左炔诺孕酮宫内缓释系统放置时机对腺肌病治疗效果的前瞻性队列研究

A prospective cohort study on the impact of placement timing of LNG-IUS for adenomyosis

目的探讨左炔诺孕酮宫内缓释系统（LNG-IUS）在妇科腹腔镜术中放置或常规放置对LNG-IUS治疗效果和不良反应的影响。方法 采用前瞻性队列研究方法对北京协和医院妇产科2006年12月至2014年12月门诊或住院部通过超声诊断为子宫腺肌病的患者给予LNG-IUS治疗，在放置前后不同随访时间点评估患者的携带情况、痛经症状、疼痛评分、出血评分、生化指标、体格参数、月经模式以及不良反应，分析不同放置时机（在妇科腹腔镜术中放置，或在经期常规放置）对LNG-IUS治疗效果、月经模式以及不良反应的影响。结果 符合入选标准患者共1 100例，中位年龄36（20～44）岁，中位随访时间35（1～108）个月，其中385例（35.0%）在妇科腹腔镜术中放置LNG-IUS。主要的手术指征和手术或病理检查发现是子宫内膜异位症（简称内异症），大部分为深部浸润型内异症。术中放置患者和非术中放置患者在60个月的累积续带率分别为73%和63%（P〈0.001），失访率分别为8.1%和16.8%（P〈0.001），取出率分别为7.8%和10.3%（P＝0.044）。是否术中放置LNG-IUS是惟一影响失访率（P〈0.001）和取出率（P〈0.001）的相关因素。LNG-IUS放置前患者的手术情况、病理学类型等因素不影响LNG-IUS的治疗效果、月经模式改变、总体不良反应以及各种亚型的不良反应。结论 妇科腹腔镜术中放置LNG-IUS能够提高症状性腺肌病患者的续带率，减少失访和取出率，但并不影响治疗效果和不良反应。

ObjectiveTo investigate the impact of placement in the procedures of gynecological laparoscopies or routine placement on the effects of levonorgestrel-releasing intrauterine system （LNG-IUS） for symptomatic adenomyosis in a prospective cohort study.MethodsFrom December, 2006 to December, 2014, patients with adenomyosis diagnosed by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital received the treatment of LNG-IUS.Before and after placement of LNG-IUS all the parameters were recorded including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects.Impact of placement timing （in the procedures of laparoscopies vesus routine placement） on the treatment effects, menstruation patterns and adverse effects of LNG-IUS were analyzed.Results1 100 patients meet the inclusion criteria, with median age 36 years （20-44 years）, median follow-up 35 months （1-108 months）, of which 385 cases （35.0%） received LNG-IUS in the procedures of gynecological laparoscopies. Most common indications and pathology outcomes were endometriosis, major of which had deep infiltrating endometriosis. The accumulative carrying ratio of LNG-IUS were 73% and 63% on 60 months for operative patients and non-operative patients respectively （P〈0.001）, and accumulative take-out ratio were 7.8% and 10.3% （P=0.044）. Placement timing of LNG-IUS was the only significant factor related with loss to follow-up （P〈0.001） and take-out ratio （P〈0.001）. Operations and pathological outcome had no significant impact on patients′ treatment effects, changes of menstruation patterns, adverse effects in total or in subclass.ConclusionPlacement of LNG-IUS in the procedures of gynecological laparoscopies for symptomatic adenomyosis increased carrying ratio and reduce take-out ratio at patients′request, but didn′t influence treatment effects or adverse effects.