Family Building in Transgender Patients: Modern Strategies with Assisted Reproductive Technology Treatment.

Purpose: Transgender and gender diverse (TGD) individuals continue to face adversity, stigma, and inequality, especially in health care. This study aimed to characterize the experience of TGD people and partners of TGD people with regard to fertility treatment. Methods: All TGD patients presenting to a single academic center between 2013 and 2021 were included. Baseline demographics collected included patient age, body mass index, anti-Mullerian hormone, basal antral follicle count, history of gender-affirming surgery, and/or gender-affirming hormone therapy. Outcomes included total patients who progressed to treatment, cycle type(s), and clinical outcomes. Results: In total, 82 patients who identified as TGD or had a partner who identified as TGD presented to care seeking fertility treatment. Of the 141 planned cycles, 106 (75.2%) progressed to treatment. Of the 15 in vitro fertilization (IVF) and co-IVF cycles, 12 achieved live birth. Of the 76 intrauterine inseminations 7 patients were discharged with ongoing pregnancies and one achieved live birth. Conclusion: These findings reaffirm that TGD individuals utilize the entire array of fertility services. With recent advances in access to care and modern medicine, assisted reproductive technology treatment has the power to support TGD patients in building contemporary family structures.

Postpartum mood among universally screened high and low socioeconomic status patients during COVID-19 social restrictions in New York City.

The mental health effects of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and the Coronavirus Disease 2019 (COVID-19) pandemic on postpartum women are of increasing concern among mental health practitioners. To date, only a handful of studies have explored the emotional impact of the pandemic surrounding pregnancy and none have investigated the consequence of pandemic-related social restrictions on the postpartum mood of those living among different socioeconomic status (SES). All postpartum patients appearing to the Mount Sinai Health System for their postpartum appointment between January 2, 2020 and June 30, 2020, corresponding to before and during pandemic imposed social restrictions, were screened for mood symptomatology using the Edinburgh Postnatal Depression Scale (EPDS). Each patient's socioeconomic status (high/low) was determined by their location of clinical service. A total of 516 postpartum patients were screened. While no differences in EPDS scores were observed by SES prior to social restrictions (U = 7956.0, z = - 1.05, p = .293), a significant change in mood symptomatology was observed following COVID-19 restrictions (U = 4895.0, z = - 3.48, p < .001), with patients living in lower SES reporting significantly less depression symptomatology (U = 9209.0, z = - 4.56, p < .001). There was no change in symptomatology among patients of higher SES (U = 4045.5, z = - 1.06, p = .288). Postpartum depression, the most common complication of childbearing, is a prevalent, cross-cultural disorder with significant morbidity. The observed differences in postpartum mood between patients of different SES in the context of temporarily imposed COVID-19-related social restrictions present a unique opportunity to better understand the specific health and social support needs of postpartum patients living in urban economic poverty. Given that maternal mental illness has negative long-term developmental implications for the offspring and that poor mental health reinforces the poverty cycle, future health policy specifically directed towards supporting postpartum women living in low SES by ameliorating some of the early maternal burdens associated with balancing employment-family-childcare demands may assist in interrupting this cycle while simultaneously improving the long-term outcomes of their offspring.

Toxicological evaluation of an aqueous suspension from leaves and stems of Petiveria alliacea L. (Phytolaccaceae).

