RESUMO
A 2003 petition to the US Food and Drug Administration by the manufacturer to move levonorgestrel emergency contraception from prescription status to over-the-counter sale embroiled the Agency in politics and remains controversial in some circles. This essay addresses the current remaining main points of contoversy about the medication and the Agency's decision.
Assuntos
Comportamento de Escolha , Anticoncepção Pós-Coito/métodos , Anticoncepcionais Orais Sintéticos/uso terapêutico , Legislação de Medicamentos , Levanogestrel/uso terapêutico , Autonomia Pessoal , Saúde da Mulher , Aborto Induzido , Comportamento de Escolha/ética , Anticoncepção Pós-Coito/ética , Anticoncepcionais Orais Sintéticos/administração & dosagem , Anticoncepcionais Orais Sintéticos/efeitos adversos , Esquema de Medicação , Prescrições de Medicamentos , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Legislação de Medicamentos/ética , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Princípios Morais , Medicamentos sem Prescrição , Ovulação/efeitos dos fármacos , Gravidez , Comportamento Sexual , Resultado do Tratamento , Estados Unidos , United States Food and Drug AdministrationRESUMO
A number of beneficial sociocultural reforms have occurred throughout our society, including a new work/family balance. This change, and a number of others, are challenging the dynamic balance within our specialty. We must advocate for appropriate social, political, and economic interventions that will realistically mesh with the health care needs of our nation, while preserving that which is best about the culture of American medicine.
Assuntos
Ginecologia/tendências , Avaliação das Necessidades , Obstetrícia/tendências , Qualidade da Assistência à Saúde , Feminino , Previsões , Ginecologia/normas , Humanos , Obstetrícia/normas , Padrões de Prática Médica , Estados UnidosAssuntos
Túbulos Renais/anormalidades , Neoplasias Fibroepiteliais/diagnóstico por imagem , Oligo-Hidrâmnio/etiologia , Ultrassonografia Pré-Natal , Neoplasias da Bexiga Urinária/diagnóstico por imagem , Anormalidades Múltiplas/patologia , Adulto , Evolução Fatal , Feminino , Humanos , Recém-Nascido , Masculino , Neoplasias Fibroepiteliais/patologia , Oligo-Hidrâmnio/diagnóstico por imagem , Pólipos/patologia , Gravidez , Terceiro Trimestre da Gravidez , Neoplasias da Bexiga Urinária/patologiaAssuntos
Diabetes Gestacional/tratamento farmacológico , Glibureto/uso terapêutico , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Glicemia/análise , Anormalidades Congênitas , Feminino , Sangue Fetal/química , Macrossomia Fetal , Glibureto/sangue , Humanos , Hipoglicemiantes/sangue , Recém-Nascido , Insulina/sangue , Gravidez , Resultado da Gravidez , Compostos de Sulfonilureia/efeitos adversos , Compostos de Sulfonilureia/uso terapêuticoRESUMO
We studied fetal lung maturity (FLM) by the amniotic fluid surfactant/albumin (FLM S/A) ratio and the disaturated phosphatidylcholine (DSPC) amniotic fluid levels at different gestational ages in diabetic (179 women with type 1 diabetes mellitus antedating pregnancy; infants delivered within 72 hours after amniotic fluid testing for DSPC level and FLM S/A ratio) and nondiabetic pregnancies (2 independent nondiabetic groups, 300 for FLM S/A ratio and 1,231 for DSPC level). The degree of maternal glycemia during gestation was estimated by serial measurements of hemoglobin A1. Multiple regression analyses, including gestational age (GAs) and diabetic status as independent variables and FLM S/A ratio and DSPC level as dependent variables, revealed significant effect from diabetic status and GA for FLM S/A ratio and a significant effect from GA but not from diabetic status for DSPC level. Glucose levels were controlled adequately throughout gestation as reflected by mean total glycated hemoglobin levels. Amniotic fluid levels of DSPC, the major surface tension-lowering component of pulmonary surfactant, are not significantly different between diabetic and nondiabetic pregnancies at different GAs.
