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1.
BMC Complement Med Ther ; 23(1): 309, 2023 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-37670337

RESUMO

BACKGROUND: Chemotherapy in breast cancer is effective but can generate significant toxicity and lead to tumor resistance. Joint treatment with standardized plant extracts can be an alternative to improve the response and allow an effective activation of the antitumor immune response that favors recovery in the short and long term. The P2Et extract of Caesalpinia spinosa presents antitumor activity in cells and animal models of breast cancer, improves the tumor microenvironment, and induces activation of the specific immune response against the tumor and is synergistic when used together with anthracyclines, which makes it a good candidate for evaluation in patients. METHODS: Conducted at a single center, this phase II study is a randomized, double-blind, placebo-controlled trial aimed at assessing the safety and efficacy of P2Et extract in patients diagnosed with stage II and III breast cancer, who are eligible for neoadjuvant treatment. The study aims to determine the safety profile at the previously established optimal biological dose from phase I trial while investigating various efficacy outcomes. These outcomes include improvements in quality of life, immunomodulation, metabolic profile, microbiome, as well as clinical indicators such as tumor reduction, disease-free survival, and pathological response, assessed at different stages of the treatment regimen. DISCUSSION: Treatment with the P2Et extract in breast cancer patients is hypothesized to enhance overall well-being, positively influencing their quality of life, while also triggering an antitumor immune response and enhancing immune infiltration. These combined effects have the potential to contribute to improved long-term survival outcomes for patients receiving the phytomedicine alongside neoadjuvant chemotherapy treatment. TRIAL REGISTRATION: This trial was registered in the US National Library of Medicine with identifier NCT05007444. First Registered August 16th, 2021. Last Updated: August 9th, 2022.


Assuntos
Caesalpinia , Neoplasias , Estados Unidos , Animais , Qualidade de Vida , Óxidos S-Cíclicos , Morfolinas , Ensaios Clínicos Controlados Aleatórios como Assunto , Ensaios Clínicos Fase II como Assunto , Ensaios Clínicos Veterinários como Assunto
2.
Biomedica ; 43(2): 252-260, 2023 06 30.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-37433160

RESUMO

INTRODUCTION: Workplace bullying and sexual harassment are concerns among general surgery residents in Colombia. OBJETIVE: To explore the prevalence and impact of workplace bullying and sexual harassment incidents among general surgery residents in Colombia. MATERIALS AND METHODS: This nationwide study was conducted in 2020. Residents selfrated their exposure to workplace bullying and to sexual harassment in the forms of gender harassment, unwanted sexual attention, and sexual coercion. We analyzed demographic variables, perpetrator's characteristics, and differences between victims and non-victims. RESULTS: The study included 302 residents. It found that 49% of general surgery residents in Colombia suffered from workplace bullying and 14.9% experienced sexual harassment. The main forms of sexual harassment were gender harassment (47%) and unwanted sexual attention (47%). Women reported significantly higher rates of being sexually harassed. Surgeons were the main perpetrators of sexual harassment. CONCLUSIONS: Workplace bullying and sexual harassment are frequent events in general surgery residency in Colombia. These findings suggest the need for interventions to improve the educational culture of surgical departments and decrease the prevalence of these behaviors.


Introducción: El acoso laboral y el acoso sexual son preocupaciones en la formación quirúrgica. Objetivo: Exploramos la magnitud de estos problemas entre los residentes de cirugía general en Colombia. Materiales y métodos: se realizó un estudio nacional en junio de 2020. Los residentes autoevaluaron su exposición a la intimidación y el acoso sexual en forma de acoso de género, atención sexual no deseada y coerción sexual. Se analizaron variables demográficas y perpetradores entre víctimas y no víctimas. Resultados: Se incluyeron un total de 302 residentes. Las tasas de acoso laboral y sexual fueron del 49% y 14,9%, respectivamente. Las principales formas de acoso sexual correspondieron al acoso de género (47%) y la atención sexual no deseada (47%). El acoso sexual fue significativamente mayor entre las mujeres. Los cirujanos fueron los principales perpetradores. Conclusiones: El acoso laboral y el acoso sexual son frecuentes en la formación quirúrgica en Colombia. Estos hallazgos conducen a intervenciones para mejorar la cultura educativa de los departamentos quirúrgicos para disminuir la prevalencia de estos comportamientos.