ETHNOPHARMACOLOGICAL RELEVANCE: Petiveria alliacea L. (Phytolaccaceae) is used in folk medicine due to its antispasmodic, diuretic, hypoglycemic, abortive, anti-inflammatory and anticancerogenic properties. Although P. alliacea is considered toxic by people, its toxicity remains a concern since it is strongly dependent on the extraction method and the part of the plant used during tests. Even if some healers prefer to use the aerial parts in a liquefied form or by chewing them, instead of decoctions or infusions, no toxicological studies exist using whole dried stems and leaves. MATERIALS AND METHODS: The toxicity of a suspension of the powder from the leaves and stems of P. alliacea was assessed in Sprague Dawley rats by oral administration using two tests: 1) the acute toxic class method, which allows classification of substances according to their intrinsic toxicity and 2) the repeated dose 28-day method, following the guidelines 423 and 407 respectively from the Organization for the Economic Cooperation and Development. Chemical characterization of this powder was performed by GC-MS, UV-fluorescence, proximate and elemental analysis. RESULTS AND CONCLUSIONS: P. alliacea powder from stems and leaves was classed in the hazard category 5 (LD50 > 2000mg/kg) according to the acute toxicology study. There were no toxicity signs at 1000mg/kg in the repeated dose study, although higher values of total leukocytes were found in the satellite and males of the experimental group, which were attributed to the immunomodulatory properties of this plant. According to GC-MS, the prevailing compounds identified were phytol, (R)-(-)-(Z)-14-methyl-8-hexadecen-1-ol, 1-(2-hydrohyethyl)-1,2,4-triazole and methyl ß-dimethylaminoisobutyrate. In conclusion, the oral administration of the P. alliacea powder to Sprague Dawley rats did not result in deaths and was not associated with adverse effects reflected in the general condition, body weights or histopathological abnormalities.

Influence of polyvinylpyrrolidone, microcrystalline cellulose and colloidal silicon dioxide on technological characteristics of a high-dose Petiveria alliacea tablet.

PURPOSE: Petiveria alliacea L. (Phytolaccaceae) is a perennial shrub used by its immunomodulatory, anticancerogenic and anti-inflammatory properties. This study determined the influence of polyvinylpyrrolidone (PVP), colloidal silicon dioxide (CSD) and microcrystalline cellulose (MC) on the technological characteristic of a high-dose P. alliacea tablet prepared by the wet granulation method. METHODOLOGY: The botanical and pharmacognostic analysis of the plant material was firstly performed, followed by a 23 factorial design considering three factors at two levels: (a) the binder (PVP) incorporated in formulation at 10% and 15% (w/w); (b) the compacting agent (CSD) added at 10% and 15% (w/w) and; (c) the diluent (MC) included at 7.33% and 12.46% (w/w). The analysis of pharmaceutical performance and the accelerated and long-term stability of the best prototype were also completed. RESULT AND DISCUSSION: The binder, compacting agent and the interaction binder/diluent had a significant impact on breaking force of high-dose P. alliacea tablet. The optimum formula was found to contain 15% (w/w) of CSD, 7.33% (w/w) of MC and 10% (w/w) of PVP. At these conditions, the tablet shows a breaking force of 77.96 N, a friability of 0.39%, a total phenol content of 1.30 mg/tablet and a maximum disintegration time of 6 min. CONCLUSIONS: The use of adequate amounts of PVP, MC and CSD as per the factorial design allowed the preparation of a tablet suitable for administration, despite the inappropriate flow and compressibility properties of the P. alliacea powder.

Safety and efficacy of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy premature infants.

