Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.
Int J Gynaecol Obstet. 2021 Aug;154(2):263-269. doi: 10.1002/ijgo.13600. Epub 2021 Feb 11.
To compare the efficacy and safety of dienogest with combined oral contraceptives (COCs) for treating adenomyosis-associated symptoms.
This was a randomized clinical trial including women with symptomatic adenomyosis conducted from March 1, 2019 to August 1, 2020 at Assiut Woman's Health Hospital, Egypt. Participants were randomly assigned to the dienogest group or COCs group. The primary outcome was the level of adenomyosis-associated pain from before to 6 months after treatment measured by a visual analog scale (VAS). Changes in the uterine bleeding pattern, uterine volume, and uterine artery blood flow were also reported.
The VAS score of pain was significantly decreased in both groups; however, the decreased rate was more pronounced in the dienogest group (3.21 ± 1.18) in comparison with the COCs group (4.92 ± 1.22). Bleeding pattern was improved greatly; uterine volume and uterine artery blood flow decreased significantly in the dienogest group. However, women in the dienogest group reported a higher rate of side effects.
Dienogest and COCs are effective in treating adenomyosis-associated symptoms after 6 months of use but dienogest is more effective. The decrease in uterine volume and uterine artery blood flow may be the cause of the treatment effect. Dienogest carries a higher risk of side effects.
gov: NCT03890042.
比较地诺孕素与复方口服避孕药（COCs）治疗子宫腺肌病相关症状的疗效和安全性。
这是一项 2019 年 3 月 1 日至 2020 年 8 月 1 日在埃及 Assiut 妇女健康医院进行的、针对有症状子宫腺肌病女性的随机临床试验。参与者被随机分配到地诺孕素组或 COCs 组。主要结局是治疗前后 6 个月通过视觉模拟量表（VAS）评估的与子宫腺肌病相关的疼痛程度。还报告了子宫出血模式、子宫体积和子宫动脉血流的变化。
两组的 VAS 疼痛评分均显著降低，但地诺孕素组（3.21±1.18）的降低率明显高于 COCs 组（4.92±1.22）。出血模式得到了很大改善；子宫体积和子宫动脉血流在地诺孕素组明显下降。然而，地诺孕素组的女性报告副作用发生率更高。
地诺孕素和 COCs 在使用 6 个月后均能有效治疗子宫腺肌病相关症状，但地诺孕素更有效。子宫体积和子宫动脉血流的减少可能是治疗效果的原因。地诺孕素的副作用风险更高。
gov：NCT03890042。
