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目的:了解布洛芬或扑热息痛初始治疗和高剂量布洛芬营救治疗早产儿血流动力显著异常动脉导管未闭（hsPDA）的疗效及安全性。方法:选择2016年10月至2019年11月徐州市中心医院新生儿重症监护病房收治的胎龄≤ 32周hsPDA早产儿。初始治疗随机分为布洛芬组（口服布洛芬10 mg/kg，24 h及48 h后5 mg/kg）、扑热息痛组（口服扑热息痛15 mg/kg，每8小时1次，共3d）和保守管理组（口服注射用水1 ml/kg，24 h及48 h后0.5 ml/kg）。治疗失败者给予高剂量布洛芬营救治疗（口服布洛芬20 mg/kg，24 h及48 h后10 mg/kg）。治疗前后均查超声心动图、血肌酐、胱抑素C、谷丙转氨酶、总胆红素、大便潜血、头颅彩超、留取尿液2 ml备查前列腺素En 2，记录尿量及并发症等。n 结果:共计纳入110例患儿，其中布洛芬组38例、扑热息痛组37例、保守管理组35例。布洛芬组［71.1%（27/38）］和扑热息痛组［70.3%（26/37）］初始治疗成功率均高于保守管理组［40.0%（14/35）］，差异有统计学意义（n P=0.008、0.010）。给予高剂量布洛芬营救治疗31例，成功率58.1%（18/31）。初始治疗期间3组患儿少尿、上消化道出血、大便隐血阳性、Ⅲ~Ⅳ级脑室内出血和≥Ⅱ期坏死性小肠结肠炎等发生率相似（均n P>0.05）；营救治疗期间上述并发症发生率与初始治疗期间比较差异无统计学意义［6.5%（2/31）比6.4%（7/110）、3.2%（1/31）比4.5%（5/110）、12.9%（4/31）比6.4%（7/110）、0比4.5%（5/110）、3.2%（1/31）比1.8%（2/110），均n P>0.05］。各组治疗前后血肌酐和谷丙转氨酶水平差异均无统计学意义（n P>0.05）。血清胱抑素C在布洛芬组［（0.44±0.17）μmol/L］和扑热息痛组［（0.18±0.09）μmol/L］治疗后均升高（n t=-15.70、-14.64；均n P0.05]. The changes of serum creatinine and GPT before and after treatment were not significant in all groups (n P>0.05). Serum cystatin C were increased in both ibuprofen group[(0.44±0.17)μmol/L] and paracetamol group [(0.18±0.09)μmol/L] after treatment (n t=-15.70, -14.64; n P<0.001), and the increase in ibuprofen group was greater than that in paracetamol group (n P<0.001). Urinary prostaglandin En 2 were decreased in both ibuprofen group [(-11.63±3.70)ng/L] and paracetamol group[(-4.89±1.91)ng/L] after treatment (n t=15.57, 7.03;n P<0.001), and the decrease in ibuprofen group was greater than that in paracetamol group (n P<0.001). Serum cystatin C was not significantly increased after high dose ibuprofen rescue treatment [(1.67±0.17)mg/L n vs.(1.71±0.21)mg/L; n t=-1.12, n P=0.273].n Conclusion:Both initial treatment with ibuprofen or paracetamol and rescue treatment with high-dose ibuprofen can effectively promote hsPDA closure in preterm infants without increase of complications. However, renal function indexes such as urine output and serum cystatin C should be monitored. The high-dose ibuprofen is relatively safe, and can be used as one of rescue treatment.