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三种三相口服避孕药的临床性能评估:一项多中心随机对照试验。

Evaluation of the clinical performance of three triphasic oral contraceptives: a multicenter, randomized comparative trial.

作者信息

Schilling L H, Bolding O T, Chenault C B, Chong A P, Fleury F, Forrest K, Glick H I, Hasson H M, Heil C G, London R S

机构信息

Student Health Services, California State University, Fresno 93740-0081.

出版信息

Am J Obstet Gynecol. 1989 May;160(5 Pt 2):1264-8. doi: 10.1016/s0002-9378(89)80011-0.

Abstract

Three hundred thirteen women participated in an open, multicenter comparison of the incidence of intermenstrual bleeding (breakthrough bleeding and or spotting) associated with the use of three triphasic oral contraceptives. Triphasil (n = 107), containing levonorgestrel and ethinyl estradiol, and Ortho-Novum 7/7/7 (n = 97) and Tri-Norinyl (n = 109), both of which contain norethindrone and ethinyl estradiol, were administered over four cycles for a total of 1141 cycles. The total incidence of intermenstrual bleeding was significantly lower with Triphasil (17.2%) than with Ortho-Novum 7/7/7 (39.5%) or Tri-Norinyl (49.0%). The pattern remained the same when findings were analyzed cycle by cycle and for breakthrough bleeding and spotting separately. The incidence of other side effects was comparable for all regimens. Results of this study demonstrate superior cycle control with Triphasil compared with Ortho-Novum 7/7/7 and Tri-Norinyl during the first four cycles of use.

摘要

313名女性参与了一项开放性多中心研究,比较了三种三相口服避孕药使用过程中间期出血(突破性出血和/或点滴出血)的发生率。含有左炔诺孕酮和炔雌醇的三相片(Triphasil,n = 107),以及均含有炔诺酮和炔雌醇的 Ortho-Novum 7/7/7(n = 97)和 Tri-Norinyl(n = 109),给药四个周期,共计1141个周期。三相片的间期出血总发生率(17.2%)显著低于 Ortho-Novum 7/7/7(39.5%)或 Tri-Norinyl(49.0%)。逐周期分析结果以及分别分析突破性出血和点滴出血时,该模式保持不变。所有方案的其他副作用发生率相当。本研究结果表明,在使用的前四个周期中,三相片相比 Ortho-Novum 7/7/7 和 Tri-Norinyl 具有更好的周期控制效果。

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