BACKGROUND: Premature infants seem to be at greater risk of hospitalization from rotavirus gastroenteritis than term infants. Safety and efficacy of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine were assessed in premature infants enrolled in the large-scale, blinded, placebo-controlled rotavirus efficacy and safety trial (REST). METHODS: Healthy infants 6-12 weeks of chronologic age at study entry were randomized to receive 3 oral doses of pentavalent rotavirus vaccine or placebo at 4- to 10-week intervals. Infants born at < or =36 weeks of gestational age were eligible if thriving at the time of enrollment. Safety and efficacy were retrospectively assessed in these premature infants comparing vaccine with placebo recipients. Cases of rotavirus gastroenteritis were defined as forceful vomiting and/or > or =3 watery or looser-than-normal stools within a 24-hour period, accompanied by detection of rotavirus antigen in the stool. RESULTS: A total of 2070 infants between 25 and 36 gestational weeks received at least 1 dose of vaccine or placebo; 1005 vaccine recipients and 1061 placebo recipients were evaluable for safety. Serious adverse events occurred in 55 vaccine recipients (5.5%) and 62 placebo recipients (5.8%). In a nested substudy of 308 premature infants evaluable for detailed safety (154 in each group), the frequencies of fever, diarrhea, vomiting, and irritability were comparable between vaccine and placebo recipients. Overall, 3 doses of the pentavalent vaccine reduced the rate of hospitalizations and emergency department visits in premature infants due to rotavirus gastroenteritis by 100% (95% CI: 82.2-100) compared with placebo. The vaccine also prevented 73.0% (95% CI: -2.2-95.2) of rotavirus gastroenteritis cases of any severity. CONCLUSIONS: In this post hoc analysis of healthy premature infants, the pentavalent rotavirus vaccine was generally well-tolerated and substantially reduced rotavirus-attributable hospitalizations and emergency department visits compared with placebo. Overall, vaccine safety and efficacy seemed to be generally comparable to the results in the REST study population as a whole. These results support vaccinating healthy premature infants on the same schedule as term infants.

Concomitant use of an oral live pentavalent human-bovine reassortant rotavirus vaccine with licensed parenteral pediatric vaccines in the United States.

BACKGROUND: A live pentavalent rotavirus vaccine (PRV) containing 5 human-bovine (WC3) reassortants expressing human serotypes G1, G2, G3, G4 and P1A[8] was evaluated in a blinded, placebo-controlled study. Possible interactions between PRV and concomitantly administered licensed pediatric vaccines were investigated in a United States-based nested substudy (Concomitant Use Study) of the Rotavirus Efficacy and Safety Trial. METHODS: From 2002 to 2003, healthy infants approximately 6 to 12 weeks of age at entry were randomized to receive either 3 oral doses of PRV or placebo at 4- to 10-week intervals. Subjects were also to receive combined Haemophilus influenzae type b and hepatitis B vaccine (2 doses), diphtheria and tetanus toxoids and acellular pertussis vaccine (3 doses), inactivated poliovirus vaccine (2 doses) and pneumococcal conjugate vaccine (3 doses) on the same day; oral poliovirus vaccine was not administered. Immunogenicity was assessed by measuring antibody responses to PRV and antigens contained in the licensed vaccines. Cases of rotavirus gastroenteritis were defined by forceful vomiting and/or -3 watery or looser-than-normal stools within a 24-hour period, and detection of rotavirus antigen in the stool. Safety was assessed by reporting of adverse events using diary cards. RESULTS: The Concomitant Use Study enrolled 662 subjects in the PRV group and 696 subjects in the placebo group. For the 17 antigens in the concomitantly administered vaccines, antibody responses were similar in PRV and placebo recipients, except for moderately diminished antibody responses to the pertactin component of pertussis vaccine. Efficacy of PRV against rotavirus gastroenteritis of any severity was 89.5% (95% CI = 26.5-99.8%). PRV was generally well tolerated when given concomitantly with the prespecified vaccines. CONCLUSIONS: In this study, antibody responses to the concomitantly administered vaccines were generally similar in PRV and placebo recipients. PRV was efficacious and well tolerated when given concomitantly with pediatric vaccines licensed in the United States.

Formulación de tabletas a partir del Extracto de Mangifera indica L (Vimang®) / Dosage form of pills from the Extract of Mangifera L indica (vimang®)

Partiendo del conocimiento etnomédico documentado de varios países sobre los beneficios que reporta la planta Mangifera indica L. para la salud humana -- conocida en Cuba como mango -- y en particular de la experiencia acumulada durante más de 20 años en la población cubana, han sido desarrollados e introducidos en la práctica social varios productos elaborados en diferentes formas con su extracto acuoso, entre las cuales se encuentra la tableta, identificada con la marca comercial VIMANG y registrada por el Centro de Química Farmacéutica. En el presente trabajo se brinda una información general sobre la planta, así como los resultados del estudio de formulación realizado del extracto de Mangifera indica L en comprimidos; forma farmacéutica muy utilizada en el ejercicio médico, de la cual se expone una panorámica actual. Las tabletas obtenidas cumplieron todas las especificaciones de calidad requeridas y fueron registradas como antioxidantes

