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目的静脉注射消炎痛是早产儿动脉导管未闭的常规治疗方法,但治疗过程中常出现一些副作用,如少尿、消化道出血、脑血流灌注减少。近年来,静脉注射布洛芬已用于治疗早产儿动脉导管未闭。布洛芬治疗不会减少脑血流灌注,也不会影响胃肠道和肾脏的血流动力学。伊朗目前尚无消炎痛和布洛芬的静脉制剂供应。该研究旨在比较这两种药的口服制剂治疗早产儿动脉导管未闭的疗效和安全性。方法36例胎龄小于34周经超声心动图确诊患有动脉导管未闭的早产儿被随机分为两组,每组18人。一组给予消炎痛口服,每次0.2 mg/kg,24 h给药1次,共3次。另一组给予布洛芬口服,共3次,间隔时间为24 h,首剂为10 mg/kg,随后两次各5 mg/kg。用药后观察导管闭合率、副作用、并发症及临床过程。结果用药后布洛芬组18例患儿动脉导管都闭合(100%),而消炎痛组18例中有15例患儿动脉导管闭合(83.3%)(P>0.05)。两组疗效差异统计学无显著性意义。治疗前后两组的血清尿素氮和肌酐含量差异也无显著性意义。消炎痛组发生了3例(16.6%)坏死性小肠结肠炎,布洛芬组则无,差异有显著性意义(P<0.05)。治疗1个月后两组成活率均为94%(17/18)。消炎痛组1例死于坏死性小肠结肠炎,布洛芬组1例死于败血症。结论口服布洛芬治疗早产儿动脉导管未闭和口服消炎痛治疗一样有效,而且坏死性小肠结肠炎的发生率较口服消炎痛治疗低。
The purpose of intravenous injection of indomethacin is a routine treatment of patent ductus arteriosus in preterm infants, but some side effects often occur during treatment, such as oliguria, gastrointestinal bleeding, decreased cerebral perfusion. In recent years, intravenous ibuprofen has been used to treat patent ductus arteriosus in preterm infants. Ibuprofen treatment did not reduce cerebral perfusion and did not affect hemodynamics in the GI tract and kidneys. There is currently no supply of intravenous preparations of indomethacin and ibuprofen in Iran. The aim of this study was to compare the efficacy and safety of oral preparations of these two drugs in the treatment of patent ductus arteriosus in preterm infants. Methods Thirty-six preterm infants with gestational age less than 34 weeks diagnosed by echocardiography with patent ductus arteriosus were randomly divided into two groups of 18 in each group. A group given oral indomethacin, each 0.2 mg / kg, 24 h dosing 1 times a total of 3 times. The other group was given ibuprofen orally for 3 times at intervals of 24 h with a first dose of 10 mg / kg followed by two 5 mg / kg each. After treatment, observe the catheter closure rate, side effects, complications and clinical course. Results All the 18 cases of ibuprofen were closed (100%) for PDA while 15 cases of indomethacin (15 cases) were closed (83.3%) (P> 0.05). No significant difference between the two groups of statistical significance. Before and after treatment, serum urea nitrogen and creatinine levels were also no significant difference. There were 3 cases (16.6%) of necrotizing enterocolitis in indomethacin group and no significant difference in ibuprofen group (P <0.05). After 1 month of treatment, the survival rates of both groups were 94% (17/18). One patient died of necrotizing enterocolitis in indomethacin group and one patient died of sepsis in ibuprofen group. Conclusions Oral ibuprofen is equally effective in the treatment of patent ductus arteriosus and oral indomethacin in preterm infants, and the incidence of necrotizing enterocolitis is lower than that of oral indomethacin.