Maiorana A, Incandela Domenico, Parazzini F, Alio W, Mercurio A, Giambanco L, Alio L
Department of Obstetrics and Gynecology, A.R.N.A.S. Civico Hospital, Piazza Nicola Leotta 4, 90127, Palermo, Italy.
Dipartimento Materno Infantile Clinica Ostetrico Ginecologica, Università di Milano, Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico, Via Commenda 12, 20122, Milan, Italy.
Arch Gynecol Obstet. 2017 Sep;296(3):429-433. doi: 10.1007/s00404-017-4442-5. Epub 2017 Jun 29.
Dienogest has recently been marketed as a medical treatment for endometriosis. Given the recent introduction on the market of Dienogest, little data are available regarding its effectiveness in routine clinical practice.
The study is an observational, single-center, cohort study. Eligible was women with a surgical diagnosis of endometriosis dating back <24 months or a clinical/instrumental diagnosis of endometriosis and endometriosis-associated pelvic pain score of at least 40 mm on a 100-mm visual analog scale (VAS) at start of treatment and who had been taking Dienogest 2 mg once daily treatment at the time of study entry for no more than 30 days, consecutively observed between September 2013 to September 2014. In accordance with routine practice, women came back for clinical assessment and evaluation of pain after 1 (V1), 3 (V2), and 12 (V3) months.
A total of 132 women were enrolled in the study. A total of 21 of the enrolled patients were released from the study during follow-up due to adverse effects. The mean pelvic pain VAS score at baseline was 8.9 (SD 1.3). The corresponding values were 6.7 (SD 3.2) and 5.7 (SD 3.7) for dyspareunia and dyschezia. The mean VAS scores progressively and significantly decreased to 0.9 (SD 1.6) for pelvic pain, 1.4 (SD 2.1) for dyspareunia and 0.2 (SD 0.9) for dyschezia, respectively, 12 months after start of treatment.
This study confirms that in routine clinical practice, Dienogest 2 mg is an effective and well-tolerated treatment for endometriosis-related pain in women with endometriosis.
地诺孕素最近作为一种治疗子宫内膜异位症的药物上市。鉴于地诺孕素最近刚投放市场，关于其在常规临床实践中的有效性的数据很少。
本研究是一项观察性、单中心队列研究。符合条件的是手术诊断为子宫内膜异位症且病程小于24个月的女性，或临床/器械诊断为子宫内膜异位症且在治疗开始时子宫内膜异位症相关盆腔疼痛评分在100毫米视觉模拟量表（VAS）上至少为40毫米，且在研究入组时连续服用地诺孕素2毫克每日一次治疗不超过30天的女性，于2013年9月至2014年9月期间进行连续观察。按照常规做法，女性在1个月（V1）、3个月（V2）和12个月（V3）后回来进行临床评估和疼痛评估。
共有132名女性纳入研究。共有21名入组患者在随访期间因不良反应退出研究。基线时盆腔疼痛VAS平均评分为8.9（标准差1.3）。性交困难和排便困难的相应值分别为6.7（标准差3.2）和5.7（标准差3.7）。治疗开始12个月后，盆腔疼痛、性交困难和排便困难的VAS平均评分分别逐渐显著降至0.9（标准差1.6）、1.4（标准差2.1）和0.2（标准差0.9）。
本研究证实，在常规临床实践中，2毫克地诺孕素是治疗子宫内膜异位症女性子宫内膜异位症相关疼痛的一种有效且耐受性良好的治疗方法。
