LNG-IUS治疗症状性子宫腺肌病过程中月经模式的改变与不良反应

Changes of menstruation patterns and adverse effects during the treatment of LNG-IUS for symptomatic adenomyosis

目的：在前瞻性队列研究中分析左炔诺孕酮宫内缓释系统（LNG-IUS）治疗症状性子宫腺肌病患者的过程中月经模式的改变和不良反应。方法北京协和医院妇产科从2006年12月至2014年12月对通过超声检查诊断为子宫腺肌病的重度痛经和（或）经量过多患者共1100例给予LNG-IUS治疗，在放置LNG-IUS前后不同随访时间点评估患者的LNG-IUS带器情况、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，分析月经模式改变和不良反应相关的影响因素及对治疗效果的影响。结果1100例子宫腺肌病患者的中位年龄为36岁（范围20~44岁），中位随访时间35个月（范围1~108个月）。随随访时间延长，月经模式改变的比例显著增加，闭经和经期缩短是月经模式改变的主要部分；在放置后3、6、12、24、36、48和60个月，闭经发生率分别为0、5.8%（43/744）、6.9%（47/682）、10.1%（60/595）、17.3%（87/502）、27.2%（104/383）和29.6%（82/277），分别比较，差异有统计学意义（P〈0.01），经期缩短的发生率分别为3.5%（28/801）、5.1%（38/744）、6.6%（45/682）、8.9%（53/595）、10.2%（51/502）、19.1%（73/383）和29.2%（81/277），分别比较，差异有统计学意义（P〈0.01）。总体不良反应发生率和不同类型的不良反应发生率均呈下降趋势（P〈0.01）；在放置12个月内，常见的不良反应为下腹痛，在放置12个月及之后，常见的不良反应为体质量增加≥5 kg/年。月经模式改变、总体不良反应、各种类型的不良反应与放置前患者的一般情况、治疗模式以及治疗效果均无显著相关性（P〉0.05），也不能预测LNG-IUS的放置状态（P〉0.05）。LNG-IUS取出或脱落后大部分的月经模式改变和不良反应消失。结论症状性子宫腺肌病患者放置LNG-IUS后随时间延长月经模式改变的比例增加，闭经和经期缩短是最主要的表现；不良反应发生率则显著下降。月经模式改变和不良反应的发生既没有高危因素，也与治疗效果无关。

Objective To investigate the changes of mestruation patterns and adverse effects during the treatment of levonorgestrel-releasing intrauterine system （LNG-IUS） for symptomatic adenomyosis in a prospective cohort study. Methods From December, 2006 to December, 2014, patients of symptomatic adenomyosis diagnosed by transvaginal ultrasound in Peking Union Medical College Hospital were given LNG-IUS. Before and after placement of IUS, all patients′ parameters were recorded, including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects. Risk factors for changes of menstruation patterns and adverse effects, and their impact on treatment effects were analyzed. Results Totally 1 100 cases met＆nbsp;inclusion criteria, with median age 36 years （range 20-44 years）, median follow-up 35 months （range 1-108 months）. During follow-up changes of menstruation patterns increased significantly with amenorrhea and shortened-menstruation being the most common manifestations. On 3, 6, 12, 24, 36, 48 and 60 months after the placement of LNG-IUS, 0, 5.8%（43/744）, 6.9%（47/682）, 10.1%（60/595）, 17.3%（87/502）, 27.2%（104/383） and 29.6%（82/277） patients achieved amenorrhea respectively （P〈0.01）. Total and subclassification of adverse effects decreased significantly （P〈0.01）. Within 12 months and 〉12 months after placement, abdominal pain and body weight increasing ≥5 kg/year were the most common adverse effects. Changes of menstruation patterns, total and subclassifications of adverse effects were neither dependent on patient parameters, treatment modes and treatment effects, nor could predict future LNG-IUS carrying status （all P〉0.05）. After taking out of LNG-IUS, most changes of menstruation and adverse effects disappeared. Conclusions During the treatment of LNG-IUS for symptomatic adenomyosis, changes of menstruation patterns increase gradually with amenorrhea and shortened-menstruation being the most common manifestations, while adverse effects decrease significantly. Changes of menstruation patterns or adverse effects neither have any risk factor nor have impact on treatment effects.