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Social determinants of gastrointestinal malformation mortality in Brazil:a national study

World Journal of Pediatric Surgery 2024年第2期7卷 134-141页

作者： Ayla Gerk Amanda Rosendo luiza telles.aricia gomes.miranda Madeleine Carroll Bruna Oliveira Trindade Sarah Bueno Motter Esther Freire Gabriella Hyman Julia Ferreira Fabio Botelho Roseanne Ferreira David P Mooney Joaquim Bustorff-Silva Program in Global Surgery and Social Change Harvard Medical SchoolBostonMassachusettsUSA Faculty of Medicine and Health Sciences McGill UniversityMontrealQuebecCanada Harvey E.Beardmore Division of Pediatric Surgery The Montreal Children's HospitalMcGill University Health CentreMontrealQuebecCanada Department of Surgery Universidade Estadual de Campinas(UNICAMP)CampinasBrazil Instituto de Educação Médica(IDOMED/Estácio Campus Vista Carioca)Rio de JaneiroBrazil Faculty of Medicine Universidade Federal do Delta do ParnaibaParnaibaPiauiBrazil Universidade Federal de Ciencias da Saude de Porto Alegre Porto AlegreBrazil Universidade Federal da Bahia SalvadorBrazil Department of Health Research Methods McMaster UniversityHamiltonSouthern OntarioCanada Department of Pediatric Surgery Boston Children's HospitalBostonMassachusettsUSA

Introduction In Brazil,approximately 5%are born with a congenital disorder,potentially fatal without *** study aims to evaluate the relationship between gastrointestinal congenital malformation(GICM)mortality,health indicators,and socioeconomic factors in *** GICM admissions(Q39-Q45)between 2012 and 2019 were collected using national *** demographics,socioeconomic factors,clinical management,outcomes,and the healthcare workforce density were also accounted *** Surgical Workforce density and the number of neonatal intensive care units in a region were extracted from national datasets and combined to create a clinical index termed'NeoSurg'.Socioeconomic variables were combined to create a socioeconomic index termed SocEcon'.Simple linear regression was used to investigate if the temporal changes of both indexes were *** correlation between mortality and the different indicators in Brazil was evaluated using Pearson's correlation *** Over 8 years,Brazil recorded 12804 GICM *** Southeast led with 6147 cases,followed by the Northeast(2660),South(1727),North(1427),and Midwest(843).The North and Northeast reported the highest mortality,lowest NeoSurg,and SocEcon Index ***,mortality rates declined across regions from 7.7%(2012)to 3.9%(2019),a 51.7%*** North and Midwest experienced the most substantial reductions,at 63%and 75%,*** significantly correlated with the indexes in nearly all regions(p<0.05).Conclusion Our study highlights the correlation between social determinants of health and GICM mortality in Brazil,using two novel indexes in the pediatric *** findings provide an opportunity to rethink and discuss new indicators that could enhance our understanding of our country and could lead to the development of necessary solutions to tackle existing challenges in Brazil and globally.

关键词： Northeast Brazil globally

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Development of a Ready-to-Use PSMA-11 Kit Formulation and Biological Evaluation of Binding Affinity

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Advances in Molecular Imaging 2024年第2期13卷 7-22页

作者： Maria Renata Valente Brandão Freire Natália Marchesan Bexiga Marco Antonio Stephano João Ezequiel Oliveira Carlos Roberto Jorge Soares Ana Cláudia Camargo miranda Anna Carolina de Alcântara Barbosa Marycel Figols de Barboza Laura Fernanda Garcia Luiz Felipe S. Teixeira Maria Helena Marumo Bellini Natanael gomes da Silva luiza Mascarenhas Balieiro Joel Mendes Elaine Bortoleti de Araújo Centro de Radiofarmcia Instituto de Pesquisas Energticas e Nucleares (IPEN) Cidade Universitria So Paulo Brasil Departamento de Tecnologia Farmacutica Faculdade de Cincias Farmacuticas (USP) Cidade Universitria So Paulo Brasil Centro de Biotecnologia Instituto de Pesquisas Energticas e Nucleares (IPEN) Cidade Universitria So Paulo Brasil Departamento de Medicina Nuclear do Hospital Israelita Albert Einstein So Paulo/SP Brasil

Introduction: 68Ga-PSMA-11 is considered the gold standard in detection of micro and oligometastases in advanced prostate cancer, being used for therapeutic planning, as well as, potentially, for evaluating response to treatment. The development of ready-to-use lyophilized kit of PSMA-11 adds quality and safety to the routine use of this radiopharmaceutical and represents a pharmacotechnical challenge as it must preserve the integrity and specificity of the ligand. Methods: PSMA-11 kit formulation was proposed, considering radiolabeling parameters and the preservation of the peptide during the lyophilization process, using mannitol as an excipient. Critical temperature characterization studies were carried out using DSC equipment and the freeze-drying process was developed. The direct radiolabeling conditions were evaluated and standardized using 68Ge/68Ga generator eluate from two different manufacturers (ITG and Eckert & Ziegler). The radiochemical purity was evaluated by TLC and HPLC. Biological evaluation was carried out with lyophilized PSMA-11 to demonstrate the integrity of the peptide and preservation of biological activity after the lyophilization process. Results: Based on critical temperature characterization studies, the freeze-drying cycle was designed to reach a freezing temperature of around −40˚C and primary drying at 2˚C. Using 20 mg of mannitol, an intact and elegant lyophilized cake was obtained. PSMA-11 lyophilized kit was directly labeled with 68Ga eluate from 68Ge/68Ga GMP generators (ITG and Eckert & Ziegler) resulting in % RP > 95% at pH 4.0 to 4.5. The results obtained from in vitro and in vivo biological competition studies confirmed the preservation of PSMA-11 affinity for the receptor after lyophilization. Conclusion: A lyophilized formulation (Kit) of PSMA-11 was successfully obtained, which preserved the integrity and biological activity of the peptide and guaranteed radiolabeling efficiency.

关键词： 68Ga-PSMA-11 Prostate-Specific Membrane Antigen (PSMA) Ready-to-Use Kit GMP-Grade Generators Metastatic Prostate Cancer PET Imaging

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Development of a Ready-to-Use PSMA-11 Kit Formulation and Biological Evaluation of Binding Affinity

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Advances in Molecular Imaging（分子影像学） 2024年第2期 7页

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