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左炔诺孕酮宫内节育系统(曼月乐)与子宫内膜切除术(NovaSure)治疗月经过多的疗效比较:一项多中心随机对照试验

Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding: a multicentre randomised controlled trial.

作者信息

Herman Malou C, van den Brink Marian J, Geomini Peggy M, van Meurs Hannah S, Huirne Judith A, Eising Heleen P, Timmermans Anne, Pijnenborg Johanna M A, Klinkert Ellen R, Coppus Sjors F, Nieboer Theodoor E, Catshoek Ruby, van der Voet Lucet F, van Eijndhoven Hugo W F, Graziosi Giuseppe C M, Veersema Sebastiaan, van Kesteren Paul J, Langenveld Josje, Smeets Nicol A C, van Vliet Huib A A M, van der Steeg Jan Willem, Lisman-van Leeuwen Yvonne, Dekker Janny H, Mol Ben W, Berger Marjolein Y, Bongers Marlies Y

出版信息

BMC Womens Health. 2013 Aug 8;13:32. doi: 10.1186/1472-6874-13-32.

Abstract

BACKGROUND

Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As an alternative, endometrial ablation is also very effective, but this treatment has to be performed by a gynaecologist. Due to lack of direct comparison of LNG-IUS with endometrial ablation, there is no evidence based preferred advice for the use of one of these treatment possibilities.

METHOD/DESIGN: A multicenter randomised controlled trial, organised in a network infrastructure in the Netherlands in which general practitioners and gynaecologists collaborate.

DISCUSSON

This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding.

TRIAL REGISTRATION

Dutch trial register, number NTR2984.

摘要

背景

月经过多是一个重要的健康问题。两种常用的治疗方法是左炔诺孕酮宫内节育系统(LNG-IUS)和子宫内膜切除术。LNG-IUS可由全科医生轻松应用,节省成本,但失败率相当高。作为替代方案,子宫内膜切除术也非常有效,但这种治疗必须由妇科医生进行。由于缺乏LNG-IUS与子宫内膜切除术的直接比较,对于使用这两种治疗方法中的哪一种,没有基于证据的首选建议。

方法/设计:一项多中心随机对照试验,在荷兰的一个网络基础设施中组织,全科医生和妇科医生在其中合作。

讨论

这项研究考虑了LNG-IUS与子宫内膜切除术的有效性和成本效益,很可能会改善对月经过多女性的护理。

试验注册

荷兰试验注册,编号NTR2984。

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