屈螺酮炔雌醇片用于中国妇女避孕的多中心临床研究

摘要

Objective To assess the efficacy,bleeding pattern,cycle control and safety of a combined oral contraceptive (YAZ) containing drospirenone 3 mg and ethinylestradiol 20 μg in a 24 + 4-day regimen in China.Methods This is a multi-center,open,one-label study.Healthy females aged 18-45 years received YAZ for 13 cycles.Following-ups were scheduled during the treatment phase on Day 12-19 of Cycle 1,4,7 and 10 and 10-17 days after completing the study.The efficacy variables were the number of unintended pregnancies,bleeding pattern and cycle control.The safety variables were adverse events (AE),lab examinations,physical and gynecological examinations,vital signs and body weights and questionnaires.Results Four pregnancies occurred among 675 women for 603.78 women-years,resulting in a Pearl index (PI) of 0.7 and adjusted PI of 0.6.The cumulative 1-year pregnancy rate was 0.66％.The mean number of bleeding/spotting days was (26.3 ± 12.4) days in reference period 1 and (15.4-± 5.5) days in reference period 4.94.2％ (582/618)-96.8％ (538/558) subjects experienced scheduled bleeding.The mean duration of scheduled bleeding decreased from (5.9-± 3.2) to (5.0 ± 1.6) days.The percentage of women with intermenstrual bleeding decreased from 14.5％ (90/621) at Cycle 1 to 2.3％ (13/558) at Cycle 12.The common AE relating treatment include nausea (3.4％,23/675),breast tenderness (1.2％,8/675),dizzy (1.2％),vagina bleeding (1.2％).No serious AE relating treatment occurred.85.6％ (542/633) subjects were satisfied or very satisfied with the study treatment.Conclusion YAZ is highly effective,acceptable and safe for Chinese women.%目的 评估屈螺酮炔雌醇片(其他名称:优思悦,简称:YAZ)24 +4给药模式用于中国健康育龄期妇女的避孕效果、出血模式、月经周期控制和安全性.方法 本研究为多中心、开放、单组临床试验,2008年12月至2011年1月共675例18 ～45岁要求避孕的健康妇女服用YAZ 13个周期,在服药第1、4、7、10周期及第13周期后进行随访.观察意外妊娠数、周期控制、出血模式及安全性,以Pearl指数(PI)评价避孕的有效性;同时在服药前和服药第13周期后完成评估生理和心理健康状况以及满意度的评价问卷.结果 YAZ 24+4给药模式用于中国健康育龄期妇女的PI为0.7/百妇女年,校正后PI为0.6/百妇女年.出血模式按WHO推荐的90 d为1个参考期评估,出血/点滴出血平均天数随服药时间的延长逐渐下降,从第1参考期的(26.3±12.4)d下降至第4参考期的(15.4±5.5)d;发生经间期出血的受试者比例从第1周期的14.5％ (90/621)下降至第12周期的2.3％(13/558).周期控制良好,从服药第2周期至第12周期,撤退性出血的发生率为94.2％(582/618)至96.4％ (538/558),≥94.0％的撤退性出血为正常出血、少量出血和点滴出血,撤退性出血的平均持续时间从第2周期(5.9±3.2)d至第12周期(5.0±1.6)d.发生与研究药物有关的不良事件89例,主要为恶心、乳房触痛、头晕、阴道出血.＞94.8％的受试者服用YAZ后对生理和心理的健康无影响或有改善,85.6％ (542/633)的受试者表示对YAZ非常满意或满意.结论 YAZ有良好的避孕效果,出血模式接近于正常周期,周期控制良好,对生理和心理健康有利,受试者满意度高.