Assuntos
Líquido Amniótico/química , Maturidade dos Órgãos Fetais , Pulmão/embriologia , Fosfatidilcolinas/análise , Gravidez em Diabéticas , Surfactantes Pulmonares/análise , Albuminas/análise , Glicemia/análise , Diabetes Mellitus Tipo 1/metabolismo , Feminino , Idade Gestacional , Hemoglobinas Glicadas/análise , Humanos , Gravidez , Análise de RegressãoRESUMO
Women with insulin dependent diabetes mellitus are at increased risk for both first trimester spontaneous abortions and major congenital malformations when they become pregnant. The magnitudes of both of these risks depend upon the degree of metabolic control of their diabetes in the first trimester. The risks differ in the degree of control necessary to minimize them and the degree to which they can ultimately be reduced. A stricter degree of metabolic control is necessary to avoid spontaneous abortions than major malformations. Although the risks for both complications can be reduced by improved metabolic control, the risk for major malformations remains elevated, when compared to the risk for non-diabetic women, despite good to excellent control. In contrast, good to excellent control does reduce the risk for spontaneous abortions to a rate comparable to that seen in non-diabetic women. Women with insulin dependent diabetes mellitus who are planning pregnancies should be encouraged to achieve the best possible degree of metabolic control prior to and throughout pregnancy. They should be re-assured, however, that perfect control is not necessary to avoid dramatically increased risks for spontaneous abortions and major malformations.
Assuntos
Aborto Espontâneo/etiologia , Anormalidades Congênitas/etiologia , Diabetes Mellitus Tipo 1/complicações , Gravidez em Diabéticas/complicações , Glicemia , Feminino , Humanos , Educação de Pacientes como Assunto , Gravidez , Primeiro Trimestre da GravidezRESUMO
A substantial risk in using live attenuated, multiply deleted viruses as vaccines against AIDS is their potential to induce AIDS. A mutant of the simian immunodeficiency virus (SIV) with large deletions in nef and vpr and in the negative regulatory element induced AIDS in six of eight infant macaques vaccinated orally or intravenously. Early signs of immune dysfunction were seen in the remaining two offspring. Prolonged follow-up of sixteen vaccinated adult macaques also showed resurgence of chronic viremia in four animals: two of these developed early signs of disease and one died of AIDS. We conclude that this multiply deleted SIV is pathogenic and that human AIDS vaccines built on similar prototypes may cause AIDS.
Assuntos
Envelhecimento/imunologia , Vacinas contra a SAIDS , Síndrome de Imunodeficiência Adquirida dos Símios/prevenção & controle , Síndrome de Imunodeficiência Adquirida dos Símios/virologia , Vacinas Atenuadas/imunologia , Líquido Amniótico/virologia , Animais , Progressão da Doença , Feminino , Produtos do Gene nef/genética , Produtos do Gene vpr/genética , Imunidade nas Mucosas , Macaca mulatta , Masculino , Dados de Sequência Molecular , Gravidez , Complicações Infecciosas na Gravidez/imunologia , Complicações Infecciosas na Gravidez/prevenção & controle , Vacinas contra a SAIDS/imunologia , Deleção de Sequência , Síndrome de Imunodeficiência Adquirida dos Símios/imunologia , Vírus da Imunodeficiência Símia/imunologiaRESUMO
PURPOSE: To summarize a conference convened to examine how cystic fibrosis screening might appropriately be introduced into routine prenatal practice. METHODS: Participants included experts from various relevant disciplines. Systematic reviews and data from individual trials were presented; issues were identified and discussed. RESULTS: Judged by published criteria, prenatal cystic fibrosis screening is suitable for introduction. Screening can be performed cost-effectively by identifying racial/ethnic groups at sufficient risk and then using either of two models for delivering laboratory services. Validated educational materials exist. Ethical issues are not unique. CONCLUSIONS: Once adequate facilities for patient and provider education, testing, counseling, quality control, and monitoring are in place, individual programs can begin prenatal screening for cystic fibrosis.
