and cutaneous fibrosis treatment. PROSPERO registration number: CRD42019132018.(AU)
Subject(s)
Humans , Scleroderma, Systemic/drug therapy , Rituximab/therapeutic use , Prognosis , Cyclophosphamide/adverse effects , Cyclophosphamide/therapeutic useABSTRACT
BACKGROUND: The pandemic following the rapid spread of the new SARS-CoV-2 virus has hit all continents and caused thousands of deaths worldwide. Evidence has been published on epidemiological and clinical characteristics of population groups considered at risk; however, information for the other population groups, especially for the child population, is needed. In this context, this protocol describes a systematic review that will aim to identify the evidence on control and prevention of COVID-19 transmission among children and adolescents, as well as to describe the epidemiological profile and clinical and immunological characteristics of COVID-19 in this population. METHODS: This protocol will be developed in accordance with PRISMA-P. The searches will be conducted in PubMed, Web of Science, ScienceDirect, EMBASE, and Scopus, seeking clinical trials. Observational studies and case reports with Children and adolescents (≤19 years) infected with SARS-CoV-2 will be included whether they report information on the control of prevention and COVID-19 transmission. Two independent researchers will perform the selection of articles, removal of duplication, and screening by Rayyan QCRI application. Cochrane's RoB 2.0, ROBINS-I, and CASP tools will be used to assess the risk of bias. Meta-analysis, subgroup analyses, and/or descriptive analyses will be carried out based on the data conditions included. RESULTS: A high-quality synthesis of the available evidences on the epidemiological profile, the clinical and immunological characteristics involved in children, and adolescents diagnosed with COVID-19, as well as the participation of this population in the transmission dynamics of SARS-CoV-2 will be provided. CONCLUSION: This systematic review has an important relevance in the current context because it has a great potential to help the development of new control and prevention strategies in the pediatric population. RECORD OF SYSTEMATIC REVIEW: CRD42020179263.
Subject(s)
Betacoronavirus , Coronavirus Infections/transmission , Disease Transmission, Infectious/prevention & control , Pneumonia, Viral/transmission , Adolescent , COVID-19 , Child , Humans , Meta-Analysis as Topic , Pandemics , Research Design , SARS-CoV-2 , Systematic Reviews as TopicABSTRACT
BACKGROUND: Multiple sclerosis (MS) is a chronic immune mediated disease which affects the central nervous system (CNS), having a substantial financial, functional, and quality of life (QOL) impact on these people. The vitamin A supplementation has been studied as a therapeutic possibility for in MS. Therefore, the objective of this protocol is to build an outline for a future systematic review, which will provide up-to-date available evidence about the clinical impact of nutritional supplementation of vitamin A in the outcomes related to the symptoms in patients with this pathology. METHODS: The search will be performed in the following databases: PubMed, Embase, Scopus, cinahl, Scielo, Web of Science, the Cochrane Library and Science Direct, randomized clinical trials published until May 2019 that evaluate the relationship of the supplementation of vitamin A and health-related outcomes in patients with MS will be included. Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) will be used to outline the protocol, and PRISMA to the systematic review. Undergraduate handbook of quality of evidence and strength of recommendations for decision making in health (GRADE) will be used to assess the quality of evidence and the strength of the recommendation, and the JADAD scale to assess the internal validity of selected studies. For the extraction of all the data found a database in Microsoft Excel will be created. For the summary of the findings the Cochrane Collaboration Handbook recommendations will be used, and for the meta-analysis standard statistical techniques the RevMan software will be used. RESULTS: In this study, we hope to find a considerable number of articles presenting evidence about the effectiveness of vitamin A supplementation in patients with MS. CONCLUSION: Currently, many lines of evidence have been produced when it comes to the use of food supplements. This systematic review proposal might provide recent, important, and trusted information for better treatment of patients. RECORD OF SYSTEMATIC REVIEW: This review was recorded in the International Register of Prospective Systematic Reviews (PROSPERO) on the January 30, 2019 (registration: CRD42019121757). Available at: http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42019121757.
