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醋酸戈舍瑞林(诺雷德)联合子宫内膜去除术治疗功能失调性子宫出血:一项大型随机双盲研究。

Goserelin acetate (Zoladex) plus endometrial ablation for dysfunctional uterine bleeding: a large randomized, double-blind study.

作者信息

Donnez J, Vilos G, Gannon M J, Stampe-Sorensen S, Klinte I, Miller R M

机构信息

Service de Gynecologie, University St. Luc, Brussels, Belgium.

出版信息

Fertil Steril. 1997 Jul;68(1):29-36.

PMID:9207580
Abstract

OBJECTIVE

To confirm the advantages of goserelin prior to endometrial ablation for the treatment of dysfunctional uterine bleeding.

DESIGN

Multicenter, prospective, randomized, double-blind study.

PATIENT(S): Cycling premenopausal women with dysfunctional uterine bleeding.

TREATMENT

Patients were randomized to goserelin or placebo (sham depot) once monthly for 2 months prior to endometrial ablation. Treatment was timed to allow surgery 6 weeks later on day 7 of the menstrual cycle.

MAIN OUTCOME MEASURE(S): Amenorrhea rates, endometrial histology and thickness, pain and blood loss scores, and surgical parameters.

RESULT(S): At 24 weeks after surgery, significantly more goserelin than placebo patients experienced amenorrhea (40% versus 26%). Blood loss was reduced from baseline, but not different between the groups. At surgery, mean endometrial thickness was 1.6 mm and 3.4 mm for the goserelin and placebo groups, respectively, with significantly more atrophic glands and stroma in the goserelin group. Surgery was significantly shorter (by 22%) and easier in the goserelin than in the placebo group, with a significantly lower median fluid absorption in the goserelin groups. In both groups, pain scores were reduced patient satisfaction was high (> 92%), and re-intervention rate was low (2.8%).

CONCLUSION(S): Goserelin in combination with endometrial ablation was superior to endometrial ablation alone for the treatment of dysfunctional uterine bleeding.

摘要

目的

确认戈舍瑞林在子宫内膜消融术前治疗功能失调性子宫出血的优势。

设计

多中心、前瞻性、随机、双盲研究。

患者

有功能失调性子宫出血的绝经前月经周期正常的女性。

治疗

在子宫内膜消融术前2个月,患者被随机分为每月接受一次戈舍瑞林或安慰剂(假长效注射剂)治疗,共治疗2个月。治疗时间安排为在月经周期第7天6周后进行手术。

主要观察指标

闭经率、子宫内膜组织学和厚度、疼痛和失血评分以及手术参数。

结果

术后24周时,经历闭经的戈舍瑞林组患者显著多于安慰剂组(40%对26%)。失血量较基线减少,但两组间无差异。手术时,戈舍瑞林组和安慰剂组的平均子宫内膜厚度分别为1.6毫米和3.4毫米,戈舍瑞林组萎缩腺体和间质明显更多。戈舍瑞林组手术时间显著缩短(缩短22%)且比安慰剂组更简便,戈舍瑞林组的中位液体吸收量显著更低。两组患者疼痛评分均降低,患者满意度高(>92%),再次干预率低(2.8%)。

结论

戈舍瑞林联合子宫内膜消融术治疗功能失调性子宫出血优于单纯子宫内膜消融术。

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