Assuntos
Fibrose Cística/diagnóstico , Fibrose Cística/genética , Aconselhamento Genético , Testes Genéticos , Diagnóstico Pré-Natal , Ensaios Clínicos como Assunto , Revelação , Ética Médica , Feminino , Aconselhamento Genético/economia , Aconselhamento Genético/tendências , Testes Genéticos/economia , Testes Genéticos/tendências , Humanos , Masculino , Mutação , Diagnóstico Pré-Natal/economia , Diagnóstico Pré-Natal/tendências , Relações Profissional-Paciente , Fatores de RiscoRESUMO
The objective was to correlate Doppler indices from the uterine arcuate arteries with an analysis of the decidual vascular histology in patients with type I diabetes. Pulsed wave Doppler was used to sample the uterine arcuate artery system beneath the placenta within 8 days of delivery in 47 patients with type I diabetes mellitus. A placental pathologist, without knowledge of either clinical outcome or Doppler information, classified the histological appearance of the decidual arteries as normal, type A (hyalinization, mural thickening), or type B (fibrinoid necrosis, atherosis, thrombosis). Patients were then grouped according to the histology of the decidual arteries. An analysis of variance (ANOVA) of the systolic/diastolic (S/D) ratios (log. S/D) showed significant variation (p < 0.025). A multiple range comparison test showed that patients with normal or only mildly abnormal (type A) vessels had similar values, whereas those with severe vasculopathy (type B) had significantly higher S/D ratios (p < 0.05). The study confirmed a relationship between arcuate artery Doppler indices and downstream decidual vascular pathology.
Assuntos
Decídua/irrigação sanguínea , Diabetes Mellitus Tipo 1/fisiopatologia , Gravidez em Diabéticas/fisiopatologia , Ultrassonografia Doppler em Cores , Útero/irrigação sanguínea , Artérias/diagnóstico por imagem , Artérias/patologia , Velocidade do Fluxo Sanguíneo , Decídua/patologia , Diabetes Mellitus Tipo 1/patologia , Feminino , Humanos , Microcirculação/patologia , Gravidez , Gravidez em Diabéticas/patologia , Ultrassonografia Pré-Natal , Útero/diagnóstico por imagemRESUMO
OBJECTIVE: The purpose of this study was to determine if insulin-requiring diabetic women undergoing nonelective cesarean section are at higher risk for postoperative infection than nondiabetic women. RESEARCH DESIGN AND METHODS: Medical records of a cohort of insulin-requiring diabetic women who underwent cesarean section after labor or rupture of membranes and nondiabetic control subjects matched for age and insurance status were retrospectively reviewed. Data abstracted included maternal characteristics, antepartum, intrapartum, and postpartum events. RESULTS: Post-cesarean section infection including endometritis, wound infection, and septic pelvic thrombophlebitis occurred in 10.2% of 205 diabetic women and 12.1% of control subjects, in whom antibiotic prophylaxis was used in 79% of diabetic women and 84% of control subjects. Duration of rupture of membranes was a significant risk factor for post-cesarean section infection in both groups. CONCLUSIONS: Insulin-requiring diabetic women undergoing nonelective cesarean section with antimicrobial prophylaxis have a rate of postoperative infection similar to that for nondiabetic women.
Assuntos
Cesárea , Diabetes Mellitus Tipo 1 , Gravidez em Diabéticas , Infecção da Ferida Cirúrgica/epidemiologia , Adulto , Endometrite/epidemiologia , Feminino , Humanos , Trabalho de Parto , Exame Físico , Gravidez , Valores de Referência , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Sepse/epidemiologia , Tromboflebite/epidemiologiaAssuntos
Vacinas contra a SAIDS/imunologia , Vírus da Imunodeficiência Símia/imunologia , Animais , Animais Recém-Nascidos , Deleção de Genes , Genes nef , Genes vpr , Macaca , Modelos Biológicos , Vírus da Imunodeficiência Símia/crescimento & desenvolvimento , Vírus da Imunodeficiência Símia/patogenicidade , Vacinas Atenuadas/classificação , Vacinas Atenuadas/imunologiaRESUMO
The authors evaluated the performance of the amniotic fluid surfactant to albumin ratio (FLM S/A), and disaturated phosphatidylcholine (DSPC) tests in assessing fetal lung maturity in infants of mothers with insulin-dependent diabetes mellitus antedating pregnancy. The distribution of the study population (n = 180) by class of diabetes was class B (27%); class C (28%); class D (29%); class F, FR and T (8%); and class R patients (8%). The diagnosis of respiratory distress syndrome (RDS) was the standard for evaluating the performance of FLM S/A and DSPC. The mean estimated gestational age was 37.4 weeks. Three infants (1.7%) were diagnosed with RDS. All three were delivered before 36 weeks. FLM S/A at the cut-off for "maturity" of > or = 70 mg/g, had a sensitivity of 66.6%, specificity of 94.9%, positive predictive value (PPV) of 18.2%, and negative predictive value (NPV) of 99.4%. DSPC at the cut-off for "maturity" of 1,000 micrograms/dL, had identical sensitivity and NPV, but lower specificity (89.2%) and PPV (9.5%) than FLM S/A. Both tests mispredicted maturity in the same case of RDS. The false "mature" rate of FLM S/A was 0.6% (95% confidence interval 0.0%-3.2%). The FLM S/A result of > or = 70 mg/g, obtained at or near-term, is a reliable predictor of the absence of RDS in infants of mothers with diabetes mellitus antedating pregnancy.
