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目的探讨长疗程和常规疗程(短疗程)消炎痛关闭早产儿动脉导管的疗效、安全性及治疗前后前列腺素水平的变化。方法设计前瞻性双盲随机对照试验。体重≥1250g的动脉导管未闭(PDA)早产儿随机分为短疗程组(对照组)[0.2mg/(kg.次),确诊后即刻、12、36h各用1次]和长疗程组(试验组)[0.15mg/(kg.次),确诊后即刻、12、36、48h各用1次]。在治疗前后监测血浆6-酮-前列腺素F1α水平,评估临床症状和心脏彩超改变,主要观察指标为动脉导管的关闭情况及不良反应。结果一个疗程消炎痛治疗后试验组动脉导管关闭率高于对照组(75.0%比64.3%,RR1.17,95%CI0.823～1.654),少尿发生率低于对照组(7.1%比32.0%,RR0.22,95%CI0.053～0.938)。两组患儿血浆6-酮-前列腺素F1α在消炎痛治疗后较治疗前明显降低(280ng/L比295ng/L,P<0.001),但两组差异无统计学意义。结论长疗程消炎痛治疗早产儿PDA的疗效与短疗程相当,且降低了少尿的发生率,并未增加坏死性小肠结肠炎发生率。血浆6-酮-前列腺素F1α在应用消炎痛后降低。
Objective To investigate the efficacy and safety of long and short courses of indomethacin in the closure of the patent ductus arteriosus in preterm infants and the changes of prostaglandin levels before and after treatment. Methods A prospective, double-blind randomized controlled trial was designed. Premature infants with patent ductus arteriosus (PDA) weighing ≥1250g were randomly divided into two groups: the short-course group (control group) [0.2mg / (kg) Test group) [0.15mg / (kg times), immediately after diagnosis, 12,36,48 h each use]. Plasma 6-keto-prostaglandin F1α levels were monitored before and after treatment to evaluate clinical symptoms and changes of cardiac ultrasonography. The main observation indicators were the closure of the patent ductus arteriosus and adverse reactions. Results After a course of indomethacin treatment, the rate of patent ductus arteriosus closure in the test group was significantly higher than that of the control group (75.0% vs 64.3%, RR 1.17, 95% CI 0.823-1.654) and the incidence of oliguria was lower than that of the control group (7.1% vs. 32.0 %, RR0.22, 95% CI0.053 ~ 0.938). Plasma 6-keto-prostaglandin F1α in both groups was significantly lower than that before treatment (280ng / L vs 295ng / L, P <0.001) after treatment with indomethacin, but there was no significant difference between the two groups. Conclusion The long-term treatment of indomethacin in preterm infants with PDA is equivalent to short course of treatment, and reduces the incidence of oliguria, did not increase the incidence of necrotizing enterocolitis. Plasma 6-keto-prostaglandin F1α is reduced after indomethacin is administered.