Assuntos
Assédio Sexual , Colômbia
3.
SAGE Open Med ; 11: 20503121231162339, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36993780

RESUMO

Objective: To evaluate and validate the medically necessary and time sensitive score by testing the variables, in order to create a surgical preoperative score for procedure prioritization in COVID-19 pandemic in Colombia. Methods: A multicenter retrospective cross-sectional study of instrument validation with a cultural adaptation and translation into the Spanish language was carried out in Bogota, Colombia. Patients over 18 years of age who had undergone elective procedures of general surgery and subspecialties were included. The translation of the medically necessary and time sensitive score into Spanish was performed independently by two bilingual surgeons fluent in both English and Spanish. A final version of the Spanish questionnaire (MeNTS Col) for testing was then produced by an expert committee. After translation and cultural adaptation, it was submitted to evaluate the psychometric properties of the medically necessary and time sensitive score. Cronbach's α was used to represent and evaluate the internal consistency and assess reliability. Results: A total of 172 patients were included, with a median age of 54 years; of which 96 (55.8%) patients were females. The vast majority of patients were treated for general surgery (n = 60) and colon and rectal surgery (n = 31). The evaluation of the internal consistency of the scale items in Spanish version was measured, and values of 0.5 for 0.8 were obtained. In the reliability and validation process, Cronbach's α values in all items remained higher than 0.7. The new MeNTS Col model was analyzed, and a result of 0.91 was obtained. Conclusions: The Spanish version of the medically necessary and time sensitive, the MeNTS Col score, and its respective Spanish translation perform similarly to the original version. Therefore, they can be useful and reproducible in Latin American countries.

5.
Rev. colomb. cir ; 38(1): 30-36, 20221230. tab
Artigo em Espanhol | LILACS | ID: biblio-1415228

RESUMO

Introducción. El síndrome de desgaste profesional incluye un estado de agotamiento físico y mental relacionado con las actividades del trabajo. El personal en formación de residencias médicas puede experimentar una salud mental y un rendimiento laboral adverso, con una alta prevalencia del síndrome. El objetivo de este trabajo fue comparar los resultados publicados del desgaste profesional en residentes de cirugía con los obtenidos en el presente estudio. Métodos. Se hizo una encuesta anónima en línea a los residentes de los veinte programas de Cirugía general en Colombia, entre junio y julio del 2020. El desgaste profesional se evaluó con el cuestionario de Maslach Burnout Inventory - Human Services Survey (MBI). Se calcularon las puntuaciones para las subescalas de agotamiento emocional, despersonalización y realización personal, así como la frecuencia del síndrome según las variables demográficas. Resultados. Participaron 302 residentes en el estudio; el 20,2 % presentaron síndrome de desgaste profesional, 43,7 % agotamiento emocional, 23,2 % despersonalización y 45 % baja realización personal. Al comparar el grupo con desgaste frente al grupo sin desgaste, no se encontraron diferencias estadísticamente significativas en las variables demográficas. Conclusiones. Aunque el porcentaje de síndrome de desgaste profesional entre los residentes de Cirugía general en Colombia fue menor al encontrado en otros estudios, es preocupante. Dado su posible impacto en la práctica médica y los resultados en el paciente, es necesario continuar describiendo la aparición del síndrome en el personal en formación, comprender el desarrollo del mismo y, de esta forma, crear intervenciones específicas para controlarlo


Introduction. Burnout syndrome includes a state of physical and mental exhaustion related to work activities. Medical residency trainees, especially surgical specialties, may experience adverse mental health and job performance, with a high prevalence of the syndrome. This work aims to compare the published results of the national and international prevalence of professional burnout in surgical residents, with those obtained in the present study. Methods. A national survey about burnout was carried out in general surgery residents in the twenty active general surgery programs in Colombia, during the period from June to July 2020 through an anonymous online survey. Burnout was assessed with the Maslach Burnout Inventory-Human Services Survey (MBI) questionnaire. Total scores were calculated for the emotional exhaustion, depersonalization, and personal accomplishment subscales, as well as the frequency of the syndrome according to demographic variables. Results. 302 residents participated in the study; 20.2% presented BS, 43.7% presented emotional exhaustion, 23.2% depersonalization and 45% low personal fulfillment. When comparing the group with attrition versus the group without attrition, no statistically significant differences were found in any of the demographic variables. Conclusions. The percentage of burnout among general surgery residents, although lower than that found in other national or international studies, is worrisome. Given the possible impact of this on medical practice and patient outcomes, it is necessary to continue describing the appearance of the syndrome in trainees, understand its development and thus create specific interventions to control it