Assuntos
Líquido Amniótico/química , Pulmão/embriologia , Fosfatidilcolinas/análise , Gravidez em Diabéticas , Surfactantes Pulmonares/análise , Síndrome do Desconforto Respiratório do Recém-Nascido/diagnóstico , Albuminas/análise , Diabetes Mellitus Tipo 1 , Feminino , Maturidade dos Órgãos Fetais , Idade Gestacional , Humanos , Recém-Nascido , Masculino , Gravidez , Transtornos Respiratórios/diagnóstico , Estudos Retrospectivos , Sensibilidade e EspecificidadeRESUMO
Massive chronic intervillositis (MCI) is an unusual placental lesion associated with poor fetal growth and adverse pregnancy outcome; it has not previously been associated with spontaneous abortion or recurrent pregnancy loss. This article reports a patient who had 10 spontaneous abortions with repetitious massive chronic intervillositis documented in four of five gestations spanning all three trimesters. Characteristic placental histology induced massive infiltration of the maternal intervillous space by chronic inflammatory cells and fibrin, without associated chronic villitis; the cellular infiltrate was composed predominantly of LCA and CD68 immunoreactive cells with scattered CD45RO positivity, consistent with a monocyte/macrophage population with occasional T lymphocytes. Elevated maternal serum alpha-fetoprotein was documented in two pregnancies. These findings support the concept that this unusual placental lesion may have an immunologic basis, and suggest that MCI may be a histopathologically recognizable cause of recurrent spontaneous abortion.
Assuntos
Aborto Habitual/etiologia , Vilosidades Coriônicas/patologia , Doenças Placentárias/complicações , Doenças Placentárias/patologia , Aborto Habitual/epidemiologia , Adulto , Antígenos CD/análise , Antígenos de Diferenciação Mielomonocítica/análise , Vilosidades Coriônicas/química , Doença Crônica , Feminino , Fibrina/análise , Humanos , Imuno-Histoquímica , Antígenos Comuns de Leucócito/análise , Macrófagos/química , Macrófagos/patologia , Masculino , Monócitos/química , Monócitos/patologia , Gravidez , Resultado da Gravidez , Linfócitos T/química , Linfócitos T/patologiaAssuntos
Vacinas contra a AIDS , Vacinas contra a SAIDS , Animais , Deleção de Genes , Humanos , Macaca , Retrovirus dos Símios/genética , Retrovirus dos Símios/crescimento & desenvolvimento , Retrovirus dos Símios/patogenicidade , Segurança , Síndrome de Imunodeficiência Adquirida dos Símios/prevenção & controle , Vacinas Atenuadas , Virulência/genética , Replicação ViralRESUMO
Adult macaques do not develop disease after infection with a nef deletion mutant of the simian immunodeficiency virus (SIV) and are protected against challenge with pathogenic virus. This finding led to the proposal to use nef-deleted viruses as live, attenuated vaccines to prevent human acquired immunodeficiency syndrome (AIDS). In contrast, neonatal macaques developed persistently high levels of viremia after oral exposure to and SIV nef, vpr, and negative regulatory element (NRE) deletion mutant. Severe hemolytic anemia, thrombocytopenia, and CD4+ T cell depletion were observed, indicating that neither nef nor vpr determine pathogenicity in neonates. Because such constructs have retained their pathogenic potential, they should not be used as candidate live, attenuated virus vaccines against human AIDS.