Erratum to: Utilization of bioimpedance spectroscopy in the prevention of chronic breast cancer-related lymphedema.

In the original publication of the article, under the heading, Study limitations in the Discussion section, the second paragraph, fifth sentence was published incorrectly as "Patients with an L-Dex increase of ≥ 5.5 undergo…sleeve for 4 weeks".

Utilization of bioimpedance spectroscopy in the prevention of chronic breast cancer-related lymphedema.

BACKGROUND: This analysis was performed to assess the impact of early intervention following prospective surveillance using bioimpedance spectroscopy (BIS) to detect and manage breast cancer-related lymphedema (BCRL). METHODS: From 8/2010 to 12/2016, 206 consecutive patients were evaluated with BIS. The protocol included pre-operative assessment with L-Dex as well as post-operative assessments at regular intervals. Patients with L-Dex scores >10 from baseline were considered to have subclinical BCRL and were treated with over-the-counter (OTC) compression sleeve for 4 weeks. High-risk patients were defined as undergoing axillary lymph node dissection (ALND), receiving regional nodal irradiation (RNI), or taxane chemotherapy. Chronic BCRL was defined as the need for complex decongestive physiotherapy (CDP). RESULTS: Median follow-up was 25.9 months. Overall, 17% of patients had one high-risk feature, 8% two, and 7% had three. 9.8% of patients were diagnosed with subclinical BCRL with highest rates seen following ALND (23 vs. 7%, p = 0.01). Development of subclinical BCRL was associated with ALND and receipt of RNI. At last follow-up, no patients (0%) developed chronic, clinically detectable, BCRL. Subset analysis was performed of the 30 patients undergoing ALND. Median number of nodes removed was 18 and median number of positive nodes was 2. 77% received taxane chemotherapy, 62% axillary RT, and 48% had elevated BMI. Overall, 86% of patients had at least one additional high-risk feature, 70% at least two, and 23% had all three. Seven patients (23%) had abnormally elevated L-Dex scores at some point during follow-up. To date, none has required CDP. CONCLUSIONS: The results of this study support prospective surveillance utilizing BIS initiated pre-operatively with subsequent post-operative follow-up measurements for the detection of subclinical BCRL. Intervention triggered by subclinical BCRL detection with an elevated L-Dex score was associated with no cases progressing to chronic, clinically detectable BCRL even in very high-risk patients.

Utilização da sílica nanoestruturada SBA-15 como adjuvante em imunizações com a vacina para hepatite B / Nanostructured SBA-15 silica as an adjuvant in immunizations with hepatitis B vaccine

Objective: To evaluate the applicability of SBA-15 silica as an adjuvant in immunizations with purified particles of the viral protein HBsAg, the main component of hepatitis B vaccine, Butang®, produced by Instituto Butantan. Methods: BALB/c mice orally or subcutaneously received 0.5 mug of HBsAg adsorbed/encapsulated to SBA-15 or adsorbed to Al(OH)3. To assess the secondary immune response, a subcutaneous booster was administered 30 days after the first immunization. Individual serum and fecal samples of each group were periodically collected for specific antibody titration by ELISA. Results: Analysis of secretory IgA showed that mice orally primed with HBsAg on SBA-15 had increased levels of specific antibodies in primary and secondary immune responses. Specific serum IgA and IgG titers in HBsAg:SBA-15-orally immunized mice reached higher levels after the booster, demonstrating the effectiveness of oral vaccination with the use of silica. All immunized groups showed higher IgG1 levels. Conclusion: Our results clearly indicate the promising use of SBA-15 as an adjuvant, especially in oral immunizations.

Objetivo: Demonstrar a aplicabilidade da sílica do tipo SBA-15 como adjuvante nas imunizações com a proteína recombinante HBsAg do vírus da hepatite B, principal componente da vacina Butang® produzida pelo Instituto Butantan. Métodos: Camundongos BALB/c receberam, pela via oral ou subcutânea, 0,5 mig do HbsAg adsorvido/encapsulado à SBA-15 ou adsorvido ao Al(OH)3. Para avaliar a resposta imune secundária, uma dose de reforço foi administrada subcutaneamente 30 dias após a primeira imunização. Amostras individuais de soro e fezes foram coletadas periodicamente para titulação de anticorpos específicos por ELISA. Resultados: A análise de IgA secretada mostrou que camundongos imunizados pela via oral com HbsAg em SBA-15 apresentaram aumento nos níveis de anticorpos específicos nas respostas primária e secundária. Ainda, após o reforço, observaram-se maiores níveis de IgA e IgG séricas anti-HBsAg no grupo preparado com HBsAg:SBA-15 pela via oral. Todos os grupos imunizados apresentaram maior produção de IgG1. Conclusão: Os resultados indicam o uso promissor da sílica SBA-15 como adjuvante, especialmente nas imunizações pela via oral.

