Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Obstetrics and Gynecology, Cheng Hsin General Hospital, Taipei, Taiwan.
Department of Emergency Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan.
Am J Obstet Gynecol. 2017 Jun;216(6):582.e1-582.e9. doi: 10.1016/j.ajog.2017.02.008. Epub 2017 Feb 15.
According to 3 randomized trials, the levonorgestrel-releasing intrauterine system significantly reduced recurrent endometriosis-related pelvic pain at postoperative year 1. Only a few studies have evaluated the long-term effectiveness of the device for preventing endometrioma recurrence, and the effects of a levonorgestrel-releasing intrauterine system as a maintenance therapy remain unclear.
The objective of the study was to evaluate whether a maintenance levonorgestrel-releasing intrauterine system is effective for preventing postoperative endometrioma recurrence.
From May 2011 through March 2012, a randomized controlled trial including 80 patients with endometriomas undergoing laparoscopic cystectomy followed by six cycles of gonadotropin-releasing hormone agonist treatment was conducted. After surgery, the patients were randomized to groups that did or did not receive a levonorgestrel-releasing intrauterine system (intervention group, n = 40, vs control group, n = 40). The primary outcome was endometrioma recurrence 30 months after surgery. The secondary outcomes included dysmenorrhea, CA125 levels, noncyclic pelvic pain, and side effects.
Endometrioma recurrence at 30 months did not significantly differ between the 2 groups (the intervention group, 10 of 40, 25% vs the control group 15 of 40, 37.5%; hazard ratio, 0.60, 95% confidence interval, 0.27-1.33, P = .209). The intervention group exhibited a lower dysmenorrhea recurrence rate, with an estimated hazard ratio of 0.32 (95% confidence interval, 0.12-0.83, P = .019). Over a 30 month follow-up, the intervention group exhibited a greater reduction in dysmenorrhea as assessed with a visual analog scale score (mean ± SD, 60.8 ± 25.5 vs 38.7 ± 25.9, P < .001, 95% confidence interval, 10.7-33.5), noncyclic pelvic pain visual analog scale score (39.1 ± 10.9 vs 30.1 ± 14.7, P = .014, 95% confidence interval, 1.9-16.1), and CA125 (median [interquartile range], -32.1 [-59.1 to 14.9], vs -15.6 [-33.0 to 5.0], P = .001) compared with the control group. The number-needed-to-treat benefit for dysmenorrhea recurrence at 30 months was 5. The number of recurrent cases requiring further surgical or hormone treatment in the intervention group (1 of 40, 2.5%, 95% confidence interval, -2.3% to 7.3%) was significantly lower than that in the control group (8 of 40, 20%, 95% confidence interval, 7.6-32.4%; P = .031).
Long-term maintenance therapy using a levonorgestrel-releasing intrauterine system is not effective for preventing endometrioma recurrence.
根据 3 项随机试验，左炔诺孕酮释放宫内节育系统可显著降低术后第 1 年复发性子宫内膜异位症相关盆腔痛。仅有少数研究评估了该设备预防子宫内膜囊肿复发的长期有效性，左炔诺孕酮释放宫内节育系统作为维持治疗的效果仍不清楚。
本研究旨在评估左炔诺孕酮释放宫内节育系统是否对预防术后子宫内膜囊肿复发有效。
2011 年 5 月至 2012 年 3 月，一项纳入 80 例接受腹腔镜囊肿切除术且术后接受 6 个周期促性腺激素释放激素激动剂治疗的子宫内膜囊肿患者的随机对照试验进行。手术后，患者被随机分为接受或不接受左炔诺孕酮释放宫内节育系统（干预组，n=40；与对照组，n=40）的两组。主要结局是术后 30 个月时子宫内膜囊肿复发。次要结局包括痛经、CA125 水平、非周期性盆腔痛和副作用。
两组 30 个月时的子宫内膜囊肿复发率无显著差异（干预组，40 例中有 10 例，25%；对照组，40 例中有 15 例，37.5%；风险比，0.60，95%置信区间，0.27-1.33，P=0.209）。干预组痛经复发率较低，估计风险比为 0.32（95%置信区间，0.12-0.83，P=0.019）。在 30 个月的随访中，干预组痛经视觉模拟评分（平均±SD，60.8±25.5 与 38.7±25.9，P<0.001，95%置信区间，10.7-33.5）、非周期性盆腔痛视觉模拟评分（39.1±10.9 与 30.1±14.7，P=0.014，95%置信区间，1.9-16.1）和 CA125（中位数[四分位数范围]，-32.1[-59.1 至 14.9]与-15.6[-33.0 至 5.0]，P=0.001）均显著低于对照组。30 个月时痛经复发的需要治疗人数（NNTB）为 5。干预组（40 例中有 1 例，2.5%，95%置信区间，-2.3%至 7.3%）需要进一步手术或激素治疗的复发病例数明显低于对照组（40 例中有 8 例，20%，95%置信区间，7.6-32.4%；P=0.031）。
长期使用左炔诺孕酮释放宫内节育系统作为维持治疗并不能预防子宫内膜囊肿复发。
