比较左炔诺孕酮宫内节育系统 (LNG-IUS) 与醋酸甲地孕酮 (MA) 在诱导拒绝子宫切除术的不典型子宫内膜增生 (AEH) 女性完全消退方面的功效。 在这项单中心、开放标签随机对照试验中，我们纳入了 148 名患有 AEH 且拒绝子宫切除术的女性。我们将参与者随机分组，接受每日口服 MA 160 mg (n=74) 或应用 LNG-IUS (n=74)，并安排在 3、6、9、12、18 和 24 个月时通过子宫内膜取样进行随访。成功率和完全消退的持续时间是主要结果。 LNG-IUS 组完全消退的平均持续时间为 5.52 个月（95% 置信区间 [CI]=4.85-6.18），而 LNG-IUS 组为 6.87 个月（95% CI=6.09） -7.64）对于甲地孕酮组（对数秩检验 p 值=0.011）。 12 个月后，LNG-IUS 的累积回归率为 91.9%，而 MA 为 77%（p=0.026）。 MA 组与 LNG-IUS 组相比，治疗一年后（4.7±4 kg vs. 2.7±2.6 kg，95% CI=0.89-3.12；p=0.001）和治疗两年后（7.8±5.1 kg vs. . 4.1±2.9 kg, 95% CI=2.29-5.06; p<0.001）。与MA相比，LNG-IUS对于拒绝子宫切除术的女性，尤其是中度/重度肥胖的女性，治疗AEH更有效，不良反应更少效果和体重增加较少。对于持续病例，将治疗延长至 12 个月将提高消退率，同时具有合理的安全性。交替宫腔镜和办公室取样似乎便于随访。ClinicalTrials.gov 标识符：NCT04385667。© 2024。亚洲妇科肿瘤学会、韩国妇科肿瘤学会和日本妇科肿瘤学会。

To compare the efficacy of the levonorgestrel intrauterine system (LNG-IUS) versus megestrol acetate (MA) in inducing complete regression among women with atypical endometrial hyperplasia (AEH) who declined hysterectomy.In this single-center, open-label randomized controlled trial, we included 148 women with AEH who declined hysterectomy. We randomized participants to receive either daily oral MA 160 mg (n=74) or apply LNG-IUS (n=74) and scheduled their follow-up by endometrial sampling at 3, 6, 9, 12, 18, and 24 months. The success rate and duration until complete regression were the primary outcomes.The mean duration until complete regression was 5.52 months (95% confidence interval [CI]=4.85-6.18) for the LNG-IUS group versus 6.87 months (95% CI=6.09-7.64) for the megestrol group (log-rank test p-value=0.011). The cumulative regression rate after 12 months was 91.9% with the LNG-IUS versus 77% with MA (p=0.026). Weight gain in the MA group vs LNG-IUS group after one year (4.7±4 kg vs. 2.7±2.6 kg, 95% CI=0.89-3.12; p=0.001) and after two years of therapy (7.8±5.1 kg vs. 4.1±2.9 kg, 95% CI=2.29-5.06; p<0.001).Compared to MA, the LNG-IUS was more efficacious in treating AEH in women who declined hysterectomy, especially those with moderate/severe obesity, with fewer adverse effects and less weight gain. Extending therapy to 12 months for persistent cases would improve regression rates with reasonable safety. Alternate hysteroscopic and office sampling seemed convenient for follow-up.ClinicalTrials.gov Identifier: NCT04385667.© 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.