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德国妇科诊所中激素避孕药使用者的静脉血栓形成风险:一项患者数据库分析。

Risk of venous thrombosis in users of hormonal contraceptives in German gynaecological practices: a patient database analysis.

作者信息

Ziller M, Ziller V, Haas G, Rex J, Kostev K

机构信息

Department of Gynecological Endocrinology, Reproductive Medicine and Osteoporosis, Philipps-University of Marburg, Marburg, Germany.

出版信息

Arch Gynecol Obstet. 2014 Feb;289(2):413-9. doi: 10.1007/s00404-013-2983-9. Epub 2013 Aug 4.

DOI:10.1007/s00404-013-2983-9
PMID:23912534
Abstract

PURPOSE

Recent studies showed differences in the risk of venous thrombosis between different combined hormonal contraceptives. Database studies comprising large cohorts can add relevant aspects from daily clinical practice. The purpose of this study was to evaluate different progestogen in combination with ethinylestradiol on the risk of venous thrombosis in Germany.

METHODS

Computerized data from 68,168 contraceptive users in gynecological practices throughout Germany (Disease Analyzer Database) were analyzed. The adjusted odds ratios for risk of thrombosis were estimated in users of different oral contraceptive (OC) formulations relative to users of levonorgestrel-containing preparations.

RESULTS

In total, 38 (0.06 %) of the 68,168 contraceptive users had a recorded diagnosis of thrombosis within 365 days after the initial prescription. The adjusted risk was 1.95 for desogestrel (95 % CI 0.52-7.29), 2.97 for dienogest (95 % CI 0.96-9.24), 1.57 for drospirenone (95 % CI 0.46-5.38), 2.54 for chlormadinone (95 % CI 0.72-9.04), and 3.24 for norgestimate (95 % CI 0.59-17.75) compared to levonorgestrel. None of those findings reached statistical significance. The maximum absolute increase versus levonorgestrel was 6 cases per 10,000 women (n.s.).

CONCLUSION

The study shows the low incidence rates of thrombosis in OC users. Since there is no significant difference, this study does not confirm an increased risk but shows only a tendency for this risk of third- and fourth-generation OC versus levonorgestrel-containing products.

摘要

目的

近期研究表明不同复方激素避孕药的静脉血栓形成风险存在差异。包含大量队列的数据库研究能够补充日常临床实践中的相关方面。本研究的目的是评估在德国不同孕激素与炔雌醇联合使用对静脉血栓形成风险的影响。

方法

分析了来自德国各地妇科诊所68168名避孕药使用者的计算机化数据(疾病分析器数据库)。相对于含左炔诺孕酮制剂的使用者,估算了不同口服避孕药(OC)制剂使用者血栓形成风险的调整比值比。

结果

在68168名避孕药使用者中,共有38人(0.06%)在首次开处方后365天内有血栓形成的记录诊断。与左炔诺孕酮相比,去氧孕烯的调整风险为1.95(95%可信区间0.52 - 7.29),地诺孕素为2.97(95%可信区间0.96 - 9.24),屈螺酮为1.57(95%可信区间0.46 - 5.38),氯地孕酮为2.54(95%可信区间0.72 - 9.04),诺孕酯为3.24(95%可信区间0.59 - 17.75)。这些结果均未达到统计学显著性。与左炔诺孕酮相比,最大绝对增加数为每10000名女性6例(无统计学意义)。

结论

该研究显示口服避孕药使用者中血栓形成的发生率较低。由于没有显著差异,本研究未证实风险增加,仅显示了第三代和第四代口服避孕药相对于含左炔诺孕酮产品的这种风险有增加的趋势。

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