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国外医学动态|参加多巴胺治疗低血压随机试验(HIP试验)的超早产儿在2岁校正年龄的神经结局

发布时间: 2025-03-21 10:56:18 浏览次数: 84来源:中华围产医学杂志

目前临床上对于超早产儿生后低血压的治疗时机和方法尚未得到统一。当被诊断为低血压后,一般干预措施包括扩容和一系列药物干预,包括儿茶酚胺和皮质类固醇,但仍缺乏强有力的获益证据。HIP试验[1]是一项国际性、多中心随机试验,比较了多巴胺与安慰剂治疗超早产儿低血压对预后的影响,结果发现2组患儿在纠正胎龄36周时存活且没有严重脑损伤方面无明显差异,但研究效能较低。其后,Marlow 等[2]对入组新生儿进行了一项前瞻性随访研究,评估了校正年龄2岁时的存活率和神经发育结局,并在2025年1月将结果发表在了Arch Dis Child Fetal Neonatal Ed

该研究纳入了参与HIP试验的58例胎龄<28周且平均动脉压较低的早产儿。这些受试者被随机分配至多巴胺输注组或安慰剂组治疗低血压。主要结局指标为校正年龄24个月时无神经发育障碍的生存率。

HIP试验因招募缓慢问题被提前终止。除3例失访,共55例婴儿(多巴胺组27例,安慰剂组28例)在校正24月龄时获得结局数据。结果显示多巴胺组13例(48%)婴儿存活且无神经发育障碍,安慰剂组为7例(25%)(OR=2.79,95%CI:0.89~8.72;P=0.078)。2组的主要结局和大多数次要结局较为相似。贝利综合评分均值及躯体障碍发生率无显著组间差异,但多巴胺组患儿在2岁时身高和体重较低。

该实验中,多巴胺未显著提高早产儿校正2岁时无神经发育障碍的生存率。但因样本量不足,无法排除临床重要效应的影响。正性肌力药物在改善早产儿神经结局中的作用仍需进一步研究。

 

原文摘要:

Outcomes of extremely preterm infants who participated in a randomised trial of dopamine for treatment of hypotension (the HIP trial) at 2 years corrected age


Objective: To determine survival and neurodevelopmental outcomes in the Hypotension in Preterm (HIP) trial.

Design: Prospective follow-up of infants enrolled in randomised controlled trial.

Participants: 58 infants born before 28 weeks of gestation with low mean arterial blood pressure.

Intervention: Random allocation to treatment of low blood pressure values with infusion of dopamine or placebo.

Primary outcome: Survival without neurodevelopmental impairment to 24 months corrected age (CA).

Results: The HIP trial stopped early due to logistic and recruitment difficulties. Outcomes were determined for 55 infants (27 in the dopamine group and 28 in the placebo group) at 24 months CA. Survival without impairment was present in 13 (48%) infants in the dopamine group and 7 (25%) infants in the placebo group (OR 2.79 (95% CI 0.89, 8.72); p=0.078). The components of the primary outcome were similarly distributed between the two arms. Mean Bayley composite scores and the frequency of somatic impairments did not differ significantly between groups but infants were shorter and lighter at 2 years of age after dopamine administration.

Conclusion: In this placebo-controlled trial of the treatment of hypotension in extremely preterm infants, dopamine administration did not increase survival without impairment at 2 years CA. However, the study was not sufficiently powered and a clinically important effect cannot be excluded. The role of inotropic medication in facilitating good outcomes requires further study.

 

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