Donnez J, Vilos G, Gannon M J, Maheux R, Emanuel M H, Istre O
Department of Gynaecology, University Hospital Saint-Luc, Brussels, Belgium.
Fertil Steril. 2001 Mar;75(3):620-2. doi: 10.1016/s0015-0282(00)01767-2.
To report the results of a 3-year follow-up evaluation of a trial comparing goserelin acetate depot injections with sham injections before endometrial ablation for the treatment of dysfunctional uterine bleeding (DUB).
Prospective, randomized, double-blind, parallel-group study.
Thirty-seven centers in 12 countries.
PATIENT(S): Three-hundred and fifty-eight premenopausal women aged over 30 years with DUB.
INTERVENTION(S): Goserelin acetate (3.6 mg depot) every 28 days for 8 weeks, or sham depot every 28 days for 8 weeks, with endometrial ablation 6 weeks +/- 3 days after the first depot injection (i.e., when the endometrium is at its thinnest). The follow-up continued for 3 years.
MAIN OUTCOME MEASURE(S): At the 3-year follow-up, bleeding in the previous 3 months and need for surgical intervention were recorded.
RESULT(S): At 3 years, amenorrhea rates were 21% in the goserelin acetate group and 14% in the control group (estimated odds ratio, 1.8; 95% CI, 0.98-3.25; P=.0571). The surgical intervention rate (since the original procedure) was low and did not differ significantly between groups. For hysterectomy, it was 21% for the goserelin acetate group and 15% for the control group. For repeat ablations, it was 5.6% for the goserelin acetate group and 2.1% for the control group.
CONCLUSION(S): Prethinning with goserelin acetate before endometrial ablation resulted in higher long-term amenorrhea rates than ablation without prethinning.
报告一项试验的3年随访评估结果,该试验比较了醋酸戈舍瑞林长效注射剂与子宫内膜消融术前假注射治疗功能失调性子宫出血(DUB)的效果。
前瞻性、随机、双盲、平行组研究。
12个国家的37个中心。
358名年龄超过30岁的绝经前DUB女性。
每28天注射一次醋酸戈舍瑞林(3.6毫克长效制剂),共8周,或每28天注射一次假长效制剂,共8周,在首次长效注射后6周±3天(即子宫内膜最薄时)进行子宫内膜消融。随访持续3年。
在3年随访时,记录前3个月的出血情况和手术干预需求。
3年时,醋酸戈舍瑞林组的闭经率为21%,对照组为14%(估计优势比为1.8;95%置信区间为0.98 - 3.25;P = 0.0571)。自原手术以来的手术干预率较低,两组之间无显著差异。子宫切除率方面,醋酸戈舍瑞林组为21%,对照组为15%。重复消融率方面,醋酸戈舍瑞林组为5.6%,对照组为2.1%。
子宫内膜消融术前使用醋酸戈舍瑞林进行预处理导致的长期闭经率高于未进行预处理的消融术。