LNG-IUS治疗子宫腺肌病相关重度痛经的前瞻性研究

A prospective cohort study on effects of levonorgestrel-releasing intrauterine system for adenomyosis with severe dysmenorrhea

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）治疗子宫腺肌病相关重度痛经的效果及痛经缓解的预测因素。方法选择2006年12月至2014年12月在中国医学科学院北京协和医院妇产科门诊或住院部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，在放置前后不同随访时点评估患者的痛经症状、疼痛评分、出血评分、生化指标、体格参数、LNG-IUS带器情况、月经模式以及不良反应，分析疼痛评分及分布的变化趋势、重度痛经缓解的预测因素以及与月经模式、不良反应的关系。结果符合入选标准的子宫腺肌病患者共1100例，其中重度痛经患者640例（58.18%，640/1100），中位随访时间35个月（范围1～60个月），在放置LNG-IUS后60个月时的累积续用率为65%。放置LNG-IUS后重度痛经患者的疼痛评分与放置前相比均显著下降（P均〈0.01），放置前、放置后3、6、12、24、36、48和60个月的视觉模拟评分（VAS）分别为（8.1±0.9）、（5.5±2.4）、（4.6±2.4）、（3.3±2.2）、（2.2±2.1）、（2.2±1.8）、（1.4±1.6）、（1.3±1.3）分。放置LNG-IUS后重度痛经患者的比例与放置前相比显著下降（P均〈0.01）。在放置LNG-IUS的36个月内，每个随访时点与前一随访时点比较，疼痛评分均有显著改善（P均〈0.01）。未能发现可以统一预测痛经缓解的相关因素。痛经缓解情况与同期患者报告的月经模式变化、总体不良反应、不同类型的不良反应等因素均无显著相关性（P均〉0.05）。结论 LNG-IUS是治疗子宫腺肌病相关重度痛经的有效方案，痛经改善状态与患者的一般情况、治疗模式、月经变化或不良反应无关。

Objective To investigate treatment effects of levonorgestrel-releasing intrauterine system （LNG-IUS） for adenomyosis with severe dysmenorrhea in a prospective cohort study. Methods From December 2006 to December 2014, patients of symptomatic adenomyosis diagnosed by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before and after placement of LNG-IUS, all the patients′parameters were recorded prospectively, including symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, carrying status of LNG-IUS, menstruation patterns and adverse effects. Changes of scores and patterns of pain during follow-up were analyzed. Results Totally 1 100 women meets inclusion criteria, among which 640 cases （58.18%, 640/1 100） had severe dysmeorrhea, with median follow-up period of 35 months （range 1-60 months）, and accumulative carrying rate of 65% at 60 months follow-up. After placement of LNG-IUS, scores of pain and ratio of severe dysmenorrhea had decreased significantly compared with baselines （all P〈0.01）, the scroes of visual analog scale （VAS） were 8.1 ± 0.9, 5.5 ± 2.4, 4.6 ±＆amp;nbsp;2.4, 3.3 ± 2.2, 2.2 ± 2.1, 2.2 ± 1.8, 1.4 ± 1.6 and 1.3 ± 1.3 at 0, 3, 6, 12, 24, 36, 48 and 60 months respectively. During 36 months after placement of LNG-IUS, scores of pain had improved significantly compared with preceding period （all P〈0.01）. We found no universal dependent factors predicting improvement of pain, which was neither relevant with simultaneous changes of menstruation patterns nor adverse effects （all P〉0.05）. Conclusion LNG-IUS is effective for adenomyosis of severe dysmenorrhea. Improvement of pain is independent on patients characters, menstruation patterns or adverse effects.