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一项 GnRH 拮抗剂加尼瑞克在中国正常反应者中的随机对照试验:高疗效和妊娠率。

A randomized controlled trial of the GnRH antagonist ganirelix in Chinese normal responders: high efficacy and pregnancy rates.

机构信息

Reproductive Medical Center, Peking University Third Hospital, Beijing, China.

出版信息

Gynecol Endocrinol. 2012 Oct;28(10):800-4. doi: 10.3109/09513590.2012.665103. Epub 2012 Mar 20.

DOI:10.3109/09513590.2012.665103
PMID:22429192
Abstract

Gonadotropin-releasing hormone (GnRH) antagonists for controlled ovarian stimulation (COS) were only recently introduced into China. The efficacy and safety of the GnRH antagonist ganirelix was assessed in a multicenter, controlled, open-label study, in which Chinese women were randomized to either ganirelix (n = 113) or a long GnRH agonist protocol of triptorelin (n = 120). The primary end point was the amount of recombinant follicle-stimulating hormone (rFSH) required to meet the human chorionic gonadotropin criterion (three follicles ≥17 mm). The amount of rFSH needed was significantly lower for ganirelix (1272 IU) vs. triptorelin (1416 IU; P< 0.001). Ongoing pregnancy rates per started cycle were 39.8% (ganirelix) and 39.2% (triptorelin). Although both treatments were well tolerated, cancellation due to risk of ovarian hyperstimulation syndrome (OHSS) was less frequent with ganirelix (1.8%) than triptorelin (7.5%) (P = 0.06). Less rFSH was needed in the ganirelix protocol than the long GnRH agonist protocol, with fewer reported cases of OHSS and similar pregnancy rates.

摘要

促性腺激素释放激素(GnRH)拮抗剂最近才被引入中国,用于控制性卵巢刺激(COS)。在中国进行的一项多中心、对照、开放性研究中评估了 GnRH 拮抗剂加尼瑞克的疗效和安全性,将中国女性随机分为加尼瑞克组(n = 113)或长效 GnRH 激动剂曲普瑞林组(n = 120)。主要终点是达到人绒毛膜促性腺激素标准(≥17mm 的三个卵泡)所需的重组卵泡刺激素(rFSH)量。加尼瑞克(1272IU)所需的 rFSH 量明显低于曲普瑞林(1416IU;P<0.001)。每个启动周期的持续妊娠率分别为 39.8%(加尼瑞克)和 39.2%(曲普瑞林)。虽然两种治疗方法均耐受良好,但加尼瑞克(1.8%)的卵巢过度刺激综合征(OHSS)风险导致取消治疗的频率低于曲普瑞林(7.5%)(P = 0.06)。加尼瑞克方案所需的 rFSH 少于长效 GnRH 激动剂方案,OHSS 的报告病例较少,妊娠率相似。

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