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Updated: Jul 19, 2025

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对严重不孕症患者进行多中心,两剂单组受控试验的塔克罗利斯

Michi Hisano¹, Koji Nakagawa², Masanori Ono³

¹Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.

|August 11, 2023

概括

这项研究调查了TACROLIMUS用于无法解释的不孕症,重点是免疫平衡. 塔克罗利马斯可以改善Th1主导免疫状态的妇女的怀孕率,为难治不育病例提供希望.

科学领域:

生殖免疫学生殖免疫学
临床试验临床试验
免疫抑制疗法免疫抑制疗法

背景情况:

无法解释的不孕不育影响15%的夫妇,母亲和胎儿的免疫异常引起了人们的注意.
一个T-助手2 (Th2) 主导的免疫状态对于胎儿的耐受性至关重要;Th1主导可能会损害这一点.
作为一种免疫抑制剂的塔克罗利斯正在被研究,因为它有可能在辅助生殖中促进胚胎耐受性.

研究的目的:

为了确定TACROLIMUS的疗效,安全性和最佳剂量,治疗不治不育的妇女.
评估塔克罗利斯对植入前子宫内膜的免疫环境的影响.
探索TACROLIMUS作为一种与免疫失调相关的不明原因不孕症的治疗方法.

主要方法:

一个多中心,2剂量,单组受控试验,涉及26名有试管婴儿受精 (IVF) 和胚胎移植 (ET) 失败史的妇女.
参与者没有确定的不育因素,Th1/Th2细胞比率≥10.3,表明Th1-主导免疫状态.
随机分配给口服塔克罗利斯 (每天2毫克或4毫克) 16天,从ET之前开始.

主要成果:

主要终点:临床怀孕,IVF/ET后3周.
二级终点:生化妊娠2周后IVF/ET.
同时评估tacrolimus治疗的安全性和发现生物标志物.

结论:

塔克罗利马斯正在研究其在患有Th1-主导原因不明不孕症的妇女中改善妊娠结果的潜力.
这项研究旨在确定tacrolimus在这种特定患者群体中的安全性和有效性.
这项研究可能为难以治愈的不孕症病例提供一种新的治疗方法.

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