School of Clinical and Experimental Medicine, University of Birmingham, Birmingham Women's Hospital, Birmingham B15 2TG, UK.
Hum Reprod. 2013 Nov;28(11):2966-71. doi: 10.1093/humrep/det320. Epub 2013 Aug 23.
What are the regression and hysterectomy rates for women treated with the levonorgestrel-releasing intrauterine system (LNG-IUS) compared with oral progestogens for endometrial hyperplasia (EH)?
The LNG-IUS achieves higher regression and lower hysterectomy rates than oral progestogens in the treatment of complex and atypical hyperplasia.
The LNG-IUS and oral progestogens are both equally used to treat women with EH. There is uncertainty about whether the LNG-IUS is a better therapy for EH.
STUDY DESIGN, SIZE, DURATION: This comparative cohort study included 344 women recruited from August 1998 until December 2010.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Women with complex non-atypical or atypical EH were treated with the LNG-IUS (n = 250) or oral progestogens (n = 94) in a tertiary referral hospital. We evaluated the proportion of women who regressed or underwent hysterectomy after treatment with the LNG-IUS compared with oral progestogens by logistic regression adjusting for confounding. The time from diagnosis to regression was explored through a survival analysis.
The follow-up rate was 95.3%. The mean length of follow-up in the two groups was 66.9 ± SD 35.1 months for the LNG-IUS and 87.2 ± SD 45.5 months for the oral progestogen group. Regression of hyperplasia was achieved in 94.8% (237/250) of patients with the LNG-IUS compared with 84.0% (79/94) of patients treated with oral progestogens (adjusted odds ratio (OR) = 3.04, 95% CI 1.36-6.79, P = 0.001). Hysterectomy rates were lower in the LNG-IUS group during follow-up (22.1, 55/250 versus 37.2%, 35/94, adjusted OR = 0.48, 95% CI 0.28-0.81, P < 0.004). Endometrial cancer was diagnosed in 8 (33%) women who had hysterectomy because of a failure to regress to normal histology during follow-up (n = 24).
LIMITATIONS, REASONS FOR CAUTION: The observational design cannot exclude residual confounding from unmeasured variables.
In treating EH, LNG-IUS achieves higher regression rates and lower hysterectomy rates than oral progestogens and should be the first-line therapy. Failure to achieve regression carries a high risk of underlying endometrial cancer and hysterectomy is advised.
与口服孕激素相比，左炔诺孕酮宫内缓释系统（LNG-IUS）治疗子宫内膜增生症（EH）的患者中，其复发率和子宫切除术率是多少？
LNG-IUS 治疗复杂性和非典型性增生的复发率高于口服孕激素，子宫切除术率低于口服孕激素。
LNG-IUS 和口服孕激素均同样用于治疗 EH 患者。对于 LNG-IUS 是否是治疗 EH 的更好方法存在不确定性。
研究设计、规模、持续时间：本比较队列研究纳入了 1998 年 8 月至 2010 年 12 月期间招募的 344 名女性。
参与者/材料、地点、方法：在一家三级转诊医院中，患有复杂非典型或非典型 EH 的女性接受 LNG-IUS（n=250）或口服孕激素（n=94）治疗。我们通过调整混杂因素的逻辑回归评估了与口服孕激素相比，LNG-IUS 治疗后患者中发生复发或接受子宫切除术的比例。通过生存分析探讨了从诊断到缓解的时间。
随访率为 95.3%。两组的平均随访时间为 LNG-IUS 组 66.9±35.1 个月，口服孕激素组 87.2±45.5 个月。LNG-IUS 组中 94.8%（237/250）的患者增生得到缓解，而口服孕激素组中这一比例为 84.0%（79/94）（调整后的优势比（OR）=3.04，95%CI 1.36-6.79，P=0.001）。在随访期间，LNG-IUS 组的子宫切除术率较低（22.1%，55/250 与 37.2%，35/94，调整后的 OR=0.48，95%CI 0.28-0.81，P<0.004）。在随访期间，由于未能恢复正常组织学而导致 24 例患者中 8 例（33%）需要进行子宫切除术，这些患者被诊断为子宫内膜癌（n=24）。
局限性、谨慎的理由：观察性设计不能排除未测量变量引起的残余混杂。
在治疗 EH 方面，LNG-IUS 比口服孕激素具有更高的缓解率和更低的子宫切除术率，应作为一线治疗方法。未能缓解会增加潜在子宫内膜癌的风险，建议进行子宫切除术。
