卵泡刺激激素生物产品:强度是否预测临床有效性?
Monica Lispi1,2, Peter Humaidan3, George R Bousfield4
1Merck Healthcare KGaA, 64293 Darmstadt, Germany.
International journal of molecular sciences
|May 27, 2023
概括
卵泡刺激激素 (FSH) 糖形结构显著影响其生物活性和治疗不孕症的临床有效性. 仅仅是功效并不能预测不同FSH产品在患者身上表现如何.
科学领域:
- 生殖内分泌学 生殖内分泌学
- 生物化学 生化学
背景情况:
- 卵泡刺激激素 (FSH),黄素化激素 (LH) 和人类胆管性腺激素 (hCG) 对于人类的繁殖至关重要.
- 外源FSH是治疗不孕症的基石,用于医疗辅助生殖 (MAR) 提供各种纯化尿和重组形式.
研究的目的:
- 审查FSH糖形式中的结构异质性如何影响生物活动.
- 解释为什么体外功效测试可能无法准确预测体内药理动力学/药理动力学 (PK/PD) 概况和临床疗效.
主要方法:
- 对FSH结构,异质性和生物活性现有文献的审查.
- 分析FSH糖形组合及其对生殖治疗的影响之间的关系.
主要成果:
- 在FSH中的宏观和微观异质性导致多样化的糖形.
- 糖形式的组成决定了FSH生物活性,PK/PD概况和临床结果.
- 在体外功效并不能可靠地预测体内性能.
结论:
- 了解FSH糖形式异质性对于优化不孕症治疗至关重要.
- 临床疗效不仅取决于FSH的功效; 糖形式的特征是关键的.
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