[Effect of adding fortifiers and protein supplements on the osmolality of donated maternal milk]. / Efecto de la adición de fortificantes y de módulo de proteínas en la osmolalidad de la leche materna donada.

INTRODUCTION AND OBJECTIVES: The fortification of maternal milk (MM) is a standard practice in order to achieve the requirements needed for the growth and development of the premature newborn. However, its osmolality could increase. According to the American Paediatrics Academy, it is recommended not to exceed 450 mOsm/kg (approximately 400 mOsm/L) in the diet of the infant, even though the safety limit is estimated to be between 400 and 600 mOsm/kg. The aim of this study is to determine the osmolality of thawed and fortified donated MM (DMM). METHOD: An analysis was performed on DMM of 6 healthy mothers, without fortifying, and with 4 levels of fortification. Measurement of the samples was carried out in triplicate at 0, 4, 9, and 24hours after their preparation. They were stored refrigerated (2-8°C) between measurements. The study groups were: (A) Non-fortified DMM; (B) DMM with vitamins added; (C) with the addition of a fortifier; (D) with the addition of a low-dose protein formula; and (E) with the addition of a high-dose protein formula. The osmolality determinations were carried out using a freezing-point osmometer. The data analysis was performed using R software (v.3.5.1). RESULTS: A total of 30 samples were analysed with 360 measurements. The osmolality of the DMM at t=0h was 301 mOsm/kg (SD 5.2) and slightly increased with time to 308.11 mOsm/kg (SD 5.21) after 24hours (t=24h), being maintained within the safety limits. The addition of vitamins (Group B) did not significantly increase the osmolality. The addition of a fortifier (C) and a low dose (D) or high dose (E) protein formula produced an increase in the baseline osmolality that increased statistically significantly in time (P=.007), but with no differences between the C, D, and E types. There were differences between the osmolality at t=0 with the fortification according to the manufacturer's data sheet (339 mOsm/l) and the findings in our laboratory (432.33 mOsm/l). CONCLUSION: The osmolality values found in the thawed DMM samples were similar to those of other studies. The fortification of the DMM samples and their storage refrigerated at 2-8°C for 24h increased the osmolality, but keeping them within the safety limits.

Revisión crítica de la oritavancina en infecciones de la piel y tejidos blandos / Review of oritavancin for the treatment of acute bacterial skin and skin structure infections

Objetivo: Evaluar críticamente la oritavancina, lipoglicopéptido de segunda generación, para el tratamiento de la infección bacteriana aguda de la piel y tejidos blandos causada por bacterias Gram-positivas susceptibles, incluyendo Staphylococcus aureus resistente a meticilina. Método: Se realizó un informe de evaluación según la metodología del Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de Medicamentos de la Sociedad Española de Farmacia Hospitalaria, con el programa MADRE 4.0. Se llevó a cabo una búsqueda en PubMed, en www.clinicaltrials.gov, Embase y UptoDate. También se utilizaron informes publicados de agencias de evaluación. Resultados: La oritavancina en dosis única demostró no ser inferior a la vancomicina en Infección bacteriana aguda de la piel y tejidos blandos, con un perfil de seguridad similar. Sus ventajas potenciales frente a otras alternativas terapéuticas radicarían en su administración en dosis única y en la no necesidad de monitorización de los niveles plasmáticos (lo que posibilitaría su administración ambulatoria), y en la mejora de la adherencia. Aunque podría ser eficiente en determinados escenarios (tratamiento ambulatorio frente al hospitalario con las alternativas), no hay estudios convincentes en este sentido. Por otra parte, los fármacos alternativos por vía oral (linezolid, tedizolid) o IM (teicoplanina) pueden permitir también el tratamiento ambulatorio, reduciendo las ventajas de la oritavancina y agrandando las diferencias de coste. Dado que su eficacia es similar a las alternativas, cabría considerar un análisis de minimización de costes. Conclusiones: La oritavancina es de una eficacia y seguridad comparables a las alternativas existentes en Infección bacteriana aguda de la piel y tejidos blandos y no mejora la relación coste-efectividad, por lo que el posicionamiento propuesto sería el tratamiento de la infección por enterococo resistente a vancomicina en pacientes adultos cuando esté contraindicado el uso de linezolid o tedizolid (AU)

