Lewis M A, Heinemann L A, Spitzer W O, MacRae K D, Bruppacher R
Department of Epidemiology and Biostatistics, McGill University, Montréal, Québec, Canada.
Contraception. 1997 Sep;56(3):129-40. doi: 10.1016/s0010-7824(97)00118-2.
The objective of this study was to assess the risk of myocardial infarction (MI) associated with the use of new and old combination oral contraceptives (OC). A matched case-control study in 16 centers in Germany, the United Kingdom, France, Austria, and Switzerland explored the association of current use of combination OC with the occurrence of MI. Our subjects were 182 women aged 16-44 years with MI; the controls were 635 women without MI (at least one hospital control and one community control per case) matched for 5-year age group and region. The main outcome measures were odds ratios comparing current use of a specific group of OC against current use of other groups or against no current use. The adjusted overall odds ratio (OR; 95% confidence intervals) for MI for second generation OC versus no current use was 2.35 (1.42 to 3.89) and 0.82 (0.29 to 2.31) for third generation OC (low dose ethinyl estradiol, gestodene, and desogestrel). A direct comparison of third generation users with second generation users yielded an OR of 0.28 (0.09 to 0.86). In subgroup analyses, the odds ratio for the UK alone was 1.25 (0.36 to 4.29), while for continental Europe it was 0.10 (0.02 to 0.48). For hospital controls, the risk estimated was 0.98 (0.22 to 4.44), and 0.18 (0.04 to 0.65) for community controls. The independent risk of MI among current smokers adjusted for OC use was 7.21 (4.58 to 11.36). Among users of third generation OC, the OR for current smokers was 3.75 (0.65 to 21.74) and among users of second generation it was 9.50 (2.93 to 30.96). A comparison of OC use in the UK for the time before and after regulatory action was taken in October 1995 shows that the likelihood of a control (last control accrued June 1996) being treated with second generation OC is seven times higher after 1 November 1995 than it was before. Third generation OC are the first to be associated with no excess risk of MI. A significantly lower risk of MI is found when comparing use of third generation OC with use of second generation OC. There seems to be an impressive amelioration of risk among smokers using newer OC. An impact of regulatory action in the UK was found in the OC use spectrum of controls.
本研究的目的是评估使用新型和老式复方口服避孕药(OC)与心肌梗死(MI)风险之间的关联。在德国、英国、法国、奥地利和瑞士的16个中心开展的一项匹配病例对照研究,探讨了当前使用复方OC与MI发生之间的关联。我们的研究对象为182名年龄在16 - 44岁之间的MI女性;对照组为635名无MI的女性(每个病例至少有一名医院对照和一名社区对照),按5岁年龄组和地区进行匹配。主要结局指标是将特定组OC的当前使用者与其他组的当前使用者或未当前使用者进行比较的优势比。第二代OC与未当前使用者相比,MI的调整后总体优势比(OR;95%置信区间)为2.35(1.42至3.89),第三代OC(低剂量炔雌醇、孕二烯酮和去氧孕烯)为0.82(0.29至2.31)。第三代使用者与第二代使用者的直接比较得出OR为0.28(0.09至0.86)。在亚组分析中,仅英国的优势比为1.25(0.36至4.29),而欧洲大陆为0.10(0.02至0.48)。对于医院对照,估计风险为0.98(0.22至4.44),对于社区对照为0.18(0.04至0.65)。经OC使用调整后,当前吸烟者中MI的独立风险为7.21(4.58至11.36)。在第三代OC使用者中,当前吸烟者的OR为3.75(0.65至21.74),在第二代使用者中为9.50(2.93至30.96)。对1995年10月采取监管行动前后英国OC使用情况的比较表明,1995年11月1日之后,一名对照(最后一名对照于1996年6月纳入)接受第二代OC治疗的可能性比之前高7倍。第三代OC是首个与MI无额外风险相关的药物。将第三代OC的使用与第二代OC的使用进行比较时,发现MI风险显著降低。使用新型OC的吸烟者的风险似乎有明显改善。在对照的OC使用谱中发现了英国监管行动的影响。