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布地奈德治疗期间哮喘儿童的生长情况:一项双盲试验。

Growth of asthmatic children during treatment with budesonide: a double blind trial.

作者信息

Wolthers O D, Pedersen S

机构信息

Department of Paediatrics, Kolding Hospital, Denmark.

出版信息

BMJ. 1991 Jul 20;303(6795):163-5. doi: 10.1136/bmj.303.6795.163.

DOI:10.1136/bmj.303.6795.163
PMID:1878641
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1670402/
Abstract

OBJECTIVE

To determine whether the inhaled glucocorticosteroid budesonide has any adverse effect on short term linear growth in children with mild asthma.

SETTING

Outpatient clinic in secondary referral centre.

PATIENTS

15 children aged 6-13 years with normal statural growth velocity during the previous year, no signs of puberty, and no use of systemic or topical steroids in the two months before the study. DESIGN OF INTERVENTIONS: Double blind, randomised crossover trial with two active periods in which budesonide was given in divided daily doses of 200 micrograms and 800 micrograms. During run in and two washout periods placebo was given. After the second washout period the children received open treatment with 400 micrograms budesonide daily. All periods were of 18 days' duration.

MAIN OUTCOME MEASURE

Growth of the lower leg as measured twice a week by knemometry.

RESULTS

Mean growth velocity of the lower leg was 0.63 mm/week during run in and during washout 0.64 mm/week. Budesonide treatment was associated with a significant dose related reduction of growth velocity: the mean reduction in growth velocity during treatment was 0.11 (95% confidence interval -0.15 0.36 (0.13 to 0.59) mm/week with 800 micrograms budesonide (p less than 0.05; Page's test). During treatment with 400 micrograms budesonide a reduction of 0.17 (-0.10 to 0.45) mm/week was found.

CONCLUSIONS

Treatment with inhaled budesonide is associated with a dose related suppression of short term linear growth in children with mild asthma.

摘要

目的

确定吸入性糖皮质激素布地奈德对轻度哮喘儿童的短期线性生长是否有不良影响。

地点

二级转诊中心的门诊诊所。

患者

15名年龄在6至13岁之间的儿童,前一年身高增长速度正常,无青春期迹象,且在研究前两个月未使用全身性或局部性类固醇。

干预措施设计

双盲、随机交叉试验,有两个活跃期,分别给予布地奈德每日200微克和800微克的分次剂量。在导入期和两个洗脱期给予安慰剂。在第二个洗脱期后,儿童接受每日400微克布地奈德的开放治疗。所有阶段持续18天。

主要观察指标

每周通过测小腿法测量两次小腿生长情况。

结果

导入期小腿平均生长速度为0.63毫米/周,洗脱期为0.64毫米/周。布地奈德治疗与生长速度显著的剂量相关性降低有关:800微克布地奈德治疗期间生长速度的平均降低为0.11(95%置信区间-0.15至0.36(0.13至0.59)毫米/周(P<0.05;佩奇检验)。在400微克布地奈德治疗期间,发现生长速度降低0.17(-0.10至0.45)毫米/周。

结论

吸入布地奈德治疗与轻度哮喘儿童短期线性生长的剂量相关性抑制有关。

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