Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use?

OBJECTIVES: To evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the first 2 years of use. STUDY DESIGN: We reanalyzed phase 3 study bleeding data for non-breastfeeding participants from the United States, Europe, Russia and Chile during the first 2 years of implant use to characterize and correlate bleeding patterns. We used 90-day reference periods with period 1.1 starting at Day 29 and ending at Day 118. We dichotomized bleeding patterns as "favorable" (amenorrhea, infrequent bleeding and normal frequency bleeding without prolonged bleeding) or "unfavorable' (prolonged and/or frequent bleeding) and tracked user groups based on these bleeding patterns in reference period 1.1 through Year 1 and from Year 1 through Year 2, respectively. RESULTS: We evaluated data from 537 and 428 women with up to 1 and 2 years use, respectively. Of the 325 (60.5%) women with favorable bleeding in reference period 1.1, 275 (84.6%) reported favorable bleeding also in reference period 2, 197 (60.6%) reported favorable bleeding throughout Year 1, and favorable bleeding in 75-85% of reference periods in Year 2. Among 212 (39.5%) women with unfavorable bleeding in reference period 1.1, 118 (55.7%) continued with unfavorable bleeding in reference period 2, while about 40%-50% reported favorable patterns in RP 2, 3 and/or 4. Initial favorable bleeding resulted in lower discontinuation rates than initial unfavorable bleeding in years 1 (3.7% vs 12.7%, p≪.0001) and 2 (2.5% vs 16.5%, p≪.0001). CONCLUSION: Implant users with favorable bleeding in the first reference period are likely to continue with favorable bleeding over the next 2 years. Initial bleeding patterns predict overall continuation rates in years 1 and 2. Implications Statement When evaluating vaginal bleeding in any 90-day reference period over 2 years of etonogestrel implant use, approximately 80% of women with favorable and 40% with unfavorable bleeding patterns will have favorable bleeding in the next reference periods. These findings can facilitate counseling regarding bleeding for women using the etonogestrel implant.

Predictors and pattern of weaning and long-term outcome of patients with prolonged mechanical ventilation at an acute intensive care unit in North India. / Preditores, padrão de desmame e desfecho em longo prazo de pacientes com ventilação mecânica prolongada em unidade de terapia intensiva no norte da Índia.

OBJECTIVE:: This study aimed to examine the clinical characteristics, weaning pattern, and outcome of patients requiring prolonged mechanical ventilation in acute intensive care unit settings in a resource-limited country. METHODS:: This was a prospective single-center observational study in India, where all adult patients requiring prolonged ventilation were followed for weaning duration and pattern and for survival at both intensive care unit discharge and at 12 months. The definition of prolonged mechanical ventilation used was that of the National Association for Medical Direction of Respiratory Care. RESULTS:: During the one-year period, 49 patients with a mean age of 49.7 years had prolonged ventilation; 63% were male, and 84% had a medical illness. The median APACHE II and SOFA scores on admission were 17 and 9, respectively. The median number of ventilation days was 37. The most common reason for starting ventilation was respiratory failure secondary to sepsis (67%). Weaning was initiated in 39 (79.5%) patients, with success in 34 (87%). The median weaning duration was 14 (9.5 - 19) days, and the median length of intensive care unit stay was 39 (32 - 58.5) days. Duration of vasopressor support and need for hemodialysis were significant independent predictors of unsuccessful ventilator liberation. At the 12-month follow-up, 65% had survived. CONCLUSION:: In acute intensive care units, more than one-fourth of patients with invasive ventilation required prolonged ventilation. Successful weaning was achieved in two-thirds of patients, and most survived at the 12-month follow-up.

Preditores, padrão de desmame e desfecho em longo prazo de pacientes com ventilação mecânica prolongada em unidade de terapia intensiva no norte da Índia / Predictors and pattern of weaning and long-term outcome of patients with prolonged mechanical ventilation at an acute intensive care unit in North India

