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目的观察米非司酮治疗围绝经期子宫肌瘤的临床疗效及安全性。方法将92例围绝经期子宫肌瘤患者随机分为对照组46例与试验组46例。对照组于月经周期第1～2日皮下注射醋酸亮丙瑞林微球3.75 mg,每4周1次;试验组于月经周期第1～3日睡前口服米非司酮10 mg,bid。2组患者均连续治疗3个月。比较2组患者的临床疗效、治疗前后血清卵泡刺激素(FSH)、黄体生成素(LH)、雌二醇(E2)、孕酮(P)、细胞淋巴瘤因子2(Bcl-2)、Bcl-2相关X蛋白(Bax)水平以及不良反应发生情况。结果治疗后,试验组的总有效率为95.65%显著高于对照组的80.43%(P<0.05)。治疗后,2组患者的血清FSH、LH、E2、P、Bcl-2水平均较治疗前显著降低,且试验组治疗后的上述指标显著低于对照组(P<0.05);2组患者的血清Bax水平较治疗前显著升高,且试验组治疗后的Bax水平显著高于对照组(P<0.05)。试验组和对照组的不良反应发生率比较差异无统计学意义(6.52%vs 15.22%,P>0.05)。结论米非司酮治疗围绝经期子宫肌瘤的临床疗效显著,且不增加不良反应的发生率。
Objective To observe the clinical efficacy and safety of mifepristone in treating peri-menopausal uterine fibroids. Methods 92 cases of menopausal uterine fibroids were randomly divided into control group 46 cases and experimental group 46 cases. The control group was subcutaneously injected with 3.75 mg leuprolide microspheres subcutaneously on days 1 to 2 of the menstrual cycle, once every 4 weeks. The test group was given mifepristone 10 mg bid on day 1 to 3 of the menstrual cycle. Two groups of patients were treated for 3 months. The clinical effects of two groups of patients were compared. Serum follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), Bcl-2, -2 related X protein (Bax) levels and the incidence of adverse reactions. Results After treatment, the total effective rate of the experimental group was 95.65%, which was significantly higher than that of the control group (80.43%, P <0.05). After treatment, the levels of serum FSH, LH, E2, P and Bcl-2 in the two groups were significantly lower than those before treatment, and the above indexes in the experimental group were significantly lower than those in the control group (P <0.05) Serum Bax levels were significantly higher than before treatment, and the experimental group Bax levels were significantly higher than the control group (P <0.05). There was no significant difference in the incidence of adverse reactions between the experimental group and the control group (6.52% vs 15.22%, P> 0.05). Conclusion Mifepristone treatment of perimenopausal uterine fibroids clinical significant effect, and does not increase the incidence of adverse reactions.