Peckham G J, Miettinen O S, Ellison R C, Kraybill E N, Gersony W M, Zierler S, Nadas A S
J Pediatr. 1984 Aug;105(2):285-91. doi: 10.1016/s0022-3476(84)80134-1.
Reported are 1-year follow-up results of a randomized clinical trial comparing three strategies of managing clinically significant patent ductus arteriosus at the time of diagnosis in premature infants: (1) immediate administration of a three-dose course of intravenously administered indomethacin in addition to usual medical therapy (fluid restriction and use of diuretics or digitalis or both), with surgery as a backup measure, (2) usual medical therapy alone initially, with indomethacin as the first and surgery as the final backup measure, and (3) usual medical therapy alone initially, with surgery alone as backup. Of primary concern were the relative merits of these three managements strategies in the terms of the long-term occurrence of a wide range of health problems. Although at the time of neonatal hospitalization there was a significant excess of bleeding episodes in infants receiving indomethacin as part of initial treatment, and a significantly higher rate of retrolental fibroplasia in the those given usual medical therapy with surgery as backup, there were no statistically significant differences at 1 year of age related to these intermediate outcomes. In other regards, too, the treatment strategies appeared interchangeable in terms of the 1-year outcome.
报告了一项随机临床试验的1年随访结果，该试验比较了早产儿诊断时临床上显著的动脉导管未闭的三种管理策略：（1）除常规药物治疗（液体限制和使用利尿剂或洋地黄或两者兼有）外，立即静脉注射三剂吲哚美辛，并将手术作为备用措施；（2）最初仅采用常规药物治疗，以吲哚美辛作为首选，手术作为最终备用措施；（3）最初仅采用常规药物治疗，仅以手术作为备用。主要关注的是这三种管理策略在长期发生各种健康问题方面的相对优点。虽然在新生儿住院期间，接受吲哚美辛作为初始治疗一部分的婴儿出血事件明显过多，而以手术作为备用接受常规药物治疗的婴儿晶状体后纤维增生率明显更高，但在1岁时，与这些中间结果相关的差异无统计学意义。在其他方面，就1年的结果而言，治疗策略似乎也可以互换。