Nanostructured SBA-15 silica as an adjuvant in immunizations with hepatitis B vaccine.

OBJECTIVE: To evaluate the applicability of SBA-15 silica as an adjuvant in immunizations with purified particles of the viral protein HBsAg, the main component of hepatitis B vaccine, Butang®, produced by Instituto Butantan. METHODS: BALB/c mice orally or subcutaneously received 0.5 µg of HBsAg adsorbed/encapsulated to SBA-15 or adsorbed to Al(OH)3. To assess the secondary immune response, a subcutaneous booster was administered 30 days after the first immunization. Individual serum and fecal samples of each group were periodically collected for specific antibody titration by ELISA. RESULTS: Analysis of secretory IgA showed that mice orally primed with HBsAg on SBA-15 had increased levels of specific antibodies in primary and secondary immune responses. Specific serum IgA and IgG titers in HBsAg:SBA-15-orally immunized mice reached higher levels after the booster, demonstrating the effectiveness of oral vaccination with the use of silica. All immunized groups showed higher IgG1 levels. CONCLUSION: Our results clearly indicate the promising use of SBA-15 as an adjuvant, especially in oral immunizations.

Caracterização anestésica da nanoemulsão não lipídica de propofol / Anesthetic profile of a non-lipid propofol nanoemulsion / Caracterización anestésica de la nanoemulsión no lipídica de propofol

JUSTIFICATIVA E OBJETIVOS: Uso clínico de formulação lipídica de propofol causa dor durante injeção, reação alérgica e crescimento microbiano. Propofol tem sido reformulado em diferentes apresentações não lipídicas para reduzir os efeitos adversos, mas essas mudanças podem modificar sua farmacocinética e farmacodinâmica. Neste trabalho, investigamos a farmacologia e a toxicologia do propofol lipídico (CLP) e da nanoemulsão não lipídica (NLP). MÉTODO: CLP and NLP foram infundidos na veia jugular de ratos sob medida da pressão arterial (PA), frequência cardíaca (FC) e frequência respiratória (FR). Ambas as formulações (1 por cento) foram infundidas (40 µL.min-1) durante 1 hora. Doses hipnóticas e anestésicas, assim como recuperações, foram determinadas. A dor induzida pelo veículo do CLP e NLP foi comparada por meio da contagem do número de contorções abdominais ("writhing test") após injeção intraperitonial (i.p.) em camundongos. Ácido acético (0,6 por cento) foi usado como controle positivo. RESULTADOS: As doses hipnóticas e anestésicas com 1 por cento CLP (6,0 ± 1,3 e 17,8 ± 2,6 mg.kg-1, respectivamente) e 1 por cento NLP (5,4 ± 1,0 e 16,0 ± 1,4 mg.kg-1, respectivamente) não foram significativamente diferentes. A recuperação da hipnose e da anestesia foi mais rápida com NLP do que com CLP. As alterações de FC, PA e FR causadas pelo NLP não foram significativamente diferentes das do CLP. Ácido acético e veículo do CLP provocaram 46,0 ± 2,0 e 12,5 ± 0,6 contorções em 20 min após injeção i.p., respectivamente. Observou-se ausência de contorções abdominais com veículo de NLP. Nenhuma resposta inflamatória abdominal foi notada com a injeção i.p. de ambos os veículos de propofol. CONCLUSÕES: O NLP pode representar melhor alternativa do que o CLP para anestesia venosa com menores efeitos adversos.

BACKGROUND AND OBJECTIVES: The clinical use of a lipid propofol formulation causes pain during injection, allergic reactions, and bacterial growth. Propofol has been reformulated in different non-lipid presentations to reduce the incidence of adverse effects, but those changes can modify its pharmacokinetics and pharmacodynamics. In the present study, we investigate the pharmacology and toxicology of lipid propofol (CLP) and the non-lipid nanoemulsion (NLP). METHODS: Conventional lipid formulation of propofol and NLP were infused in the jugular veins of rats and blood pressure (BP), heart rate (HR), and respiratory rate (RR) were measured. Both formulations (1 percent) were infused (40 µL.min-1) over 1 hour. Hypnotic and anesthetic doses as well as recoveries were determined. The pain induced by the CLP and NLP vehicles was compared by counting the number of abdominal contortions ("writhing test") after the intraperitoneal (i.p.) injection in mice. Acetic acid (0.6 percent) was used as positive control. RESULTS: Hypnotic and anesthetic doses of 1 percent CLP (6.0 ± 1.3 and 17.8 ± 2.6 mg.kg-1, respectively) and 1 percent NLP (5.4 ± 1.0 and 16.0 ± 1.4 mg.kg-1, respectively) were not significantly different. Recovery from hypnosis and anesthesia was faster with NLP than with CLP. Changes in HR, BP, and RR caused by NLP were not significantly different from those caused by CLP. Acetic acid and the vehicle of CLP caused 46.0 ± 2.0 and 12.5 ± 0.6 abdominal contortions 20 min after i.p. injection, respectively. The absence of abdominal contractions was observed with the vehicle of NLP. Abdominal inflammatory response was not observed after the i.p. injection of both propofol vehicles. CONCLUSIONS: Non-lipid formulation of propofol can be a better alternative to CPL for intravenous anesthesia with fewer adverse effects.

