布洛芬与吲哚美辛治疗早产儿动脉导管未闭的疗效及安全性对比研究

Comparison of Efficacy and Safety of Oral Ibuprofen or Indomethacin for Closure of Patent Ductus Arteriosus in Premature Infants

目的对比观察口服布洛芬与吲哚美辛对早产儿动脉导管未闭(PDA)的疗效及安全性。方法将近3a收治的36例PDA早产儿作为布洛芬组。于出生2～7d分3次予口服布洛芬治疗,首剂给予10mg/kg,于24h、48h后再分别给予5mg/kg。将2003年6月-2005年12月采用吲哚美辛治疗的33例PDA早产儿作为吲哚美辛组。服药首剂0.2mg/kg,间隔12h1次,共3次。观察二组疗效和不良反应。结果布洛芬组PDA关闭29例(80.56%),吲哚美辛组关闭27例(81.82%),二组比较差异无统计学意义(χ2=0.02P>0.05)。布洛芬组5d前与5d后用药关闭率分别为91.30%、61.54%(21/23例、8/13例),二者比较差异有统计学意义(χ2=4.70P<0.05);吲哚美辛组5d前及5d后用药关闭率分别为95.0%、61.54%(19/20例、8/13例),二者比较差异有统计学意义(χ2=5.93P<0.05)。布洛芬组与吲哚美辛组比较5d前与5d后用药关闭率均无统计学差异。布洛芬组发生不良反应6例(16.67%),吲哚美辛组发生不良反应16例(48.48%),二组比较差异有统计学意义(χ2=8.03P<0.01)。结论口服布洛芬治疗早产儿PDA疗效与吲哚美辛相当,但前者不良反应少,安全系数高。

Objective To compare the efficacy and safety of oral ibuprofen or indomethacin for the closure of patent ductus arteriosus （PDA） in premature infants. Methods Thirty - six cases of premature infants with PDA during latest 3 years were assigned into the ibupro- fen group and received oral ibuprofen suspension （ 10 mg/kg followed by 2 doses of 5 mg/kg after 24 hours,48 hours） postnatal 3 to 7 days. Thirty - three cases of premature infants with PDA from Jan. 2003 to Dec. 2005 were assigned into indomethacin group and received oral indomethacin （0.2 mg/kg every 12 hours for 3 doses）. The effectiveness and adverse effects of both groups after treated were observed. Results The rate of ductal closure in ibuprofen group was 80.56% （29/36 cases） and that in indomethacin group was 81.82% （27/33 cases） ,there was no significant difference between 2 groups （χ^2 = 0.02 P 〉 0.05 ）. In ibuprofen group, the rate of ductal closure, when ibuprefen was used either before or after 5 days,was 91.30% （21/23 cases） or 61.54% （8/13 cases）, respectively, there was significant difference between 2 groups 0（χ^2 = 4.70 P 〈 0.05 ）. In indomethacin group, the rates of ductal closure were similar to those of ibuprofen group. But there was no significant difference between 2 groups when ibuprofen or indomethacin was used either before or after 5 days. The incidence of adverse effects in ibuprofen group （6 cases, 16.67% ） was significantly lower than that in .indomethacin group （ 16 cases, 48.48% ） （χ^2= 8.03 P 〈 0.01 ）. Conclusions The efficacy of ibuprofen for the closure of PDA in premature infants is similar to indomethacin, but ibuprofen has less adverse effects and higher safety than indomethacin.