ORAL CONTRACEPTIVES AND THROMBOEMBOLIC DISEASE

描述：(改编自《调查者摘要》) 研究的目的是确定以下内容：a)相对风险和归因风险 静脉血栓栓塞症(深静脉血栓形成和肺血栓 目前服用低剂量(50微克)雌激素的患者) 避孕(OC)制剂；和b)因子V的流行率 病例和对照中的Leiden突变与相对和归因风险 与其存在相关的静脉血栓栓塞性疾病。一个 将在确定的妇女人群中进行病例对照研究 年龄15-44岁，北加州或南加州的成员 加州凯撒永久医疗保健计划(KPMCP)。病例(n=248) 年龄在15-44岁的女性是否在40个月的时间内住院治疗 24名凯撒人中任何一人发生静脉血栓栓塞病的事件 北加州和南加州永久医院 地区。对于每个病例，将随机选择3个年龄匹配的对照 来自北加州或南加州毕马威会计师事务所的女性 成员与该病例住院同年。病例和对照 将接受采访，以获取有关OC使用和其他方面的详细信息 可能影响静脉血栓形成的因素。血样 样本将被分析是否存在因子V莱顿突变， 静脉血栓形成最常见的已知遗传危险因素。 调查人员表示，这项拟议的研究将是第一次 低剂量OC静脉给药相关性的合理大规模研究 在美国进行的血栓栓塞症，这将是 首次利用以人群为基础的控制组检查 这个协会。他们指出，它将在 所有研究人群都有平等的医疗保健机会，而且在 哪些普遍接受的诊断实践可能被用于 确定是否存在静脉血栓栓塞症。最后，他们 指出它将提供对因子V流行程度的估计 Leiden突变及其对血栓性疾病的影响 异质加州研究群体。

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.