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1.
N Engl J Med ; 379(8): 743-752, 2018 Aug 23.
Article in English | MEDLINE | ID: mdl-29949473

ABSTRACT

BACKGROUND: Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin. METHODS: We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 µg) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°C) to maintain double-blinding. There were two primary outcomes: the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively. RESULTS: A total of 29,645 women underwent randomization. The frequency of blood loss of at least 500 ml or the use of additional uterotonic agents was 14.5% in the carbetocin group and 14.4% in the oxytocin group (relative risk, 1.01; 95% confidence interval [CI], 0.95 to 1.06), a finding that was consistent with noninferiority. The frequency of blood loss of at least 1000 ml was 1.51% in the carbetocin group and 1.45% in the oxytocin group (relative risk, 1.04; 95% CI, 0.87 to 1.25), with the confidence interval crossing the margin of noninferiority. The use of additional uterotonic agents, interventions to stop bleeding, and adverse effects did not differ significantly between the two groups. CONCLUSIONS: Heat-stable carbetocin was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents. Noninferiority was not shown for the outcome of blood loss of at least 1000 ml; low event rates for this outcome reduced the power of the trial. (Funded by Merck Sharpe & Dohme; CHAMPION Australian New Zealand Clinical Trials Registry number, ACTRN12614000870651 ; EudraCT number, 2014-004445-26 ; and Clinical Trials Registry-India number, CTRI/2016/05/006969 .).


Subject(s)
Oxytocics/therapeutic use , Oxytocin/analogs & derivatives , Oxytocin/therapeutic use , Postpartum Hemorrhage/prevention & control , Adult , Double-Blind Method , Drug Stability , Female , Humans , Injections, Intramuscular , Oxytocics/adverse effects , Oxytocin/adverse effects , Pregnancy , Risk , Young Adult
2.
Mem Inst Oswaldo Cruz ; 97(6): 881-5, 2002 Sep.
Article in English | MEDLINE | ID: mdl-12386715

ABSTRACT

Since the internal defense system of mollusks consists of cellular and humoral mechanisms, we examined the role of hydrocortisone in mollusks defense cells and the influence of this steroid on the development of Schistosoma mansoni in its intermediary host. Hydrocortisone had an immunosuppressive action in Biomphalaria glabrata, as reflected in the reduced number of defense cells and the altered cell physiology. Histopathological analysis showed that hydrocortisone facilitated the intramolluscan development of S. mansoni, by reducing the extent of the inflammatory response, seen as a greater number of viable sporocysts with no surrounding hemocytes.


Subject(s)
Anti-Inflammatory Agents/pharmacology , Biomphalaria/drug effects , Blood Cells/drug effects , Hydrocortisone/pharmacology , Schistosoma mansoni/drug effects , Animals , Biomphalaria/cytology , Biomphalaria/parasitology , Blood Cell Count , Blood Cells/physiology , Hemolymph/drug effects , Oocysts/drug effects , Schistosoma mansoni/growth & development
3.
Arch. latinoam. nutr ; 45(3): 167-71, sept. 1995. tab
Article in Portuguese | LILACS | ID: lil-199275

ABSTRACT

O presente estudo teve como objetivos determinar as adequacôes calórica e proteíca, diagnosticar a modalidade operativa e as dificuldades operacionais do Programa de Merenda Escolar nacidade de Campinas do Brasil, Foi analisada uma amostra aleatórica com 6 escolas e 1.237 criacas. Para determinar o cansumo de energía e proteína empregou-se o método de pesagem direta dos alimentos. Um modelo de projeto alimentar foi elaborado para a análise da operacionalizacâo. Os valores determinados das adequacôes foram muito baixos: 48.6 ñ 17.3 de energía e 52.7 ñ 17.2 por ciento de proteína. Os valores de adequacâo das escolas nâo + estatísticamente (Ó=0.05) que a eficócia e/ou impactos do programa em Campinas poderiam estar sendo entravados pela falta de de recursos e por diferentes distorcôes operacionais. Dentre estas destacam-se as elevadas quantidades de alimentos preparados e nâo servidos as criancas, o tipo de alimento utilizado, a ineficiência dos controles administrativos, a baixa frequência de superviâo de recursos humanos, a pequena producâo de hortas escolares e a inexisténcia de controle de aqualidade dos alimentos, de avaliacôes, de participacâo popular, de educacâo nutricional e de integracâo com programas de saúde


Subject(s)
Child, Preschool , Child , Humans , Male , Female , School Feeding , Infant Nutritional Physiological Phenomena/supply & distribution , Food and Nutrition Education
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