Doull I J, Lampe F C, Smith S, Schreiber J, Freezer N J, Holgate S T
University Medicine, Southampton General Hospital.
BMJ. 1997 Oct 4;315(7112):858-62. doi: 10.1136/bmj.315.7112.858.
To determine the effect of regular prophylactic inhaled corticosteroids on wheezing episodes associated with viral infection in school age children.
Randomised, double blind, placebo controlled trial.
Community based study in Southampton.
104 children aged 7 to 9 years who had had wheezing in association with symptoms of upper and lower respiratory tract infection in the preceding 12 months.
After a run in period of 2-6 weeks children were randomly allocated twice daily inhaled beclomethasone dipropionate 200 micrograms or placebo through a Diskhaler for 6 months with a wash out period of 2 months. Children were assessed monthly.
Forced expiratory volume in 1 second (FEV1); bronchial responsiveness to methacholine (PD20); percentage of days with symptoms of upper and lower respiratory tract infection with frequency, severity, and duration of episodes of upper and lower respiratory symptoms and of reduced peak expiratory flow rate.
During the treatment period there was a significant increase in mean FEV1 (1.63 v 1.53 1; adjusted difference 0.09 1 (95% confidence interval 0.04 to 0.14); P = 0.001) and methacholine PD20 12.8 v 7.2 mumol/l; adjusted ratio of means 1.7 (1.2 to 2.4); P = 0.007) in children receiving beclomethasone dipropionate compared with placebo. There were, however, no significant differences in the percentage of days with symptoms or in the frequency, severity, or duration of episodes of upper or lower respiratory symptoms or of reduced peak expiratory flow rate during the treatment period between the two groups.
Although lung function is improved with regular beclomethasone dipropionate 400 micrograms/day, this treatment offers no clinically significant benefit in school age children with wheezing episodes associated with viral infection.
确定规律预防性吸入皮质类固醇对学龄儿童病毒感染相关喘息发作的影响。
随机、双盲、安慰剂对照试验。
南安普敦的社区研究。
104名7至9岁儿童，在过去12个月内有与上、下呼吸道感染症状相关的喘息。
经过2至6周的导入期后，儿童通过都保装置随机分配，每日两次吸入200微克二丙酸倍氯米松或安慰剂，为期6个月，洗脱期为2个月。每月对儿童进行评估。
第1秒用力呼气量（FEV1）；对乙酰甲胆碱的支气管反应性（PD20）；上、下呼吸道感染症状天数的百分比，以及上、下呼吸道症状发作的频率、严重程度和持续时间，以及呼气峰值流速降低情况。
在治疗期间，与安慰剂相比，接受二丙酸倍氯米松治疗的儿童平均FEV1显著增加（1.63对1.53升；校正差异0.09升（95%置信区间0.04至0.14）；P = 0.001），乙酰甲胆碱PD20为12.8对7.2微摩尔/升；校正均值比为1.7（1.2至2.4）；P = 0.007）。然而，两组在治疗期间有症状天数的百分比，或上、下呼吸道症状发作的频率、严重程度或持续时间，或呼气峰值流速降低情况方面，均无显著差异。
尽管每日规律使用400微克二丙酸倍氯米松可改善肺功能，但该治疗对患有病毒感染相关喘息发作的学龄儿童无临床显著益处。
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