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

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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Efficacy of acupuncture on cancer pain:A systematic review and meta-analysis

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journal of Integrative Medicine 2024年第3期22卷 235-244页

作者： Miguel Faria Mónica Teixeira Maria joão Pinto Paulo Sargento Núcleo de Investigação em Ciências e Tecnologias da Saúde Instituto Politécnico da Lusofonia1950-396 LisboaPortugal Clínica São joão de Deus 1700-048 LisboaPortugal REQUIMTE/LAQV(Rede de Química e Tecnologia/Laboratório Associado para a Química Verde) Instituto Superior de EngenhariaInstituto Politécnico do Porto4051-401 PortoPortugal Hospital SoERAD 2560-312 Torres VedrasPortugal Centro de Estudos Avançados em Direito“Francisco Suarez ”1749-024 LisboaPortugal

Background:Pain associated with cancer is one of the greatest causes of reduced quality of life in *** is one of the treatments used to address this issue,with the great advantage of having little or no side effects,especially when compared with pharmacological ***:The aim of this systematic review and meta-analysis was to evaluate the current evidence regarding the efficacy of acupuncture for cancer *** strategy:Six electronic databases(PubMed,EBSCo,Cochrane Library,Scielo,b-on and Scopus)were searched for relevant articles about pain relief in cancer patients from their beginning until 2022using MeSH terms such as“acupuncture,”“electroacupuncture,”“ear acupuncture,”“acupuncture analgesia,”“oncological pain,”and“cancer pain.”Inclusion criteria:Studies included were randomized controlled trials(RCTs)where acupuncture was compared with no treatment,placebo acupuncture or usual *** extraction and analysis:Three independent reviewers participated in data extraction and evaluation of risk of bias,and a meta-analysis was *** primary outcome was pain intensity,measured with the visual analog scale,numeric rating scale,or brief pain *** outcomes also assessed were quality of life,functionality,xerostomia,pain interference,and analgesic *** were expressed as standardized mean difference(SMD)with 95%confidence interval(CI).Results:Sixteen RCTs with a total of 1124 participants were included in the meta-analysis,with the majority of the studies presenting a low or unclear risk of *** was more effective in reducing pain than no treatment(SMD=–0.90,95%CI[–1.68,–0.12]),sham acupuncture(SMD=–1.10,95%CI[–1.59,–0.61])or usual care(SMD=–1.16,95%CI[–1.38,–0.93]).Conclusion:The results of this study suggest that acupuncture may be an effective intervention to reduce pain associated with *** some limitations due to the low quality and small sample size of some included st

关键词： Acupuncture Cancer pain Meta-analysis Systematic review

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Dysregulated microRNAs in type 2 diabetes and breast cancer:Potential associated molecular mechanisms

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World journal of Diabetes 2024年第6期15卷 1187-1198页

作者： Alex Cleber Improta-Caria Filipe Ferrari joão Lucas Penteado Gomes Paloma Brasilio Villalta Úrsula Paula RenóSoci Ricardo Stein Edilamar M oliveira Laboratory of Biochemistry and Molecular Biology of the Exercise Physical Education and Sport SchoolUniversity of São PauloSão Paulo 05508-030Brazil Graduate Program in Cardiology and Cardiovascular Sciences Federal University of Rio Grande do SulHospital de Clínicas de Porto AlegrePorto Alegre 90035003Brazil Laboratory of Metabolic Disorders(Labdime) School of Applied SciencesUniversity of Campinas-UNICAMPCampinas 13484-350Brazil Departments of Internal Medicine Molecular Pharmacology and PhysiologyCenter for Regenerative MedicineUSF Health Heart InstituteMorsani College of MedicineUniversity of South FloridaTampaFL 33602United States

Type 2 diabetes(T2D)is a multifaceted and heterogeneous syndrome associated with complications such as hypertension,coronary artery disease,and notably,breast cancer(BC).The connection between T2D and BC is established through processes that involve insulin resistance,inflammation and other *** this comprehension the specific cellular and molecular mechanisms linking T2D to BC,especially through microRNAs(miRNAs),remain *** are regulators of gene expression at the post-transcriptional level and have the function of regulating target genes by modulating various signaling pathways and biological ***,the signaling pathways and biological processes regulated by miRNAs that are associated with T2D and BC have not yet been *** review aims to identify dysregulated miRNAs in both T2D and BC,exploring potential signaling pathways and biological processes that collectively contribute to the development of BC.

