桂枝茯苓胶囊联合米非司酮治疗子宫肌瘤的临床观察

Clinical Observation of Guizhi Fuling Capsule Combined with Mifepristone in Treatment of Uterine Fibroids

目的:观察桂枝茯苓胶囊联合米非司酮治疗子宫肌瘤的疗效和安全性。方法:116例子宫肌瘤患者随机均分为对照组和观察组。对照组患者于月经期第1天开始饭前2 h口服米非司酮片25 mg,每日1次,连用10 d;观察组患者在对照组治疗的基础上于非月经期加服桂枝茯苓胶囊3粒,每日3次。两组患者均3个月为1个疗程,连续治疗2个疗程。观察两组患者的临床疗效,治疗前后血清促卵泡生成素(FSH)、雌二醇(E2)、性激素结合球蛋白(SHBG)、子宫体积、月经量、子宫肌瘤体积及不良反应发生情况。结果:观察组患者总有效率显著高于对照组,差异有统计学意义(P<0.05)。治疗后,两组患者FSH、E2、子宫体积、月经量、子宫肌瘤体积均显著低于同组治疗前,且观察组低于对照组,差异均有统计学意义(P<0.05);而两组患者治疗前后SHBG、不良反应发生率比较,差异均无统计学意义(P>0.05)。结论:桂枝茯苓胶囊联合米非司酮治疗子宫肌瘤较单用米非司酮疗效更显著,安全性较好。

OBJECTIVE：To observe the efficacy and safety of Guizhi fuling capsule combined with mifepristone in treatment of uterine fibroids. METHODS：116 patients with uterine fibroids were randomly divided into control group and observation group.Control group was orally given Mifepristone tablet 25 mg,2 h before meal in the first day of menstrual period,once a day,for continuous 10 d;observation group was additionally given Guizhi fuling capsule 3 pills in non-menstrual period,3 times a day. 3months was regarded as a treatment course,it lasted 2 courses. Clinical efficacy,and E2,FSH,SHBG,uterine volume,menstrual blood volume,uterine fibroid volume and incidence of adverse reactions in 2 groups before and after treatment were observed. RESULTS：Total effective rate in observation group was significantly higher than control group,the difference was statistically significant（P〈0.05）. After treatment,the FSH,E2,uterine volume,menstrual blood volume and uterine fibroid volume in 2 groups were significantly lower than before,and observation group was lower than control group,the differences were statistically significant（P〈0.05）;but there were no significant difference in the SHBG and adverse reactions between 2 groups（P〉0.05）. CONCLUSIONS：The clinical efficacy of Guizhi fuling capsule combined with mifepristone in treatment of uterine fibroids is more significant than mifepristone alone,with good safety.