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Comparative Pharmacokinetic Study between Metformin Alone and Combined with Orlistat in Healthy Mexican Volunteers

Pharmacology & Pharmacy 2012年第3期3卷 300-306页

作者： noemí Santos-caballero Francisco Javier Flores-Murrieta Landsteiner Scientific S.A. de C.V. México D.F. Mexico Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina Instituto Politécnico Nacional México D.F. Mexico

Traditional treatment of type 2 diabetes mellitus (T2DM) has focused on correcting hyperglycemia. However, T2DM is almost always accompanied by other conditions and risk factors that affect its morbidity and mortality. Obesity represents one of the main risk factors associated in the T2DM and a modest weight loss around 5% is linked with significant reduction in the blood glucose levels. The objective of this study was to compare the pharmacokinetic parameters between two formulations of metformin, alone or combined with orlistat, in healthy volunteers. A single-blinded, single dose, two-period, two-sequence, crossover, randomized and balanced study design with a 7-day washout period was performed in 26 Mexican volunteers. Plasma samples were collected over a 24-hour period after administration of 500 mg metformin alone or combined with 60 mg orlistat in each period. A validated high-performance liquid chromatography coupled with a ultraviolet detector was used to analyze metformin concentration in plasma. Bioequivalence between metformin alone and metformin combined with orlistat was determined when the ratio for the 90% confidence intervals (CI) of area under the curve (AUC24h) and maximum concentration (Cmax) of the two formulations were within 80% and 125%. In the current study, the mean ± standard deviation (SD) of Cmax, AUC24h and AUC∞ of the formulation containing only metformin were 1.39 ± 0.44 μg/mL, 7.59 ± 3.17 μg h/mL and 8.48 ± 4.13 μg h/mL, respectively, while the mean ± SD of Cmax, AUC24h and AUC∞ of the formulation containing metformin and orlistat were 1.38 ± 0.48 μg/mL, 7.80 ± 2.83 μg h/mL and 9.13 ± 4.29 μg h/mL, respectively. The parametric 90% CI for Cmax and AUC24h were 87.5-109.3 and 88.7-124.7, respectively. These results suggest that both formulations are bioequivalent and there is not pharmacokinetic interaction between metformin and orlistat.

关键词： Metformin Orlistat Diabetes Obesity Bioequivalence Pharmacokinetic

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Safety and Efficacy of Oral Mirodenafil in Mexican with Erectile Dysfunction

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International Journal of Clinical Medicine 2016年第9期7卷 628-638页

作者： Juan Gerardo Reyes-García noemí Santos-caballero Francisco Javier Flores-Murrieta Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina Instituto Politécnico Nacional Ciudad de México Mexico Landsteiner Scientific S.A. de C.V. Ciudad de México Mexico Unidad de Investigación en Farmacología Instituto Nacional de Enfermedades Respiratorias “Ismael Cosio Villegas” Ciudad de México Mexico

Erectile dysfunction is treated with 5-phospodiesterase inhibitors as Mirodenafil, which has shown its efficacy and safety in Koreans, however;no information in other populations is available. An open clinical trial study was designed to evaluate the efficacy and safety in real life of a fixed-dose of Mirodenafil in Mexican patients with erectile dysfunction. Forty-seven male patients received a 100 mg tablet of Mirodenafil, during 12 weeks. Primary outcome efficacy measure was the percentage of male patients with successful intercourse. Secondary outcomes measures included patient satisfaction, mood and self-esteem level. Safety assessments included laboratory tests, vital signs, physical examination, 12-lead electrocardiogram recordings, and incidence of adverse events by patients. Oral administration of Mirodenafil improved in an 80% - 90% the number of successful intercourses from 7 to 84 days of treatment. Moreover, patients reported a significant increment in their sexual satisfaction, mood and self-esteem. Mirodenafil treatment did not modify vital signs nor anthropometric parameters during 84 days. Mild headache was the most frequent adverse event (17.0%) and there were no severe adverse events during pharmacological treatment. Data suggest that oral Mirodenafil is safety, well tolerated and effective in the Mexican population with erectile dysfunction.

