Carlborg L
Contraception. 1983 May;27(5):439-52. doi: 10.1016/0010-7824(83)90041-0.
In a Swedish multicenter study, a total number of 835 women completed a total of 6472 treatment cycles. Half of them were allotted at random to use the monophasic oral contraceptive Neovletta, also known as Microgynon 30 (30 micrograms ethinyl oestradiol + 150 micrograms levonorgestrel in each tablet). The second half was allotted to Trionetta, also known as Triquilar, Trigynon and Logynon (6 tablets with 30 micrograms ethinyl oestradiol + 50 micrograms levonorgestrel, 5 tablets with 40 micrograms ethinyl oestradiol + 75 micrograms levonorgestrel and 10 tablets with 30 micrograms ethinyl oestradiol + 125 micrograms levonorgestrel). The latter version was also present in a 28-day version containing in addition 7 "placebo" tablets to be used in the otherwise tablet-free interval. The contraceptive reliability was excellent although one pregnancy occurred in the three-phase version. It could be attributed to patient failure. In all aspects of bleeding control, the three-phasic pill proved to be superior to the reference monophasic preparation. The extreme low incidence of missed withdrawal bleeding and stability already during the first months of use are noteworthy features. For both preparations, continuation rate was at six months of use about 85% and at 12 months it was a similar figure. The most common reason for withdrawal was bleeding, about 5% each for both preparation. No serious side-effects were reported. The study clearly indicates that the three-phasic version is a major improvement in spite of a considerably decreased total dose of the gestagen.
在一项瑞典多中心研究中,共有835名女性完成了总计6472个治疗周期。其中一半被随机分配使用单相口服避孕药Neovletta,也称为Microgynon 30(每片含30微克炔雌醇+150微克左炔诺孕酮)。另一半被分配使用Trionetta,也称为Triquilar、Trigynon和Logynon(6片含30微克炔雌醇+50微克左炔诺孕酮,5片含40微克炔雌醇+75微克左炔诺孕酮,10片含30微克炔雌醇+125微克左炔诺孕酮)。后一种版本还有28天的剂型,在原本无药的间隔期还额外含有7片“安慰剂”片。尽管三相剂型发生了1例妊娠,但避孕可靠性极佳。这可能归因于患者使用不当。在出血控制的各个方面,三相片均被证明优于对照单相制剂。值得注意的是,漏服撤退性出血的发生率极低,且在使用的头几个月就已表现出稳定性。两种制剂在使用6个月时的持续使用率约为85%,12个月时的数字相近。停药的最常见原因是出血,两种制剂的停药率均约为5%。未报告严重副作用。该研究清楚地表明,尽管孕激素的总剂量大幅降低,但三相剂型仍是一项重大改进。