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炔雌醇/去氧孕烯片与复方炔诺酮片的疗效及可接受性双盲比较。

A double-blind comparison of the efficacy and acceptability of Femodene and Microgynon-30.

作者信息

Loudon N B, Kirkman R J, Dewsbury J A

机构信息

Family Planning Clinic, Edinburgh, U.K.

出版信息

Eur J Obstet Gynecol Reprod Biol. 1990 Mar;34(3):257-66. doi: 10.1016/0028-2243(90)90079-g.

Abstract

The efficacy, cycle-control and tolerance of Microgynon-30, a widely prescribed levonorgestrel containing oral contraceptive, and Femodene, a new oral-contraceptive containing gestodene, were compared in a randomised, double-blind study involving 456 healthy women over a 6 month period. 229 women were allocated to receive Femodene and 227 received Microgynon-30. No differences between the groups in terms of obstetric and gynaecological history, previous contraceptive history, smoking habits, blood-pressure or body weight at admission were observed. No pregnancies were reported in either group, despite tablet-taking errors recorded in 6.3% of the Femodene group and 7.6% of the Microgynon-30 group. Both oral contraceptives were compared in terms of cycle length, intensity of the withdrawal bleed and side effects. Cycle-control was similar in the two groups. However, significantly fewer subjects reported breakthrough bleeding (with or without spotting) in the Femodene group (18% of patients) compared with the Microgynon-30 group (26% of patients). The incidence of absent withdrawal bleeds was 1% or less in both groups and no significant effects on body weight or blood pressure were observed.

摘要

在一项为期6个月的随机双盲研究中,对广泛处方的含左炔诺孕酮口服避孕药炔雌醇-30(Microgynon-30)和含孕二烯酮的新型口服避孕药去氧孕烯炔雌醇片(Femodene)的疗效、周期控制和耐受性进行了比较。该研究涉及456名健康女性。229名女性被分配接受去氧孕烯炔雌醇片,227名女性接受炔雌醇-30。两组在产科和妇科病史、既往避孕史、吸烟习惯、入院时血压或体重方面未观察到差异。尽管去氧孕烯炔雌醇片组有6.3%的人以及炔雌醇-30组有7.6%的人记录有服药错误,但两组均未报告怀孕情况。对两种口服避孕药在周期长度、撤退性出血强度和副作用方面进行了比较。两组的周期控制相似。然而,与炔雌醇-30组(26%的患者)相比,去氧孕烯炔雌醇片组报告突破性出血(伴或不伴点滴出血)的受试者明显较少(18%的患者)。两组撤退性出血缺失的发生率均为1%或更低,且未观察到对体重或血压有显著影响。

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