关键词： Efficacy Erectile Dysfunction Mexicans Mirodenafil Safety

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Predicting grain size-dependent superplastic properties in friction stir processed ZK30 magnesium alloy with machine learning methods

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Journal of Magnesium and Alloys 2024年第5期12卷 1931-1943页

作者： Farid Bahari-Sambran Fernando Carreno C.M.Cepeda-Jiménez Alberto Orozco-caballero Physical Metallurgy Department CENIM-CSICAv.Gregorio del Amo 828040 MadridSpain Department of Mechanical Engineering Chemistry and Industrial DesignPolytechnic University of MadridRonda de Valencia 328012MadridSpain

The aim of this work is to predict,for the first time,the high temperature flow stress dependency with the grain size and the underlaid deformation mechanism using two machine learning models,random forest(RF)and artificial neural network(ANN).With that purpose,a ZK30 magnesium alloy was friction stir processed(FSP)using three different severe conditions to obtain fine grain microstructures(with average grain sizes between 2 and 3μm)prone to extensive superplastic *** three friction stir processed samples clearly deformed by grain boundary sliding(GBS)deformation mechanism at high *** maximum elongations to failure,well over 400% at high strain rate of 10^(-2)s^(-1),were reached at 400℃ in the material with coarsest grain size of 2.8μm,and at 300℃ for the finest grain size of 2μ***,the superplastic response decreased at 350℃ and 400℃ due to thermal instabilities and grain coarsening,which makes it difficult to assess the operative deformation mechanism at such *** work highlights that the machine learning models considered,especially the ANN model with higher accuracy in predicting flow stress values,allow determining adequately the superplastic creep behavior including other possible grain size scenarios.

关键词： Machine learning Artificial intelligence Magnesium alloys Superplasticity Friction stir processing Grain coarsening

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Context-dependent role of sirtuin 2 in inflammation

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Neural Regeneration Research 2025年第3期20卷 682-694页

作者： noemíSola-Sevilla Maider Garmendia-Berges MCarmen Mera-Delgado Elena Puerta Department of Pharmaceutical Sciences Division of PharmacologySchool of Pharmacy and NutritionUniversity of NavarraPamplonaSpain Navarra Institute for Health Research(IdiSNA) PamplonaSpain

Sirtuin 2 is a member of the sirtuin family nicotinamide adenine dinucleotide(NAD~+)-dependent deacetylases, known for its regulatory role in different processes, including inflammation. In this context, sirtuin 2 has been involved in the modulation of key inflammatory signaling pathways and transcription factors by deacetylating specific targets, such as nuclear factor κB and nucleotide-binding oligomerization domain-leucine-rich-repeat and pyrin domain-containing protein 3(NLRP3). However, whether sirtuin 2-mediated pathways induce a pro-or an anti-inflammatory response remains controversial. Sirtuin 2 has been implicated in promoting inflammation in conditions such as asthma and neurodegenerative diseases, suggesting that its inhibition in these conditions could be a potential therapeutic strategy. Conversely, arthritis and type 2 diabetes mellitus studies suggest that sirtuin 2 is essential at the peripheral level and, thus, its inhibition in these pathologies would not be recommended. Overall, the precise role of sirtuin 2 in inflammation appears to be context-dependent, and further investigation is needed to determine the specific molecular mechanisms and downstream targets through which sirtuin 2 influences inflammatory processes in various tissues and pathological conditions. The present review explores the involvement of sirtuin 2 in the inflammation associated with different pathologies to elucidate whether its pharmacological modulation could serve as an effective strategy for treating this prevalent symptom across various diseases.

关键词： interferon inflammation lipopolysaccharide neuroinflammation NLRP3 nuclear factorκB sirtuin 2

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Oral Pharmacokinetics of Mirodenafil in Mexican Healthy Volunteers

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Pharmacology & Pharmacy 2014年第1期5卷 112-116页

作者： Miriam del Carmen Carrasco-Portugal Francisco Javier Flores-Murrieta Juan Gerardo Reyes-García noemí Santos-caballero Landsteiner Scientific S.A. de C.V. México DF México Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina Instituto Politécnico Nacional México DF México Unidad de Investigación en Farmacología Insituto Nacional de Enfermedades Respiratorias “Ismael Cosio Villegas” México DF México Unidad de Investigación en Farmacología Insituto Nacional de Enfermedades Respiratorias “Ismael Cosio Villegas” México DF México Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina Instituto Politécnico Nacional México DF México

