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子宫内膜异位症的腹腔镜手术

Laparoscopic surgery for endometriosis.

作者信息

Duffy James M N, Arambage Kirana, Correa Frederico J S, Olive David, Farquhar Cindy, Garry Ray, Barlow David H, Jacobson Tal Z

机构信息

Women's Health Research Unit, Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry, 58 Turner Street, London, Greater London, UK, E1 2AB.

出版信息

Cochrane Database Syst Rev. 2014 Apr 3(4):CD011031. doi: 10.1002/14651858.CD011031.pub2.

Abstract

BACKGROUND

Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy.

OBJECTIVES

To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis.

SEARCH METHODS

This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013.

SELECTION CRITERIA

Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only.

DATA COLLECTION AND ANALYSIS

Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods.

MAIN RESULTS

Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin-releasing hormone analogue (GnRHa) (goserelin) with add-back therapy. Common limitations in the primary studies included lack of clearly-described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias.Laparoscopic surgery was associated with decreased overall pain (measured as 'pain better or improved') compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I(2) = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I(2) = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I(2) = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence).When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add-back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence).The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI -1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence).

AUTHORS' CONCLUSIONS: There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety.

摘要

背景

子宫内膜异位症是指子宫内膜腺体或间质出现在子宫腔以外的部位,与疼痛和生育力低下相关。手术干预旨在切除子宫内膜异位症的可见病灶并恢复解剖结构。

目的

评估腹腔镜手术治疗与子宫内膜异位症相关的疼痛症状和生育力低下的有效性和安全性。

检索方法

本综述采用了Cochrane月经紊乱与生育力低下小组制定的检索策略,包括检索CENTRAL、MEDLINE、EMBASE、PsycINFO以及自数据库建立至2013年7月的试验注册库。

入选标准

选取随机对照试验(RCT),比较用于治疗与子宫内膜异位症相关的疼痛或生育力低下的腹腔镜手术与其他任何腹腔镜或机器人手术、整体治疗或药物治疗或仅诊断性腹腔镜检查的有效性和安全性。

数据收集与分析

两名综述作者独立进行研究选择、试验质量评估及相关数据提取,分歧由第三名综述作者解决。采用GRADE方法评估证据质量。

主要结果

本综述纳入了10项RCT。这些研究将973名患有与子宫内膜异位症相关的疼痛或生育力低下的参与者进行了随机分组。5项RCT比较了腹腔镜消融或切除与仅诊断性腹腔镜检查。2项RCT比较了腹腔镜切除与仅诊断性腹腔镜检查。2项RCT比较了腹腔镜切除与消融。1项RCT比较了腹腔镜消融与诊断性腹腔镜检查以及注射用促性腺激素释放激素类似物(GnRHa)(戈舍瑞林)加反向添加疗法。原始研究的常见局限性包括缺乏清晰描述的盲法、未能充分描述随机化和分配隐藏方法以及失访偏倚风险。与诊断性腹腔镜检查相比,腹腔镜手术在6个月时(比值比(OR)6.58,95%置信区间3.31至13.10,3项RCT,171名参与者,I² = 0%,中等质量证据)和12个月时(OR 10.00,95%置信区间3.21至31.17,1项RCT,69名参与者,低质量证据)均与总体疼痛减轻(以“疼痛好转或改善”衡量)相关。与诊断性腹腔镜检查相比,腹腔镜手术还与活产或持续妊娠率增加(OR 1.94,95%置信区间1.20至3.16,P = 0.007,2项RCT,382名参与者,I² = 0%,中等质量证据)和临床妊娠率增加(OR 1.89,95%置信区间1.25至2.86,P = 0.003,3项RCT,528名参与者,I² = 0%,中等质量证据)相关。两项研究收集了不良事件数据(包括感染、血管和内脏损伤以及转为开腹手术),并报告两组均无事件发生。其他研究未报告此结果。腹腔镜手术和诊断性剖腹手术对每次妊娠流产率的相似影响不精确(OR 0.94,95%置信区间0.35至2.54,2项研究,112名女性,中等质量证据)。当将腹腔镜消融与诊断性腹腔镜检查加药物治疗(GnRHa加反向添加疗法)进行比较时,消融组更多女性报告在12个月时无痛(OR 5.63,95%置信区间1.18至26.85,1项RCT,35名参与者,低质量证据)。在0至10分疼痛视觉模拟量表(VAS)上,报告12个月时总体疼痛缓解的女性比例中,腹腔镜消融与腹腔镜切除之间的差异为0(95%置信区间 -1.22至1.22,P = 1.00,1项RCT,103名参与者,低质量证据)。

作者结论

有中等质量证据表明,腹腔镜手术治疗轻度和中度子宫内膜异位症可减轻总体疼痛并提高活产或持续妊娠率。有低质量证据表明,腹腔镜切除和消融在缓解疼痛方面同样有效,尽管仅有一项相关研究。对于重度子宫内膜异位症、与子宫内膜异位症相关的不同类型疼痛(例如痛经(经期疼痛))以及比较腹腔镜手术与整体治疗和药物治疗,还需要更多研究。关于不良事件的证据不足,无法就安全性得出任何结论。

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