重组人粒细胞殖民地刺激因子在未解释的重复妊娠流产患者的疗效和安全性:多中心,随机,双盲,受控试验的协议
Fangxiang Mu1, Zhuhua Cai2, Lirong Du3
1Department of Reproductive Medicine, Lanzhou University Second Hospital, Lanzhou, 730030, China.
Trials
|July 14, 2025
概括
这项研究研究了对不明原因的重复妊娠损失 (uRPL) 的花细胞殖民地刺激因子 (G-CSF). 该试验旨在确定G-CSF在中国妇女中的疗效和安全性,提供一种潜在的新治疗选择.
科学领域:
- 生殖免疫学 生殖免疫学
- 孕产妇和胎儿医学 孕产妇和胎儿医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 无法解释的重复妊娠损失 (uRPL) 影响1-2%的女性,可能与母胎免疫不耐受有关.
- 颗粒细胞殖民地刺激因子 (G-CSF) 对RRPL有希望,但临床试验数据不一致.
- 需要高质量的研究来确认G-CSF在RRPL管理中的临床实用性.
研究的目的:
- 评估G-CSF在被诊断为RRPL的中国妇女的疗效和安全性.
- 为G-CSF在 uRPL治疗中的临床应用提供更强有力的证据基础.
- 探索G-CSF治疗在RRPL中的潜在子组影响.
主要方法:
- 一个随机,双盲,安慰剂控制的多中心试验,涉及528名参与者.
- 参与者接受了G-CSF (150微克每隔一天皮下注射) 或安慰剂,以及丁固和阿司匹林.
- 主要终点:胎儿存活到24周;次要终点包括各种妊娠结果和并发症.
主要成果:
- 本部分应在研究完成后填写.
结论:
- 这项试验旨在在中国人群中为RRPL提供高质量的G-CSF证据.
- 结果将为基于证据的建议提供RRPL治疗建议,在选择有限的情况下.
- 这项研究旨在澄清G-CSF在改善RRPL妇女怀孕结果方面的作用.
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