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子宫内膜消融或切除术与左炔诺孕酮宫内节育系统治疗宫腔正常的月经过多妇女:系统评价与荟萃分析。

Endometrial ablation or resection versus levonorgestrel intra-uterine system for the treatment of women with heavy menstrual bleeding and a normal uterine cavity: a systematic review with meta-analysis.

机构信息

Université Laval, 2325 Rue de l'Université, QC, Québec, Canada G1V 0A6.

CHU de Québec, 2705, boul. Laurier, QC, Québec, Canada GIV 4G2.

出版信息

Hum Reprod Update. 2020 Feb 28;26(2):302-311. doi: 10.1093/humupd/dmz051.

DOI:10.1093/humupd/dmz051
PMID:31990359
Abstract

BACKGROUND

Endometrial ablation/resection and the levonorgestrel intra-uterine system (LNG-IUS) are well-established treatment options for heavy menstrual bleeding to avoid more invasive alternatives, such as hysterectomy.

OBJECTIVE

The aim was to compare the efficacy and safety of endometrial ablation or resection with the LNG-IUS in the treatment of premenopausal women with heavy menstrual bleeding and to investigate sources of heterogeneity between studies.

SEARCH METHODS

We searched the databases MEDLINE, EMBASE, CENTRAL, Web of Science, Biosis and Google Scholar as well as citations and reference lists published up to August 2019. Two authors independently screened 3701 citations for eligibility. We included randomized controlled trials published in any language, comparing endometrial ablation or resection to the LNG-IUS in the treatment of premenopausal women with heavy menstrual bleeding and a normal uterine cavity.

OUTCOMES

Thirteen studies (N = 884) were eligible. Two independent authors extracted data and assessed the quality of included studies. Random effect models were used to compare the modalities and evaluate sources of heterogeneity. No significant differences were observed between endometrial ablation/resection and the LNG-IUS in terms of subsequent hysterectomy (primary outcome, risk ratio (RR) = 1.13, 95% CI 0.60 to 2.11, P = 0.71, I2 = 14%, 12 studies, 726 women), satisfaction, quality of life, amenorrhea and treatment failure. However, side effects were less common in women treated with endometrial ablation/resection compared to the LNG-IUS (RR = 0.52, 95% CI 0.37 to 0.71, P < 0.001, I2 = 0%, 10 studies, 580 women). Three complications were reported in the endometrial ablation/resection group and none in the LNG-IUS group (P = 0.25). Mean age of the studied populations was identified as a significant source of heterogeneity between studies in subgroup analysis (P = 0.01). In fact, endometrial ablation/resection was associated with a higher risk of subsequent hysterectomy compared to the LNG-IUS in younger populations (mean age ≤ 42 years old, RR = 5.26, 95% CI 1.21 to 22.91, P = 0.03, I2 = 0%, 3 studies, 189 women). On the contrary, subsequent hysterectomy seemed to be less likely with endometrial ablation/resection compared to the LNG-IUS in older populations (mean age > 42 years old), although the reduction did not reach statistical significance (RR = 0.51, 95% CI 0.21 to 1.24, P = 0.14, I2 = 0%, 5 studies, 297 women). Finally, sensitivity analysis taking into account the risk of bias of included studies and type of surgical devices (first and second generation) did not modify the results. Most of the included studies reported outcomes at up to 3 years, and the relative performance of endometrial ablation/resection and LNG-IUS remains unknown in the longer term.

WIDER IMPLICATIONS

Endometrial ablation/resection and the LNG-IUS are two excellent treatment options for heavy menstrual bleeding, although women treated with the LNG-IUS are at higher risk of experiencing side effects compared to endometrial ablation/resection. Otherwise, younger women seem to present a lower risk of eventually requiring hysterectomy when treated with the LNG-IUS compared to endometrial ablation/resection.

摘要

背景

子宫内膜消融/切除术和左炔诺孕酮宫内节育系统(LNG-IUS)是治疗月经过多的成熟治疗选择,可避免采用更具侵袭性的替代方法,如子宫切除术。

目的

旨在比较子宫内膜消融/切除术与 LNG-IUS 治疗有生育能力的月经过多女性的疗效和安全性,并探讨研究间异质性的来源。

检索方法

我们检索了 MEDLINE、EMBASE、CENTRAL、Web of Science、Biosis 和 Google Scholar 数据库以及截至 2019 年 8 月发表的参考文献列表。两位作者独立筛选了 3701 条引文以确定其是否符合纳入标准。我们纳入了以任何语言发表的比较子宫内膜消融/切除术与 LNG-IUS 治疗有生育能力的月经过多女性且子宫腔正常的随机对照试验。

结局

13 项研究(N=884)符合纳入标准。两位独立作者提取了数据并评估了纳入研究的质量。采用随机效应模型比较了两种治疗方法,并评估了异质性的来源。子宫内膜消融/切除术与 LNG-IUS 相比,在随后的子宫切除率(主要结局,风险比(RR)=1.13,95%CI 0.60 至 2.11,P=0.71,I2=14%,12 项研究,726 名女性)、满意度、生活质量、闭经和治疗失败方面无显著差异。然而,与 LNG-IUS 相比,子宫内膜消融/切除术的副作用较少(RR=0.52,95%CI 0.37 至 0.71,P<0.001,I2=0%,10 项研究,580 名女性)。子宫内膜消融/切除术组报告了 3 例并发症,而 LNG-IUS 组则没有(P=0.25)。在亚组分析中,研究人群的平均年龄被确定为研究间异质性的一个显著来源(P=0.01)。事实上,与 LNG-IUS 相比,子宫内膜消融/切除术在年轻人群(平均年龄≤42 岁,RR=5.26,95%CI 1.21 至 22.91,P=0.03,I2=0%,3 项研究,189 名女性)中与更高的后续子宫切除率相关。相反,与 LNG-IUS 相比,子宫内膜消融/切除术在年龄较大的人群(平均年龄>42 岁)中似乎不太可能导致后续子宫切除,尽管这种减少没有达到统计学意义(RR=0.51,95%CI 0.21 至 1.24,P=0.14,I2=0%,5 项研究,297 名女性)。最后,纳入研究的偏倚风险和手术设备类型(第一代和第二代)的敏感性分析并没有改变结果。大多数纳入的研究报告了最多 3 年的结局,子宫内膜消融/切除术和 LNG-IUS 的相对疗效在长期内仍不清楚。

意义

子宫内膜消融/切除术和 LNG-IUS 是治疗月经过多的两种极好的治疗选择,尽管与子宫内膜消融/切除术相比,LNG-IUS 治疗的女性发生副作用的风险更高。否则,与子宫内膜消融/切除术相比,年轻女性在接受 LNG-IUS 治疗时最终需要子宫切除术的风险似乎较低。

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