双极射频子宫内膜消融术与水热消融术治疗功能失调性子宫出血的随机对照试验。

Bipolar radiofrequency endometrial ablation compared with hydrothermablation for dysfunctional uterine bleeding: a randomized controlled trial.

机构信息

From the Department of Obstetrics and Gynecology, Máxima Medical Centre, Veldhoven, The Netherlands; the Department of Obstetrics and Gynecology, AMC Amsterdam, Amsterdam, The Netherlands; and the Department of Obstetrics & Gynecology and GROW-School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.

出版信息

Obstet Gynecol. 2010 Oct;116(4):819-826. doi: 10.1097/AOG.0b013e3181f2e3e3.

DOI:10.1097/AOG.0b013e3181f2e3e3

PMID:20859144

Abstract

OBJECTIVE

To compare the effectiveness of two second-generation ablation techniques, bipolar radiofrequency impedance-controlled endometrial ablation and hydrothermablation, in the treatment of menorrhagia.

METHODS

This study was a double-blind, randomized controlled trial, which took place in a large teaching hospital in The Netherlands with 500 beds. Women with menorrhagia were randomly allocated to bipolar radiofrequency ablation (bipolar group) and hydrothermablation (hydrotherm group). At follow-up, both women and observers remained unaware of the type of treatment that had been performed. The primary outcome was amenorrhea. Secondary outcome measures were patient satisfaction and reintervention.

RESULTS

We included 160 women in the study, of which 82 were allocated to the bipolar group and 78 to the hydrotherm group. No complications occurred in either of the treatment groups. After 12 months, 87% (65 of 75) of the patients in the bipolar group were completely satisfied with the result of the treatment compared with 68% (48 of 71) in the hydrotherm group (relative risk 1.3, 95% confidence interval [CI] 1.03-1.6). The amenorrhea rates were 47% (35 of 75) in the bipolar group and 24% (17 of 71) in the hydrotherm group (relative risk 2.0, 95% CI 1.2-3.1). The relative risks for a reintervention in the bipolar group compared with the hydrotherm group was 0.29 (95% CI 0.12-0.67), whereas for hysterectomy, this was 0.49 (95% CI 0.15-1.5).

CONCLUSION

In the treatment of menorrhagia, bipolar radiofrequency endometrial ablation system is superior to hydrothermablation.

CLINICAL TRIAL REGISTRATION

ISRCTN Register, www.isrctn.org, ISRCTN23845359.

LEVEL OF EVIDENCE

摘要

目的

比较两种第二代消融技术（双极射频阻抗控制子宫内膜消融术和水热消融术）治疗月经过多的效果。

方法

这是一项在荷兰一家拥有 500 张床位的大型教学医院进行的双盲、随机对照试验。将月经过多的女性随机分配至双极射频消融（双极组）和水热消融（水热组）。随访时，女性和观察者均不知道所接受的治疗类型。主要结局为闭经。次要结局指标为患者满意度和再次干预。

结果

研究纳入了 160 名女性，其中 82 名分配至双极组，78 名分配至水热组。两组均未发生治疗相关并发症。12 个月时，双极组 87%（75 例中的 65 例）患者对治疗结果完全满意，而水热组为 68%（71 例中的 48 例）（相对风险 1.3，95%置信区间 [CI] 1.03-1.6）。双极组闭经率为 47%（75 例中的 35 例），水热组为 24%（71 例中的 17 例）（相对风险 2.0，95%CI 1.2-3.1）。与水热组相比，双极组再次干预的相对风险为 0.29（95%CI 0.12-0.67），而子宫切除术的相对风险为 0.49（95%CI 0.15-1.5）。