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戈舍瑞林与刮宫术在Thermachoice II型球囊子宫内膜切除术之前的随机对照比较:一年结果

Randomized comparison of goserelin versus suction curettage prior to Thermachoice II balloon endometrial ablation: one-year results.

作者信息

Vilos George A, Vilos Angelos G, Abu-Rafea Basim

机构信息

Department of Obstetrics and Gynaecology, University of Western Ontario, London, ON.

出版信息

J Obstet Gynaecol Can. 2010 Oct;32(10):973-9. doi: 10.1016/s1701-2163(16)34686-2.

DOI:10.1016/s1701-2163(16)34686-2
PMID:21176307
Abstract

OBJECTIVES

To evaluate the clinical outcomes following the use of goserelin and suction curettage prior to ThermaChoice II balloon endometrial ablation to treat menorrhagia.

METHODS

Qualified patients (n = 105) were randomized to receive either goserelin 3.6 mg one month before or suction curettage immediately before undergoing thermal balloon endometrial ablation. All patients had negative Papanicolaou smears, normal endometrial histology, and normal findings on transvaginal sonography. Uterine bleeding was documented by menstrual diary scores at baseline (Higham score > 150), and at three, six, and 12 months after the procedure. Five patients withdrew prior to surgery and 50 patients were anaesthetized in each group. Two patients in the suction curettage group had their management converted to hysteroscopic ablation, one because of a large uterine cavity (> 12 mL) and one because of a submucous myoma. The ThermaChoice II system circulated the liquid within the silicone balloon for eight minutes at approximately 180 mmHg pressure and 87°C.

RESULTS

Participants' mean age, weight, and duration of menorrhagia were not significantly different between the groups. No safety issues related to the device were noted. At one year after ablation, the median reduction in Higham score was from 286 to 10 (96.5%) in the goserelin group (n = 47), and from 272 to 14 (94.9%) in the curettage group (n = 45). The combined amenorrhea/hypomenorrhea rates (higham score 0 to 35), eumenorrhea rate (higham score 36 to 75) and menorrhagia rate (higham score > 75) were 85%, 9%, and 6% (goserelin), and 76%, 16%, 9% (curettage), respectively. Patients' reported self-assessment of dysmenorrhea was none (51%), mild (30%), moderate (10%), and severe (9%) in both groups. Patient satisfaction was 89% in the goserelin group and 95% in the curettage group. In the goserelin group, one patient had a hysterectomy for bleeding and two had repeat resectoscopic endometrial ablations, one for pain (hematometra) and one for pain and bleeding. In the curettage group, one patient had repeat resectoscopic ablation, one patient withdrew, and one requested hormone therapy. The overall success rates were 88% in the goserelin group and 89% in the curettage group.

CONCLUSION

At one year after ThermaChoice II treatment, 88.5% of women had normal menstrual bleeding or less. There was a non-significant trend (a lower Higham score) towards superiority of goserelin therapy before ablation compared with curettage.

摘要

目的

评估在使用ThermaChoice II型球囊子宫内膜消融术治疗月经过多之前使用戈舍瑞林和刮宫术的临床效果。

方法

符合条件的患者(n = 105)被随机分为两组,一组在进行热球囊子宫内膜消融术前1个月接受3.6 mg戈舍瑞林治疗,另一组在术前立即接受刮宫术。所有患者巴氏涂片检查结果均为阴性,子宫内膜组织学正常,经阴道超声检查结果正常。通过月经日记评分记录基线时(海厄姆评分> 150)以及术后3个月、6个月和12个月时的子宫出血情况。5例患者在手术前退出,每组50例患者接受麻醉。刮宫术组中有2例患者的治疗改为宫腔镜消融术,1例是因为子宫腔较大(> 12 mL),另1例是因为黏膜下肌瘤。ThermaChoice II系统在硅胶球囊内以约180 mmHg的压力和87°C循环液体8分钟。

结果

两组患者的平均年龄、体重和月经过多持续时间无显著差异。未发现与该设备相关的安全问题。消融术后1年,戈舍瑞林组(n = 47)海厄姆评分的中位数从286降至10(96.5%),刮宫术组(n = 45)从272降至14(94.9%)。闭经/月经过少合并率(海厄姆评分0至35)、月经过率(海厄姆评分36至75)和月经过多率(海厄姆评分> 75)在戈舍瑞林组分别为85%、9%和6%,在刮宫术组分别为76%、16%和9%。两组患者报告的痛经自我评估均为无(51%)、轻度(30%)、中度(10%)和重度(9%)。戈舍瑞林组患者满意度为89%,刮宫术组为95%。戈舍瑞林组中,1例患者因出血行子宫切除术,2例患者重复进行了宫腔镜子宫内膜切除术,1例是因为疼痛(子宫积血),1例是因为疼痛和出血。刮宫术组中,1例患者重复进行了宫腔镜消融术,1例患者退出,1例患者要求激素治疗。戈舍瑞林组总成功率为88%,刮宫术组为89%。

结论

在ThermaChoice II治疗后1年,88.5%的女性月经出血正常或减少。与刮宫术相比,消融术前使用戈舍瑞林治疗有非显著的优势趋势(海厄姆评分更低)。

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