Subject(s)
Dietary Supplements/standards , Meta-Analysis as Topic , Multiple Sclerosis/diet therapy , Randomized Controlled Trials as Topic/standards , Review Literature as Topic , Humans , Nutrition Therapy/methods , Outcome Assessment, Health Care/methods , Outcome Assessment, Health Care/standards , Randomized Controlled Trials as Topic/methods , Vitamin A/therapeutic use , Vitamins/therapeutic useABSTRACT
Introdução: A esclerose múltipla (EM) é o distúrbio autoimune mais prevalente na atualidade e está associado à desmielinização dos neurônios no sistema nervoso central por meio da ativação do sistema imunológico. Estudos utilizando a vitamina A vêm se mostrando promissores na melhora da doença. Dessa forma, a presente dissertação tem como objetivo fornecer as melhores evidências disponíveis sobre o impacto clínico da vitamina A nos desfechos relacionados aos sintomas de pacientes portadores de EM. Métodos: Foi utilizado o formato de coletânea de artigos para a produção de dois artigos, sendo o primeiro um artigo de protocolo de revisão sistemática, usado como subsídio para a produção do segundo artigo, a revisão sistemática. Foram realizadas buscas no Pubmed, Embase, Scopus, Cinahl, Scielo, Web of science, Biblioteca cochrane e Science direct, de estudos que avaliassem a relação da suplementação de vitamina A e/ou concentrações séricas e os sintomas em pacientes portadores de EM. Para o delineamento da revisão sistemática foi utilizado o protocolo PRISMA. Para avaliar a qualidade metodológica dos estudos foi utilizada a escala JADAD para os ensaios clínicos randomizados e a NewcastleOttawa para os estudos observacionais. Para a extração de todos os dados encontrados foi criado um banco de dados no programa Microsoft Excel. Resultados: Na busca inicial encontramos 2053 estudos, e ao final das buscas foram selecionados 6 artigos elegíveis à pesquisa, sendo 2 Ensaios Clínicos Randomizados e 4 coortes. Dos seis estudos incluídos, dois utilizaram a suplementação de vitamina A e verificaram que a vitamina A é capaz de conter a progressão da doença nos membros superiores e as deficiências cognitivas, além de melhorar significativamente os escores de depressão, fadiga total e as três subescalas de fadiga (física, cognitiva e psicossocial). Os outros quatro estudos realizaram as dosagens das concentrações séricas da vitamina A e constataram que os níveis séricos de retinol não foram associados ao risco ou ao número de recidivas, nem ao agravamento da Escala de status Status de incapacidade Incapacidade expandida Expandida de Kurtzke. Porém, concentrações séricas elevadas de retinol foram associadas a menor da atividade da doença e foram capazes de predizer resultados de novas lesões por meio da ressonância magnética. Conclusão: as evidências identificadas no presente estudo permitem recomendar a suplementação de vitamina A como uma alternativa complementar ao tratamento da EM. Porém, novos ensaios clínicos controlados e bem realizados se fazem necessários para uma melhor definição da dosagem segura (AU).
Introduction: Multiple sclerosis (MS) is the most prevalent autoimmune disorder today and is associated with demyelination of neurons in the central nervous system through activation of the immune system. Studies using vitamin A have been promising to improve the disease. Thus, the present dissertation aims to provide the best available evidence on the clinical impact of vitamin A on the symptoms-related outcomes of patients with MS. Methods: The article collection format was used for the production of two articles. The first one was a systematic review protocol article, used as a subsidy for the production of the second article, the systematic review. We searched on Pubmed, Embase, Scopus, Cinahl, Scielo, Web of Science, Cochrane Library, and Science Direct for studies evaluating the relationship of vitamin A supplementation and/or serum concentrations and symptoms in MS patients. For the design of the systematic review the PRISMA protocol was used. To assess the methodological quality of the studies, the JADAD scale was used for randomized controlled trials and Newcastle-Ottawa for observational studies. To extract all the data found, a database was created in the Microsoft Excel program. Results: At the initial search we found 2053 studies, and at the end of the searches 6 articles were selected for the research (2 randomized clinical trials and 4 cohorts). Of the six studies included, two used vitamin A supplementation and found that vitamin A is capable of containing upper limb disease progression and cognitive impairment, as well as significantly improving depression, total fatigue, and all three subscales fatigue (physical, cognitive and psychosocial). The other four studies measured serum vitamin A concentrations and found it was not associated with risk or number of relapses or worsening of the Kurtzke Expanded Disability Expanded Disability Status Scale. However, elevated serum retinol concentrations were associated with lower disease activity and were able to predict results of new lesions by magnetic resonance imaging. Conclusion: evidence identified in this study allow to recommend supplementation of vitamin A as an additional alternative to the treatment of MS. However, new controlled clinical trials well done are needed to define safe dosing better (AU).