Assuntos
Humanos , Esgotamento Profissional , Educação Médica , Cirurgia Geral , Educação de Pós-Graduação em Medicina , Internato e Residência
6.
Sci Rep ; 12(1): 7981, 2022 05 13.
Artigo em Inglês | MEDLINE | ID: mdl-35562400

RESUMO

Neoadjuvant chemotherapy (NAT) in breast cancer (BC) has been used to reduce tumor burden prior to surgery. However, the impact on prognosis depends on the establishment of Pathological Complete Response (pCR), which is influenced by tumor-infiltrating lymphocyte levels and the activation of the antitumor immune response. Nonetheless, NAT can affect immune infiltration and the quality of the response. Here, we showed that NAT induces dynamic changes in the tumor microenvironment (TME). After NAT, an increase of regulatory T cells and a decrease of CD8+ T cells was found in tumor, correlated with the presence of metastatic cells in lymph nodes. In addition, an increase of polymorphonuclear myeloid-derived suppressor like cells was found in luminal patients post-NAT. pCR patients showed a balance between the immune populations, while non-pCR patients presented an inverse relationship in the frequency of CD68+ versus CD3+, CD8+, and CD20+ cells. Moreover, activated T cells were found in peripheral blood, as well as an increase in T cell clonality with a lower diversity post-NAT. Overall, these results shown that NAT induces an activation of immune response, however, a balance in the TME seems to be related to a better antigenic presentation and therefore a better response to treatment.


Assuntos
Neoplasias da Mama , Terapia Neoadjuvante , Neoplasias da Mama/patologia , Linfócitos T CD8-Positivos , Feminino , Humanos , Linfócitos do Interstício Tumoral , Terapia Neoadjuvante/métodos , Microambiente Tumoral
7.
Artigo em Inglês | MEDLINE | ID: mdl-35251213

RESUMO

The polyphenol-enriched extract called P2Et derived from Caesalpinia spinosa (C. spinosa) had antitumor and immunomodulatory activities reported in breast cancer, leukemia, and melanoma. The aim of this study was to evaluate the safety and maximum tolerated dose of P2Et extract in Colombian healthy volunteers in a phase 1 clinical trial, open labelled, single-arm, dose-escalation design 3 + 3. Seven healthy volunteers were included; P2Et was administrated in capsules of 600 mg/d for 28 days. Analysis by intention to treat was performed. 4 volunteers showed adverse events and discontinued the intervention. 94.6% of AE were grade 1, and most of AE had a reasonable possibility of a relationship with the P2Et (83.8%). We found that the oral administration of P2Et is safe in healthy humans with a maximum tolerated dose of 600 mg/d. There was no severe toxicity; most of the adverse events were mild, without significant changes in the safety parameters evaluated.