关键词： Type 2 diabetes Breast cancer MicroRNAs Molecular mechanisms

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A review on the scale-up of high-shear wet granulation processes and the impact of process parameters

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颗粒学报（英文版） 2024年第9期92卷 180-195页

作者： Ana Rita Alves Marta Filipe Simões Sérgio Simões joão Gomes University of Coimbra CERESDepartment of Chemical EngineeringFaculty of Sciences and TechnologyRua Sílvio Lima3030-790CoimbraPortugal Bluepharma-Indústria Farmacêutica São Martinho do BispoCoimbra3045-016Portugal Adalvo Ltd. Malta Life Sciences ParkBuilding 1Level 4Sir Temi Zammit BuildingsSan Gwann Industrial EstateSan Gwann SGN3000Malta Bluepharma-Indústria Farmacêutica São Martinho do BispoCoimbra3045-016Portugal Faculty of Pharmacy University of CoimbraAzinhaga de Santa Comba3000-548CoimbraPortugal

Wet granulation is one of the most important agglomeration processes,and high-shear granulation(HSG)one of the most employed technologies in the pharmaceutical *** most critical process parameters of HSG are discussed in this *** main concern in scaling up the wet granulation process is the differences between scales,which prevent the particles from having the same experience across all scales.The scale-up of wet granulation processes is commonly divided into two categories:engineering and attribute-based *** engineering-based scale-up approach is a strategy based on dimensional analysis and an attribute-based supported on the principles of"equifinality",where process variables are adjusted to obtain equivalent granule *** work presents the effect of different HSG process parameters on the scale-up,as well as the use of process analytical tools(PAT)and modelling *** aim is to review applied scale-up approaches in HSG and discuss benefits and *** is proven why the scale-up for oral solid pharmaceutical products is still considered a hot topic and a very chal-lenging task for development and engineering teams.

关键词： High-shear wet granulation Parametric-based Attribute-based Physics-based modelling Impeller design Scale-up

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Peritoneal interposition flap reduces symptomatic lymphocele following transperitoneal robot-assisted radical prostatectomy and pelvic lymph node dissection:An updated meta-analysis

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Current Urology 2024年第3期18卷 167-176页

作者： joão Henrique Sendrete de Pinho Lorrane Vieira Siqueira Riscado joão Padua Manzano Faculty of Medicine of the Federal University of Juiz de Fora Minas GeraisBrazil Faculty of Medicine of the Federal University of São Paulo São PauloBrazil

Background Robot-assisted radical prostatectomy with intraoperative pelvic lymph node dissection is the criterion standard for surgical treatment of nonmetastatic intermediate-and high-risk prostate ***,this method is associated with symptomatic lymphocele(SLC),which is an important morbidity *** overcome this complication,several modifications of the technique have been developed,including the peritoneal interposition flap(PIF).We performed an updated systematic review and meta-analysis to investigate the efficacy and safety of this technique for preventing SLC and lymphocele(LC)*** and methods Searches were performed using databases and references from included studies and previous systematic *** randomized controlled trials and nonrandomized cohorts were *** outcomes were the incidence of SLC and LC formation,and safety outcomes were defined as operation time,estimated blood loss,length of hospital stay,and urinary *** assessment was performed using the Newcastle-ottawa Scale and Cochrane Collaboration's *** treatment effects were estimated using odds ratios with 95%confidence intervals(CIs)for binary *** was examined using Cochran's Q test and I2 statistics;p values25%were considered significant for *** used Mantel-Haenszel fixed-effect models in the analyses with low ***,the DerSimonian and Laird random-effects model was *** The initial search yielded 510 *** the removal of duplicate records and application of the exclusion criterion,9 studies were fully reviewed for *** randomized controlled trials and 5 retrospective cohorts met all the inclusion criteria,comprising 2261 patients,of whom 1073(47.4%)underwent *** studies reported a significant reduction in SLC in the PIF group,and 3 of the 4 studies reported LC formation yielded significant results in preventing this complication.

关键词： Robot-assisted radical prostatectomy Lymphocele Peritoneal reapproximation Peritoneal interpolated flap Meta-analysis

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Testicular prostheses-impact on quality of life and sexual function

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Asian journal of Andrology 2024年第2期26卷 160-164页

作者： Ana Sofia Araujo Sara Anacleto Ricardo Rodrigues Catarina Tinoco Andreia Cardoso Carlos oliveira Ricardo Leao Department of Urology Braga's HospitalBraga 4710Portugal Faculty of Medicine Coimbra UniversityCoimbra 3000Portugal

orchiectomy is the recommended treatment for many testicular ***,testicular prosthesis placement is not always performed for different *** this study,we aimed to evaluate patients'opinions and the impact on sexual function and quality of *** retrospective observational single-center study included patients who underwent orchiectomy between January 2014 and December 2020 at the Department of Urology,Braga's Hospital(Braga,Portugal),where testicular implants were always available and the decision to undergo the procedure was made fully independent of *** completed four questionnaires that assessed demographic data,satisfaction,self-esteem,and sexual *** the 96 patients who underwent orchidectomy,59 replied to the questionnaires,and of these patients,86.4%decided to undergo silicone-based testicular prostheses *** remaining 13.6%refused the implant based on concerns about complications(37.5%),because they felt that it was unnecessary(37.5%),or because it was not offered by the doctor(25.0%).overall,96.1%of these patients were satisfied with the implant;however,25.5%classified it as"too firm".No statistically significant differences were found in sexual function(all P>0.05).However,it can be observed that there are more patients with prostheses presenting normal sexual activity compared to patients without prostheses(74.0%vs 50.0%),and none of them reported severe erectile dysfunction(0 vs 16.7%).Regarding self-esteem,both patients with and without prostheses present very similar average scores with no statistically significant *** present study highlights the highest level of satisfaction among patients who received testicular *** prostheses implantation is a safe procedure that does not hamper sexual function after orchiectomy.