Mirodenafil is a 5-phosphodiesterase inhibitor that is currently marketed in Korea for the treatment of erectile dysfunction;however, no information in other populations is available. It has been described that Mirodenafil is metabolized by CYP3A4, a metabolic pathway in which interethnic differences have been reported. The purpose of this study was to characterize the oral pharmacokinetics of Mirodenafil in Mexicans. Seventeen male healthy volunteers were enrolled in this study. After an overnight fast, volunteers received an oral 100 mg dose and blood samples were collected at selected times during 24 h. Plasma was stored frozen and analyzed by an HPLC method. Pharmacokinetic parameters obtained were: Cmax 331.129 ± 32.689 ng/mL, tmax 1.574 ± 0.293 h, AUC24h 883.293 ± 104.088 ng·h/mL, AUC￥ 976.477 ± 108.812 ng·h/mL and t1/2 1.807 ± 0.171 h. Parameter values observed in this study are similar to those reported in Koreans. Since efficacy and safety studies of Mirodenafil have been conducted in Koreans, it is expected that dosage regime to employ in Mexicans should be similar to the approved for Korean population.

关键词： Erectile Dysfunction Healthy Volunteers Mexican Mirodenafil Pharmacokinetic

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Game changer:How Janus kinase inhibitors are reshaping the landscape of ulcerative colitis mana

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World Journal of Gastroenterology 2024年第35期30卷 3942-3953页

作者： Antonio M caballero-Mateos Guillermo Arturo Cañadas-de la Fuente Department of Gastroenterology and Hepatology San Cecilio University HospitalGranada 18014Spain Department of Nursing Faculty of Health SciencesUniversity of GranadaGranada 18004Spain

Recent advancements in the treatment landscape of ulcerative colitis(UC)have ushered in a new era of possibilities,particularly with the introduction of Janus kinase(JAK)-signal transducer and activator of transcription *** novel agents offer a paradigm shift in UC management by targeting key signaling pathways involved in inflammatory *** approved JAK inhibitors(JAKis),such as tofacitinib,filgotinib,and upadacitinib,clinicians now have powerful tools to modulate immune responses and gene expression,potentially revolutionizing the treatment algorithm for *** trials have demonstrated the efficacy of JAKis in inducing and maintaining remission,presenting viable options for patients who have failed conventional ***-world data support the use of JAKis not only as first-line treatments but also in subsequent lines of therapy,particularly in patients with aggressive disease phenotypes or refractory to biologic *** rapid onset of action and potency of JAKis have broadened the possibilities in the management strategies of UC,offering timely relief for patients with active disease and facilitating personalized treatment *** safety concerns,including cardiovascular risks and infections,ongoing research and post-marketing surveillance will continue to refine our understanding of the risk-benefit profile of JAKis in UC management.

关键词： Ulcerative colitis Janus kinase inhibitors Filgotinib Tofacitinib Upadacitinib

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Submucosal injection of platelet-rich plasma in endoscopic resection of large sessile lesions

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World Journal of Gastrointestinal Endoscopy 2018年第11期10卷 348-353页

作者： Vicente Lorenzo-Zuniga Vicente Moreno de Vega Ramón Bartolí Ingrid Marín noemícaballero Ignacio Bon Jaume Boix Department of Gastrointestinal Endoscopy University Hospital Germans Trias/CIBERehdBarcelona 08916Spain

AIM To prospectively evaluate the efficacy of submucosal injection of platelet-rich plasma(PRP) on endoscopic resection of large sessile *** Eleven patients were submitted to endoscopic mucosal resection(EMR) with prior injection of PRP, obtained at the time of endoscopy. Patients were followed during 1 mo. The incidence of adverse events(delayed bleeding or perforation) and the percentage of mucosal healing(MHR) after 4 wk were registered. RESULTS EMR was performed in 11 lesions(46.4 mm ± 4 mm, range 40-70 mm). Delayed bleeding or perforation was not observed in any patient. Mean ulcerated area atbaseline was 22.7 cm^2 ± 11.7 cm^2 whereas at week 4 were 2.9 cm^2 ± 1.5 cm^2. Patients treated with PRP showed a very high MHR after 4 wk(87.5%). CONCLUSION PRP is an easy-to-obtain solution with proven and favourable biological activities that could be used in advanced endoscopic resection.