JUSTIFICATIVA Y OBJETIVOS: El uso clínico de la formulación lipídica del propofol, causa dolor durante la inyección, reacción alérgica y crecimiento microbiano. El propofol ha sido reformulado en diferentes presentaciones no lipídicas para reducir los efectos adversos, pero esos cambios pueden modificar su farmacocinética y farmacodinámica. En este trabajo, investigamos la farmacología y la toxicología del propofol lipídico (CLP) y de la nanoemulsión no lipídica (NLP). MÉTODO: El CLP y el NLP fueron infundidos en la vena yugular de ratones midiendo la presión arterial (PA), frecuencia cardíaca (FC) y frecuencia respiratoria (FR). Las dos formulaciones (1 por ciento) fueron infundidas (40 µL.min-1) durante 1 hora. Dosis hipnóticas y anestésicas y recuperaciones, fueron determinadas. El dolor inducido por el vehículo del CLP y NLP se comparó por medio del conteo del número de contorciones abdominales ("writhing test") después de la inyección intraperitoneal en ratones. El ácido acético (0,6 por ciento) fue usado como control positivo. RESULTADOS: Las dosis hipnóticas y anestésicas con 1 por ciento CLP (6,0 ± 1,3 y 17,8 ± 2,6 mg.kg-1, respectivamente) y 1 por ciento NLP (5,4 ± 1,0 y 16,0 ± 1,4 mg.kg-1, respectivamente), no fueron significativamente diferentes. La recuperación de la hipnosis y de la anestesia fue más rápida con NLP que con CLP. Las alteraciones de FC, PA y FR causadas por el NLP no fueron significativamente diferentes de las del CLP. El ácido acético y el vehículo del CLP provocaron 46,0 ± 2,0 y 12,5 ± 0,6 contorciones en 20 minutos después de la inyección i.p., respectivamente. No se observaron contorciones abdominales con vehículo de NLP. Ninguna respuesta inflamatoria abdominal fue notada con la inyección i.p. de los dos vehículos de propofol. CONCLUSIONES: El NLP puede representar una mejor alternativa que el CLP para la anestesia venosa, con menores efectos adversos.

Anesthetic profile of a non-lipid propofol nanoemulsion.

BACKGROUND AND OBJECTIVES: The clinical use of a lipid propofol formulation causes pain during injection, allergic reactions, and bacterial growth. Propofol has been reformulated in different non-lipid presentations to reduce the incidence of adverse effects, but those changes can modify its pharmacokinetics and pharmacodynamics. In the present study, we investigate the pharmacology and toxicology of lipid propofol (CLP) and the non-lipid nanoemulsion (NLP). METHODS: Conventional lipid formulation of propofol and NLP were infused in the jugular veins of rats and blood pressure (BP), heart rate (HR), and respiratory rate (RR) were measured. Both formulations (1%) were infused (40 µL.min⁻¹) over 1 hour. Hypnotic and anesthetic doses as well as recoveries were determined. The pain induced by the CLP and NLP vehicles was compared by counting the number of abdominal contortions ("writhing test") after the intraperitoneal (i.p.) injection in mice. Acetic acid (0.6%) was used as positive control. RESULTS: Hypnotic and anesthetic doses of 1% CLP (6.0 ± 1.3 and 17.8 ± 2.6 mg.kg⁻¹, respectively) and 1% NLP (5.4 ± 1.0 and 16.0 ± 1.4 mg.kg⁻¹, respectively) were not significantly different. Recovery from hypnosis and anesthesia was faster with NLP than with CLP. Changes in HR, BP, and RR caused by NLP were not significantly different from those caused by CLP. Acetic acid and the vehicle of CLP caused 46.0 ± 2.0 and 12.5 ± 0.6 abdominal contortions 20 min after i.p. injection, respectively. The absence of abdominal contractions was observed with the vehicle of NLP. Abdominal inflammatory response was not observed after the i.p. injection of both propofol vehicles. CONCLUSIONS: Non-lipid formulation of propofol can be a better alternative to CPL for intravenous anesthesia with fewer adverse effects.