摘要
目的：观察小剂量米非司酮治疗围绝经期排卵障碍性异常子宫出血的临床疗效和安全性。方法：选取2012年9月~2014年9月本院收治的150例围绝经期排卵障碍性异常子宫出血患者,按照随机数字法随机分为观察组和对照组各75例,观察组口服米非司酮10mg,1次/d;对照组口服米非司酮25mg,1次/d;疗程均为3个月,观察两组治疗前后血清雌二醇（E2）、孕酮（P）、促卵泡生成激素（FSH）、促黄体生成激素（LH）、睾酮（T）及子宫内膜变化,并对药代动力学参数进行检测,评价其临床疗效和安全性。结果：总有效率观察组为97.3%,对照组为100%,两组相比差异无统计学意义（χ2=2.027,P〉0.05）;治疗后两组FSH、LH、P及E2均较治疗前显著下降（P〈0.05）,但两组间比较无差异（P〉0.05）;两组平均控制出血及平均完全控制止血时间比较无差异（P均〉0.05）;治疗后两组子宫内膜厚度均显著下降（P均〈0.05）,但两组间比较无差异（P〉0.05）。观察组治疗第1天及第90天tmax、Cmax、AUC0-t、t1/2无明显变化（P均〉0.05）,但对照组第90天Cmax、AUC0-t显著高于第1天（P〈0.05）。观察组不良反应发生率低于对照组（χ2=7.292,P〈0.05）。结论：与25mg剂量米非司酮相比,采用小剂量10mg米非司酮治疗围绝经期功能失调性子宫出血疗效相似,但安全性更高。
Objective：To explore the clinical effect and safety of a low dose of mifepristone for the treatment of perimenopausal abnormal uterine bleeding associated with ovulatory dysfunction Methods：From September 2012 to September 2014 in our hospital clinical data of 150 patients experiencing perimenopausal abnormal uterine bleeding associated with ovulatory dysfunction were recruited.According to the random number method,they were divided into the observation group and the control group（75 cases in each group）.Women in the observation group were given 10 mg of mifepristone orally once a day,while those in the control group received 25 mg of mifepristone orally once a day.A treatment course of 3 months was conducted.Serum levels of estradiol（E2）and progesterone（P）,follicle stimulating hormone（FSH）,luteinizing hormone（LH）,testosterone（T）and the change of endometrial thickness of the two groups before and after treatment were recorded and compared in order to evaluate the curative effect and clinical safety,as well as the pharmacokinetic parameters.Results：In the observation group the total effective rate was 97.3%while that in the control group was 100.0%,showing no significant difference（χ2= 2.027,P〉0.05）.After treatment,P,E2,FSH and LH levels in the observation group significantly decreased（P all〈 0.05）,but there was no statistically significant difference between two groups（P all〉0.05）.There were no significant difference in terms of average hemorrhage control time and fully-controlled bleeding time between two groups（P〉0.05）.Endometrial thickness of two groups after treatment were all significantly decreased（P all〈0.05）,but there was no statistical significance between two groups（P〉0.05）.In the treatment group Tmax,Cmax,AUC0-tand t1/2on 1st and 90 th day after the treatment had no significant change（P〉0.05）;but on the 90 th day Cmax and AUC0-tof the control group were significantly higher than those on the first day（P〈0.05）.In the observation group the incidence rate of adverse reaction was significantly lower than that in the control group（χ2= 7.292,P〈0.05）.Conclusion：Compared with a large dose of mifepristone,a low dose of mifepristone has better curative effect as well as higher clinical safety.
出处
《中国计划生育学杂志》
2015年第6期395-398,共4页
Chinese Journal of Family Planning
关键词
小剂量米非司酮
围绝经期
子宫出血
Low dose of mifepristone
Perimenopause
uterine bleeding
