齐申玉泰药在晚产期妇女中增加了活产:一项随机临床试验
Yu Li1,2, Fei Gong3, Xiaohong Wang4
1Center for Reproductive Medicine, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China.
Nature communications
|December 24, 2025
概括
齐申玉台药 (ZYP) 在接受辅助生殖技术 (ART) 的35-42岁妇女中显著增加了活产率. 这项研究证实了ZYPYP.
科学领域:
- 生殖医学 生殖医学
- 临床药理学 临床药理学
- 基于证据的医学基于证据的医学.
背景情况:
- 先进的孕产妇年龄 (35岁以上) 与辅助生殖技术 (ART) 中活产率 (LBR) 的降低有关.
- 之前的研究表明,Zishen Yutai Pill (ZYP) 可能会改善晚产期妇女的LBR,但缺乏足够的统计能力.
- 需要进行一项强大的临床试验,以确认ZYP在这个人群中的有效性和安全性.
研究的目的:
- 评估Zishen Yutai Pill (ZYP) 在增加活产率 (LBR) 在接受ART的35-42岁妇女中的有效性.
- 评估ZYP在该人群中对孕产妇和新生儿的不良事件的安全性.
- 提供高质量的证据,证明ZYP可用于管理母亲晚年不孕症.
主要方法:
- 一个多中心,前性,双盲,安慰剂控制,随机化试验 (NCT03703700) 涉及1467名参与者.
- 35-42岁的女性BMI<28 kg/m2被随机分配给接受ZYP或安慰剂.
- 治疗时间从前一个月经周期延长到胚胎移植后的5周,如果怀孕得到确认.
主要成果:
- 接受ZYP治疗的参与者中有23.3%的活产发生,而接受安慰剂的参与者中有19.0% (相对比率:1.23;P=0.042).
- 在LBR的绝对差异为4.3% (95% CI,0.2-8.5),表明一个统计学上显著的增加与ZYP.
- 在ZYP组中没有观察到母亲或新生儿不良事件的显著增加.
结论:
- 齐申玉台药 (ZYP) 有效地提高了35-42岁的妇女接受辅助生殖技术 (ART) 的活产率.
- ZYP表现出良好的安全性,没有增加对母亲或新生儿不良结果的风险.
- 这项研究提供了强有力的证据,支持ZYP作为一种治疗选择,用于改善晚产妇年龄妇女的ART结果.
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