Jick H, Kaye J A, Vasilakis-Scaramozza C, Jick S S
Boston Collaborative Drug Surveillance Program, Boston University School of Medicine, Lexington, MA 02421, USA.
BMJ. 2000 Nov 11;321(7270):1190-5. doi: 10.1136/bmj.321.7270.1190.
To compare the risk of idiopathic venous thromboembolism among women taking third generation oral contraceptives (with gestodene or desogestrel) with that among women taking oral contraceptives with levonorgestrel.
Cohort and case-control analyses derived from the General Practice Research Database.
UK general practices, January 1993 to December 1999.
Women aged 15-39 taking third generation oral contraceptives or oral contraceptives with levonorgestrel.
Relative incidence (cohort study) and odds ratios (case-control study) as measures of the relative risk of venous thromboembolism.
The adjusted estimates of relative risk for venous thromboembolism associated with third generation oral contraceptives compared with oral contraceptives with levonorgestrel was 1.9 (95% confidence interval 1.3 to 2.8) in the cohort analysis and 2.3 (1.3 to 3.9) in the case-control study. The estimates for the two types of oral contraceptives were similar before and after the warning issued by the Committee on Safety of Medicines in October 1995. A shift away from the use of third generation oral contraceptives after the scare was more pronounced among younger women (who have a lower risk of venous thromboembolism) than among older women. Fewer cases of venous thromboembolism occurred in 1996 and later than would have been expected if the use of oral contraceptives had remained unchanged.
These findings are consistent with previously reported studies, which found that compared with oral contraceptives with levonorgestrel, third generation oral contraceptives are associated with around twice the risk of venous thromboembolism.
比较服用第三代口服避孕药(含孕二烯酮或去氧孕烯)的女性与服用含左炔诺孕酮口服避孕药的女性发生特发性静脉血栓栓塞的风险。
基于全科医疗研究数据库进行队列分析和病例对照分析。
英国全科医疗,1993年1月至1999年12月。
年龄在15 - 39岁、服用第三代口服避孕药或含左炔诺孕酮口服避孕药的女性。
相对发病率(队列研究)和比值比(病例对照研究),作为静脉血栓栓塞相对风险的衡量指标。
在队列分析中,与含左炔诺孕酮口服避孕药相比,第三代口服避孕药相关的静脉血栓栓塞相对风险的校正估计值为1.9(95%置信区间1.3至2.8);在病例对照研究中为2.3(1.3至3.9)。1995年10月药品安全委员会发出警告前后,两种口服避孕药的估计值相似。恐慌后,年轻女性(静脉血栓栓塞风险较低)比年长女性更明显地减少了第三代口服避孕药的使用。1996年及以后发生的静脉血栓栓塞病例比在口服避孕药使用情况不变时预期的要少。
这些发现与先前报道的研究一致,即与含左炔诺孕酮口服避孕药相比,第三代口服避孕药使静脉血栓栓塞风险增加约两倍。