Spannagl M, Heinemann L A, Schramm W
Ludwig-Maximilian University, Department of Hemostasiology, City Center Clinic, Medical Hospital, Munich, Germany.
Eur J Contracept Reprod Health Care. 2000 Jun;5(2):105-12. doi: 10.1080/13625180008500383.
Major concern was raised by an earlier study regarding oral contraceptive use in women with the factor V Leiden mutation. A more than 30-fold increase in relative risk for venous thromboembolism was reported; for homozygotes, the relative risk was as much as 100-fold or more.
To replicate the reported risk estimates with a new population-based case-control study.
Eighty women with a diagnosis of venous thromboembolism were consecutively identified and compared with population-based controls (n = 406). Factor V Leiden mutation was identified by genotype analysis. The evaluation was performed with conditional logistic regression (matched for 5-year age group).
Matched, adjusted odds ratios (OR) for idiopathic venous thromboembolism in women without and with the factor V Leiden mutation who used oral contraceptives were 4.1 (95% confidence interval (CI) 2.1-7.8) and 10.2 (95% CI 1.2-88.4), respectively. The adjusted OR for factor V Leiden carriers was 2.0 (95% CI 1.0-4.4). The OR for women with the factor V Leiden mutation and oral contraceptive use versus no factor V Leiden mutation and no oral contraceptive use was 10.2 (95% CI 3.8-27.6).
The results confirm the increased relative risk of idiopathic venous thromboembolism for users of oral contraceptives and factor V Leiden carriers. However, we suspect that the true risk for women who are factor V Leiden carriers may be increased two- to four-fold rather than seven-fold or more, and that the risk for the combination of factor V Leiden and oral contraceptive use may be increased in the order often- to 15-fold rather than over 30-fold.
一项早期研究引发了对携带凝血因子V莱顿突变的女性使用口服避孕药的重大关注。据报道，静脉血栓栓塞的相对风险增加了30倍以上；对于纯合子，相对风险高达100倍或更高。
通过一项新的基于人群的病例对照研究来重现报告的风险估计值。
连续确定80名诊断为静脉血栓栓塞的女性，并与基于人群的对照组（n = 406）进行比较。通过基因型分析确定凝血因子V莱顿突变。采用条件逻辑回归（按5岁年龄组匹配）进行评估。
使用口服避孕药的无凝血因子V莱顿突变和有凝血因子V莱顿突变的女性特发性静脉血栓栓塞的匹配调整比值比（OR）分别为4.1（95%置信区间（CI）2.1 - 7.8）和10.2（95% CI 1.2 - 88.4）。凝血因子V莱顿携带者的调整OR为2.0（95% CI 1.0 - 4.4）。有凝血因子V莱顿突变且使用口服避孕药的女性与无凝血因子V莱顿突变且未使用口服避孕药的女性相比，OR为10.2（95% CI 3.8 - 27.6）。
结果证实了口服避孕药使用者和凝血因子V莱顿携带者特发性静脉血栓栓塞的相对风险增加。然而，我们怀疑凝血因子V莱顿携带者女性的真实风险可能增加两到四倍，而不是七倍或更多，并且凝血因子V莱顿与口服避孕药联合使用的风险可能增加到十到十五倍，而不是超过30倍。
