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RESUMEN Introducción: La diabetes continúa siendo una de las principales causas de discapacidad y muerte en la población mundial. Alrededor del 25% de las personas con diabetes desarrollarán una úlcera en alguno de sus miembros pélvicos inferiores. Objetivo: El presente estudio evalúa los aspectos clínicos relacionados con la amputación del miembro inferior pélvico en una cohorte de pacientes con diabetes mellitus. Métodos: Estudio retrospectivo, transversal, realizado en colaboración entre el Instituto Mexicano del Seguro Social y la Facultad de Farmacia de la Universidad Autónoma del Estado de Morelos, implicó una revisión de expedientes de pacientes con diabetes mellitus tipo 2 en el Hospital General Regional "Ignacio García Téllez". Se seleccionaron 100 expedientes clínicos y Electrónicos basados en criterios de inclusión, que incluían edad mayor de 18 años, afiliación en el sitio del estudio, evolución de la diabetes de al menos 10 años, tratamiento farmacológico para la diabetes y diagnóstico de pie diabético con curación completa o amputación como resultado. Los análisis estadísticos se realizaron mediante STATA y se obtuvo aprobación ética. Resultados: Los pacientes con un control glucémico óptimo cuantificando sus niveles de glucosa en ayunas (<130 mg/dl) así como sus valores de hemoglobina glicosilada (< 7%) tuvieron una menor frecuencia de amputaciones (p˂0,001; Chi2) en comparación con aquellos pacientes sin un control glucémico adecuado. Conclusión: Se encontró que ser hombre, valores de hemoglobina glucosilada superiores al 7% y valores promedio de glucosa en ayunas superiores a 130 mg/L aumentan la probabilidad de presentar una amputación de extremidad inferior.
ABSTRACT Introduction: Diabetes continues to be a leading cause of disability and death in the world's population. About 25% of people with diabetes will develop an ulcer in one of their lower pelvic limbs. Objective: The present study evaluates the clinical aspects related to lower pelvic limb amputation in a cohort of patients with diabetes mellitus. Lazarte Echegaray Hospital during the period 2017-2020. Methods: Retrospective, cross-sectional study, conducted in collaboration between the Mexican Institute of Social Security and the School of Pharmacy of the Autonomous University of Morelos State, involved a review of records of patients with type 2 diabetes mellitus at the Regional General Hospital "Ignacio García Téllez". One hundred clinical and electronic records were selected based on inclusion criteria, which included age over 18 years, affiliation at the study site, diabetes evolution of at least 10 years, pharmacological treatment for diabetes and diagnosis of diabetic foot with complete healing or amputation as an outcome. Statistical analyses were performed using STATA and ethical approval was obtained. Results: Patients with optimal glycemic control by quantifying their fasting glucose levels (<130 mg/dl) as well as their glycated hemoglobin values (< 7%) had a lower frequency of amputations (p˂0.001; Chi2) compared to those patients without adequate glycemic control. Conclusion: Being male, glycosylated hemoglobin values greater than 7% and mean fasting glucose values greater than 130 mg/L were found to increase the likelihood of having a lower extremity amputation.
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Melanin is an insoluble, amorphous polymer that forms planar sheets that aggregate naturally to create colloidal particles with several biological functions. Based on this, here, a preformed recombinant melanin (PRM) was utilized as the polymeric raw material to generate recombinant melanin nanoparticles (RMNPs). These nanoparticles were prepared using bottom-up (nanocrystallization-NC, and double emulsion-solvent evaporation-DE) and top-down (high-pressure homogenization-HP) manufacturing approaches. The particle size, Z-potential, identity, stability, morphology, and solid-state properties were evaluated. RMNP biocompatibility was determined in human embryogenic kidney (HEK293) and human epidermal keratinocyte (HEKn) cell lines. RMNPs prepared by NC reached a particle size of 245.9 ± 31.5 nm and a Z-potential of -20.2 ± 1.56 mV; 253.1 ± 30.6 nm and -39.2 ± 0.56 mV compared to that obtained by DE, as well as RMNPs of 302.2 ± 69.9 nm and -38.6 ± 2.25 mV using HP. Spherical and solid nanostructures in the bottom-up approaches were observed; however, they were an irregular shape with a wide size distribution when the HP method was applied. Infrared (IR) spectra showed no changes in the chemical structure of the melanin after the manufacturing process but did exhibit an amorphous crystal rearrangement according to calorimetric and PXRD analysis. All RMNPs presented long stability in an aqueous suspension and resistance to being sterilized by wet steam and ultraviolet (UV) radiation. Finally, cytotoxicity assays showed that RMNPs are safe up to 100 µg/mL. These findings open new possibilities for obtaining melanin nanoparticles with potential applications in drug delivery, tissue engineering, diagnosis, and sun protection, among others.