Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10.
Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10.
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DOI：
10.1136/bmj.e2990
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发表时间：
2012-05-10
期刊：
影响因子：
--
通讯作者：
Løkkegaard E
中科院分区：
文献类型：
--
作者：
Lidegaard O;Nielsen LH;Skovlund CW;Løkkegaard E
目的评价非口服激素避孕药使用者静脉血栓形成的危险性。设计基于国家历史登记的队列研究。设置丹麦的四个国家登记处。所有年龄在15-49岁的丹麦非孕妇（n=1 626 158），既往无血栓性疾病或癌症，从2001年到2010年随访。主要观察指标：经皮、阴道、宫内或皮下激素避孕使用者静脉血栓形成的发生率，静脉血栓形成的相对危险性，与非使用者相比，目前使用非口服产品的使用者静脉血栓形成的比率与标准参考口服避孕药左炔诺孕酮和30-40µg雌激素的比率。诊断后至少四周的抗凝治疗证实了诊断。结果在9429128名女性的观察年中，记录了5287例首次静脉血栓形成事件，其中3434例确诊。在未使用激素避孕的人群中，确诊事件的发生率为每1万名妇女年2.1例。与非激素避孕者相比，经年龄、日历年和教育程度调整后，经皮联合避孕贴片使用者确诊静脉血栓形成的相对风险为7.9(95%可信区间为3.5 ~ 17.7)，阴道环使用者确诊静脉血栓形成的相对风险为6.5（95%可信区间为4.7 ~ 8.9）。每1万暴露年相应的发病率分别为9.7和7.8例。使用皮下植入物的妇女的相对风险增加（1.4,0.6至3.4），但使用左炔诺孕酮宫内系统的妇女的相对风险没有增加（0.6,0.4至0.8）。与含左炔诺孕酮的联合口服避孕药使用者相比，透皮贴片使用者的静脉血栓形成校正相对危险度为2.3(1.0 ~ 5.2)，阴道环使用者的静脉血栓形成校正相对危险度为1.9（1.3 ~ 2.7）。结论：使用透皮贴剂或阴道环避孕的女性与未使用激素避孕的同龄女性相比，确诊静脉血栓形成的风险增加7.9倍和6.5倍，对应于每10,000暴露年9.7和7.8事件。使用皮下植入物的妇女的风险略有增加，但使用左炔诺孕酮宫内系统的妇女的风险没有增加。
Objective To assess the risk of venous thrombosis in current users of non-oral hormonal contraception. Design Historical national registry based cohort study. Setting Four national registries in Denmark. Participants All Danish non-pregnant women aged 15-49 (n=1 626 158), free of previous thrombotic disease or cancer, were followed from 2001 to 2010. Main outcome measures Incidence rate of venous thrombosis in users of transdermal, vaginal, intrauterine, or subcutaneous hormonal contraception, relative risk of venous thrombosis compared with non-users, and rate ratios of venous thrombosis in current users of non-oral products compared with the standard reference oral contraceptive with levonorgestrel and 30-40 µg oestrogen. Diagnoses were confirmed by at least four weeks of anticoagulation therapy after the diagnosis. Results Within 9 429 128 woman years of observation, 5287 first ever venous thrombosis events were recorded, of which 3434 were confirmed. In non-users of hormonal contraception the incidence rate of confirmed events was 2.1 per 10 000 woman years. Compared with non-users of hormonal contraception, and after adjustment for age, calendar year, and education, the relative risk of confirmed venous thrombosis in users of transdermal combined contraceptive patches was 7.9 (95% confidence interval 3.5 to 17.7) and of the vaginal ring was 6.5 (4.7 to 8.9). The corresponding incidences per 10 000 exposure years were 9.7 and 7.8 events. The relative risk was increased in women who used subcutaneous implants (1.4, 0.6 to 3.4) but not in those who used the levonorgestrel intrauterine system (0.6, 0.4 to 0.8). Compared with users of combined oral contraceptives containing levonorgestrel, the adjusted relative risk of venous thrombosis in users of transdermal patches was 2.3 (1.0 to 5.2) and of the vaginal ring was 1.9 (1.3 to 2.7). Conclusion Women who use transdermal patches or vaginal rings for contraception have a 7.9 and 6.5 times increased risk of confirmed venous thrombosis compared with non-users of hormonal contraception of the same age, corresponding to 9.7 and 7.8 events per 10 000 exposure years. The risk was slightly increased in women using subcutaneous implants but not in those using the levonorgestrel intrauterine system.
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14.6
作者：
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