Am J Obstet Gynecol:左炔诺孕酮宫内缓释系统预防术后子宫内膜异位症复发是否有效?

2017-06-28 Emma MedSci原创

根据3项已报道的随机试验,左炔诺孕酮宫内缓释系统显著减少术后1年复发性子宫内膜异位症相关的盆腔疼痛。因此,研究人员设计随机对照试验,探究将左炔诺孕酮宫内缓释系统作为预防术后子宫内膜异位症复发的维持治疗手段是否有效。

根据3项已报道的随机试验,左炔诺孕酮宫内缓释系统显著减少术后1年复发性子宫内膜异位症相关的盆腔疼痛。因此,研究人员设计随机对照试验,探究将左炔诺孕酮宫内缓释系统作为预防术后子宫内膜异位症复发的维持治疗手段是否有效。

2011年5月至2012年3月期间,共80例接受腹腔镜手术的子宫内膜异位症患者,之后进行了六个周期的促性腺激素释放激素激动剂治疗。手术后,患者按有或没有接受左炔诺孕酮宫内缓释系统(干预组n = 40;对照组n = 40)进行随机分组。主要指标是手术后30个月后 子宫内膜异位症复发。次要指标包括痛经,CA125水平,非周期性盆腔疼痛和一些副作用。

结果显示,两组间主要指标差异无统计学意义(干预组40例中10例,25%;对照组40例中15例,37.5%;风险比0.60,95%置信区间,0.27-1.33,P =0.209)。干预组显示较低的痛经复发率,估计风险比为0.32(95%置信区间,0.12-0.83,P = 0.019)。使用视觉模拟量表评分,经过30个月的随访,干预组与对照组相比,痛经(平均值±SD,60.8±25.5和38.7±25.9;P <0.001,95%置信区间,10.7-33.5);非周期性盆腔疼痛(平均值±SD,39.1±10.9 和 30.1±14.7;P = 0.014,95%置信区间,1.9-16.1);CA125水平(中位数[四分位数范围],-32.1 [-59.1至14.9]和 -15.6 [-33.0至5.0];P = .001)。痛经复发需要治疗的患者数是5,干预组复发病例中需要进一步手术或激素治疗的患者(40例中1例,2.5%;95%置信区间,-2.3%-7.3%),显著低于对照组(40例中8例,20%;95%置信区间,7.6%-32.4%,P = 0.031)。结果说明,将左炔诺孕酮宫内缓释系统作为预防术后子宫内膜异位症复发的维持治疗手段是没有效果的。

原始出处:
Chen, Y. J., et al. Postoperative maintenance levonorgestrel-releasing intrauterine system and endometrioma recurrence: a randomized controlled study. Am J Obstet Gynecol. 2017 Jun;216(6):582.e1-582.e9. doi: 10.1016/j.ajog.2017.02.008.

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    2017-11-13 yhy100200
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    2017-06-30 周虎
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