Koetsawang S, Charoenvisal C, Banharnsupawat L, Singhakovin S, Kaewsuk O, Punnahitanont S
Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Contraception. 1995 Apr;51(4):225-9. doi: 10.1016/0010-7824(95)00037-b.
The efficacy and acceptability of two third generation oral contraceptives in Thai women were evaluated in a prospective, open, group-comparative, randomized, multicenter trial of women asking for contraception. In six Family Planning Centers and Outpatient Gynaecological Clinics in urban areas in Thailand, 783 healthy women who were at risk for pregnancy and did not have contraindications to oral contraceptive use were randomly allocated to one of the two study groups. An oral contraceptive containing 30 mcg ethinylestradiol and 150 mcg desogestrel was given to 394 women and an oral contraceptive with the same amount of ethinylestradiol and 75 mcg gestodene to 389 women during 6 cycles. Criteria of cycle control, side effects and the presence and severity of acne vulgaris were assessed and blood pressure and body weight measured at pretreatment and after cycles 1, 3 and 6. Furthermore, the efficacy was evaluated after the last cycle. No pregnancies occurred with either of the contraceptives. The incidences of irregular bleeding and minor side effects in both groups were very low and decreased after an initial increase in the first cycle. Acne improved in both groups. Blood pressure and body weight remained unchanged. The two oral contraceptives were found to be effective and acceptable in Thai women. Compared to Caucasian women, the incidences of irregular bleeding and side effects were apparently lower in these Asian women. Furthermore, the effects of both oral contraceptives were comparable.
在一项针对寻求避孕的泰国女性进行的前瞻性、开放性、组间比较、随机、多中心试验中,评估了两种第三代口服避孕药的疗效和可接受性。在泰国城市地区的六个计划生育中心和妇科门诊,783名有怀孕风险且无口服避孕药使用禁忌的健康女性被随机分配到两个研究组之一。在6个周期内,给394名女性服用含有30微克炔雌醇和150微克去氧孕烯的口服避孕药,给389名女性服用含有相同剂量炔雌醇和75微克孕二烯酮的口服避孕药。评估周期控制标准、副作用以及寻常痤疮的存在和严重程度,并在治疗前以及第1、3和6周期后测量血压和体重。此外,在最后一个周期后评估疗效。两种避孕药均未发生妊娠。两组的不规则出血和轻微副作用发生率都非常低,且在第一个周期最初增加后有所下降。两组的痤疮都有所改善。血压和体重保持不变。发现这两种口服避孕药对泰国女性有效且可接受。与白人女性相比,这些亚洲女性的不规则出血和副作用发生率明显较低。此外,两种口服避孕药的效果相当。