Vilos GA, Donnez J, Gannon M, Stampe-Sorensen S, Klinte J, Miller RM
Department of Obstetrics and Gynecology, St. Joseph's Health Centre, 268 Grosvenor St., London, Onatrio, Canada N6A 4V2.
J Am Assoc Gynecol Laparosc. 1996 Aug;3(4, Supplement):S54-5. doi: 10.1016/s1074-3804(96)80318-5.
The multinational, multicenter, prospective, double-blind study compared randomized 358 premenopausal women with regular cycles to receive two injections 1 month apart of goserelin acetate depot or sham depot before endometrial ablation. Injections were started to permit surgery (resection ± rollerball) 6 weeks later on day 7 of the cycle when the endometrium would be at its thinnest for the sham group, and allowing down-regulation to continue after surgery. End points were endometrial thickness at surgery, change in blood loss score, amenorrhea, severe hypomenorrhea (score <10), ease and duration of surgery, fluid absorption, change in pain score and endometrial histology. Intent-to-treat analysis was performed. Significantly more women receiving goserelin experienced amenorrhea (40%) than those receiving sham (26%, p = 0.004). The change in blood loss score was significantly reduced from baseline but not different between the groups. The combination of amenorrhea and severe hypomenorrhea favored the goserelin group (p = 0.059). Mean endometrial thickness for goserelin was 1.6 mm and for sham 3.4 mm (p = 0.0001). The majority of women given goserelin had atrophic glands and stroma. Surgery in these patients was significantly shorter (22%, p = 0.0001) and easier than for those treated with sham (p = 0.0001). Operative complications were similar between the groups, with a small but significant difference in favor of goserelin for less fluid absorption (p = 0.04). Pain scores were reduced in both groups. Patient satisfaction was very high in both groups (>92%) with a very low reintervention rate (2.8% for both groups). Overall menstrual loss was reduced. Despite timing the surgery to favor the sham group, the goserelin-treated women had significantly more amenorrhea and significant thinner endometria than seen in the immediate postmenstrual phase, and this resulted in significantly shorter and easier surgery.
这项多中心、前瞻性、双盲的跨国研究将358名月经周期规律的绝经前女性随机分为两组,在子宫内膜消融术前1个月分别接受戈舍瑞林醋酸盐长效注射剂或安慰剂注射,注射间隔为1个月。对于安慰剂组,在月经周期的第7天开始注射,6周后进行手术(切除术±滚球法),此时子宫内膜最薄;对于戈舍瑞林组,注射后让降调节继续至术后。研究终点包括手术时的子宫内膜厚度、失血评分变化、闭经、严重月经过少(评分<10)、手术的难易程度和持续时间、液体吸收情况、疼痛评分变化以及子宫内膜组织学。进行了意向性分析。接受戈舍瑞林治疗的女性闭经发生率(40%)显著高于接受安慰剂的女性(26%,p = 0.004)。失血评分较基线显著降低,但两组之间无差异。闭经和严重月经过少的联合情况有利于戈舍瑞林组(p = 0.059)。戈舍瑞林组的平均子宫内膜厚度为1.6 mm,安慰剂组为3.4 mm(p = 0.0001)。大多数接受戈舍瑞林治疗的女性有萎缩的腺体和间质。这些患者的手术时间显著缩短(22%,p = 0.0001),且比接受安慰剂治疗的患者更容易(p = 0.0001)。两组的手术并发症相似,在液体吸收较少方面,戈舍瑞林组有微小但显著的优势(p = 0.04)。两组的疼痛评分均降低。两组患者的满意度都很高(>92%),再次干预率非常低(两组均为2.8%)。总体月经失血量减少。尽管手术时间选择对安慰剂组有利,但接受戈舍瑞林治疗的女性闭经发生率显著更高,子宫内膜也显著更薄,这使得手术时间显著缩短且更容易。