新型口服避孕药屈螺酮炔雌醇片的多中心随机对照临床观察

目的 观察屈螺酮炔雌醇片(商品名:优思明)用于健康育龄期妇女的避孕效果、出血模式、副作用及避孕以外的其他作用.方法 采用多中心随机对照的研究方法对768例要求避孕的健康育龄期妇女,以3:1的比例随机分配到屈螺酮组(服用屈螺酮炔雌醇片,573例)和去氧孕烯组(服用去氧孕烯-炔雌醇,195例),均服药13个周期,在服药后的第4、7、10和13个周期进行随访,观察身高、体重、月经情况等.在服药前和服药后第7、13个周期完成月经不适问卷(MDQ).结果 屈螺酮组的方法失败率(Pearl指数)为0.208/百妇女年,优于去氧孕烯组的0.601/百妇女年.两组受试者的出血模式相似,发生出血和(或)点滴出血、仅有点滴出血的天数、次数及每次出血最长时间在各个参考时相基本相似.第7个周期与服药前比较,两组受试者用药后在经期水潴留和食欲增加方面的MDQ量表评分变化、月经间期水潴留和身心健康感方面的MDQ量表评分变化,屈螺酮组(分别为-0.297、-0.057、0.033、0.150分)较去氧孕烯组(分别为-0.108、0.023、0.231、-0.023分)改善明显,两组分别比较,差异均有统计学意义(P<0.05).在皮肤异常方面,第13个周期月经前期时,屈螺酮组的改善率(18.0%,89/494)较去氧孕烯组(11.3%,19/168)明显增高,两组比较,差异有统计学意义(P<0.05);在乳房疼痛或触痛方面,在第7个周期经期时,屈螺酮组改善率(12.6%,62/494)较去氧孕烯组(5.4%,9/168)明显增高,两组比较,差异也有统计学意义(P<0.05).屈螺酮组妇女的体重呈下降趋势,去氧孕烯组反之;在第13个周期随访时,两组体重的变化(与服药前比较)分别为-0.28、0.57 kg,两组比较,差异有统计学意义(P<0.01).结论 屈螺酮炔雌醇片和去氧孕烯.炔雌醇均具有良好的避孕效果,出血模式相似,而在体重变化、经前期症状改善等方面,屈螺酮炔雌醇片优于去氧孕烯.炔雌醇.

Efficacy and safety of drospirenone-ethinylestradiol on contraception in healthy Chinese women: a multicenter randomized controlled trial

Objective To evaluate the contraception efficacy, mode of bleeding, side effects and other positive effects of drospirenone-ethinylestradiol (Yasmin) in healthy Chinese women. Methods This was a multicenter, randomized, control study of 768 healthy Chinese women who consulted about contraception. The subjects were randomized into Yasmin group (30 μg ethinylestradiol plus 3 mg drospirenone, 573 cases) or desogestrel group (30 μg ethinylestradiol plus 150 μg desogestrel, 195 cases) with the ratio of 3: 1. Each individual was treated for 13 cycles. Further visits were required at cycle 4, cycle 7, cycle 10 and cycle 13 of treatment. Weight, height, body mass index were evaluated at each visit. The menstrual distress questionnaire (MDQ) was given to the women at baseline, visit 3 (cycle 7) and visit 5 (after cycle 13). Results The values of basal features were similar between two groups (P> 0.05). The Pearl index (method failure) of Yasmin was 0. 208/hundred women year which was lower than that of desogestrel (0. 601/hundred women year). The mode of bleeding was similar between two groups after trial without showing any significant difference. According to MDQ subscale, the improvement of water retention and increasing appetite during inter-menstrual period and water retention and general well-being during menstrual period in the Yasmin group ( -0. 297, -0. 057, 0. 033, 0. 150 respectively) was more obvious than that in the desogestrel group ( - 0. 108, 0. 023, 0. 231, - 0. 023 respectively) with a significant difference (P < 0. 05 ). Some other values which improved in beth two groups, especially the improvement of breast tenderness and pain and skin abnormality in Yasmin group (18.0%, 89/494; 12. 6%, 62/494) was more distinct than that in desogestrel group (11.3%, 19/168; 5.4%, 9/168). The mean weight increased in desogestrel group (0. 57 kg) while it decreased in Yasmin group ( -0. 28 kg) with a significant difference (P < 0. 01 ). Conclusions Both Yasmin and desogestrel have good efficacy on contraception and similar modes of menstrual bleeding. Yasmin is better than desogestrel in terms of weight control and premenstrual syndrome of oral contraceptive.