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新药研发前沿动态 / 医药领域趋势进展

曼月乐环、地屈孕酮片在子宫内膜息肉电切术后患者中的应用

Mirena and Dydrogesterone Tablets in Patients after Hysteroscopic Polypectomy

  • 摘要: 目的 探讨曼月乐环、地屈孕酮片对子宫内膜息肉(endometrial polyp,EP)电切术患者子宫内膜厚度及月经血量、激素受体水平、复发情况的影响。方法 选取2021年9月至2023年12月于海宁市人民医院行宫腔镜电切术治疗的330例EP患者,按照随机数字表法将其分为曼月乐环(左炔诺孕酮宫内缓释系统)组(术后放置曼月乐环,n=110)、地屈孕酮组(术后口服地屈酮片,n=110)、对照组(单纯行手术,n=110)3组。对比3组的子宫内膜厚度、月经血量、激素代谢指标及复发率。结果 与同组治疗前相比,术后1个月、3个月、6个月、12个月曼月乐环组、地屈孕酮组、对照组子宫内膜厚度均有减小(P < 0.001);与同组术后1个月比较,术后3个月、6个月、12个月3组子宫内膜厚度均有减小(P < 0.001);与同组术后3个月比较,术后6个月、12个月3组子宫内膜厚度均有减小(P < 0.001);与同组术后6个月比较,术后12个月3组子宫内膜厚度均有减小(P < 0.001)。治疗前、术后1个月,3组间子宫内膜厚度经比较,无明显统计学差异(P > 0.05);术后3个月、6个月、12个月,曼月乐环组、地屈孕酮组的子宫内膜厚度较对照组薄(P < 0.001);曼月乐环组在术后1个月、3个月、6个月、12个月的子宫内膜厚度与地屈孕酮组相比较,无明显统计学差异(P > 0.05)。与同组治疗前相比,术后1个月、3个月、6个月、12个月曼月乐环组、地屈孕酮组、对照组月经血量均有减少(P < 0.001);与同组术后1个月比较,术后3个月、6个月、12个月3组月经血量均有减少(P < 0.001);与同组术后3个月比较,术后6个月、12个月3组月经血量均有减少(P < 0.001);与同组术后6个月比较,术后12个月,3组月经血量均有减少(P < 0.001)。治疗前、术后1个月,3组间月经血量经比较,无明显统计学差异(P > 0.05);术后3个月、6个月、12个月,曼月乐环组、地屈孕酮组的月经血量较对照组少(P < 0.001);术后1个月、3个月、6个月、12个月,曼月乐环组的月经血量与地屈孕酮组比较无明显差异(P > 0.05)。治疗前,3组的雌激素受体(estrogen receptor,ER)、孕激素受体(progesterone receptor,PR)水平比较无明显差异(P > 0.05)。与治疗前比较,术后6个月、12个月,3组ER、PR水平均有降低(P < 0.001)。术后6个月、12个月,曼月乐环组、地屈孕酮组的ER、PR水平均低于对照组(P < 0.001)。术后6个月、12个月,曼月乐环组、地屈孕酮组ER、PR水平比较无明显差异(P > 0.05)。术后随访12个月期间,3组复发率比较存在明显差异(χ2=40.94,P < 0.001);曼月乐环组、地屈孕酮组的复发率较对照组低(χ2=32.637、19.478,P < 0.001);曼月乐环组的复发率与地屈孕酮组比较无明显差异(χ2=2.379,P=0.123)。结论 曼月乐环、地屈孕酮片均可改善EP患者的子宫内膜厚度、月经血量、激素受体状态和复发率,相较于单纯宫腔镜电切术者疗效优势明显。

     

    Abstract: Objective To investigate the effects of the Mirena and dydrogesterone tablets on endometrial thickness, menstrual blood loss, hormone receptor levels, and recurrence in patients undergoing hysteroscopic polypectomy. Methods A total of 330 endometrial polyp (EP) patients who underwent hysteroscopic polypectomy at Haining People's Hospital from September 2021 to December 2023 were enrolled and randomly assigned to three groups using a random number table (n = 110 each): the Mirena group (levonorgestrelreleasing intrauterine system inserted postoperatively), the dydrogesterone group (oral dydrogesterone tablets postoperatively), and the control group (surgery only). Endometrial thickness, menstrual blood volume, hormone receptor levels, and recurrence rates were compared among the three groups. Results Compared with pre-treatment levels within the same group, endometrial thickness decreased at 1, 3, 6, and 12 months postoperatively in all three groups (P < 0.001). Additionally, compared to 1 month postoperatively within the same group, endometrial thickness decreased further at 3, 6, and 12 months in all three groups (P < 0.001). Similarly, decreases were observed at 6 and 12 months compared to 3 months postoperatively, and at 12 months compared to 6 months postoperatively within each group (P < 0.001). No significant differences in endometrial thickness were found among the three groups before treatment and at 1 month postoperatively (P > 0.05). However, at 3, 6, and 12 months postoperatively, endometrial thickness in both the Mirena and dydrogesterone groups was thinner than in the control group (P < 0.001). There was no significant difference in endometrial thickness between the Mirena and dydrogesterone groups at any postoperative time point (1, 3, 6, 12 months) (P > 0.05). Compared with pretreatment levels within the same group, menstrual blood volume decreased at 1, 3, 6, and 12 months postoperatively in all three groups (P < 0.001). Sequential decreases were also observed at 3, 6, and 12 months compared to 1 month postoperatively, at 6 and 12 months compared to 3 months postoperatively, and at 12 months compared to 6 months postoperatively within each group (P < 0.001). No significant differences in menstrual blood volume were found among the three groups before treatment and at 1 month postoperatively (P > 0.05). At 3, 6, and 12 months postoperatively, menstrual blood volume in both the Mirena and dydrogesterone groups was less than in the control group (P < 0.001). There was no significant difference in menstrual blood volume between the Mirena and dydrogesterone groups at any postoperative time point (P > 0.05). Before treatment, there were no significant differences in the levels of estrogen receptor (ER) and progesterone receptor (PR) among the three groups (P > 0.05). Compared to pre-treatment levels, ER and PR levels decreased at 6 and 12 months postoperatively in all three groups (P < 0.001). At 6 and 12 months postoperatively, ER and PR levels in both the Mirena and dydrogesterone groups were lower than those in the control group (P < 0.001). There were no significant differences in ER and PR levels between the Mirena and dydrogesterone groups at 6 and 12 months postoperatively (P > 0.05). During the 12-month postoperative follow-up period, there was a significant difference in the recurrence rates among the three groups (χ2 = 40.94, P < 0.001). The recurrence rates in both the Mirena and dydrogesterone groups were lower than that in the control group (χ2 = 32.637, 19.478 respectively, P < 0.001). There was no significant difference in the recurrence rate between the Mirena and dydrogesterone groups (χ2 = 2.379, P = 0.123). Conclusion Both the Mirena and dydrogesterone tablets can improve endometrial thickness, menstrual blood volume, and hormone receptor status, and reduce recurrence rates in patients with EP, demonstrating significant therapeutic advantages compared to hysteroscopic polypectomy alone.

     

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