Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users

Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users
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DOI:
10.1097/01.aog.0000250968.82370.04
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发表时间:
2007-02-01
影响因子:
7.2
通讯作者:
Walker, Alexander M.
Walker, Alexander M.
中科院分区:
医学2区
文献类型:
--
作者:
Cole, J. Alexander;Norman, Heather;Walker, Alexander M.

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目的:估计静脉血栓栓塞症,急性心肌梗死,缺血性中风之间的透皮避孕药系统的用户与用户的诺孕酯含口服避孕药与35微克炔雌醇。方法:我们开始从联合医疗保险索赔数据。我们确定了2002年4月至2004年12月暴露于透皮避孕系统或含诺孕酯的口服避孕药的妇女。根据医疗记录证实了结局。我们计算了发病率和年龄调整的发病率比。在巢式病例对照分析中,我们调查并控制了混杂因素。结果:透皮避孕系统暴露量为49,048女性年,含硝西泮的口服避孕药暴露量为202,344女性年。与含诺孕酯的口服避孕药使用者(37例,18.3/100,000女性-年)相比,透皮避孕系统使用者(20例,40.8/100,000女性-年)的静脉血栓栓塞发生率(发生率比2.2,95%置信区间[CI] 1.3-3.8)增加了2倍以上。3名透皮避孕系统使用者发生急性心肌梗死,而含诺孕酯的口服避孕药使用者中有7人发生急性心肌梗死(发生率比1.8,95%CI 0.5-6-8)。透皮避孕系统使用者中没有发生中风,而含诺孕酯的口服避孕药使用者中有10例发生中风。在巢式病例对照分析中,排除高危因素后,静脉血栓栓塞的优势比为2.4(95%CI 1.1-5.5)。结论:与使用经皮避孕系统相关的静脉血栓栓塞风险增加了2倍以上。急性心肌梗死和中风发生太少,无法确定准确的风险估计。
OBJECTIVE: To estimate the incidence of venous thromboembolism, acute myocardial infarction, and ischemic stroke among transdermal contraceptive system users compared with users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol.METHODS: We began with insurance claims data from United Healthcare. We identified women exposed to the transdermal contraceptive system or norgestimate-containing oral contraceptives from April 2002 through December 2004. Outcomes were confirmed from medical records. We calculated incidence rates and age-adjusted incidence rate ratios. In a nested case-control analysis, we investigated and controlled for confounding.RESULTS: There were 49,048 woman-years of transdermal contraceptive system exposure and 202,344 woman years of norgestimate-containing oral contraceptives exposure. There was a more than'two-fold increase in the venous thromboembolism rate (incidence rate ratio 2.2, 95% confidence interval [CI] 1.3-3.8) among transdermal contraceptive system users (20 cases, 40.8 per 100,000 woman-years) compared with norgestimate-containing oral contraceptives users (37 cases, 18.3 per 100,000 woman-years). Acute myocardial infarction occurred in three transdermal contraceptive system users compared with seven among norgestimate-containing oral contraceptives users (incidence rate ratio 1.8, 95% CI 0.5-6-8). No strokes occurred among transdermal contraceptive system users, whereas 10 occurred among norgestimate-containing oral contraceptives users. In the nested case-control analysis, after exclusions for high-risk factors, the odds ratio for venous thromboembolism was 2.4 (95% CI 1.1-5.5).CONCLUSION: There was a more than two-fold increase in the risk of venous thromboembolism associated with use of the transclermal contraceptive system. Acute myocardial infarction and stroke occurred too rarely to ascertain precise risk estimates.