Wong J Y, Moon S, Beardsmore C, O'Callaghan C, Simpson H
Dept of Child Health, University of Leicester, Leicester Royal Infirmary, UK.
Eur Respir J. 2000 Feb;15(2):388-94. doi: 10.1034/j.1399-3003.2000.15b27.x.
A double-blind randomized placebo-controlled trial was conducted to investigate the efficacy of 3 months' inhaled steroids delivered via a spacer device with face mask attachment to infants recovering from bronchiolitis. Forty-eight previously healthy infants recovering from their first documented episode of acute bronchiolitis were randomized to receive 150 microg fluticasone propionate (FP) b.i.d. or placebo delivered via the Babyhaler spacer. Longitudinal assessments were performed on seven occasions over 1 yr based on symptom diaries and health records, clinical examinations, overnight cough recordings and oxygen saturation readings. Lung function was measured 6 months after hospital discharge. Forty-three infants completed the trial (FP 21, placebo 22). There were no significant differences in the three objective end-points measured, recorded night cough, oxygen saturation and lung function test results. Symptom scores were low in both the FP and placebo groups with the absence of (0) or mild (1) symptoms > or =90% of the trial days. No statistical differences in symptom frequency, use of rescue respiratory medications or hospital admissions between treatment groups were found throughout the trial or follow-up periods. In conclusion, the use of inhaled fluticasone propionate in infants recovering from acute bronchiolitis cannot be recommended.
开展了一项双盲随机安慰剂对照试验，以研究通过带有面罩的储雾罐装置给患细支气管炎后正在康复的婴儿吸入3个月类固醇的疗效。48名首次记录患急性细支气管炎且正在康复的健康婴儿被随机分组，分别通过婴儿储雾罐接受每日两次150微克丙酸氟替卡松（FP）或安慰剂。基于症状日记和健康记录、临床检查、夜间咳嗽记录和血氧饱和度读数，在1年中进行了7次纵向评估。出院6个月后测量肺功能。43名婴儿完成了试验（FP组21名，安慰剂组22名）。所测量的三个客观终点（记录的夜间咳嗽、血氧饱和度和肺功能测试结果）没有显著差异。FP组和安慰剂组的症状评分均较低，在超过90%的试验日中没有（0）或仅有轻度（1）症状。在整个试验期或随访期内，未发现治疗组之间在症状频率、急救呼吸药物使用或住院情况方面存在统计学差异。总之，不建议对患急性细支气管炎后正在康复的婴儿使用吸入丙酸氟替卡松。
