米非司酮联合左炔诺孕酮宫内节育系统治疗围绝经期功能失调性子宫出血的疗效和安全性

Clinical effects and safety of mifepristone combined with levonorgestrel-releasing intrauterine system on perimenopausal dysfunctional uterine bleeding

目的评价米非司酮联合左炔诺孕酮宫内节育系统(LNG-IUS)治疗围绝经期功能失调性子宫出血(功血)的疗效和安全性。方法将82例围绝经期功血患者随机分为两组,每组41例,治疗组放置LNG-IUS的同时联合使用米非司酮(置环后即予米非司酮100 mg口服,后每30 d口服1次,共3个月,总剂量400 mg)治疗,对照组单纯放置LNG-IUS治疗。治疗1、3、6个月后随访,观察比较两组不规则阴道出血例数、月经量、患者满意度及不良反应发生情况等。结果治疗1、3个月后,治疗组月经间期不规则阴道出血例数、月经量PBAC评分和子宫内膜厚度均低于对照组(P<0.05)。治疗6个月后,上述指标组间比较无显著差异(P>0.05)。治疗组不良反应发生率为12%(5/41),与对照组(17%,7/41)比较无显著差异(P>0.05)。治疗组患者满意度(93%)高于对照组(71%),差异有显著意义(P<0.05)。结论米非司酮联合LNG-IUS治疗围绝经期功血安全有效,依从性高,值得临床推广。

AIM To evaluate the clinical effects and safety of mifepristone combined with levonorgestrelreleasing intrauterine system（ LNG-IUS） on perimenopausal dysfunctional uterine bleeding. METHODS Eighty-two perimenopausal patients with dysfunctional uterine bleeding were randomly divided into two groups,with 41 cases in each group. The patients in the treatment group were treated with mifepristone combined with LNG-IUS（ patients were given mifepristone 100 mg at the time of LNG-IUS insertion and then at 30-day intervals for 3 months with a total dose of 400 mg）. The patients in the control group were treated with LNG-IUS alone. The number of irregular vaginal bleeding, menstrual blood volume, patient satisfaction, adverse reactions and so on were observed and compared between the two groups by follow-up in 1, 3 and 6 months after the treatment. RESULTS Compared with the control group, the irregular vaginal bleeding cases,menstrual volume pictorial blood loss assessment chart（ PBAC） score and endometrial thickness were significantly lower in the treatment group（P〈0.05）, respectively in 1 and 3 months after the treatment. There were no significant differences in above indexes between the two groups（ P〈0.05） in 6 months after the treatment. The incidence of adverse reactions in the treatment group was 12%（5/41）, which was not significantly different from that in the control group（ 17%, 7/41, P〈0.05）. However, the patient satisfaction rate was significantly higher in the treatment group compared with control group（93% vs. 71%, P〈0.05）. CONCLUSION Mifepristone combined with LNG-IUS in treatment of perimenopausal dysfunctional uterine bleeding is safe and effective with higher compliance, which is worth to be spread.