ORAL CONTRACEPTIVES AND THROMBOEMBOLIC DISEASE

口服避孕药和血栓栓塞性疾病

• 批准号: 6056376
• 负责人: Stephen Sidney
• 金额: $ 40.12万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-01 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6056376
• 关键词: adolescence (12-20); clinical research; coagulation factor V; disease /disorder proneness /risk; drug adverse effect; estrogens; female; gene mutation; human subject; oral contraceptives; thromboembolism; women's health; young adult human (21-34)

DESCRIPTION: (Adapted from Investigator's Abstract) The primary aims of the study are to determine the following: a) the relative and attributable risk of venous thromboembolic disease (deep venous thrombosis and pulmonary embolism) in current users of low-dose (<50 micrograms estrogen) oral contraceptive (OC) preparations; and b) the prevalence of the factor V Leiden mutation in cases and controls and the relative and attributable risk of venous thromboembolic disease associated with its presence. A case-control study will be carried out in the defined population of women age 15-44 years who are members of the Northern California or the Southern California Kaiser Permanente Medical Care Program (KPMCP). Cases (n=248) are women age 15-44 years hospitalized during a 40 month period with an incident episode of venous thromboembolic disease in any of the 24 Kaiser Permanente hospitals of the Northern California and Southern California regions. For each case, 3 age-matched controls will be selected at random from among women who are Northern California or Southern California KPMCP members in the same year as the case's hospitalization. Cases and controls will be interviewed to obtain detailed information about OC use and other factors that may influence the development of venous thromboembolism. Blood specimens will be analyzed for presence of the Factor V Leiden mutation, the most common known hereditary risk factor for venous thrombosis. The investigators state that the proposed study would be the first reasonably large-scale study of the association of low-dose OC use to venous thromboembolism performed in the United States and that it would be the first study utilizing a population-based control group in its examination of this association. They note that it would be performed in a setting in which the entire study population has equal access to medical care, and in which commonly accepted diagnostic practices are likely to be used in determining the presence of venous thromboembolic disease. Finally, they point out that it would provide estimates of the prevalence of the Factor V Leiden mutation and its impact on thromboembolic disease in a racially heterogeneous California study population.

描述：（改编自研究者摘要） 研究旨在确定以下内容：a）相对和可归因风险 静脉血栓栓塞性疾病（深静脉血栓形成和肺血栓形成） 栓塞）在目前使用低剂量（<50微克雌激素）口服 避孕（OC）制剂;和B）因子V的流行率 病例和对照中的Leiden突变以及相对和归因风险 静脉血栓栓塞性疾病的风险。 一 将在确定的妇女人群中进行病例对照研究 年龄15-44岁，是北方加州或南方的成员 加州Kaiser Permanente医疗保健计划（KPMCP）。 病例（n=248） 15-44岁的妇女在40个月期间因 24例Kaiser患者中任何一例发生静脉血栓栓塞性疾病 北方加州和南方加州的永久性医院 地区 对于每例病例，将随机选择3例年龄匹配的对照 来自北方加州或南方加州KPMCP的女性 在同一年的住院病人。 病例和对照 将接受采访，以获得有关OC使用和其他 可能影响静脉血栓栓塞发展的因素。 血液 将分析标本中是否存在凝血因子V Leiden突变， 静脉血栓形成的最常见的已知遗传危险因素。 研究人员表示，这项研究将是第一个 一项关于低剂量OC使用与静脉给药相关性的合理大规模研究 血栓栓塞在美国进行，这将是 第一项研究利用基于人口的对照组， 这个协会。 他们指出，这将是在一个环境中进行， 整个研究人群都有平等的医疗保健机会， 哪些被普遍接受的诊断实践可能被用于 确定静脉血栓栓塞性疾病的存在。 最后他们 指出，它将提供对因子V患病率的估计， Leiden基因突变及其对一个种族血栓栓塞性疾病的影响 异质性加州研究人群。