Monash IVF, 50 Burwood Road, Hawthorn 3122, Melbourne, Victoria, Australia.
Expert Opin Biol Ther. 2012 Jan;12(1):107-12. doi: 10.1517/14712598.2012.641530. Epub 2011 Nov 30.
Follicle-stimulating hormone (FSH) is essential for the development of ovarian follicles. Urinary-derived and recombinant FSH (rFSH) preparations are widely used in infertility treatment but have to be administered daily to achieve steady-state serum levels. Corifollitropin alfa is a hybrid molecule with a prolonged half-life.
The development and clinical testing of corifollitropin alfa, including the pharmacodynamics and kinetics, efficacy and drug safety. Searches were performed using the Medline database.
Corifollitropin alfa is composed of the FSH α-subunit and a hybrid of the FSH β-subunit and the C-terminal peptide (CTP) of the human chorionic gonadotropin (hCG) β-subunit. The rationale of developing such a molecule was to reduce patient burden, by reducing the number of injections required to sustain multifollicular growth. Two strengths of corifollitropin are available (for patients ≤ 60 kg and > 60 kg). Compared with a daily dose of 200 IU of rFSH, 150 mcg of corifollitropin is equivalent in safety and pregnancy outcomes in women > 60 and < 90 kg using an antagonist protocol. Another RCT in women ≤ 60 kg also confirmed safety and efficacy of follicular stimulation (100 mcg of corifollitropin versus 150 IU of rFSH), but it was not powered to demonstrate equivalence in terms of pregnancy rates.
卵泡刺激素（FSH）是卵泡发育所必需的。尿源性和重组 FSH（rFSH）制剂广泛用于不孕治疗，但为了达到稳定的血清水平，必须每天给药。促滤泡素α是一种具有延长半衰期的杂交分子。
促滤泡素α的开发和临床测试，包括药效学和药代动力学、疗效和药物安全性。使用 Medline 数据库进行了搜索。
促滤泡素α由 FSH α 亚单位和 FSH β 亚单位与人类绒毛膜促性腺激素（hCG）β 亚单位的 C 端肽（CTP）的杂交组成。开发这种分子的基本原理是通过减少维持多卵泡生长所需的注射次数来减轻患者的负担。有两种规格的促滤泡素可供选择（适用于体重≤60 公斤和>60 公斤的患者）。与每日 200IU 的 rFSH 相比，在拮抗剂方案中，体重>60 至<90 公斤的女性使用 150mcg 的促滤泡素与 150IU 的 rFSH 在安全性和妊娠结局方面等效。另一项≤60 公斤的女性 RCT 也证实了卵泡刺激的安全性和有效性（100mcg 促滤泡素与 150IU 的 rFSH），但在妊娠率方面没有显示等效性的功效。