关键词： Platelet-rich plasma endoscopic mucosal resection submucosal injection large lesions

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Evaluation of the Influence of Hyoscine Butylbromide on the Oral Bioavailability of Lansoprazole in Healthy Adult Volunteers

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Pharmacology & Pharmacy 2016年第7期7卷 264-271页

作者： noemí Santos-caballero Lina Marcela Barranco-Garduño José Carlos Aguilar-Carrasco Miriam del Carmen Carrasco-Portugal Francisco Javier Flores-Murrieta Landsteiner Scientific S.A. de C.V. Mexico City Mexico Unidad de Investigación en Farmacología Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas Mexico City Mexico Departamento de Biología Celular Instituto Nacional de Perinatología Isidro Espinosa de los Reyes Mexico City Mexico Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina Instituto Politécnico Nacional Mexico City Mexico

The gastroesophageal reflux and/or peptic ulcer diseases are clinical conditions that occur usually accompanied of symptomatic pain. Lansoprazole, a proton pump inhibitor class drug is widely used in clinical practice for treatment of these diseases. However, its efficacy can be improved by combining with spasmolytic and/or visceral analgesic such as hyoscine butylbromide. Since hyoscine butylbromide is barely absorbed and exerts some local effects at gastrointestinal tract which may modify the absorption of lansoprazole, it is important to establish if there is a pharmacokinetic interaction after the oral concomitant administration of both drugs. For this objective, twenty-five subjects received under a crossover design an oral administration of lansoprazole (15 mg) plus placebo or a fixed-dose combination with hyoscine butiylbromide (15 mg + 10 mg, respectively). Plasma samples were obtained at different times during 10 hours. Lansoprazole plasma concentrations were determined by a high performance liquid chromatography method coupled to tandem mass spectrometry. Fixed-dose combination was well tolerated. Lansoprazole pharmacokinetic parameters were: Cmax 621.81 ± 212.79 and 450.38 ± 192.14 ng/mL;AUC0-t 1941.36 ± 845.57 and 1454.66 ± 757.28 ng·h/mL;tmax 2.83 ± 0.99 and 3.40 ± 1.82h;t1/2 1.35 ± 0.39 and 1.45 ± 0.51 h, for alone and combined fixed-dose formulation, respectively. Pharmacokinetic parameters were compared by analysis of variance and ratios of AUC0-t, Cmax and 90% confidence intervals obtained. Since confidence intervals exceed the 80% - 125% limits for these parameters, we conclude that there is a significantly pharmacokinetic interaction of lansoprazole when it is administered concomitantly with hyoscine butylbromide.

关键词： Lansoprazole Hyoscine Butylbromide Fixed-Dose Formulation Pharmacokinetic Interaction

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Advancing Malaria Prediction in Uganda through AI and Geospatial Analysis Models

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Journal of Geographic Information System 2024年第2期16卷 115-135页

作者： Maria Assumpta Komugabe Richard caballero Itamar Shabtai Simon Peter Musinguzi Center for Information Systems & Technology Claremont Graduate University Claremont California USA Department of Information Technology Faculty of Business and ICT University of Kisubi Entebbe Uganda Faculty of Health Sciences University of Kisubi Entebbe Uganda Department of Agriculture Production Faculty of Agriculture Kyambogo University Kyambogo Uganda Department of Agriculture and Natural Sciences Faculty of Agriculture Uganda Martyrs University Kampala Uganda

The resurgence of locally acquired malaria cases in the USA and the persistent global challenge of malaria transmission highlight the urgent need for research to prevent this disease. Despite significant eradication efforts, malaria remains a serious threat, particularly in regions like Africa. This study explores how integrating Gregor’s Type IV theory with Geographic Information Systems (GIS) improves our understanding of disease dynamics, especially Malaria transmission patterns in Uganda. By combining data-driven algorithms, artificial intelligence, and geospatial analysis, the research aims to determine the most reliable predictors of Malaria incident rates and assess the impact of different factors on transmission. Using diverse predictive modeling techniques including Linear Regression, K-Nearest Neighbor, Neural Network, and Random Forest, the study found that;Random Forest model outperformed the others, demonstrating superior predictive accuracy with an R2 of approximately 0.88 and a Mean Squared Error (MSE) of 0.0534, Antimalarial treatment was identified as the most influential factor, with mosquito net access associated with a significant reduction in incident rates, while higher temperatures correlated with increased rates. Our study concluded that the Random Forest model was effective in predicting malaria incident rates in Uganda and highlighted the significance of climate factors and preventive measures such as mosquito nets and antimalarial drugs. We recommended that districts with malaria hotspots lacking Indoor Residual Spraying (IRS) coverage prioritize its implementation to mitigate incident rates, while those with high malaria rates in 2020 require immediate attention. By advocating for the use of appropriate predictive models, our research emphasized the importance of evidence-based decision-making in malaria control strategies, aiming to reduce transmission rates and save lives.

