目的 比较期待管理与对乙酰氨基酚早期治疗极早产儿有血流动力学意义的动脉导管未闭（hemodynamically significant patent ductus arteriosus, hsPDA）的疗效及安全性。 方法 前瞻性选取2024年4月—2025年11月收治的日龄4~7 d、诊断为hsPDA的99例极早产儿为研究对象，采用随机数字表法随机分为期待管理组（54例）和对乙酰氨基酚组（45例）。期待管理组不给予药物干预；对乙酰氨基酚组给予对乙酰氨基酚15 mg/（kg·次），每6 h一次，疗程3 d。比较两组入组后3~4 d（相当于日龄7~11 d）、日龄14~17 d和出院/校正胎龄36周时hsPDA率、呼吸支持总时间、谷丙转氨酶和血胱抑素C等指标，以及少尿、上消化道出血、脑室内出血和支气管肺发育不良（bronchopulmonary dysplasia, BPD）等发生率的差异。 结果 对乙酰氨基酚组日龄14~17 d hsPDA率、入组后3~4 d hsPDA率低于期待管理组（P0.05）。两组出院/校正胎龄36周时hsPDA率、呼吸支持总时间，以及少尿、上消化道出血、脑室内出血和中重度BPD等发生率的比较差异均无统计学意义（P0.05）。入组3~4 d后，对乙酰氨基酚组谷丙转氨酶和血清胱抑素C水平高于期待管理组，入组4 d内每小时尿量低于期待管理组（P0.05）。胎龄小和母亲接受辅助生殖技术治疗是极早产儿日龄14~17 d仍存在hsPDA的危险因素（分别OR=8.569、7.092，P0.05），使用对乙酰氨基酚是其保护因素（OR=0.126，P0.05）。 结论 与期待管理相比，hsPDA极早产儿日龄4~7 d口服对乙酰氨基酚能降低日龄14~17 d hsPDA率，且安全性较好，但未能降低出院/校正胎龄36周时hsPDA率、中重度BPD率。

Objective To compare the efficacy and safety of expectant management versus acetaminophen for early treatment of hemodynamically significant patent ductus arteriosus (hsPDA) in very preterm infants. Methods A prospective randomized controlled trial was conducted from April 2024 to November 2025, enrolling 99 very preterm infants aged 4 to 7 days diagnosed with hsPDA. Participants were randomly assigned to either the expectant management group (n=54), which received no drug intervention, or the acetaminophen group (n=45), which received oral acetaminophen at 15 mg/kg every 6 hours for 3 days. Rates of hsPDA persistence at 3-4 days post-enrollment (7-11 days of age), 14-17 days of age, and at discharge or 36 weeks of corrected gestational age were compared between the two groups. Additionally, total duration of respiratory support, serum levels of alanine aminotransferase and cystatin C, and incidences of oliguria, upper gastrointestinal bleeding, intraventricular hemorrhage, moderate to severe bronchopulmonary dysplasia (BPD) were compared. Results The acetaminophen group showed lower rates of hsPDA persistence at 3-4 days post-enrollment and at 14-17 days of age compared to the expectant management group (both P0.05). No significant differences were found between groups at discharge or 36 weeks of corrected gestational age in hsPDA persistence, total respiratory support duration, or incidences of oliguria, upper gastrointestinal bleeding, intraventricular hemorrhage, and moderate to severe BPD (all P0.05). The acetaminophen group exhibited higher serum alanine aminotransferase and cystatin C levels at 3-4 days post-enrollment, and lower hourly urine output within 4 days post-enrollment compared with the expectant management group (all P0.05). Smaller gestational age and assisted reproductive technology were independent risk factors for persistent hsPDA at 14-17 days of age (OR=8.569 and 7.092, respectively; P0.05), while acetaminophen use was an independent protective factor (OR=0.126, P0.05). Conclusions Early oral acetaminophen treatment in very preterm infants with hsPDA aged 4-7 days reduces the rate of persistent hsPDA at 14-17 days and demonstrates a favorable safety profile compared with expectant management, but does not affect hsPDA persistence at discharge or 36 weeks of corrected gestational age or the rate of moderate to severe BPD.