Department of Obstetrics & Gynaecology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Department of Cytology & Gynecological Pathology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Asian Pac J Cancer Prev. 2021 Mar 1;22(3):983-989. doi: 10.31557/APJCP.2021.22.3.983.
Endometrial cancer is the second most frequent genital malignancy in women, which is showing a constant rise all over world. Endometrial hyperplasia is the precursor of endometrial cancer. Levonorgestrel intrauterine system is the first line management in patients with endometrial hyperplasia without atypia. Metformin has shown to reverse endometrial hyperplasia, but its effectiveness and safety in endometrial hyperplasia is uncertain.
To compare the efficacy in terms of histopathological response, clinical response and safety at the end of 6 months in patients with endometrial hyperplasia without atypia managed with Levonorgestrel intrauterine system alone versus patients managed with Levonorgestrel intrauterine system plus metformin.
The randomized control trial was conducted on 51 cases of endometrial hyperplasia without atypia. Twenty-five subjects were prescribed metformin 500mg twice daily with Levonorgestrel intrauterine system and 26 subjects, with Levonorgestrel intrauterine system only for 6 months. At the end of 6 months, endometrial sampling was performed for histopathological response.
Clinical response was observed in 23 of 25 subjects in metformin group and 22 of 24 in Levonorgestrel only group. The metformin group responded significantly with amenorrhea (p= 0.0053), while Levonorgestrel only group responded with regular cycles (p=0.027). At the end of study, of 46 subjects available for histopathological evaluation, 100% subjects in metformin group and 95.45% in Levonorgestrel only group (p=0.47826) showed complete response. The metformin group had a significant reduction in body mass index at end of study [P = 0∙023, 95% confidence interval (-1.7802, -0.1418)].
No significant difference in regression of endometrial hyperplasia was observed on adjunctive use of metformin but a significant reduction in BMI was observed. Use of metformin in obese patients may improve the treatment response.
子宫内膜癌是女性第二常见的生殖系统恶性肿瘤，在全球范围内呈持续上升趋势。子宫内膜增生是子宫内膜癌的前驱病变。左炔诺孕酮宫内节育系统是治疗非典型子宫内膜增生患者的一线治疗方法。二甲双胍已被证明可逆转子宫内膜增生，但在子宫内膜增生中的有效性和安全性尚不确定。
比较单独使用左炔诺孕酮宫内节育系统与联合使用左炔诺孕酮宫内节育系统加二甲双胍治疗非典型子宫内膜增生患者在 6 个月时的组织病理学反应、临床反应和安全性。
对 51 例非典型子宫内膜增生患者进行随机对照试验。25 例患者给予二甲双胍 500mg，每日 2 次，联合左炔诺孕酮宫内节育系统治疗，26 例患者仅给予左炔诺孕酮宫内节育系统治疗 6 个月。6 个月后行子宫内膜取样行组织病理学反应。
二甲双胍组 25 例患者中有 23 例出现临床反应，左炔诺孕酮组 24 例中有 22 例出现临床反应。二甲双胍组出现闭经的比例明显高于左炔诺孕酮组（p=0.0053），而左炔诺孕酮组出现规律周期的比例高于二甲双胍组（p=0.027）。研究结束时，在可进行组织病理学评估的 46 例患者中，二甲双胍组和左炔诺孕酮组的完全反应率分别为 100%和 95.45%（p=0.47826）。研究结束时，二甲双胍组的体重指数显著降低[P=0.023，95%置信区间（-1.7802，-0.1418）]。
联合使用二甲双胍对子宫内膜增生的消退无显著影响，但体重指数显著降低。在肥胖患者中使用二甲双胍可能会改善治疗反应。
