帕拉西他摩尔或布洛芬? 一项试点研究比较了在第一个月内早产婴儿PDA的救援疗法
Arindam Mukherjee1,2, Anupam Gupta1,2, Catherine Fullwood1,2
1The University of Manchester, Manchester, United Kingdom.
这项试点研究发现,在治疗早产婴儿血液动力学上显著的专利动脉通道 (hsPDA) 时,IV 甲与IV 布洛芬的有效性或安全性没有显著差异. 需要进一步的研究来证实这些发现.
科学领域:
- 新生儿重症监护中心
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 专利性动脉管 (PDA) 在早产婴儿中很常见.
- 血液动力学显著的PDA (hsPDA) 需要有效的治疗.
- 目前的治疗方法包括静脉注射类降醇和静脉注射类ibuprofen.
研究的目的:
- 为了评估IV白醇的有效性和安全性,与IV布洛芬相比,在早产婴儿hsPDA的救援治疗中.
- 为更大的试验评估研究设计.
主要方法:
- 在英国新生儿重症监护病房进行试点随机对照试验.
- 招募的早产婴儿 (<32周妊娠或<1500g) 患有hsPDA.
- 随机选择的婴儿接受了静脉cetamol或静脉 ibuprofen;评估了hsPDA关闭/减少的初级结果和并发症和不良反应的次要结果.
主要成果:
- 招募了32名婴儿;招募率高 (91.4%),完成率高 (100%).
- 降醇组:37.5%转化为非hsPDA; 布洛芬组:25.0%转化 (p=0.704).
- 两组之间并发症 (BPD,NEC,IVH,ROP) 或不良影响没有显著差异.
结论:
- 在PAIR试验中,在hsPDA救援治疗中,IV 青和IV 布洛芬之间在疗效或安全性方面没有发现差异.
- 该试验证明了更大规模研究的可行性.
- 为了验证这些发现,需要进行更大规模的,最终的研究.
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