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使用促性腺激素释放激素(GnRH)拮抗剂加尼瑞克或GnRH激动剂曲普瑞林的长效方案预防接受卵巢刺激的女性过早出现促黄体生成素(LH)峰,临床结局相当。

Comparable clinical outcome using the GnRH antagonist ganirelix or a long protocol of the GnRH agonist triptorelin for the prevention of premature LH surges in women undergoing ovarian stimulation.

出版信息

Hum Reprod. 2001 Apr;16(4):644-51. doi: 10.1093/humrep/16.4.644.

DOI:10.1093/humrep/16.4.644
PMID:11278211
Abstract

This multicentre, randomized study was performed to assess the efficacy and safety of 0.25 mg ganirelix (Orgalutran, Antagon) treatment, using triptorelin (Decapeptyl) in a long protocol as a reference treatment. In total, 236 subjects were randomized to treatment with ganirelix (0.25 mg, s.c.) and 119 to triptorelin (0.1 mg, s.c.) treatment (treatment ratio 2:1). Treatment with ganirelix started on day 6 of stimulation, whereas treatment with triptorelin started on menstrual cycle day 21 to 24 of the previous cycle (i.e. the midluteal phase). The ganirelix regimen was on average 17 days shorter (9 versus 26 days) compared to the triptorelin regimen. The median total dose of recombinant FSH (Puregon) used was 450 IU less (1350 versus 1800 IU) in the ganirelix protocol. The initial follicular growth was faster and, consequently, oestradiol concentrations were higher in the ganirelix group. On the day of human chorionic gonadotrophin (HCG), the mean number of follicles > or = 11 mm was 10.1 and 10.7 and the median serum oestradiol concentration was 1090 and 1370 pg/ml in the ganirelix and triptorelin groups respectively. Per attempt, 7.9 and 9.6 oocytes (mean) were retrieved in the ganirelix and triptorelin groups respectively. The fertilization rates (64.0% ganirelix and 64.9% triptorelin) and the mean number of good quality embryos (2.7 and 2.9) were comparable in both treatment groups. The implantation rate was identical (22.9%). The ongoing pregnancy rate per attempt was 31.0 and 33.9% in the ganirelix and triptorelin groups respectively. The ganirelix regimen showed an improved local tolerance in that the percentage of subjects with at least one local skin reaction was 2-fold lower than in the triptorelin group (11.9 versus 24.1%). Taking all data together, it may be concluded that ganirelix offers a new treatment regimen in ovarian stimulation that is short, safe and well-tolerated, optimizing convenience for the patient.

摘要

本多中心随机研究旨在评估0.25mg加尼瑞克(Orgalutran,Antagon)治疗的有效性和安全性,采用长效方案的曲普瑞林(Decapeptyl)作为对照治疗。总共236名受试者被随机分配接受加尼瑞克(0.25mg,皮下注射)治疗,119名接受曲普瑞林(0.1mg,皮下注射)治疗(治疗比例为2:1)。加尼瑞克治疗在刺激第6天开始,而曲普瑞林治疗在前一周期的月经周期第21至24天(即黄体中期)开始。与曲普瑞林方案相比,加尼瑞克方案平均短17天(9天对26天)。加尼瑞克方案中使用的重组促卵泡素(Puregon)的总剂量中位数少450IU(1350IU对1800IU)。加尼瑞克组初始卵泡生长更快,因此雌二醇浓度更高。在人绒毛膜促性腺激素(HCG)日,加尼瑞克组和曲普瑞林组中直径≥11mm的卵泡平均数分别为10.1和10.7,血清雌二醇浓度中位数分别为1090和1370pg/ml。每次取卵,加尼瑞克组和曲普瑞林组分别平均获得7.9个和9.6个卵母细胞。两个治疗组的受精率(加尼瑞克组为64.0%,曲普瑞林组为64.9%)和优质胚胎平均数(2.7个和2.9个)相当。着床率相同(22.9%)。每次取卵的持续妊娠率在加尼瑞克组和曲普瑞林组分别为31.0%和33.9%。加尼瑞克方案显示局部耐受性改善,即至少有一次局部皮肤反应的受试者百分比比曲普瑞林组低2倍(11.9%对24.1%)。综合所有数据,可以得出结论,加尼瑞克在卵巢刺激中提供了一种新的治疗方案,该方案疗程短、安全且耐受性良好,为患者优化了便利性。

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