A comparative study of paracetamol and ibuprofen on patent ductus arteriosus in preterm infants at different stages of gestational age
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摘要:
目的 观察口服对乙酰氨基酚与布洛芬治疗不同胎龄早产儿动脉导管未闭(patent ductus arteriosus,PDA)的疗效和安全性。 方法 选取2016年1月—2018年1月在蚌埠医学院第三附属医院新生儿科住院的胎龄<37周,体重<2 500 g,口服布洛芬的56例PDA早产儿为对照组,2018年1月—2020年1月在蚌埠医学院第三附属医院新生儿科住院的胎龄<37周, 体重<2 500 g,54例PDA早产儿为观察组,予口服对乙酰氨基酚。所有患儿根据胎龄再分为3组,28~30+6周组,31~33+6周组,34~36+6周组;观察比较2种药物的疗效和安全性及3组不同胎龄早产儿PDA的关闭率差异。 结果 对乙酰氨基酚组动脉导管关闭率(79.63%)和布洛芬组(78.57%)比较差异无统计学意义(P>0.05)。28~30+6周组、31~33+6周组、34~36+6周组动脉导管关闭率分别为62.5%、84.2%、87.5%。对乙酰氨基酚组和布洛芬组之间上消化道出血、脑室内出血(intraventricular hemorrhage,IVH)、坏死性小肠结肠炎(necrotizing enterocolitis,NEC)、早产儿视网膜病(retinopathy of prematurity,ROP)、支气管肺发育不良(bronchopulmonary dysplasia,BPD)、尿量减少及高胆红素血症的发生率比较差异无统计学意义(均P>0.05)。 结论 对乙酰氨基酚与布洛芬均可有效治疗PDA;2种药物的不良反应发生率无显著差异;胎龄不同的早产儿动脉导管关闭率不完全相等,胎龄最小组关闭率最低。 Abstract:Objective To observe the efficacy and safety of paracetamol and ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants of different gestational ages. Methods Total 110 preterm infants with gestational age ≤37 weeks, birthweight ≤2 500 g confirmed PDA were enrolled, including group Ⅰ (ibuprofen group, from January 2016 to January 2018, a total of 56 preterm infants received oral ibuprofen) and group Ⅱ (paracetamol group, from January 2018 to January 2020, a total of 54 preterm infants received oral paracetamol). According to gestational age, all the infants were divided into three groups: 28-30+6 weeks group, 31-33+6 weeks group, 34-36+6 weeks group. The efficacy and safety of the two drugs and the difference of PDA closure rate among the three groups were observed and compared. Results There was no significant difference in PDA closure rate between group Ⅰ (78.57%) and Ⅱ (79.63%), P>0.05. The closure rate of PDA were 62.5%, 84.2% and 87.5%, respectively, in 28-30+6 weeks group, 31-33+6 weeks group and 34-36+6 weeks. In addition, oral paracetamol was as safe as oral ibuprofen in terms of gastrointestinal bleeding, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, intraventricular hemorrhage, hyperbilirubinemia, uri nary output (all P>0.05). Conclusion The efficacy and safety of paracetamol and ibuprofen on PDA are similar. There was no significant difference in the incidence of adverse reactions between the two drugs. The closure rate of patent ductus arteriosus is not equal in different gestational age and is inversely proportional to gestational age. -
Key words:
- Patent ductus arteriosus /
- Paracetamol /
- Ibuprofen /
- Treatment effect /
- Safety /
- Preterm infant
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表 1 2组PDA早产儿一般资料比较
组别 例数 性别(例) 胎龄(x±s,周) 出生体重(x±s,g) 男 女 观察组 54 29 25 32.57±2.00 1 791.91±371.97 对照组 56 26 30 32.47±2.03 1 782.21±390.19 统计量 0.045a 0.254b 0.133b P值 0.832 0.800 0.894 注:a为χ2值,b为t值。 表 2 不同治疗方法动脉导管未闭患儿不良反应发生率比较[例(%)]
组别 例数 上消化道出血 NEC ROP BPD IVH 尿量减少 高胆红素血症 观察组 54 5(9.26) 3(5.56) 3(5.56) 2(3.70) 2(3.70) 13(24.07) 16(29.63) 对照组 56 3(5.36) 4(7.14) 2(3.57) 5(8.93) 1(1.79) 11(19.64) 13(23.21) χ2值 0.316 0.583 P值 0.485a >0.999a 0.676a 0.438a 0.615a 0.574 0.445 注:a为采用Fisher精确检验。 -
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