阿齐思罗米辛剂量和早产前膜破裂治疗 (ADAPT):一项随机对照I期试验
Rupsa C Boelig1, Kevin Lam2, Ankit Rochani3
1Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College (Boelig); Department of Pharmacology, Physiology, and Cancer Biology, Sidney Kimmel Medical College, Thomas Jefferson University (Boelig Kraft, and Lam), Philadelphia, PA.
American journal of obstetrics & gynecology MFM
|July 8, 2024
概括
每天500毫克的阿齐思罗米辛剂量用于早产前膜破裂,与单次1克剂量相比,保持更高的胎液度. 这表明每日剂量更有效地维持治疗药物水平.
科学领域:
- 药理学 药理学是指药理学的学科.
- 产科 产科 产科 产科 产科
- 传染性疾病 传染性疾病
背景情况:
- 建议使用抗生素治疗早产前膜破裂 (PPROM),以延长潜伏期.
- 阿齐思罗米是常用的,但在PPROM中最佳剂量尚不清楚.
- 一次1g的阿齐思罗米剂量可能无法达到持续的治疗性羊水度.
研究的目的:
- 为了比较单剂量与PPROM中阿齐思罗米辛每日剂量的药理动力学.
- 为了评估8天内羊水和血中阿兹罗米辛度.
主要方法:
- 随机临床试验比较PPROM中1g口服亚齐思罗米辛一次与每天500mg每天7天.
- 主要结局:羊水中阿齐思罗米辛度.
- 二级结局:血中阿齐思罗米的最低度.
主要成果:
- 每天500毫克的阿齐思罗米导致与单次1g剂量相比,子宫液度显著更高,更持续.
- 血中阿齐思罗米水平最初在1g剂量时较高,但迅速下降,而每日剂量维持了较高的水平.
- 该研究因入学率低而提前停止,每组3名参与者.
结论:
- 大约每天500毫克的阿齐思罗米剂量可以在PPROM中长时间保持较高的羊水度,超过最小抑制度.
- 每日剂量似乎比单次剂量更有效,可以在PPROM管理中在羊水中达到持续的治疗药物水平.
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