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宫腔镜输卵管绝育术:Essure 系统的系统评价。

Hysteroscopic tubal sterilization: a systematic review of the Essure system.

机构信息

Department of Obstetrics and Gynecology, Hyvinkää Hospital, Hyvinkää, Finland.

出版信息

Fertil Steril. 2010 Jun;94(1):16-9. doi: 10.1016/j.fertnstert.2009.02.080. Epub 2009 May 5.

DOI:10.1016/j.fertnstert.2009.02.080
PMID:19409549
Abstract

OBJECTIVE

To update the evidence of the efficacy and safety of the Essure system. Female sterilization has undergone changes in the last decade. Besides laparoscopic tubal occlusion, the Essure system is now a viable option, with about 200,000 women sterilized using this method.

DESIGN

The review is based on the report of the Alberta Heritage Foundation for Medical Research and completed with systematic literature searches up to April 8, 2008.

SETTING

The Managed Uptake of Medical Methods program of the Finnish National Research and Development Center for Health and Welfare.

PATIENT(S): Women over 30 years, who had been sterilized by the Essure method.

INTERVENTION(S): Hysteroscopic tubal sterilization using Essure system.

MAIN OUTCOME MEASURE(S): Efficacy/effectiveness, adverse events, costs.

RESULT(S): Sterilization by Essure can be performed under local anesthesia or with oral analgesics in ambulatory settings. However, sterilization is not immediate and women must use additional contraception for 3 months until permanent tubal occlusion is verified by transvaginal ultrasound, hysterosalpingosonography, hysterosalpingography, or pelvic radiography. The evidence on efficacy and safety is mainly available from short follow-up case series but shows good efficacy and safety of the Essure system. Only a few small risks are associated with the procedure. Two economic studies, one of which implemented Essure as an in-office procedure, suggest that Essure could be more cost-effective than laparoscopic sterilization, but more information on the total cost is needed.

CONCLUSION(S): The Essure system appears to be safe, permanent, irreversible, and a less invasive method of contraception compared with laparoscopic sterilization.

摘要

目的

更新 Essure 系统的疗效和安全性证据。过去十年女性绝育方式发生了变化。除了腹腔镜输卵管结扎术,Essure 系统现在是一种可行的选择,约有 20 万名女性通过这种方法绝育。

设计

该综述基于艾伯塔省健康与福利省医学研究基金会的报告,并结合截至 2008 年 4 月 8 日的系统文献检索完成。

地点

芬兰国家卫生和福利研究与发展中心管理的医疗方法应用项目。

患者

年龄超过 30 岁,通过 Essure 方法绝育的女性。

干预措施

使用 Essure 系统进行宫腔镜输卵管绝育术。

主要观察指标

疗效/有效性、不良事件、成本。

结果

Essure 绝育可在局部麻醉或口服镇痛剂下于门诊环境中进行。然而,绝育不是即刻完成的,女性必须在 3 个月内使用额外的避孕方法,直到通过经阴道超声、子宫输卵管超声造影、子宫输卵管造影或盆腔 X 线检查确认永久性输卵管阻塞。关于疗效和安全性的证据主要来自短期随访病例系列,但显示 Essure 系统具有良好的疗效和安全性。该程序仅与少数小风险相关。两项经济研究,其中一项将 Essure 实施为门诊手术,表明 Essure 可能比腹腔镜绝育更具成本效益,但需要更多关于总成本的信息。

结论

与腹腔镜绝育相比,Essure 系统似乎是一种安全、永久、不可逆且侵入性较小的避孕方法。

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