Kim Sang Bum, Lee Jang Hoon, Lee Juyoung, Shin Seung Han, Eun Ho Sun, Lee Soon Min, Sohn Jin A, Kim Han Suk, Choi Byung Min, Park Min Soo, Park Kook In, Namgung Ran, Park Moon Sung
Department of Pediatrics, Ajou University School of Medicine, Suwon, Korea.
Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.
Korean J Pediatr. 2015 Sep;58(9):347-53. doi: 10.3345/kjp.2015.58.9.347. Epub 2015 Sep 21.
The purpose of this study was to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonarydysplasia (BPD).
The Interventional study was designed as a multicenter, prospective, and randomized trial, with open labeled and parallel-experimental groups, 66 infants were enrolled and allocated to either the case group (n=30) or the control group (n=36) based on gestational age (GA). Infants in the case group were given Montelukast sodium (Singulair) based on their body weight (BW). Zero week was defined as the start time of the study.
The incidence of moderate to severe BPD was not different between the groups (case group: 13 of 30 [43.3%] vs. control group: 19 of 36 [52.8%], P=0.912). Additionally, secondary outcomes such as ventilation index, mean airway pressure and resort to systemic steroids were not significantly different. There were no serious adverse drug reactions in either group, and furthermore the rate of occurrence of mild drug related-events were not significantly different (case group: 10 of 42 [23.8%] vs. control group: 6 of 48 (15.8%), P=0.414).
Montelukast was not effective in reducing moderate or severe BPD. There were no significant adverse drug events associated with Montelukast treatment.
本研究旨在评估孟鲁司特钠预防支气管肺发育不良（BPD）的疗效和安全性。
本干预性研究设计为一项多中心、前瞻性、随机试验，采用开放标签和平行试验组，根据胎龄（GA）纳入66例婴儿并将其分为病例组（n = 30）或对照组（n = 36）。病例组婴儿根据体重给予孟鲁司特钠（顺尔宁）。第0周定义为研究开始时间。
两组中重度BPD的发生率无差异（病例组：30例中有13例[43.3%]，对照组：36例中有19例[52.8%]，P = 0.912）。此外，诸如通气指数、平均气道压力和全身使用类固醇等次要结局也无显著差异。两组均未出现严重药物不良反应，此外，轻度药物相关事件的发生率也无显著差异（病例组：42例中有10例[23.8%]，对照组：48例中有6例[15.8%]，P = 0.414）。
孟鲁司特在降低中重度BPD方面无效。孟鲁司特治疗未出现显著的药物不良事件。
