子宫内膜不典型增生和分化良好的子宫内膜癌保留生育治疗中比较二甲双胍联合醋酸甲地孕酮与单用甲地孕酮的疗效：一项随机对照研究
【目的】
评价二甲双胍在基于醋酸甲地孕酮（MA）治疗保留生育子宫内膜不典型增生（atypical endometrial hyperplasia，AEH）和子宫内膜样腺癌（endometrioidendometrial cancer，EEC）中的疗效。
【设计】
2013年10月至2017年12月期间进行的一项随机、单中心、非盲、对照试验。
【处所】
中国上海复旦大学附属妇产科医院。
【人群】
共纳入150名（18-45岁）罹患原发性AEH或分化良好的EEC患者，随机分为MA组（n=74）和MA联合二甲双胍组（n=76）。
【方法】
罹患AEH或EEC妇女首先进行分层，后随机接受MA（每日口服160mg）或MA（每日口服160mg）联合二甲双胍（500mg每日口服3次）。
【主要测量结局】
主要疗效指标是治疗16周累积完全缓解率（16w-CR rate）；次要疗效指标是20周累积完全缓解率（30w-CR rate）和不良反应。
【结果】
二甲双胍联合MA组的16w-CR率高于单用MA组（34.3% vs 20.7%，OR 2.0，95%CI 0.89-4.51，p=0.09），但差异在102名AEH患者中更显著（34.3 vs 20.7%, OR 2.0, 95% CI 0.89–4.51, P = 0.09）。AEH患者亚组中，二甲双胍的效应在非肥胖患者（51.4vs 24.3%, OR 3.28, 95% CI 1.22–8.84, P = 0.02）和胰岛素敏感患者（54.8 vs 28.6%, OR 3.04, 95% CI 1.03–8.97, P = 0.04）中更显著。次要终点结局未发现差异结论。
【结论】
作为AEH保留生育力治疗方式，二甲双胍联合MA较单用MA有较高的早期CR率。
Metformin plus megestrol acetate compared with MA alone asfertility‐sparing treatment in patients with atypical endometrial hyperplasiaand well‐differentiated endometrial cancer: a randomised controlled trial
B‐YYang，YGulinazi ，YDu ，C‐CNing ，Y‐LCheng ，W‐WShan ，X‐ZLuo ，H‐WZhang ，QZhu ，F‐HMa ，JLiu ，LSun ，MYu ，JGuan ，X‐JChen
First published:21 January 2020
https://doi.org/10.1111/1471-0528.16108
Trial Registration: ClinicalTrials.gov(NCT01968317)
【Objective】
To assess the efficacy of metformin inmegestrol acetate (MA)‐based fertility‐sparing treatment for patients withatypical endometrial hyperplasia (AEH) and endometrioid endometrial cancer(EEC).
【Design】
A randomised, single‐centre, open‐label,controlled trial conducted between October 2013 and December 2017.
【Setting】
Shanghai OBGYN Hospital of FudanUniversity, China.
【Population】
A total of 150 patients (18–45 yearsold) with primary AEH or well‐differentiated EEC were randomised into an MAgroup (n = 74) and an MA plus metformin group (n = 76).
【Methods】
Patients with AEH or EEC were firstlystratified, then randomised to receive MA (160 mg orally, daily) or MA(160 mg orally, daily) plus metformin (500 mg orally, three times aday).
【Main outcomes andmeasures】
The primary efficacy parameter was thecumulate complete response (CR) rate within 16 weeks of treatment (16w‐CRrate); the secondary efficacy parameters were 30w‐CR rate and adverse events.
【Results】
The 16w‐CR rate was higher in the metforminplus 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 metforminwas 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 versus28.6%, OR 3.04, 95% CI 1.03–8.97, P = 0.04) subgroupsof AEH women. No significant result was found in secondary endpoints.
【Conclusion】
As a fertility‐sparing treatment, metforminplus MA was associated with a higher early CR rate compared with MA alone inAEH patients.
点击链接，阅读Atiomo撰写的述评“Is there any move to use metformin for endometrial hyperplasia in routine clinical practice?”
（编译 王伟琳）
