Abstract:

Objective　To compare the differences of pain and disease recurrence rates in patients after ovarian endometriosis cyst (OEC) excision treated with dienogest and gonadotropin-releasing hormone agonist (GnRH-a). Methods　This study was a randomized controlled trial. According to the random coin toss method, 113 patients who met the treatment criteria of OEC excision in the Department of Obstetrics and Gynecology of XD Group Hospital from May 2020 to April 2022 were divided into a GnRH-a group (61 cases) and a dienogest group (52 cases). The age of the GnRH-a group was (35.38±4.49) years old, the course of disease was (3.28±1.04) years, the cyst size was 6.00 (5.00, 8.00) cm, and the American Society for Reproductive Medicine (ASRM) staging was stage Ⅰ to Ⅱ in 30 cases and stage Ⅲ to Ⅳ in 31 cases. The age of the dienogest group was (35.52±4.61) years old, the course of disease was (3.52±1.06) years, the cyst size was 6.00 (5.00, 8.00) cm, and the ASRM staging was stage Ⅰ to Ⅱ in 26 cases and stage Ⅲ to Ⅳ in 26 cases. From the first day of the first menstrual period after OEC excision, the GnRH-a group was treated with subcutaneous injection of leuprelin acetate in the anterior abdominal wall, 3.75 mg/time, once every 4 weeks; the dienogest group received oral dienogest tablets, 2 mg/time, once a day. Both groups were treated for 24 weeks. The Visual Analogue Scale (VAS) score, adverse reactions, recurrence rate, and treatment satisfaction were compared between the two groups. Independent sample t test, non-parametric Wilcoxon test, Mann-Whitney U test, and χ² test were used for statistical analysis. Results　After 24 weeks of treatment, the VAS scores of dysmenorrhea, chronic pelvic pain, and sexual pain in the dienogest group were lower than those in the GnRH-a group [0.50 (0, 2.00) points vs. 1.00 (0, 3.00) points, 1.00 (0, 3.00) points vs. 2.00 (1.00, 4.00) points, 0 (0, 2.00) points vs. 1.00 (0, 2.00) points] (Z=2.396, 2.669, and 2.929, all P<0.05). There was no statistically significant difference in the incidence of adverse reactions or the recurrence rate within 12 months after withdrawal between the GnRH-a group and the dienogest group [14.75% (9/61) vs. 5.77% (3/52), 8.20% (5/61) vs. 1.92% (1/52)] (χ²=2.378 and 2.197, both P>0.05). The total satisfaction of the dienogest group was higher than that of the GnRH-a group [94.23% (49/52) vs. 81.97% (50/61)] (χ²=3.889, P<0.05). Conclusion　Compared with GnRH-a, supplement of dienogest after OEC excision can more effectively relieve the patients' pain, prevent the disease recurrence, and obtain higher treatment satisfaction.

Key words:

Ovarian endometriosis cyst,  , Excision, Dienogest, Gonadotropin releasing hormone agonist, Pain, Recurrence

摘要： 目的　比较卵巢子宫内膜异位囊肿（OEC）剔除术后辅以地诺孕素与促性腺激素释放激 素激动剂（GnRH-a）治疗后患者疼痛和疾病复发率的差异。方法　本研究为随机对照试验。依据随 机硬币投掷法，将2020年5月至2022年4月西电集团医院妇产科符合OEC剔除术治疗标准的113例 患者分为 GnRH-a 组（61例）和地诺组（52例）。GnRH-a 组年龄（35.38±4.49）岁；病程（3.28±1.04）年； 囊肿大小 6.00（5.00，8.00）cm；美国生殖医学学会（American Society for Reproductive Medicine，ASRM） 分期：Ⅰ～Ⅱ期 30 例，Ⅲ～Ⅳ期 31 例。地诺组年龄（35.52±4.61）岁；病程（3.52±1.06）年；囊肿大小 6.00（5.00，8.00）cm；ASRM分期：Ⅰ～Ⅱ期26例，Ⅲ～Ⅳ期26例。从剔除术后首次月经来潮的第1天 开始，GnRH-a组采用腹前壁皮下注射醋酸亮丙瑞林进行辅助治疗，3.75 mg/次，4周一次；地诺组口服 地诺孕素片进行辅助治疗，2 mg/次，每天一次。两组均持续治疗 24 周。比较两组视觉模拟评分法 （VAS）评分、不良反应、复发率和治疗满意度。采用独立样本 t 检验、非参数 Wilcoxon 检验、 Mann-Whitney U检验、χ2 检验进行统计学分析。结果　用药24周后，地诺组痛经、慢性盆腔痛和性交 痛 VAS 评分均低于 GnRH-a 组［0.50（0，2.00）分比1.00（0，3.00）分，1.00（0，3.00）分比2.00（1.00，4.00）分， 0（0，2.00）分比 1.00（0，2.00）分］（Z=2.396、2.669、2.929，均 P<0.05）。GnRH-a组和地诺组不良反应发 生率和停药后 12个月复发率比较［14.75%（9/61）比 5.77%（3/52），8.20%（5/61）比 1.92%（1/52）］，差异 均无统计学意义（χ2 =2.378、2.197，均 P>0.05）。地诺组治疗总满意度高于 GnRH-a组［94.23%（49/52） 比 81.97%（50/61）］（χ2 =3.889，P<0.05）。结论　相较于 GnRH-a，OEC 剔除术后辅以地诺孕素能有效 缓解患者疼痛，预防疾病复发，获得更高的治疗满意度。

关键词:

卵巢子宫内膜异位囊肿, 剔除术, 地诺孕素, 促性腺激素释放激素激动剂, 疼痛, 复发