9.
Rev. colomb. cir ; 36(4): 626-636, 20210000. fig, tab
Artigo em Espanhol | LILACS | ID: biblio-1291156

RESUMO

Introducción. La apendicectomía por laparoscopia se considera el patrón de oro en el tratamiento de la apendicitis aguda. Sin embargo, su disponibilidad es limitada en nuestro sistema de salud, principalmente por los costos asociados. El objetivo de este estudio fue evaluar la relación entre el uso de los diferentes tipos de energía y los métodos de ligadura de la base apendicular, con las complicaciones postoperatorias, al igual que describir los costos asociados. Métodos. Estudio observacional analítico de una cohorte retrospectiva de pacientes mayores de 15 años a quienes se les realizó apendicectomía por laparoscopia, en un hospital universitario entre los años 2014 y 2018. Se utilizaron modelos de regresión logística y lineal para evaluar la relación entre métodos de ligadura del meso y base apendicular, desenlaces operatorios y costos. Resultados. Se realizaron 2074 apendicectomías por laparoscopia, 58,2 % (n=1207) en mujeres, la edad mediana fue de 32 años. En el 71,5 % (n=1483) la apendicitis aguda no fue complicada. La energía monopolar para la liga-dura del meso apendicular fue la utilizada más frecuentemente en 57,2 % (n=1187) y el Hemolok® el más utilizado para la ligadura de la base apendicular en el 84,8 % (n=1759) de los pacientes. No se observaron diferencias estadísticamente significativas en la tasa de infección del sitio operatorio, reintervención o íleo. El uso de energía simple redujo los costos del procedimiento de manera significativa durante el período evaluado. Discusión. El uso de energía monopolar demostró ser una técnica segura, reproducible y de menor costo en comparación con el uso de energía bipolar, independientemente de la fase de la apendicitis aguda. Lo anterior ha permitido que se realicen más apendicectomías por laparoscopia y que los médicos residentes de cirugía general puedan realizar procedimientos laparoscópicos de forma más temprana


Introduction. Laparoscopic appendectomy is considered the gold standard in the treatment of acute appendicitis. However, its availability is limited in our health system mainly due to the associated costs. The objective of this study is to evaluate the relationship between the use of different types of energy and the methods of ligation of the appendicular base with postoperative complications, as well as to describe the associated costs. Methods. Retrospective observational study of a cohort of patients older than 15 years old who underwent laparoscopic appendectomy in a university hospital between 2014 and 2018. Logistic and linear regression models were used to evaluate the relationship between methods of ligation of the meso and appendicular base, operative outcomes and costs. Results: 2074 laparoscopic appendectomies were performed. Of those, 58.2% (n=1207) were women, median age was 32 years. In 71.5% (n=1483), acute appendicitis was uncomplicated. Monopolar energy for ligation was the most frequently used for ligation of the appendicular meso in 57.2% (n=1187) and Hem-o-lok® the most used for ligation of the appendicular base in 84.8% (n=1759) of the patients. There were no statistically significant differences in the rate of surgical site infection, reoperation, or ileus. The use of simple energy reduced the costs of the procedure significantly during the study period. Discussion. The use of monopolar energy proved to be a safe, reproducible and a lower cost technique compared to the use of bipolar energy, regardless of the phase of acute appendicitis. This has allowed more laparoscopic appendectomies to be performed and the general surgery residents to perform laparoscopic procedures earlier


Assuntos
Humanos , Apendicite , Laparoscopia , Apendicectomia , Fontes de Energia Bioelétrica , Controle de Custos , Ligadura
10.
Cancer Rep (Hoboken) ; 4(6): e1400, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-33939336

RESUMO

BACKGROUND: The incidence of breast cancer (BC) in LMICs has increased by more than 20% within the last decade. In areas such as Latin America (LA), addressing BC at national levels evoke discussions surrounding fragmented care, limited resources, and regulatory barriers. Precision Medicine (PM), specifically companion diagnostics (CDx), links disease diagnosis and treatment for better patient outcomes. Thus, its application may aid in overcoming these barriers. RECENT FINDINGS: A panel of LA experts in fields related to BC and PM were provided with a series of relevant questions to address prior to a multi-day conference. Within this conference, each narrative was edited by the entire group, through numerous rounds of discussion until a consensus was achieved. The panel proposes specific, realistic recommendations for implementing CDx in BC in LA and other LMIC regions. In these recommendations, the authors strived to address all barriers to the widespread use and access mentioned previously within this manuscript. CONCLUSION: This manuscript provides a review of the current state of CDx for BC in LA. Of most importance, the panel proposes practical and actionable recommendations for the implementation of CDx throughout the Region in order to identify the right patient at the right time for the right treatment.


Assuntos
Biomarcadores Tumorais/genética , Neoplasias da Mama/tratamento farmacológico , Testes Genéticos/estatística & dados numéricos , Guias de Prática Clínica como Assunto/normas , Medicina de Precisão , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/genética , Feminino , Humanos , América Latina/epidemiologia
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