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左炔诺孕酮宫内节育系统替代子宫切除术的开放性随机研究。

Open randomised study of use of levonorgestrel releasing intrauterine system as alternative to hysterectomy.

作者信息

Lähteenmäki P, Haukkamaa M, Puolakka J, Riikonen U, Sainio S, Suvisaari J, Nilsson C G

出版信息

BMJ. 1998 Apr 11;316(7138):1122-6. doi: 10.1136/bmj.316.7138.1122.

Abstract

OBJECTIVES

To assess whether the levonorgestrel intrauterine system could provide a conservative alternative to hysterectomy in the treatment of excessive uterine bleeding.

DESIGN

Open randomised multicentre study with two parallel groups: a levonorgestrel intrauterine system group and a control group.

SETTING

Gynaecology departments of three hospitals in Finland.

SUBJECTS

Fifty six women aged 33-49 years scheduled to undergo hysterectomy for treatment of excessive uterine bleeding.

INTERVENTIONS

Women were randomised either to continue with their current medical treatment or to have a levonorgestrel intrauterine system inserted.

MAIN OUTCOME MEASURE

Proportion of women cancelling their decision to undergo hysterectomy.

RESULTS

At 6 months, 64.3% (95% confidence interval 44.1 to 81.4%) of the women in the levonorgestrel intrauterine system group and 14.3% (4.0 to 32.7%) in the control group had cancelled their decision to undergo hysterectomy (P < 0.001).

CONCLUSIONS

The use of the levonorgestrel intrauterine system is a good conservative alternative to hysterectomy in the treatment of menorrhagia and should be considered before hysterectomy or other invasive treatments.

摘要

目的

评估左炔诺孕酮宫内节育系统在治疗子宫出血过多时能否作为子宫切除术的一种保守替代方法。

设计

开放性随机多中心研究,分为两个平行组:左炔诺孕酮宫内节育系统组和对照组。

地点

芬兰三家医院的妇科。

研究对象

56名年龄在33至49岁之间、计划因子宫出血过多接受子宫切除术的女性。

干预措施

将女性随机分组,一组继续当前的治疗,另一组植入左炔诺孕酮宫内节育系统。

主要观察指标

取消子宫切除决定的女性比例。

结果

6个月时,左炔诺孕酮宫内节育系统组64.3%(95%置信区间44.1%至81.4%)的女性和对照组14.3%(4.0%至32.7%)的女性取消了子宫切除决定(P<0.001)。

结论

左炔诺孕酮宫内节育系统在治疗月经过多时是子宫切除术的一种良好保守替代方法,在进行子宫切除术或其他侵入性治疗前应予以考虑。

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本文引用的文献

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Hysterectomy: will it pay the bills in 2007?子宫切除术:它能在2007年带来收益吗?
BMJ. 1997 Jan 18;314(7075):160-1. doi: 10.1136/bmj.314.7075.160.
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Assessment of medical treatments for menorrhagia.月经过多的医学治疗评估。
Br J Obstet Gynaecol. 1994 Jul;101 Suppl 11:15-8. doi: 10.1111/j.1471-0528.1994.tb13690.x.

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