口服避孕药Mercilon~避孕有效性、安全性和可接受性的多中心临床研究  

An Open-label,Randomized,Comparative,Multi-center Trial on Contraception Efficacy,Safety and Acceptability of Mercilon~

作　　者：于晓兰[1] 郑淑蓉[2] 陈淑玲[2] 范光升[3] 卢青[3] 翁梨驹[4] 经小平[4] 吴尚纯[5] 

机构地区：[1]北京大学第一医院妇产科,100034 [2]北京大学第一医院,100034 [3]北京协和医院 [4]首都医科大学附属北京朝阳医院 [5]国家人口计生委科学技术研究所

出　　处：《中国计划生育学杂志》2008年第6期357-361,共5页Chinese Journal of Family Planning

摘　　要：目的：通过与Minulet的随机对比临床研究评估Mercilon在中国妇女中避孕的有效性、安全性和可接受性。方法：将238例18—40岁有生育能力的健康妇女随机盲法分为Mercilon组（120例），Minulet组（118例）。服药周期为6个月经周期，每个周期28天，并分别在服药周期的第5～6周、13～14周、25～26周随访。测量体重、血压，评价其有效性、周期控制及各种不良事件。结果：两组无一例妊娠，避孕效果满意；Mercilon组停用率是10％，其中4．17％因副反应停用，主要是不规则或点滴出血；Minulet组停用率是11．02％，其中9．32％因副反应停用，主要是恶心、头痛，两组比较差异有统计学意义（P〈0．01）。两组用药前后体重无明显变化，月经量和经期明显减少和缩短。两组副反应发生率无明显差异，Mercilon组41．6％，其中出血和点滴出血占24．2％，为主要副反应；Minulet组44．1％，其主要副反应是恶心（22．03％）、头痛头晕（23．72％）。各种副反应主要发生在用药的第1周期，以后明显减少。结论：Mercilon是一种避孕效果好，安全性和接受性较好的口服避孕药。Objective： To assess the contraception efficacy, safety and acceptability of Mercilon compared to Minulet in women in China by randomized comparative clinical trial. To compare cycle control and tolerability of two oral contraceptives in healthy women in China. Methods： This was an open - label, randomized, group - comparative, muhicenter trial. 238 healthy women aged 18 -40 years were randomized to Mercilon group（120cases） and Minulet group（118cases） who accepted six cycles of treatment, and each cycle was 28 days. Follow - up survey was performed at 5 -6weeks, 13 - 14weeks and 25 -26 weeks. Diary cards were used to monitor compliance, bleeding pattern and subjective side effects. Results： No pregnancies were observed during the study. The discontinuation rate were 10% in Mercilon group and 11.02% in Minulet group due to subjective side effects（4.17% vs 9.3%, respectively）, which showed significandy different（P 〈0. 01 ）. There were no serious adverse events and no significant weight changes were observed in either group. The amount and days of menses were decreased. The side effects of two groups showed no significant difference, which were 41.6% and 44. 1% in Mercilon group and Minulet group, respectively. In Mercilon group, the main side effect was bleeding/spetting which accounted for 24.2%. In Minulet group, the main side effect was nausea （22.03%） and headache/dizziness （23. 72% ）. The side effects were occurred at the first week of treatment and decreased afterword. Conclusion： Mercilon is an oral contraceptive that reliable and well tolerated in Chinese women.

关 键 词：Mercilon 敏定偶 临床研究 口服避孕药 

分 类 号：R169.4[医药卫生—公共卫生与预防医学]