Objective: To assess critically oritavancin, a second-generation lipoglycopeptide, for the treatment of Acute Bacterial Skin and Skin Structure Infections caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. Method: An evaluation report of oritavancin in Acute Bacterial Skin and Skin Structure Infections was carried out according to the methodology of the Group for drug evaluation, standardization and research in drug selection of the Spanish Society of Hospital Pharmacy (SEFH)1 , with the MADRE 4.0 program. A search was made in PubMed, in the web www.clinicaltrials. gov, Embase, PubMed and UptoDate. The European Medication Agency and Food and Drug Administration evaluation reports were also used. Results: Single-dose oritavancin demonstrated its non-inferiority efficacy versus vancomycin in Acute Bacterial Skin and Skin Structure Infections, with a similar safety profile. Its potential advantage over other therapeutic alternatives lies in its administration in single dose and in its no need for plasma levels monitoring, which would allow its administration on an outpatient basis. Regarding to the other alternative possibilities of oral (linezolid, tedizolid) or IM (teicoplanin) treatment, oritavancin would improve the adherence to the treatment. Although oritavancin could be more efficient in certain scenarios (outpatient treatment versus inpatient treatment with alternatives), there are no convincing studies in this regard so far. On the other hand, alternative drugs above-mentioned, can also allow outpatient treatment, reducing advantages of oritavancin and further increasing cost differences. Therefore, given that the efficacy is similar to the alternatives, a cost minimization analysis could be considered. Conclusions: Oritavancin is comparable in terms of efficacy and safety to the existing alternatives in Acute Bacterial Skin and Skin Structure Infections, without improvements in the cost-effectiveness ratio, because of the proposed positioning is to consider it for the treatment of vancomycin resistant enterococcal infection in adult patients when the use of linezolid or tedizolid is contraindicated (AU)

Review of oritavancin for the treatment of acute bacterial skin and skin structure infections.

OBJECTIVE: To assess critically oritavancin, a second-generation  lipoglycopeptide, for the treatment of Acute Bacterial Skin and Skin Structure Infections caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. METHOD: An evaluation report of oritavancin in Acute Bacterial Skin and Skin  Structure Infections was carried out according to the methodology of the Group  for drug evaluation, standardization and research in drug selection of the  Spanish Society of Hospital Pharmacy (SEFH)1, with the MADRE 4.0 program. A  search was made in PubMed, in the web www.clinicaltrials. gov, Embase,  PubMed and UptoDate. The European Medication Agency and Food and Drug  Administration evaluation reports were also used. RESULTS: Single-dose oritavancin demonstrated its non-inferiority efficacy versus  vancomycin in Acute Bacterial Skin and Skin Structure  nfections, with a similar safety profile. Its potential advantage over other  therapeutic alternatives lies in its administration in single dose and in its no need for plasma levels monitoring, which would allow its administration on an outpatient basis. Regarding to the other alternative possibilities of oral  (linezolid, tedizolid) or IM (teicoplanin) treatment, oritavancin would improve the  adherence to the treatment. Although oritavancin could be more  efficient in certain scenarios (outpatient treatment versus inpatient treatment  with alternatives), there are no convincing studies in this regard so far. On the  other hand, alternative drugs above-mentioned, can also allow outpatient  treatment, reducing advantages of oritavancin and further increasing cost  differences. Therefore, given that the efficacy is similar to the alternatives, a  cost minimization analysis could be considered. CONCLUSIONS: Oritavancin is comparable in terms of efficacy and safety to the  existing alternatives in Acute Bacterial Skin and Skin Structure Infections,  without improvements in the cost-effectiveness ratio, because of the proposed  positioning is to consider it for the treatment of  vancomycinresistant enterococcal infection in adult patients when the use of  linezolid or tedizolid is contraindicated.

Objetivo: Evaluar críticamente la oritavancina, lipoglicopéptido de segunda generación, para el tratamiento de la infección bacteriana aguda de la  piel y tejidos blandos causada por bacterias Gram-positivas susceptibles,  incluyendo Staphylococcus aureus resistente a meticilina.Método: Se realizó un informe de evaluación según la metodología del Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de  Medicamentos de la Sociedad Española de Farmacia Hospitalaria, con el  programa MADRE 4.0. Se llevó a cabo una búsqueda en PubMed, en  www.clinicaltrials.gov, Embase y UptoDate. También se utilizaron informes  publicados de agencias de evaluación.Resultados: La oritavancina en dosis única demostró no ser inferior a la vancomicina en Infección bacteriana aguda de la piel y tejidos blandos, con un perfil de seguridad similar. Sus ventajas potenciales frente a otras alternativas  terapéuticas radicarían en su administración en dosis única y en la no necesidad  de monitorización de los niveles plasmáticos (lo que posibilitaría su  administración ambulatoria), y en la mejora de la adherencia. Aunque podría ser  eficiente en determinados escenarios (tratamiento ambulatorio frente al  hospitalario con las alternativas), no hay estudios convincentes en este sentido.  Por otra parte, los fármacos alternativos por vía oral (linezolid, tedizolid) o IM  (teicoplanina) pueden permitir también el tratamiento ambulatorio, reduciendo  las ventajas de la oritavancina y agrandando las diferencias de coste. Dado que  su eficacia es similar a las alternativas, cabría considerar un análisis de  minimización de costes.Conclusiones: La oritavancina es de una eficacia y seguridad comparables a las alternativas existentes en Infección bacteriana aguda de la piel y tejidos blandos y no mejora la relación coste-efectividad, por lo que el posicionamiento  propuesto sería el tratamiento de la infección por enterococo resistente a  vancomicina en pacientes adultos cuando esté contraindicado el uso de linezolid  o tedizolid.