左炔诺孕酮宫内节育系统与米非司酮治疗围绝经期功能失调性子宫出血的疗效和安全性比较

Comparison of the Efficacy and Safety of Levonorgestrel Intrauterine System and Mifepristone in the Treatment of Perimenopausal Dysfunctional Uterine Bleeding

目的:比较左炔诺孕酮宫内节育系统与米非司酮治疗围绝经期功能失调性子宫出血的疗效和安全性。方法:200例围绝经期功能失调性子宫出血患者随机分为观察组(100例)和对照组(100例)。观察组患者放置左炔诺孕酮宫内节育系统(含左炔诺孕酮52 mg),对照组患者口服米非司酮胶囊10 mg/d。两组疗程均为3个月。观察两组患者的临床疗效和治疗前后子宫内膜厚度、月经量[根据图示应用出血评分法(PBAC)评估]、血红蛋白水平及不良反应发生情况。结果:治疗后,观察组患者总有效率显著高于对照组,不良反应发生率显著低于对照组,差异均有统计学意义(P<0.01)。治疗前,两组患者子宫内膜厚度、PBAC评分、血红蛋白水平比较差异无统计学意义(P>0.05);治疗后,两组患者子宫内膜厚度、PBAC评分显著低于同组治疗前,且观察组低于对照组,而血红蛋白水平显著高于同组治疗前,且观察组高于对照组,差异均有统计学意义(P<0.01或P<0.05)。结论: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显著优于米非司酮。

OBJECTIVE：To compare the efficacy and safety of levonorgestrel intrauterine system and mifepristone in the treatment of perimenopausal dysfunctional uterine bleeding. METHODS：200 patients with perimenopausal dysfunctional uterine bleeding were randomly divided into observation group（100 cases） and control group（100 cases）. Patients in the observation group placed levonorgestrel intrauterine system（containing levonorgestrel 52 mg）,patients in control group received Mifepristone capsule 10 mg/d,oral,the treatment course for 2 groups were 3 months. Clinical efficacy,endometrial thickness,menstruation（PBAC score）,hemoglobin level before and after treatment and incidence of adverse reaction in 2 groups were observed. RESULTS：After treatment,the total effective rate in observation group was significantly higher than control group,incidence of adverse reactions was significantly lower than control group,the differences were statistically significant（P〈0.01）. Before treatment,there were no significant differences in the endometrial thickness,PBAC score and hemoglobin level between 2 groups;after treatment,endometrial thickness and PBAC score were significantly lower than before,and observation group was lower than control group;hemoglobin level was significantly higher than before,and observation group was higher than control group,the differences were statistically significant（P〈0.01 or P〈0.05）. CONCLUSIONS：The efficacy and safety of levonorgestrel intrauterine system are significantly superior to mifepristone in the treatment of perimenopausal dysfunctional uterine bleeding.