Formulación de tabletas a partir del Extracto de Mangifera indica L (Vimang®) / Dosage form of pills from the Extract of Mangifera L indica (vimang®)

Partiendo del conocimiento etnomédico documentado de varios países sobre los beneficios que reporta la planta Mangifera indica L. para la salud humana -- conocida en Cuba como mango -- y en particular de la experiencia acumulada durante más de 20 años en la población cubana, han sido desarrollados e introducidos en la práctica social varios productos elaborados en diferentes formas con su extracto acuoso, entre las cuales se encuentra la tableta, identificada con la marca comercial VIMANG y registrada por el Centro de Química Farmacéutica. En el presente trabajo se brinda una información general sobre la planta, así como los resultados del estudio de formulación realizado del extracto de Mangifera indica L en comprimidos; forma farmacéutica muy utilizada en el ejercicio médico, de la cual se expone una panorámica actual. Las tabletas obtenidas cumplieron todas las especificaciones de calidad requeridas y fueron registradas como antioxidantes

Empleo de comprimidos de manzanilla en ancianos con afecciones digestivas / Chamomile tablets use in old men with digestive affections

Se realiza un estudio analítico, transversal y prospectivo, con el objetivo de estudiar el efecto de los comprimidos de manzanilla (Manzanisan) producidos en los Laboratorios Farmacéuticos de Oriente, como tratamiento sintomático, sobre el aparato digestivo en un grupo de ancianos con diversas enfermedades de dicho aparato. Los pacientes son procedentes de la comunidad y vinculados a la consulta externa de geriatría del Policlínico de Especialidades Saturnino Lora de Santiago de Cuba. Se comprueba el beneficio de su uso en los pacientes estudiados y que su aplicación no tuvo efectos indeseables. Se concluye que la manzanilla, (Matricaria recutita L) en su presentación de comprimidos, es útil para el tratamiento de algunos síntomas del tracto digestivo en pacientes ancianos y se recomienda la extensión del estudio a grupos más numerosos de pacientes mayores para lograr resultados estadísticamente más significativos(AU)

Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine.

BACKGROUND: Rotavirus is a leading cause of childhood gastroenteritis and death worldwide. METHODS: We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events. RESULTS: The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1-G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1-G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1-G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent). CONCLUSIONS: This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.)

La tableta de anamú: un medicamento herbario inmunoestimulante / The anamú tablet: an herbal immunostimulant medication

Se presenta una amplia información general sobre la planta medicinal de uso tradicional anamú (Petiveria alliacea L.), muy abundante en el país. Adicionalmente se exponen los principales resultados etnomédicos, preclínicos, farmacológicos y toxicológicos, cuya evaluación por la autoridad regulatoria cubana de medicamentos condujo a la aprobación del registro de la tableta de Anamú en la categoría de medicamento herbario inmunoestimulante

La tableta de anamú: un medicamento herbario inmunoestimulante / The anamú tablet: an herbal immunostimulant medication

Se presenta una amplia información general sobre la planta medicinal de uso tradicional anamú (Petiveria alliacea L.), muy abundante en el país. Adicionalmente se exponen los principales resultados etnomédicos, preclínicos, farmacológicos y toxicológicos, cuya evaluación por la autoridad regulatoria cubana de medicamentos condujo a la aprobación del registro de la tableta de Anamú en la categoría de medicamento herbario inmunoestimulante(AU)

La alfalfa: un remineralizante de excelencia en el mundo vegetal / Alfalfe: an excellence remineralizing element in the vegetable world

