屈螺酮炔雌醇片用于健康育龄女性避孕的临床观察

Clinical Observation of Drospirenone Ethinylestradiol Tablets on Contraception in Health Women of Childbearing Age

目的:观察屈螺酮炔雌醇片(YAZ)用于健康育龄女性避孕的临床效果及安全性。方法:选择要求避孕的健康育龄女性103例口服YAZ(每片含炔雌醇20μg+屈螺酮3 mg)避孕,28 d为1个周期,每名受试者均用药13个周期,采用日记卡的形式每日记录受试者的出血情况、皮肤状况及体质量等的变化情况,根据世界卫生组织推荐的参考期方法评价受试者的出血模式,并于服药后第4、7、10、13个周期进行随访,观察其避孕效果和不良反应发生情况。结果:103例受试者均无避孕失败者。试验期间,受试者发生出血或点滴出血的天数、次数逐渐下降;在第13个周期随访时,与用药前比较,受试者的皮肤改善满意率为94.1%,且与用药前比较,受试者体质量呈下降趋势,平均减少了0.25 kg。共有14例次的受试者发生了包括恶心、慢性咽炎、胆囊息肉在内的各类不良反应,但所有受试者用药前、后心电图检测均未见异常。结论:YAZ有良好的避孕效果,且能有效改善受试者的出血和皮肤状况,并可以减轻受试者的体质量。

OBJECTIVE： To observe the clinical effects and safety of oral contraceptive Drospirenone ethinylestradiol tablet for contraception in healthy women of childbearing age. METHODS： 103 healthy women of childbearing age required for contracep-tion were selected to take contraceptive YAZ （drospirenore 3 mg, ethinyle stradiol 20 μg）orally for 13 cycles. The changes of haem-orrhage, skin and body weight were recorded in diary card; the bleeding patterns of subjects were evaluated according to WHO ref-erence period. Follow-up was taken at 4th, 7th, 10th and 13th cycles after administration; contraceptive effect and ADR were ob- served. RESULTS： Contraceptive failure was not found among 103 subjects; the number of days and times of bleeding and spot bleeding declined gradually during the trial. At the 13th follow-up period, the satisfaction degree of skin condition improvement was 94.1%, compared with before treatment; the body weight of subjects decreased by 0.25 kg in average, compared with before treatment. 14 subjects suffered from various ADR as nausea, chronic pharyngitis and gallbladder polyp, but electrocardiogram change could not be found before and after treatment. CONCLUSIONS： YAZ has a good contraceptive effect, and can effectively improve bleeding, skin condition and reduce body weight.