糠酸莫米松吸入对生长速度和肾上腺功能的影响：4～9岁轻度持续性哮喘患儿安慰剂-对照试验
2011/10/13
摘要
目的：评价哮喘儿童长期使用干粉吸入器（MF-DPI）吸入糠酸莫米松对生长速度和下丘脑-垂体-肾上腺轴功能的影响。
研究设计：将4～9岁哮喘患儿（n = 187）随机分为MF-DPI 100 μg（给药剂量；驱动剂量为110 μg）每日一次上午给药组（QD AM）；100 μg 一日两次（BID）组；200 μg QD AM组和安慰剂组。治疗52周后随访3个月。主要检测指标为生长速度（测量每次就诊时的站立高度），次要指标为血清和12-h尿可的松、血清骨钙素和尿N- 端肽。
结果：与安慰剂组相比，MF-DPI 100 μg QD AM 治疗并未显著影响生长速度(-0.10 ± 0.31 cm/y, p = 0.76)。至于MF-DPI日总剂量200 μg对生长速度的影响，虽然MF-DPI 200 μg QD A组的平均生长速度变化有统计学意义(-0.70 ± 0.29 cm/y, p = 0.02)，但是MF-DPI 100 μg BID组与安慰剂组相比并无明显差异(-0.64 ± 0.39 cm/y, p = 0.10)。MF-DPI各试验剂量组的平均血浆可的松水平变化与安慰剂组相似，表明未产生药物相关的效应。12-h尿可的松和其他指标也无组间差异。
结论：与安慰剂相比，MF-DPI以日总剂量100 μg上午给药治疗1年未对哮喘患儿的生长速度产生明显影响，但当日总剂量达到200 μg时产生了一定的影响。生长速上的度差异以及药物相关可的松效应的缺乏为MF-DPI以日总剂量100 μg治疗4～9岁患儿的轻度持续性哮喘提供了依据。
目的：评价哮喘儿童长期使用干粉吸入器（MF-DPI）吸入糠酸莫米松对生长速度和下丘脑-垂体-肾上腺轴功能的影响。
研究设计：将4～9岁哮喘患儿（n = 187）随机分为MF-DPI 100 μg（给药剂量；驱动剂量为110 μg）每日一次上午给药组（QD AM）；100 μg 一日两次（BID）组；200 μg QD AM组和安慰剂组。治疗52周后随访3个月。主要检测指标为生长速度（测量每次就诊时的站立高度），次要指标为血清和12-h尿可的松、血清骨钙素和尿N- 端肽。
结果：与安慰剂组相比，MF-DPI 100 μg QD AM 治疗并未显著影响生长速度(-0.10 ± 0.31 cm/y, p = 0.76)。至于MF-DPI日总剂量200 μg对生长速度的影响，虽然MF-DPI 200 μg QD A组的平均生长速度变化有统计学意义(-0.70 ± 0.29 cm/y, p = 0.02)，但是MF-DPI 100 μg BID组与安慰剂组相比并无明显差异(-0.64 ± 0.39 cm/y, p = 0.10)。MF-DPI各试验剂量组的平均血浆可的松水平变化与安慰剂组相似，表明未产生药物相关的效应。12-h尿可的松和其他指标也无组间差异。
结论：与安慰剂相比，MF-DPI以日总剂量100 μg上午给药治疗1年未对哮喘患儿的生长速度产生明显影响，但当日总剂量达到200 μg时产生了一定的影响。生长速上的度差异以及药物相关可的松效应的缺乏为MF-DPI以日总剂量100 μg治疗4～9岁患儿的轻度持续性哮喘提供了依据。
（苏楠 审校）
J Asthma. 2011 Aug 22. [Epub ahead of print]
J Asthma. 2011 Aug 22. [Epub ahead of print]
Source
Allegheny General Hospital , Pittsburgh, PA , USA.
Abstract
OBJECTIVE： To assess the effects of long-term mometasone furoate delivered via a dry powder inhaler (MF-DPI) on growth velocity and hypothalamic-pituitary-adrenal axis function in children with asthma.
STUDY DESIGN： Children aged 4-9 years with asthma (n = 187) were randomized to MF-DPI 100 μg (delivered dose; actuated dose is 110 μg) once daily in the morning (QD AM), 100 μg twice daily (BID), 200 μg QD AM, or placebo for 52 weeks followed by a 3-month follow-up period. The primary outcome was growth velocity calculated from stadiometric heights recorded at each visit. Secondary outcomes included serum and 12-h urinary cortisol, serum osteocalcin, and urinary N-telopeptide.
RESULTS：MF-DPI 100 μg QD AM treatment did not significantly affect growth velocity compared with placebo (-0.10 ± 0.31 cm/y, p = 0.76). When the effect of a total daily dose of 200 μg MF-DPI on growth velocity was examined, no significant effect was demonstrated for MF-DPI 100 μg BID compared with placebo (-0.64 ± 0.39 cm/y, p = 0.10), although the change in mean growth velocity with MF-DPI 200 μg QD AM reached statistical significance (-0.70 ± 0.29 cm/y, p = 0.02). The effects of all examined doses of MF-DPI on mean plasma cortisol levels were similar to cortisol changes seen in the placebo group, suggesting an absence of drug-related effects. No differences in 12-h urinary cortisol or other outcomes were observed between groups.
CONCLUSIONS： One year of treatment with a total daily dose of 100 μg of MF-DPI in the morning resulted in no significant difference, whereas a total daily dose of 200 μg of MF-DPI was associated with some changes in growth velocity when compared with placebo. The differences in growth velocity, and the absence of drug-related cortisol effects, support the use of a total daily dose of 100 μg of MF-DPI in children aged 4-9 years with mild persistent asthma.
J Asthma. 2011 Aug 22. [Epub ahead of print]
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