Se presenta una panorámica basada en una amplia revisión bibliográfica sobre el uso actual de la alfalfa (Medicago sativa L.) en beneficio de la salud humana, adicionalmente a su tradicional empleo como forraje para el ganado, incluido el desarrollo tecnológico de una forma terminada comprimida. Se brindan los resultados obtenidos en la evaluación físico- mecánica del producto, que permiten continuar los estudios con vista a su registro como remineralizante, acorde con los similares existentes en el mercado internacional(AU)

Eficacia de las tabletas masticables de jalea real en el estado nutricional del adulto mayor / Efficacy of the chewing pills of royal jelly in elderly people in the state nutritional

La jalea real, por su contenido de proteínas, grasas, azúcares, vitaminas y sustancias minerales, se considera un alimento rico y tonificante. Aproximadamente la mitad de su peso en base seca está constituida por proteínas y su complejidad en cuanto a composición incluye también gran número de oligopéptidos. El objetivo del presente estudio consistió en evaluar la efectividad de la jalea real en forma de tabletas masticables para el mejoramiento del estado nutricional en una muestra poblacional de 37 ancianos. Dicha evaluación se realizó a través del análisis de parámetros antropométricos y de laboratorio, los primeros de los cuales no habían variado significativamente a los 3 meses del tratamiento, pero sí los segundos (hemoglobina, proteínas y albúmina). Acorde con los resultados obtenidos se concluye que el suplemento dietético evaluado es eficaz para el mejoramiento del estado nutricional del adulto mayor(AU)

Escalado por modelación en la producción farmacéutica

Se estudia el escalado de los procesos de mezclado y secado según el flujo tecnológico instalado en un laboratorio de producción farmacéutica, haciendo uso del principio de semejanza (rigurosa para el mezclado y extrapolada para el secado), fundamento de la teoría de los modelos. A partir de las metodologías aplicadas, se obtienen ecuaciones de escala convenientemente validadas, que permiten predecir a partir del laboratorio el comportamiento de los procesos considerados.

The scale-up of the mixing and drying processes in studies according to the technological flow installed in a pharmaceutical production laboratory, making use of the resemblance principle (rigorous for mixing and extrapolated for drying), which is the basis of the theory of models. Conveniently validated scale ecuations are obtained from the applied methodologies, allowing to predict, starting from the laboratory, the behaviour of the processes under consideration.

Escalado por modelación en la producción farmacéutica / Climbed by modelación in the pharmaceutical production

Se estudia el escalado de los procesos de mezclado y secado según el flujo tecnológico instalado en un laboratorio de producción farmacéutica, haciendo uso del principio de semejanza (rigurosa para el mezclado y extrapolada para el secado), fundamento de la teoría de los modelos. A partir de las metodologías aplicadas, se obtienen ecuaciones de escala convenientemente validadas, que permiten predecir a partir del laboratorio el comportamiento de los procesos considerados(AU)

Escalado Por Modelación en la Producción Farmacéutica / Climbed by Modelation in the pharmaceutical production

Se estudia el escalado de los procesos de mezclado según el flujo tecnológico instalado en un laboratorio de producción farmacéutica, haciendo uso del principio de semejanza (rigurosa paa el mezclado y extrapolada para el secado), fundamento de la teoría de los modelos. A partir de las metodologías aplicadas, se obtienen ecuaciones de escala convenientemente validadas, que permiten predecir a partir del laboratorio el comportamiento de los procesos considerados

Escalado Por Modelación en la Producción Farmacéutica / Climbed by Modelation in the pharmaceutical production

Se estudia el escalado de los procesos de mezclado según el flujo tecnológico instalado en un laboratorio de producción farmacéutica, haciendo uso del principio de semejanza (rigurosa paa el mezclado y extrapolada para el secado), fundamento de la teoría de los modelos. A partir de las metodologías aplicadas, se obtienen ecuaciones de escala convenientemente validadas, que permiten predecir a partir del laboratorio el comportamiento de los procesos considerados