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一项关于口服吲哚美辛对内科治疗无效的动脉导管未闭早产儿影响的双盲研究。

A double blind study of the effects of oral indomethacin in preterm infants with patent ductus arteriosus who failed medical management.

作者信息

Neu J, Ariagno R L, Johnson J D, Pitlick P T, Cohen R S, Beets C L, Sunshine P

出版信息

Pediatr Pharmacol (New York). 1981;1(3):245-9.

PMID:7346744
Abstract

Over a two year period, 52 infants were found to have clinical signs of patent ductus arteriosus (PDA). Twenty-seven responded to fluid restriction and furosemide; the remaining 25 infants entered the Indomethacin (IN) study protocol. Their mean (+/- SE) gestational age was 29.3 (+/- 0.6) weeks and birth weight was 1,142 (+/- 80) gm. Either a placebo or IN (0.25 mg/kg) orally was given for two doses, 24 hours apart; if no response occurred, the patient was crossed over to the opposite medication. Using Chi-square analysis, a significant response rate to IN was found. There were no significant differences in birth weights, gestational ages, or fluid intake between responders and nonresponders. However, both responders and nonresponders required a prolonged ventilator course, suggesting factors other than PDA causing prolonged ventilatory requirements in these babies.

摘要

在两年的时间里,发现52例婴儿有动脉导管未闭(PDA)的临床症状。27例对液体限制和速尿有反应;其余25例婴儿进入吲哚美辛(IN)研究方案。他们的平均(±标准误)胎龄为29.3(±0.6)周,出生体重为1142(±80)克。口服安慰剂或IN(0.25mg/kg),分两剂,间隔24小时;如果没有反应,患者改用另一种药物。使用卡方分析,发现对IN有显著反应率。反应者和无反应者之间的出生体重、胎龄或液体摄入量没有显著差异。然而,反应者和无反应者都需要延长呼吸机使用时间,这表明除PDA外的其他因素导致这些婴儿需要延长通气时间。

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