Department of Gynecological Endocrinology and Reproductive Medicine, University of Heidelberg, Vossstrasse 9, 69115 Heidelberg, Germany.
Int J Gynaecol Obstet. 2012 Jun;117(3):228-33. doi: 10.1016/j.ijgo.2012.01.009. Epub 2012 Mar 27.
To analyze the secondary efficacy and safety outcomes from a recent trial comparing dienogest (DNG) with leuprolide acetate (LA) in women with endometriosis.
A 24-week, open-label, randomized, multicenter study of DNG versus LA in women with endometriosis-related pain was assessed for outcomes such as responder rates (using predefined thresholds of pain relief), changes in single symptoms/signs and sum scores from the Biberoglu and Behrman (B&B) scale, clinical laboratory parameters, and measures of quality of life.
Dienogest was non-inferior to LA for treatment response using all predefined thresholds of pain relief and provided equivalent improvements in B&B symptoms and signs. No clinically relevant changes in laboratory parameters were observed during DNG treatment, whereas estrogen levels decreased in the LA group. Compared with LA, DNG was associated with pronounced improvements in specific quality-of-life measures.
The analyses provide supportive evidence that the efficacy of DNG is equivalent to that of LA for treating endometriosis symptoms, with specific quality-of-life benefits and a favorable safety profile.
分析最近一项比较地诺孕素（DNG）与醋酸亮丙瑞林（LA）治疗子宫内膜异位症女性的次要疗效和安全性结局。
对一项为期 24 周、开放性、随机、多中心的 DNG 与 LA 治疗子宫内膜异位症相关疼痛的研究进行评估，评估的结局包括应答率（使用预先定义的疼痛缓解阈值）、Biberoglu 和 Behrman（B&B）量表的单个症状/体征和总分的变化、临床实验室参数以及生活质量的衡量标准。
DNG 在使用所有预先定义的疼痛缓解阈值时对治疗反应均不劣于 LA，并且在 B&B 症状和体征方面提供了等效的改善。在 DNG 治疗期间未观察到实验室参数的临床相关变化，而 LA 组的雌激素水平下降。与 LA 相比，DNG 与特定生活质量衡量标准的显著改善相关。
这些分析提供了支持性证据，表明 DNG 的疗效与 LA 相当，可用于治疗子宫内膜异位症症状，具有特定的生活质量获益和有利的安全性特征。