关键词： Malaria Predictive Modeling Geospatial Analysis Climate Factors Preventive Measures

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Landscape of global urban environmental resistome and its association with local socioeconomic and medical status

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Science China(Life Sciences) 2024年第6期67卷 1292-1301页

作者： Jun Wu Yige Hu Michael H Perlin David Danko Jun Lu Manuela Oliveira Johannes Werner Maria M Zambrano Maria A Sierra Olayinka O Osuolale Paweł Łabaj Nicolás Rascovan Nur Hazlin Hazrin-Chong Soojin Jang Haruo Suzuki Marina Nieto-caballero Bharath Prithiviraj Patrick K H Lee Agnieszka Chmielarczyk Anna Różańska Yongxiang Zhao Lan Wang Christopher E Mason Tieliu Shi Center for Bioinformatics and Computational Biology and the Institute of Biomedical SciencesSchool of Life SciencesEast China Normal UniversityShanghai 200241China Department of Biology Program on Disease EvolutionUniversity of LouisvilleLouisville 40292USA Weill Cornell Medicine New York 10065USA The Bin Talal Bin Abdulaziz Alsaud Institute for Computational Biomedicine New York 10065USA Department of Pulmonary Medicine Shanghai Chest HospitalShanghai Jiao Tong UniversityShanghai 200025China i3S-Instituto de Investiga玢o e Inova玢o em Saúde Universidade do PortoPorto 4050-290Portugal Ipatimup-Instituto de Patologia e Imunologia Molecular da Universidade do Porto Porto 4200-465Portugal Departamento de Biologia Faculdade de CiênciasUniversidade do PortoPorto 4050-290Portugal High Performance and Cloud Computing Group Zentrum für Datenverarbeitung(ZDV)Eberhard Karls University of TübingenW鋍hterstra遝7672074TübingenGermany Corporación Corpogen Research Center Bogotá110311Colombia Applied Environmental Metagenomics and Infectious Diseases Research(AEMIDR) Department of Biological SciencesElizade UniversityIlara-Mokin 340271Nigeria Maopolska Centre of Biotechnology Jagiellonian UniversityKraków 30-005Poland Aix-Marseille Université Mediterranean Institute of OceanologyUniversitéde ToulonCNRSIRDUM 110Marseille 83041France Department of Biological Sciences and Biotechnology Faculty of Science and TechnologyUniversiti Kebangsaan Malaysia43600 UKM BangiSelangor Institut Pasteur Korea Seoul 13488Republic of Korea Faculty of Environment and Information Studies Keio UniversityFujisawaKanagawa 252-0882Japan University of Colorado at Boulder CivilEnvironmental and Architectural DepartmentBoulder 80303USA Brooklyn College of the City University of New York Brooklyn 11210USA School of Energy and Environment City University of Hong KongHong Kong 999077China Department of Microbiology Faculty of MedicineJagiellonian UniversityKraków 30-005Poland Biological Targeting Diagnosis and The

Antimicrobial resistance(AMR)poses a critical threat to global health and development,with environmental factors—particularly in urban areas—contributing significantly to the spread of antibiotic resistance genes(ARGs).However,most research to date has been conducted at a local level,leaving significant gaps in our understanding of the global status of antibiotic resistance in urban *** address this issue,we thoroughly analyzed a total of 86,213 ARGs detected within 4,728 metagenome samples,which were collected by the Meta SUB International Consortium involving diverse urban environments in 60 cities of 27 countries,utilizing a deep-learning based *** findings demonstrated the strong geographical specificity of urban environmental resistome,and their correlation with various local socioeconomic and medical *** also identified distinctive evolutionary patterns of ARG-related biosynthetic gene clusters(BGCs)across different countries,and discovered that the urban environment represents a rich source of novel *** study provides a comprehensive overview of the global urban environmental resistome,and fills a significant gap in our knowledge of large-scale urban antibiotic resistome analysis.

关键词： urban environment metagenome antibiotic resistance resistance diversity biosynthetic gene clusters

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