Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea.
Int J Gynaecol Obstet. 2013 Apr;121(1):24-30. doi: 10.1016/j.ijgo.2012.10.028. Epub 2013 Jan 20.
To compare clinical outcomes, including cumulative continuation rate (CCR), in the treatment of idiopathic heavy menstrual bleeding (HMB) with the levonorgestrel-releasing intrauterine system (LNG-IUS) and with conventional medical therapies (CMTs), including combined oral contraceptives, oral progestins, and antifibrinolytics, either alone or in combination, in the Asia-Pacific region.
In a prospective observational cohort study conducted between September 2008 and December 2010, 647 women (LNG-IUS, n=483; CMTs, n=164), aged 18-45 years and diagnosed with HMB, were recruited from 8 countries and followed for up to 1 year. The primary outcome was the CCR at 12 months. Secondary outcomes included bleeding pattern, an assessment of treatment efficacy by the treating physician, and safety.
The CCR at 12 months was significantly higher for LNG-IUS than for CMTs (87.6% vs 56.3% P<0.05). Compared with CMTs, LNG-IUS offered a better reduction in both subjectively assessed menstrual blood loss and the number of bleeding days, and had better efficacy for HMB, as determined by the physician's final evaluation.
The present study provides information on the real-life patterns of treatment of HMB in the Asia-Pacific region. The efficacy of CMTs was inferior compared with LNG-IUS in the clinical outcomes measured. ClinicalTrials.gov:NCT00864136.
比较左炔诺孕酮宫内缓释系统（LNG-IUS）与传统医学疗法（CMTs）在亚太地区治疗特发性月经过多（HMB）的临床结局，包括累积续用率（CCR）。
在 2008 年 9 月至 2010 年 12 月期间进行的一项前瞻性观察性队列研究中，招募了 647 名年龄在 18-45 岁之间、被诊断为 HMB 的女性（LNG-IUS 组 n=483；CMTs 组 n=164），并随访了长达 1 年。主要结局是 12 个月时的 CCR。次要结局包括出血模式、治疗医师评估的治疗效果和安全性。
LNG-IUS 组的 12 个月 CCR显著高于 CMTs 组（87.6% vs. 56.3%，P<0.05）。与 CMTs 相比，LNG-IUS 组在主观评估的月经失血量和出血天数方面有更好的减少，并且在医生的最终评估中对 HMB 有更好的疗效。
本研究提供了亚太地区治疗 HMB 的真实模式的信息。与 LNG-IUS 相比，CMTs 在测量的临床结局方面疗效较差。ClinicalTrials.gov:NCT00864136。
