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目的:评估左炔诺孕酮(LNG)宫内释放系统用于子宫出血过多是否可作为替代子宫切除术的保守治疗方法。 设计:开放性随机多中心研究,有两个平行组:LNG宫内系统组及对照组。 地点:芬兰3家医院的妇科。 对象:56例年龄为33~49岁、因子宫出血过多计划行子宫切除术治疗的妇女。 干预措施:将研究对象随机分为继续现用治疗措施或放置LNG宫内系统。 主要结果评价指标:取消行子宫切除术决定的妇女所占比例。 结果:6个月时,LNG宫内系统组中64.3%(95%可信区间44.1%~81.4%)及对照组中14.3%(4%~32.3%)妇女取消行子宫切除术的决定(P<0.001)。 结论:LNG宫内系统用于月经过多者可作为替代子宫切除术的良好保守治疗方法,在施行子宫切除术或其它创伤性治疗前应予考虑。
OBJECTIVE: To assess whether levonorgestrel (LNG) intrauterine release system for uterine bleeding is a conservative treatment alternative to hysterectomy. DESIGN: Open-label randomized multicenter study with two parallel groups: LNG intrauterine system group and control group. Location: Three hospitals in Finland, gynecology. PARTICIPANTS: Fifty-six women aged 33-49 years who were scheduled for hysterectomy due to excessive uterine bleeding. Interventions: Subjects were randomly assigned to continue active treatment or place LNG intrauterine system. MAIN OUTCOME EVALUATION INDICATORS: Percentage of women who have decided to hysterectomy. Results: At 6 months, 64.3% (95% confidence interval, 44.1% ~ 81.4%) in LNG intrauterine system group and 14.3% (4% ~ 32.3% %) Women’s decision to cancel hysterectomy (P <0.001). CONCLUSIONS: LNG intrauterine system for menorrhagia can be used as a conservative alternative to hysterectomy and should be considered before hysterectomy or other traumatic treatments.