探讨新生儿动脉导管未闭(patent ductus arteriosus，PDA)的自然关闭率及口服布洛芬干预的利弊。

选择2008年10月至2011年9月因"早产儿/新生儿肺炎、发绀"入院，生后15 h～24 d经心脏彩超确诊为PDA的患儿96例为研究对象。将其按照治疗方式的不同分为治疗组[n＝61，确诊后立即给予布洛芬混悬液口服治疗，首剂为10 mg/kg，24 h，48 h后再分别给予5 mg/kg；治疗(72～96)h后复查心脏彩超]，安慰剂组[n＝35，确诊后立即给予生理盐水口服，首剂为1 mL/kg，24 h，48 h后再分别给予0.5 mL/kg；(72～96)h后复查心脏彩超。对仍存在PDA的患儿，则按照治疗组方案治疗，(72～96)h后再复查心脏彩超](本研究遵循的程序符合本院人体试验委员会制定的伦理学标准，得到该委员会批准，分组征得受试对象监护人的知情同意，并与其签署临床研究知情同意书)。两组患儿一般临床资料及治疗前彩超检查结果比较，差异无统计学意义(P>0.05)。对两组治疗后复查心脏彩超结果及不良反应发生率进行统计学分析。

①治疗组全部患儿，治疗组足月儿、非症状性PDA儿、不合并其他心脏病患儿、出生72 h内确诊为PDA患儿的动脉导管关闭率(分别为88.5%，91.3%，92.9%，89.6%及93.0%)均显著高于安慰剂组的同类患儿(62.9%，50.0%，68.0%，60.7%及66.7%)，差异均有统计学意义(P<0.05)；治疗组早产儿、症状性PDA儿、合并其他心脏病患儿、出生72 h后确诊为PDA患儿的动脉导管关闭率(分别为86.8%，78.9%，84.6%及77.8%)分别与安慰剂组的同类患儿(71.4%，50.0%，71.4%及50.0%)比较，差异均无统计学意义(P>0.05)。②两组早产儿与足月儿、症状性与非症状性PDA患儿、合并其他心脏病与不合并其他心脏病患儿、出生72 h内确诊与出生72 h后确诊的PDA患儿的动脉导管关闭率组内比较，差异均无统计学意义(P>0.05)。③安慰剂组第1次复查心脏彩超的结果显示，动脉导管关闭率为62.9%(22/35，均自发性关闭)，第2次则为61.5%(8/13，在治疗后关闭)。④4例早产儿出生10 d后接受布洛芬治疗，2例动脉导管关闭，2例导管内径缩小。⑤治疗过程中出现少尿，治疗组为6例(9.8%)，安慰剂组为2例(5.7%)。⑥未完成治疗/临床病历资料不完整的接受布洛芬治疗患儿中，出现血小板(PLT)严重下降、上消化道出血及便血各1例。

口服布洛芬不但可有效促进出生10 d内的PDA早产儿动脉导管闭合，对于足月儿肺炎/发绀伴PDA及出生10 d后PDA早产儿的动脉导管闭合亦有效，而且临床应用相对安全。

To investigate rate of spontaneous closure, efficacy and safety of oral ibuprofen on neonatal patent ductus arteriosus (PDA).

From October 2008 to September 2011, a total of 96 neonates admitted to department of pediatrics with premature infants, neonate pneumonia or cyanosis associated with PDA confirmed by echocardiography from 15 h to 24 d after delivery. They were divided into two groups based on different treatment strategies: Treatment group (n=61, treatment by oral ibuprofen suspension 10 mg/kg, 5 mg/kg at 24 h and 48 h, respectively, and echocardiography examination after treatment 72 h to 96 h); placebo group (n=35, treatment by oral physiological saline 1 mL/kg, 0.5 mL/kg at 24 h and 48 h, respectively, echocardiography examination after treatment 72 h to 96 h. They were treatment by oral ibuprofen suspension as strategies of treatment group if PDA persistence, and echocardiography examination again after treatment by ibuprofen 72 h to 96 h. There had no significance difference between two groups among general clinical data and results of echocardiography of heart before treatment etc.(P>0.05). Data of reexamine results of echocardiography of heart and incidence of adverse reactions were analysis between two groups by statistics. Informed consent was obtained from the parents of each participating neonate.

①The PDA closing rates of overall, full term infants, asymptomatic infants, without others cardiopathy infants, PDA confirmed born within 72 h in treatment group (88.5%, 91.3%, 92.9%, 89.6%, 93.0%) were significant higher than those in placebo group (62.9%, 50.0%, 68.0%, 60.7%, 66.7%)(P<0.05). There were no significant difference in PDA closing rates of preterm infants, symptomatic infants, with other cardiopathy infants, PDA confirmed born after 72 h between treatment group (86.8%, 78.9%, 84.6%, 77.8%) and placebo group (71.4%, 50.0%, 71.4%, 50.0%)(P>0.05). ②There were no significant difference between two groups in closing rates of PDA of preterm infants and full term infants, symptomatic and asymptomatic, with and without others cardiopathy, PDA confirmed born within and after 72 h (P>0.05). ③ In placebo group, PDA disappear spontaneously in 22/35 (62.9%) cases after treatment by placebo, and PDA were closed in 8/13 (61.5%) cases after treatmen by strategies as that of treatment group.④There were 4 cases premature infants born after 10 d treatment by ibuprofen, closed in 2/4 cases, and diameter reduced in the other 2/4 cases.⑤Oliguria occurred in 6 cases (9.8%) in treatment group, and 2 cases (5.7%) in placebo group. ⑥Another 3 cases treatment by ibuprofen who had been excluded by this study, occurred serious decrease of platelet (PLT), upper gastrointestinal hemorrhage, and hematochezia one case, respectively.

Oral ibuprofen is effective in closing PDA in preterm infants within 10 days of life. It is effective in closing PDA in full term infants with neonate pneumonia or cyanosis and preterm infants after 10 days of life, too. It is safe to clinical use.