对乙酰氨基酚治疗早产儿动脉导管未闭的疗效和安全性

Efficacy and safety of paracetamol in the treatment of patent ductus arteriosus in premature infants

目的评价口服对乙酰氨基酚治疗有血流动力学意义的动脉导管未闭(hsPDA)早产儿的疗效和安全性。方法选取2017年6月至2019年5月期间在开封市妇幼保健院治疗的76例hsPDA早产儿。根据随机数字表法随机分为对乙酰氨基酚组(n=38)与布洛芬组(n=38)。布洛芬组患儿给予布洛芬混悬液口服治疗,20 mg/mL稀释为10 mg/mL,初始剂量为10 mg/kg,24 h与48 h后再给予患儿5 mg/kg,3 d为1个疗程。对乙酰氨基组患儿给予对乙酰氨基酚混悬液口服治疗,32 mg/mL稀释为15 mg/mL,剂量为15 mg/kg,每6 h服用1次,3 d为1个疗程。如患儿导管关闭失败,则对患儿进行第2疗程用药治疗。治疗前、治疗后比较2组患儿未闭动脉导管(PDA)直径、左肺动脉(LPA)舒张末期血流速度、右心室收缩压(RVSP)等超声心动图指标,比较2组患儿的临床预后和不良反应发生情况。结果对乙酰氨基酚组患儿PDA直径治疗1个疗程后[(1.7±0.7)mm vs.(2.2±0.6)mm,t=3.551,P<0.001]及治疗2个疗程后[(1.5±0.4)mm vs.(2.2±0.6)mm,t=4.527,P<0.001]较治疗前显著降低。在第2疗程后,对乙酰氨基酚组PDA直径显著低于布洛芬组[(1.5±0.4)mm vs.(1.7±0.5)mm,t=2.430,P=0.018]。对乙酰氨基酚组与布洛芬组患儿总动脉导管非手术闭合率比较差异无统计学意义(65.8%vs.63.2%,χ^(2)=0.831,P=0.362)。没有患儿发生与布洛芬和对乙酰氨基酚相关不良反应。结论对乙酰氨基酚可以作为早产儿hsPDA的一线药物,安全有效、耐受性好。

Objective To evaluate the efficacy and safety of oral paracetamol in the treatment of premature infants with hemodynamically significant patent ductus arteriosus(hsPDA).Methods A total of 76 cases of preterm infants with hsPDA treated in Kaifeng Maternal and Child Care Center from June 2017 to May 2019 were selected.According to the random num⁃ber table method,76 premature patent ductus arteriosus(PDA)infants were randomly divided into paracetamol group(n=38)and ibuprofen group(n=38).The children in ibuprofen group were treated with ibuprofen suspension orally,20 mg/mL dilut⁃ed to 10 mg/mL,the initial dose was 10 mg/kg;after 24 h and 48 h,the children were given 5 mg/kg;we set 3 days as a course of treatment.The children in paracetamol group were treated with paracetamol suspension orally,32 mg/mL diluted to 15 mg/mL,the dosage was 15 mg/kg,once every 6 hours,3 days as a course of treatment.If the catheter closure fails,the child will be treated with medication in the second course.Before and after treatment,the diameter of PDA,left pulmonary ar⁃tery(LPA)end-diastolic blood flow velocity,right ventricular systolic pressure(RVSP)and other echocardiographic indicators were compared between the two groups.The clinical prognostic indicators and adverse drug reactions were compared be⁃tween the two groups.Results The diameter of PDA in the paracetamol group decreased significantly after the first course of treatment[(1.7±0.7)mm vs.(2.2±0.6)mm,t=3.551,P<0.001],and the second courses of treatment[(1.5±0.4)mm vs.(2.2±0.6)mm,t=4.527,P<0.001].After the second course of treatment,the diameter of PDA in paracetamol group was significantly lower than that in ibuprofen group[(1.5±0.4)mm vs.(1.7±0.5)mm,t=2.430,P=0.018].There was no significant difference in the non-operative closure rate of common ductus arteriosus between the paracetamol group and the ibuprofen group(65.8%vs.63.2%,χ^(2)=0.831,P=0.362).No adverse reactions associated with ibuprofen and paracetamol occurred.Conclusion Paracetamol can be used as the first choice for early treatment of PDA in premature infants,and it is an effective and well tolerated first-line drug for PDA in premature infants.