RESUMO Objetivo: Examinar as características clínicas, o padrão de desmame e o desfecho de pacientes que necessitaram de ventilação mecânica por tempo prolongado em uma unidade de terapia intensiva em um país com recursos financeiros limitados. Métodos: Estudo prospectivo observacional em centro único, realizado na Índia, no qual todos os pacientes adultos que necessitaram de ventilação mecânica prolongada foram acompanhados quanto a duração e padrão do desmame, e à sobrevivência, tanto por ocasião da alta da unidade de terapia intensiva quanto após 12 meses. A definição de ventilação mecânica prolongada adotada foi a do consenso da National Association for Medical Direction of Respiratory Care. Resultados: Durante o período de 1 ano, 49 pacientes com média de idade de 49,7 anos receberam ventilação mecânica prolongada; 63% deles eram do sexo masculino e 84% tinham uma enfermidade de natureza clínica. As medianas dos escores APACHE II e SOFA quando da admissão foram, respectivamente, 17 e 9. O tempo mediano de ventilação foi 37 dias. A razão mais comum para início da ventilação foi insuficiência respiratória secundária à sepse (67%). O desmame foi iniciado em 39 (79,5%) pacientes, com sucesso em 34 deles (87%). A duração mediana do desmame foi de 14 (9,5 - 19) dias, e o tempo mediano de permanência na unidade de terapia intensiva foi 39 (32 - 58,5) dias. A duração do suporte com vasopressores e a necessidade de hemodiálise foram preditores independentes significantes de insucesso no desmame. No acompanhamento após 12 meses, 65% dos pacientes sobreviveram. Conclusão: Mais de um quarto dos pacientes com ventilação invasiva na unidade de terapia intensiva necessitaram de ventilação mecânica prolongada. Os desmames foram bem-sucedido em dois terços dos pacientes, e a maioria deles sobreviveu até o acompanhamento após 12 meses.

ABSTRACT Objective: This study aimed to examine the clinical characteristics, weaning pattern, and outcome of patients requiring prolonged mechanical ventilation in acute intensive care unit settings in a resource-limited country. Methods: This was a prospective single-center observational study in India, where all adult patients requiring prolonged ventilation were followed for weaning duration and pattern and for survival at both intensive care unit discharge and at 12 months. The definition of prolonged mechanical ventilation used was that of the National Association for Medical Direction of Respiratory Care. Results: During the one-year period, 49 patients with a mean age of 49.7 years had prolonged ventilation; 63% were male, and 84% had a medical illness. The median APACHE II and SOFA scores on admission were 17 and 9, respectively. The median number of ventilation days was 37. The most common reason for starting ventilation was respiratory failure secondary to sepsis (67%). Weaning was initiated in 39 (79.5%) patients, with success in 34 (87%). The median weaning duration was 14 (9.5 - 19) days, and the median length of intensive care unit stay was 39 (32 - 58.5) days. Duration of vasopressor support and need for hemodialysis were significant independent predictors of unsuccessful ventilator liberation. At the 12-month follow-up, 65% had survived. Conclusion: In acute intensive care units, more than one-fourth of patients with invasive ventilation required prolonged ventilation. Successful weaning was achieved in two-thirds of patients, and most survived at the 12-month follow-up.

Antidiabetic Potential of Potentilla fulgens Roots in Validated Animal Models of Diabetes

The present study was undertaken to investigate the antidiabetic potential of tap roots of Potentilla fulgens in streptozotocin induced diabetic rat models. The crude powder, ethanolic, ethanolic: aqueous and aqueous extracts of tap roots were administered to normoglycemic- and streptozotocin (STZ)-induced diabetic rats in a single dose study. The ethanolic extract showed significant improvement in oral glucose tolerance and antihyperglycemic effect on sucrose loaded normal rats and STZ-induced diabetic rats. Of the isolated aqueous, n-butanol, chloroform and n-hexane soluble fractions of the active ethanolic extract of the roots, the aqueous fraction (100 mg/kg body weight) showed significant blood glucose lowering effect on STZ-induced diabetic rats. In a multiple dose study, aqueous fraction of ethanolic extract of P. fulgens roots significantly improved the body weight, percent glycated hemoglobin (%HbA1c), fasting blood glucose, oral glucose tolerance (OGTT), serum insulin, lipid profile, liver and kidney parameters in STZ-induced diabetic rats. The aqueous fraction also showed marked improvement in OGTT and serum insulin level in neonatal STZ-induced diabetic rats for 30 consecutive days. The aqueous fraction of the roots also inhibited the activity of alpha (α)-glucosidase enzyme in a dose dependent manner. In conclusion, the finding suggested that an aqueous fraction of tap roots of P. fulgens possessed potential antidiabetic activity.