Medical Department, Grünenthal GmbH, 52099 Aachen, Germany.
Contraception. 2010 Jan;81(1):49-56. doi: 10.1016/j.contraception.2009.06.011.
This study investigated the effects of the low-dose combined oral contraceptive (COC) 2.0 mg chlormadinone acetate (CMA)/0.03 mg ethinylestradiol (EE) (Belara, Balanca) on cycle-related physical and emotional disorders in women >or=25 years of age.
A prospective, non-interventional, observational study of 3772 women over six cycles was conducted in 303 office-based gynecological centers throughout Germany.
CMA/EE provided high contraceptive efficacy with a Pearl index of 0 (95% confidence interval=0.00-0.22) and was generally well tolerated, with no statistically significant weight changes during the observation period (p=.147). CMA/EE intake resulted in a statistically significant improvement in cycle-related physical and emotional symptoms, with a 67% overall reduction in sum score for number and intensity of cycle-related symptoms per patient.
The results of this study in women >or=25 years of age support previous findings that 2.0 mg CMA/0.03 mg EE is an effective low-dose COC, with an excellent tolerability profile, with the additional benefits of significantly reducing both cycle-related physical and emotional symptoms (p<or=.001); women with the respective preexisting symptoms may, therefore, benefit from CMA/EE contraceptive treatment. Further research is warranted.
本研究旨在调查低剂量复方口服避孕药（COC）2.0 毫克氯地孕酮（CMA）/0.03 毫克炔雌醇（EE）（Belara，Balanca）对>或=25 岁女性与月经周期相关的躯体和情绪障碍的影响。
一项针对 3772 名女性的前瞻性、非干预性、观察性研究，在德国 303 个以办公室为基础的妇科中心进行了 6 个周期的随访。
CMA/EE 具有较高的避孕效果，Pearl 指数为 0（95%置信区间为 0.00-0.22），且一般耐受性良好，观察期间体重无统计学显著变化（p=.147）。CMA/EE 摄入可显著改善与月经周期相关的躯体和情绪症状，患者的月经周期相关症状的数量和强度总分降低了 67%。
这项在>或=25 岁女性中的研究结果支持了先前的发现，即 2.0 毫克 CMA/0.03 毫克 EE 是一种有效的低剂量 COC，具有良好的耐受性，并且还能显著减轻与月经周期相关的躯体和情绪症状（p<或=.001）；因此，有相应既往症状的女性可能会从 CMA/EE 避孕治疗中获益。需要进一步的研究。
