Osuga Yutaka, Watanabe Manabu, Hagino Atsushi
Department of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
Clinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.
J Obstet Gynaecol Res. 2017 Sep;43(9):1441-1448. doi: 10.1111/jog.13406. Epub 2017 Jul 24.
We aimed to investigate the safety and efficacy of dienogest (DNG), a progestational 19-norsteroid, administered for 52 weeks in patients with symptomatic adenomyosis.
A total of 130 patients with adenomyosis received 2 mg of DNG orally each day for 52 weeks. In cases of complicated anemia, patients were treated for anemia prior to receiving the medication. Adverse events and adverse drug reactions were evaluated. The patients' pain symptoms (dysmenorrhea and pelvic pain from adenomyosis) were assessed using a pain-scoring tool. This was a verbal rating scale comprising a 0-3-point pain-severity score measuring disability to work, and an analgesics-usage score measuring need for analgesics.
The most common adverse drug reactions included metrorrhagia (96.9%) and hot flush (7.7%). However, in most cases, metrorrhagia was tolerable and no clinically significant changes were observed concerning the incidence or severity of reactions during the 52-week treatment period. There were no serious adverse events. Both the pain-severity score and analgesics-usage score decreased after the start of treatment with DNG. The mean ± standard deviation changes from baseline for the pain score were -3.4 ± 1.8 at 24 weeks and -3.8 ± 1.5 at 52 weeks, respectively.
The long-term use of DNG was well-tolerated and effective in patients with symptomatic adenomyosis.
我们旨在研究孕激素19-去甲甾体地诺孕素（DNG）对有症状的子宫腺肌病患者进行52周治疗的安全性和有效性。
总共130例子宫腺肌病患者每天口服2mg DNG，持续52周。对于合并贫血的患者，在接受药物治疗前先治疗贫血。评估不良事件和药物不良反应。使用疼痛评分工具评估患者的疼痛症状（痛经和子宫腺肌病引起的盆腔疼痛）。这是一种言语评定量表，包括一个衡量工作能力丧失的0-3分疼痛严重程度评分和一个衡量镇痛药使用需求的镇痛药使用评分。
最常见的药物不良反应包括子宫出血（96.9%）和潮热（7.7%）。然而，在大多数情况下，子宫出血是可以耐受的，并且在52周的治疗期间，反应的发生率或严重程度没有观察到临床上的显著变化。没有严重不良事件。开始使用DNG治疗后，疼痛严重程度评分和镇痛药使用评分均下降。疼痛评分相对于基线的平均±标准差变化在24周时为-3.4±1.8，在52周时为-3.8±1.5。
地诺孕素的长期使用在有症状的子宫腺肌病患者中耐受性良好且有效。
