[Efficacy of dienogest versus gonadotropin-releasing hormone agonist combined with dienogest sequential therapy in the treatment of adenomyosis].

Objective: To investigate the efficacy and safety of dienogest (DNG) alone and gonadotropin-releasing hormone agonist (GnRH-a) combined with DNG sequential treatment to adenomyosis. Methods: The clinical data of 110 patients with adenomyosis attending the First Affiliated Hospital of Nanjing Medical University from December 2019 to March 2022 were retrospectively analyzed, including 40 patients treated with DNG (2 mg/day) alone (DNG group) and 70 patients treated with sequential DNG (2 mg/day) after 3-6 injections of GnRH-a (GnRH-a+DNG group). The clinical data before and after treatment were compared between the two groups. Results: (1) The dysmenorrhea visual analogue scale (VAS) scores, cancer antigen 125 (CA125) and cancer antigen 19-9 (CA19-9) levels at different time periods after treatment were significantly lower than before treatment in both groups (median before treatment: DNG group 70.0 mm, 68.55 kU/L, 22.45 kU/L respectively, GnRH-a+DNG group 80.0 mm, 151.50 kU/L, 20.44 kU/L respectively; all P<0.001). (2) The hemoglobin (Hb) levels of patients in both groups at different time periods after treatment were significantly higher than those before treatment (median: DNG group 102.00 g/L, GnRH-a+DNG group 94.00 g/L; all P<0.001). (3) Treatment with DNG alone did not have a significant effect on uterine volume in patients of DNG group (P>0.05), and uterine volume decreased significantly in the 15th-24th months of GnRH-a+DNG group compared with that before treatment (median: 167.76 vs 227.77 cm3; P<0.05). (4) There were no significant differences in hepatic and renal function and coagulation indexes between the two groups before and after treatment (all P>0.05), and no significant abnormal lesions were observed in breast tissue during the follow-up period. (5) The incidence of amenorrhea of GnRH-a+DNG group was higher than that of DNG group, and the incidences of irregular spotting bleeding and breakthrough hemorrhage were lower than those in DNG group. Conclusions: Whether DNG is used alone or in combination with GnRH-a in sequence, it could significantly relieve dysmenorrhea symptoms, improve the level of Hb, reduce the levels of CA125 and CA19-9 in patients with adenomyosis, with no adverse effects on coagulation and hepatic or renal function. GnRH-a sequential DNG therapy is superior to DNG alone in improving uterine bleeding patterns and controlling the growth of uterine volume in patients with adenomyosis.目的： 比较单用地诺孕素（DNG）与促性腺激素释放激素激动剂（GnRH-a）联合DNG序贯治疗子宫腺肌病的疗效和安全性。 方法： 回顾性分析2019年12月至2022年3月在南京医科大学第一附属医院进行药物治疗的110例子宫腺肌病患者的临床资料，其中单用DNG（2 mg/d）治疗的患者40例（DNG组），注射GnRH-a（3.6或3.75 mg/针）3~6针后序贯DNG（2 mg/d）治疗的患者70例（GnRH-a+DNG组），比较两组患者治疗前、后的各项临床指标。 结果： （1）两组患者治疗后不同时间段的痛经视觉模拟评分（VAS）、血癌相关抗原125（CA125）、癌相关抗原19-9（CA19-9）水平均显著低于治疗前（治疗前DNG组的中位数分别为70.0 mm、68.55 kU/L、22.45 kU/L，GnRH-a+DNG组的中位数分别为80.0 mm、151.50 kU/L、20.44 kU/L），分别比较，差异均有统计学意义（P均<0.001）。（2）两组患者治疗后不同时间段的血红蛋白（Hb）含量均显著高于治疗前（治疗前DNG组、GnRH-a+DNG组的中位数分别为102.00、94.00 g/L；P均<0.001）。（3）DNG组患者的子宫体积在治疗前后无显著变化（P>0.05），GnRH-a+DNG组治疗第15~24个月子宫体积与治疗前相比明显减小（中位数分别为167.76、227.77 cm3；P<0.05）。（4）两组患者治疗前、后的肝肾功能和凝血指标分别比较均无显著差异（P均>0.05），随访期间乳腺未见明显异常病变。（5）GnRH-a+DNG组患者的闭经率高于DNG组，不规则点滴出血和突破性大出血的发生率低于DNG组。 结论： 无论是单用DNG治疗还是GnRH-a+DNG序贯治疗均可显著降低子宫腺肌病患者的痛经VAS评分、提高Hb含量、降低血CA125和CA19-9水平，同时对凝血指标及肝肾功能无不良影响。GnRH-a+DNG序贯治疗在改善子宫腺肌病患者的出血模式、减少突破性大出血发生和控制子宫体积方面优于单用DNG。.