双极射频子宫内膜切除术与球囊子宫内膜切除术的随机对照试验

Randomised controlled trial of bipolar radio-frequency endometrial ablation and balloon endometrial ablation.

作者信息

Bongers Marlies Y, Bourdrez Petra, Mol Ben W J, Heintz A Peter M, Brölmann Hans A M

机构信息

Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.

出版信息

BJOG. 2004 Oct;111(10):1095-102. doi: 10.1111/j.1471-0528.2004.00253.x.

DOI:10.1111/j.1471-0528.2004.00253.x

PMID:15383112

Abstract

OBJECTIVE

To compare the effectiveness of two second-generation ablation techniques, bipolar radio-frequency impedance-controlled endometrial ablation (NovaSure) and balloon ablation (ThermaChoice), in the treatment of menorrhagia.

DESIGN

Double-blind, randomised, controlled trial.

SETTING

A large teaching hospital with 500 beds in The Netherlands.

POPULATION

Women suffering from menorrhagia referred by their general practitioner.

METHODS

Women suffering from menorrhagia, without intracavitary abnormalities, were randomly allocated to bipolar radio-frequency ablation (bipolar group) and balloon ablation (balloon group) in a 2:1 ratio. At follow up, both women and observers were unaware of the type of treatment that had been performed.

MAIN OUTCOME MEASURES

The main outcome measure was amenorrhea at 3, 6 and 12 months after randomisation.

RESULTS

One hundred and twenty-six women were included in the study, of which 83 were allocated to the bipolar group, and 43 to the balloon group. No complications occurred in either of the treatment groups. At the one-year follow up stage, amenorrhea rates were 43% (34/83) in the bipolar group and 8% (3/43) in the balloon group (treatment effect in time P < 0.001). At this stage, 90% of the patients in the bipolar group were satisfied with the result of the treatment against 79% in the balloon group (treatment effect in time P= 0.003).

CONCLUSION

The bipolar radio-frequency impedance-controlled endometrial ablation system is more effective than balloon ablation in the treatment of menorrhagia.

摘要

目的

比较两种第二代消融技术，即双极射频阻抗控制子宫内膜切除术（NovaSure）和球囊消融术（ThermaChoice）治疗月经过多的有效性。

设计

双盲、随机、对照试验。

地点

荷兰一家拥有500张床位的大型教学医院。

研究对象

由全科医生转诊的月经过多女性。

方法

月经过多且无腔内异常的女性按2:1的比例随机分配至双极射频消融组（双极组）和球囊消融组（球囊组）。随访时，患者和观察者均不知道所进行的治疗类型。

主要观察指标

主要观察指标为随机分组后3个月、6个月和12个月时的闭经情况。

结果

126名女性纳入研究，其中83名分配至双极组，43名分配至球囊组。两个治疗组均未发生并发症。在1年随访阶段，双极组闭经率为43%（34/83），球囊组为8%（3/43）（治疗效果随时间变化P<0.001）。在此阶段，双极组90%的患者对治疗结果满意，球囊组为79%（治疗效果随时间变化P=0.003）。