Black Garlic and Thiosulfinate-Enriched Extracts as Adjuvants to Ceftriaxone Treatment in a Rat Peritonitis Model of Sepsis.

To date, there have been no new drugs or adjuvants able to decrease both morbidity and mortality in the context of sepsis and septic shock. Our objective was to evaluate the use of thiosulfinate-enriched Allium sativum and black garlic extracts as adjuvants in the management of sepsis. An experimental in vivo study was carried out with male Sprague-Dawley® rats. Animals were randomized in four treatment groups: antibiotic (ceftriaxone) treatment (group I), ceftriaxone plus thiosulfinate-enriched extract (TASE, group II), ceftriaxone plus thiosulfinate-enriched extract and black garlic extracts (TASE + BGE, group III), and ceftriaxone plus black garlic extract (BGE, group IV). All animals were housed and inoculated with 1 × 1010 CFU/15 mL of intraperitoneal Escherichia coli ATCC 25922. Subsequently, they received a daily treatment according to each group for 7 days. Clinical, analytical, microbiological, and histopathological parameters were evaluated. Statistically significant clinical improvement was observed in rats receiving garlic extracts in weight (groups II and III), ocular secretions, and piloerection (group IV). Moreover, less liver edema, vacuolization, and inflammation were observed in groups receiving adjuvant support (groups II, III, and IV). When comparing interleukins 24 h after bacteria inoculum, we found statistically significant differences in TNF-alpha levels in groups receiving BGE (groups III and IV, p ≤ 0.05). Blood and peritoneal liquid cultures were also analyzed, and we detected a certain level of Enterococcus faecalis in peritoneal cultures from all treatment groups and less bacteria presence in blood cultures in rats receiving garlic extracts (groups II, III, and IV). In conclusion, TASE and BGE could be promising nutraceutical or medicinal agents as coadjuvants in the treatment of sepsis because of its effects in modulating the inflammatory response.

Efficacy and safety of alendronic acid in the treatment of osteoporosis in children.

OBJECTIVES: to describe the efficacy and safety of the off-label use of alendronate in the treatment of osteoporosis in children and adolescents. METHOD: a retrospective study (2008-2014) of all patients under 18 years who were dispensed alendronate for this indication. The criteria for initiating treatment were: bone mineral density with a Z-score ≤ -2.5 SD, a past history of bone fractures without a previous traumatism, and persistent pain. The variables collected were: demographic, treatment-related, clinical. and safety data. The treatment was considered to be effective when there was an increase in bone mineral density up to a Z-score > -2.5 SD. RESULTS: a total of 12 patients, 8 of them male, with a mean age of 11 years (± 3 SD), were treated with alendronate. After a mean time of treatment of 2.15 years (± 1.2 SD), there was an increase in bone mineral density in all patients, 9 of which achieved a Z-score > -2.5 SD, so the drug was considered effective in 75% of cases. No patient had bone fractures or expressed adverse effects during treatment. CONCLUSIONS: alendronate increased bone mineral density and was well tolerated in all patients, therefore it could be considered as a therapeutic option in the treatment of osteoporosis in children.

Objetivos: describir la efectividad y seguridad del uso de acido alendronico en el tratamiento de la osteoporosis en ninos y adolescentes, en condiciones distintas a las autorizadas en la ficha tecnica. Métodos: estudio retrospectivo (2008-2014) de todos los pacientes menores de 18 anos a los que se dispenso acido alendronico para esta indicacion. Los criterios para iniciar tratamiento fueron: densidad mineral osea con puntuacion Z-score ≤ -2,5 DE, antecedentes de fracturas oseas sin traumatismo previo y dolor persistente. Las variables recogidas fueron: demograficas, de tratamiento, clinicas y de seguridad. Se considero efectividad del tratamiento al aumento de la densidad mineral osea hasta obtener Z-score > -2,5 DE. Resultados: un total de 12 pacientes, 8 varones, con una media de edad de 11 anos (} 3 DE), fueron tratados con acido alendronico. Tras un tiempo medio de tratamiento de 2,15 anos (} 1,2 DE), se produjo aumento de la densidad mineral osea en todos los pacientes, 9 de los cuales obtuvieron Z-score > -2,5 DE, por lo que el farmaco se considero efectivo en el 75% de los casos. Ningun paciente presento fracturas oseas ni manifesto efectos adversos durante el tratamiento. Conclusiones: el acido alendronico incremento la densidad mineral osea y se tolero bien en todos los pacientes, por lo que se podria considerar como opcion terapeutica en el tratamiento de la osteoporosis infantil.

Efficacy and safety of alendronic acid in the treatment of osteoporosis in children / Efectividad y seguridad del ácido alendrónico en el tratamiento de la osteoporosis infantil

Objectives: to describe the efficacy and safety of the off-label use of alendronate in the treatment of osteoporosis in children and adolescents. Method: a retrospective study (2008-2014) of all patients under 18 years who were dispensed alendronate for this indication. The criteria for initiating treatment were: bone mineral density with a Z-score ≤-2.5 SD, a past history of bone fractures without a previous traumatism, and persistent pain. The variables collected were: demographic, treatment-related, clinical. and safety data. The treatment was considered to be effective when there was an increase in bone mineral density up to a Z-score >-2.5 SD. Results: a total of 12 patients, 8 of them male, with a mean age of 11 years (± 3 SD), were treated with alendronate. After a mean time of treatment of 2.15 years (±1.2 SD), there was an increase in bone mineral density in all patients, 9 of which achieved a Z-score >-2.5 SD, so the drug was considered effective in 75% of cases. No patient had bone fractures or expressed adverse effects during treatment. Conclusions: alendronate increased bone mineral density and was well tolerated in all patients, therefore it could be considered as a therapeutic option in the treatment of osteoporosis in children (AU)

Objetivos: describir la efectividad y seguridad del uso de ácido alendrónico en el tratamiento de la osteoporosis en niños y adolescentes, en condiciones distintas a las autorizadas en la ficha técnica. Métodos: estudio retrospectivo (2008-2014) de todos los pacientes menores de 18 años a los que se dispensó ácido alendrónico para esta indicación. Los criterios para iniciar tratamiento fueron: densidad mineral ósea con puntuación Z-score ≤-2,5 DE, antecedentes de fracturas óseas sin traumatismo previo y dolor persistente. Las variables recogidas fueron: demográficas, de tratamiento, clínicas y de seguridad. Se consideró efectividad del tratamiento al aumento de la densidad mineral ósea hasta obtener Z-score >-2,5 DE. Resultados: un total de 12 pacientes, 8 varones, con una media de edad de 11 años (± 3 DE), fueron tratados con ácido alendrónico. Tras un tiempo medio de tratamiento de 2,15 años (± 1,2 DE), se produjo aumento de la densidad mineral ósea en todos los pacientes, 9 de los cuales obtuvieron Z-score >-2,5 DE, por lo que el fármaco se consideró efectivo en el 75% de los casos. Ningún paciente presentó fracturas óseas ni manifestó efectos adversos durante el tratamiento. Conclusiones: el ácido alendrónico incrementó la densidad mineral ósea y se toleró bien en todos los pacientes, por lo que se podría considerar como opción terapéutica en el tratamiento de la osteoporosis infantil (AU)