不同剂量米非司酮联合去氧孕烯炔雌醇治疗围绝经期功能失调性子宫出血的临床试验研究

A Clinical Trial Study on the Curative Effect of Different Doses of Mifepristone Combined with Desogestrel Ethinyloestradiol on Dysfunctional Uterine Bleeding During Perimenopause

目的研究不同剂量米非司酮联合去氧孕烯炔雌醇治疗围绝经期功能失调性子宫出血(dysfunctional uterine bleeding during perimenopause,P-DUB)的临床疗效。方法选择2015年3月至2016年2月于河南省中医院接受治疗的P-DUB患者158例,按照随机数字表法分为A、B、C组,每组53例。3组均给予去氧孕烯炔雌醇治疗。A组给予米非司酮10mg,B组给予米非司酮15mg,C组给予米非司酮20mg。观察3组子宫出血控制时间、停止时间,治疗前后子宫内膜厚度、月经量、血红蛋白水平、性激素水平和不良反应。结果 A组子宫出血控制时间、子宫出血停止时间长于B、C组(P<0.05)。B、C组子宫出血控制时间、子宫出血停止时间差异无统计学意义(P>0.05)。治疗后,A组子宫内膜厚度及促黄体激素(LH)、雌二醇(E_2)、孕酮(P)、促卵泡生成素(FSH)大于B、C组,血红蛋白小于B、C组(P<0.05)。治疗后,B、C组子宫内膜厚度、血红蛋白及LH、E_2、P和FSH差异无统计学意义(P>0.05)。A组总有效率(69.81%)低于B组(92.45%)、C组(96.23%)(P<0.05)。B、C组总有效率差异无统计学意义(P>0.05)。A组不良反应发生率(5.66%)低于B组(9.43%)(P>0.05)。A组不良反应发生率低于C组(22.64%)(P<0.05)。B、C组不良反应发生率差异无统计学意义(P>0.05)。结论15mg剂量米非司酮联合去氧孕烯炔雌醇治疗P-DUB疗效显著,安全可靠,值得临床推广应用。

Objective to study the curative effect of different doses of mifepristone combined with desogestrel ethinyloestradiol on dysfunctional uterine bleeding during perimenopause（P-DUB）.Methods 158 patients with PDUB treated in Henan Province Hospital of TCM from March of 2015 to February of 2016 were selected and divided into the three groups including Group A（n=53）,Group B（n=53）and Group C（n=53）according to the random number table.The patients of the three groups were given the treatment of desogestrel ethinyloestradiol and the patients in Group A,Group B and Group C were treated with 10 mg,15mg and 20 mg mifepristone respectively.The control time and stop time of uterine bleeding and the endometrial thickness,menstrual blood volume,hemoglobin level and gonadal hormone concentrations before and after the treatment and untoward effects of patients in the three groups were observed.Results The control time and stop time of uterine bleeding of patients in Group A were significantly longer than those in Group B and Group C respectively（P〈0.05）,while there were no significant differences in the control time and stop time of uterine bleeding between Group B and Group C（P〈0.05）.After the treatment,the endometrial thickness,luteinizing hormone（LH）,estradiol（E_2）,progesterone（P）and follicle stimulating hormone（FSH）of patients in Group A were significantly better than those in Group B and Group C respectively（P〈0.05）,while there were no significant differences in the endometrial thickness,LH,E_2,P and FSH between Group B and Group C（P〈0.05）.The total effective rate of Group A（69.81%）was significantly lower than that of Group B（92.45%）and that of Group C（96.23%）respectively（P〈0.05）,while the total effective rates of Group B and Group C were not significantly different（P〉0.05）.The untoward effect rate of Group A（5.66%）was lower than that of Group B（9.43%）（P〉0.05）,while it was significantly lower than that of Group C（22.64%）（P〈0.05）.However,the untoward effect rates of Group B and Group C were not significantly different（P〉0.05）.Conclusion 15 mg mifepristone combined with desogestrel ethinyloestradiol is effective in treating P-DUB patients with safety and reliability,so it is worthy of clinical application.