孕期糖尿病中的早期甲胺:随机临床试验
Fidelma Dunne1,2,3, Christine Newman1,2,3, Alberto Alvarez-Iglesias2
1College of Medicine Nursing and Health Sciences, University of Galway, Co Galway, Ireland.
JAMA
|October 3, 2023
概括
与安慰剂相比,早期对孕期糖尿病的使用并没有显著降低胰岛素需求或改善禁食高血糖. 然而,二次结果表明潜在的益处需要在更大的试验中进行进一步研究.
科学领域:
- 产科和妇科
- 产妇和胎儿医学
- 内分泌学
背景情况:
- 孕期糖尿病 (GDM) 是一种常见的妊娠并发症,其最佳治疗策略尚不确定.
- 目前的治疗指南通常涉及改变生活方式,如果需要,药物治疗.
研究的目的:
- 评估早期开始使用甲胺是否会降低胰岛素的需要或改善孕妇高血糖症.
- 评估甲胺对初级综合结局和二次母婴结局的影响.
主要方法:
- 一个双盲,安慰剂对照试验,涉及510名被诊断患有GDM的参与者 (535例怀孕).
- 参与者被随机分配到接受甲胺 (高达2500毫克/天) 或安慰剂,除了通常的护理.
- 主要结局结果是32周或38周的胰岛素开始或快餐葡萄糖≥5. 1毫摩尔/ 升.
主要成果:
- 在甲胺和安慰剂组之间,主要综合结果没有显著差异 (56. 8% vs 63. 7%,P = . 13).
- 甲胺使用与胰岛素启动时间的缩短,自我报告的血糖控制的改善和更低的妊娠体重增加有关.
- 新生儿结局显示,在甲素组中,新生儿体重和长度较小,新生儿不良事件没有增加.
结论:
- 在GDM治疗中,早期的甲福明治疗对主要综合结果并不优于安慰剂.
- 二次结果数据表明,甲素可能有好处,支持在更大规模的临床试验中进行进一步调查.
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