Controlled trial of dexamethasone in respirator-dependent infants with bronchopulmonary dysplasia.
Controlled trial of dexamethasone in respirator-dependent infants with bronchopulmonary dysplasia.
复制标题
地塞米松在患有支气管肺发育不良的呼吸器依赖婴儿中的对照试验。
作者：
G. Avery;A. B. Fletcher;M. Kaplan;D. S. Brudno
地塞米松治疗依赖呼吸机且在常规治疗下临床进展不佳的支气管肺发育不良婴儿进行了随机试验。如果婴儿有X光检查和临床诊断为支气管肺发育不良，2-6周大，体重低于1,500克，在过去5天内断奶没有进展，没有脓毒症、动脉导管未闭和先天性心脏病，并且至少24小时没有静脉脂肪，就可以进入研究。在获得父母同意后，婴儿被随机分配到对照组或治疗组。研究假设是，通过类固醇治疗，婴儿可以在72小时内脱离呼吸机，并在这段时间内表现出显著的肺顺应性改善。序贯分析超过标准(P<0.05)，当连续7对松绑的婴儿显示地塞米松脱机和对照组婴儿脱机失败时。治疗组肺顺应性改善%，对照组改善5%(P<0.01)。组间在死亡率、住院时间、败血症、高血压、高血糖或电解质异常方面没有显著差异。研究设计允许这样的结论：地塞米松可以在短期内显著改善肺功能，通常允许快速撤机，但长期有效性和安全性必须通过进一步的研究来证明。
A randomized trial was conducted of dexamethasone therapy in infants with bronchopulmonary dysplasia who were dependent on respirators and were not progressing clinically despite conventional treatment. Babies were admitted to the study if they had a roentgenogram and clinical diagnosis of bronchopulmonary dysplasia, were 2 to 6 weeks in age, weighed less than 1,500 g, had made no progress in weaning for the preceding five days, and were free of sepsis, patent ductus arteriosus, and congenital heart disease, and had had no intravenous fat for at least 24 hours. After parental consent was obtained, infants were randomly assigned to control or treatment groups. The study hypothesis was that with steroid treatment, babies could be weaned from the respirator within 72 hours and would show a significant improvement in lung compliance within that time. Sequential analysis exceeded criterion (P less than .05) when seven consecutive untied pairs showed weaning with dexamethasone and failure to wean in control infants. Pulmonary compliance improved by 64% in the treated group and 5% in the control group (P less than .01). No significant intergroup differences were noted in mortality, length of hospital stay, sepsis, hypertension, hyperglycemia, or electrolyte abnormalities. Study design permits the conclusion that dexamethasone can produce substantial short-term improvement in lung function, often permitting rapid weaning from the respirator, but long-term efficacy and safety must be demonstrated by further investigations.