Pulmonary outcome at 1 year corrected age in premature infants treated at birth with recombinant human CuZn superoxide dismutase
Pulmonary outcome at 1 year corrected age in premature infants treated at birth with recombinant human CuZn superoxide dismutase
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DOI：
10.1542/peds.111.3.469
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发表时间：
2003-03-01
期刊：
影响因子：
8
通讯作者：
Rosenfeld, W
中科院分区：
文献类型：
--
作者：
Davis, JM;Parad, RB;Rosenfeld, W
Objective.研究早产儿气管内注射重组人铜锌超氧化物歧化酶（r-h CuZnSOD）是否能减少支气管肺发育不良并改善1岁校正年龄时的肺部预后。302名早产儿（600 - 1200克出生体重）在出生时接受外源性表面活性剂治疗呼吸窘迫综合征，随机接受气管内r-h CuZnSOD（5毫克/公斤，2毫升/公斤生理盐水）或安慰剂，每48小时（只要需要插管）长达1个月的年龄。评估短期和长期肺部结果。在出生后28天或月经后36周，两组之间的死亡率或支气管肺发育不良（Edwards胸片评分大于或等于3的需氧量）的发生率没有差异。r-h CuZnSOD耐受性良好，与任何不良事件的显著增加无关。在校正年龄中位数为1岁时，对209名（80%）存活婴儿进行了健康评估和体格检查，其中189名婴儿的完整数据可用。37%的安慰剂治疗的婴儿反复发作喘息或其他呼吸道疾病，严重到需要用哮喘药物治疗，如支气管扩张剂和/或皮质类固醇，而r-h CuZnSOD治疗的婴儿为24%，减少了36%。婴儿
Objective. To examine whether treatment of premature infants with intratracheal recombinant human CuZn superoxide dismutase (r-h CuZnSOD) reduces bronchopulmonary dysplasia and improves pulmonary outcome at 1 year corrected age.Design. Three hundred two premature infants (600 1200 g birth weight) treated with exogenous surfactant at birth for respiratory distress syndrome were randomized to receive either intratracheal r-h CuZnSOD (5 mg/kg in 2 mL/kg saline) or placebo every 48 hours (as long as intubation was required) for up to 1 month of age. Shortterm, as well as longer-term pulmonary outcome was assessed.Results. There were no differences between groups in the incidence of death or the development of bronchopulmonary dysplasia (oxygen requirement with an Edwards chest radiograph score of greater than or equal to3) at 28 days of life or 36 weeks' postmenstrual age. r-h CuZnSOD was well-tolerated and not associated with significant increases in any adverse event. At a median of 1 year corrected age, health assessments and physical examinations were performed on 209 (80%) surviving infants, with complete data available on 189 infants. Thirty-seven percent of placebo-treated infants had repeated episodes of wheezing or other respiratory illness severe enough to require treatment with asthma medications such as bronchodilators and/or corticosteroids compared with 24% of r-h CuZnSOD-treated infants, a 36% reduction. In infants