关键词： orchiectomy patient satisfaction quality of life sexual dysfunction sexual health testicular prostheses

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Determination of critical state line(CSL)for silty-sandy iron ore tailings subjected to low-high confining pressures

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journal of Rock Mechanics and Geotechnical Engineering 2024年第5期16卷 1684-1695页

作者： Nilo Cesar Consoli joão Vítor de Azambuja Carvalho Alexia Cindy Wagner Hugo Carlos Scheuermann Filho Inácio Carvalho Pedro Pazzoto Cacciari joão Paulo de Sousa Silva Civil Engineering Universidade Federal do Rio Grande do SulPorto AlegreRS90035-190Brazil Exploration and Mineral Projects-Mineral Development Centre VALE S.A.Santa LuziaMG33040-900Brazil Department of Civil Geological and Mining EngineeringPolytechnique MontrealQuebecH3C 3A7Canada

The disposal of filtered tailings in high dry stacks can induce particle breakage,changing the material's behaviour during the structure's *** grading changes influence material properties at the critical state,and this is not mature for intermediate artificial soils(tailings)in a broad range of confining *** this paper,it aims to describe the behaviour of iron ore tailings in a spectrum of confining pressures broader than the reported in previous studies.A series of consolidated drained(CD)triaxial tests was carried out with confining pressures ranging from 0.075 MPa to 120 *** results show that the amount of breakage plays an essential role in the response of iron ore *** existence of curved critical state line(CSL)in both specific volume(ν)-logarithm of mean effective stress(p′)and deviatoric stress(q)-mean effective stress(p′)planes,and different responses in the deviatoric stress-axial strain-volumetric strain curves were *** inverse S-shaped equation was proposed to represent the silty-sandy tailings'behaviour up to high pressures onν-lnp′*** proposed equation provides a basis for enhancing constitutive models and considers the evolution of the grading up to severe loading *** adjustment considered three regions with different responses associated with particle breakage at different pressure levels.

关键词： Tailings Iron ore tailings dry stacking Silty-sandy material Critical state soil mechanics High confining pressures Particle breakage

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Could school programs based on social-emotional learning prevent substance abuse among adolescents?

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World journal of Psychiatry 2024年第8期14卷 1143-1147页

作者： joão Mauricio Castaldelli-Maia Nicolas Kohatsu Matakas Department of Neuroscience Medical SchoolFMABC University CenterSão Paulo 09060870SPBrazil Department of Substance Use Disorders Perdizes Institute-HCFMUSPSao Paulo 05021001SPBrazil

In this editorial,we comment on the article Adolescent suicide risk factors and the integration of social-emotional skills in school-based prevention programs by Liu et *** the article focused on the issue of suicide and social-emotional learning programs as a possible intervention,we here discuss evidence of other reported outcomes and if it could be an effective way to prevent substance abuse among adolescents.

关键词： Social-emotional learning Substance use Adolescent Student Prevention Mental health

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Interface engineering of Co_(9)S_(8)/SnS heterostructure as a high-performance anode for lithium/sodium-ion batteries

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Rare Metals 2024年第2期43卷 612-623页

作者： Jia Luo Shi-Li Xiang Dan-Yang Han An Liu joão Cunha Gang-Yong Li Zhao-Hui Hou Hong Yin School of Chemistry and Chemical Engineering Key Laboratory of Hunan Province for Advanced Carbon-based Functional MaterialsHunan Institute of Science and TechnologyYueyang414006China Hubei Jiufengshan Laboratory Wuhan430206China International Iberian Nanotechnology Laboratory(INL) Av.Mestre Jose Veiga4715-330BragaPortugal

Transition metal sulfide(TMS)anodes exhibit the characteristics of phase stability and high capacity for lithium/sodium-ion batteries(LIBs/SIBs).However,the TMS anodes often suffer from poor electronic conductivity,low ionic diffusion and large volume expansion during Li/Na-ion intercalation significantly impairing the Li/Na-storage ***,a long chain heterostructure composed of the Co_(9)S_(8) and SnS are first reported,which can generate rich phase interfaces,and small crystal *** unique structure can facilitate the properties of reactivity,conductivity and ionic *** addition,the heterostructure surface is modified by the N-doped carbon(N-DC@(CoSn)S),successfully improving the structural *** synergistic effects of Co_(9)S_(8)/SnS heterostructure and coated carbon layer effectively increase the capacity and cycling *** N-DC@(CoSn)S anode delivers enhanced high specific capacities of 820.6 mAh·g^(−1) at 1.0 A·g^(–1) after 500 cycles for LIBs and 339.2 mAh·g^(–1)at 0.5 A·g^(–1) after 1000 cycles for SIBs,*** work is expected to provide a material design idea for preparing LIBs/SIBs with high capacity and long cycling life.

关键词： Interface engineering Long chain heterostructure High capacity Cycling stability Li Na-ion batteries

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