Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.
Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases, Shanghai, China.
BJOG. 2020 Jun;127(7):848-857. doi: 10.1111/1471-0528.16108. Epub 2020 Feb 16.
To assess the efficacy of metformin in megestrol acetate (MA)-based fertility-sparing treatment for patients with atypical endometrial hyperplasia (AEH) and endometrioid endometrial cancer (EEC).
A randomised, single-centre, open-label, controlled trial conducted between October 2013 and December 2017.
Shanghai OBGYN Hospital of Fudan University, China.
A total of 150 patients (18-45 years old) with primary AEH or well-differentiated EEC were randomised into an MA group (n = 74) and an MA plus metformin group (n = 76).
Patients with AEH or EEC were firstly stratified, then randomised to receive MA (160 mg orally, daily) or MA (160 mg orally, daily) plus metformin (500 mg orally, three times a day).
The primary efficacy parameter was the cumulate complete response (CR) rate within 16 weeks of treatment (16w-CR rate); the secondary efficacy parameters were 30w-CR rate and adverse events.
The 16w-CR rate was higher in the metformin plus MA group than in the MA-only group (34.3 versus 20.7%, odds ratio [OR] 2.0, 95% confidence interval [CI] 0.89-4.51, P = 0.09) but the difference was more significant in 102 AEH patients (39.6 versus 20.4%, OR 2.56, 95% CI 1.06-6.21, P = 0.04). This effect of metformin was also significant in non-obese (51.4 versus 24.3%, OR 3.28, 95% CI 1.22-8.84, P = 0.02) and insulin-sensitive (54.8 versus 28.6%, OR 3.04, 95% CI 1.03-8.97, P = 0.04) subgroups of AEH women. No significant result was found in secondary endpoints.
As a fertility-sparing treatment, metformin plus MA was associated with a higher early CR rate compared with MA alone in AEH patients.
For AEH patients, metformin plus MA might be a better fertility-sparing treatment to achieve a higher early CR rate compared with MA alone.
评估二甲双胍在醋酸甲地孕酮（MA）为基础的保留生育力治疗不典型子宫内膜增生（AEH）和子宫内膜样腺癌（EEC）患者中的疗效。
一项于 2013 年 10 月至 2017 年 12 月期间在中国复旦大学妇产科医院进行的随机、单中心、开放标签、对照试验。
中国复旦大学妇产科医院。
共纳入 150 名（18-45 岁）原发性 AEH 或高分化 EEC 患者，随机分为 MA 组（n=74）和 MA 加二甲双胍组（n=76）。
AEH 或 EEC 患者首先分层，然后随机接受 MA（160mg 口服，每日一次）或 MA（160mg 口服，每日一次）加二甲双胍（500mg 口服，每日三次）治疗。
主要疗效参数为治疗 16 周内的累积完全缓解（CR）率（16w-CR 率）；次要疗效参数为 30w-CR 率和不良事件。
二甲双胍加 MA 组的 16w-CR 率高于 MA 单药组（34.3%比 20.7%，比值比[OR]2.0，95%置信区间[CI]0.89-4.51，P=0.09），但在 102 名 AEH 患者中差异更为显著（39.6%比 20.4%，OR 2.56，95%CI 1.06-6.21，P=0.04）。二甲双胍在非肥胖（51.4%比 24.3%，OR 3.28，95%CI 1.22-8.84，P=0.02）和胰岛素敏感（54.8%比 28.6%，OR 3.04，95%CI 1.03-8.97，P=0.04）亚组的 AEH 患者中也有显著效果。次要终点无显著结果。
作为一种保留生育力的治疗方法，与 MA 单药治疗相比，二甲双胍加 MA 治疗 AEH 患者可获得更高的早期 CR 率。
对于 AEH 患者，与 MA 单药治疗相比，二甲双胍加 MA 可能是一种更好的保留生育力的治疗方法，可获得更高的早期 CR 率。
