米非司酮治疗皮下埋植避孕剂阴道出血的疗效研究

Effectiveness of Administration of Mifepristone Treating Vaginal Bleeding in Women using Implants.

本研究采用双盲法随机分组,应用米非司酮和安慰剂进行药物临床试验,以了解服用米非司酮是否能改善左炔诺孕酮(LNG)皮下埋植剂使用妇女阴道异常出血的情况。结果;研究组与对照组的出血/滴血天数、出血/滴血平均时间均短于服药前参照期;出血/滴血间歇天数均大于服药前参照期(P<0.01)。服药参照期中,研究组的出血/滴血平均长度短于对照组,且服药4～6个月内出血/滴血天数小于对照组,而其出血/滴血间歇天数大于对照组(P<0.01)。疗效自我评估满意率研究组明显高于对照组。研究中共测试600份尿HCG无一例阳性,测定了520份尿孕激素值,研究组与对照组无明显差异(P>0.05)。提示每月一次50mg米非司酮口服对皮下埋植避孕剂后阴道异常出血有一定疗效,而不影响埋植剂的避孕效果。对照组也有疗效,说明心理咨询也是皮下埋植避孕后阴道异常出血的重要对策之一,临床应予以重视。

Purpose The aim was to find out whether administration of mifepristone could improve abnormal vaginal bleeding among women using Levonorgestrel (LNG)implants. Material and Method Using double-blind randomized method,patients were divided into two groups,one using mifepristone, the other placebo. Result During the treatment period (mifepristone or placebo), the bleeding/ spotting days and the mean duration of bleeding/spotting episodes were are shorter than those of period before treatment, while bleeding/spotting free days were longer than before (P<0. 01). In the treatment period, the mean duration of bleeding/spotting episodes in the study group was shorter than that of the control group. During 4-6 months of treatment,bleeding/spotting days of the former were shorter and bleeding/spotting free days longer than the latter(P<0. 01). The rate of self-evaluation of post-treatment satisfaction in the study group was significantly higher than the control. In this study,none of 600 samples of urinal HCG was positive. All of 520 samples of urinal progestin were measured,and there was no significant difference between the two groups (P>0. 05). Conclusion This study hints that taking mifepristone 50mg once a month is effective in treating abnormal vaginal bleeding caused by LNG implants,and will not reduce the contraceptive effectiveness. Psychological advisory is also an important strategy in treating abnormal vaginal bleeding caused by implants, and more attention should be paid to in the clinical work.