Abstract：
BACKGROUND: Although international guidelines generally recommend the back to back use of short-acting β-agonizts (SABA) within a short time in the management of acute wheezing in children with asthma, there is still uncertainty in the evidence of short term outcome. Thus, this study aimed to investigate the efficacy of back to back and single use of inhaled SABA by lung function testing.
METHODS: This was a prospective, double-blinded, placebo controlled study conducted in children ≥6 years of age with a history of asthma. Children who presented with an acute asthma exacerbation (AAE) with a forced expiratory volume in 1 s (FEV1) between 40% to 60% were enrolled in the study if they had a first dose to SABA response of FEV1 ≥ 12%. All children were then randomly assigned either to receive two additional doses of inhaled SABA (300 µg per dose) or placebo. Spirometric analysis included forced vital capacity (FVC), FEV1, FEV1/FVC, PEF, and FEF25-75 at baseline, 15, 30, and 45 min for each group. Oxygen saturation and heart rate were monitored during the study period.
RESULTS: A total of 93 patients (inhaled SABA group; n = 48 vs. placebo group; n = 45) out of 110 enrolled patients completed the study. Baseline demographic characteristics of patients include age, gender, age of diagnosis, parental asthma, history of allergic rhinitis and atopic dermatitis, current asthma treatment, IgE and skin prick test were similar among groups. (p > .05) When lung function parameters were compared at each time interval during the study period, there were no statistical significance found in FVC, FEV1, FEV1/FVC, PEF and forced expiratory flow between 25% and 75% (FEF25-75) among groups. (p > .05) There were also no differences between groups for changes in heart rate and oxygen saturation. (p > .05) CONCLUSION: A single dose of inhaled SABA provides similar short term bronchodilator effect as back to back administration of inhaled SABA in children with AAE who showed an initial response to SABA of FEV1 ≥ 12%.
METHODS: This was a prospective, double-blinded, placebo controlled study conducted in children ≥6 years of age with a history of asthma. Children who presented with an acute asthma exacerbation (AAE) with a forced expiratory volume in 1 s (FEV1) between 40% to 60% were enrolled in the study if they had a first dose to SABA response of FEV1 ≥ 12%. All children were then randomly assigned either to receive two additional doses of inhaled SABA (300 µg per dose) or placebo. Spirometric analysis included forced vital capacity (FVC), FEV1, FEV1/FVC, PEF, and FEF25-75 at baseline, 15, 30, and 45 min for each group. Oxygen saturation and heart rate were monitored during the study period.
RESULTS: A total of 93 patients (inhaled SABA group; n = 48 vs. placebo group; n = 45) out of 110 enrolled patients completed the study. Baseline demographic characteristics of patients include age, gender, age of diagnosis, parental asthma, history of allergic rhinitis and atopic dermatitis, current asthma treatment, IgE and skin prick test were similar among groups. (p > .05) When lung function parameters were compared at each time interval during the study period, there were no statistical significance found in FVC, FEV1, FEV1/FVC, PEF and forced expiratory flow between 25% and 75% (FEF25-75) among groups. (p > .05) There were also no differences between groups for changes in heart rate and oxygen saturation. (p > .05) CONCLUSION: A single dose of inhaled SABA provides similar short term bronchodilator effect as back to back administration of inhaled SABA in children with AAE who showed an initial response to SABA of FEV1 ≥ 12%.
摘要：
背景：尽管国际指南通常建议在短时间内背对背使用短效β-激动药（SABA）来治疗哮喘儿童的急性喘息，短期结果的证据仍然存在不确定性。因此，本研究旨在通过肺功能检测来探讨背靠背和单次使用吸入SABA的疗效。
方法：这是一个前瞻性的，双盲,在有哮喘病史的≥6岁儿童中进行的安慰剂对照研究.出现急性哮喘加重（AAE）且用力呼气量在1s内（FEV1）在40％至60％之间的儿童，如果他们对SABA反应的第一剂FEV1≥12％，则纳入研究。然后，所有儿童被随机分配接受两个额外剂量的吸入SABA（每剂300µg）或安慰剂。肺活量分析包括强迫肺活量(FVC)，FEV1,FEV1/FVC,PEF,和基线时的FEF25-75，每组15、30和45分钟。在研究期间监测氧饱和度和心率。
结果：共93例患者（吸入SABA组；n=48vs.安慰剂组；n=45）在110名入选患者中完成了研究。患者的基线人口统计学特征包括年龄，性别,诊断年龄,父母哮喘,过敏性鼻炎和特应性皮炎的病史，目前的哮喘治疗，各组IgE和皮肤点刺试验相似。（p>0.05）当在研究期间的每个时间间隔比较肺功能参数时，在FVC中没有发现统计学意义，FEV1,FEV1/FVC,各组中PEF和用力呼气流量在25%和75%之间(FEF25-75)。（p>.05）两组之间的心率和氧饱和度变化也没有差异。（p>0.05）结论：单剂量的吸入SABA提供了类似的短期支气管扩张剂效果的背对背施用吸入SABA的AAE儿童谁表现出对SABA的FEV1≥12％的初始反应。
方法：这是一个前瞻性的，双盲,在有哮喘病史的≥6岁儿童中进行的安慰剂对照研究.出现急性哮喘加重（AAE）且用力呼气量在1s内（FEV1）在40％至60％之间的儿童，如果他们对SABA反应的第一剂FEV1≥12％，则纳入研究。然后，所有儿童被随机分配接受两个额外剂量的吸入SABA（每剂300µg）或安慰剂。肺活量分析包括强迫肺活量(FVC)，FEV1,FEV1/FVC,PEF,和基线时的FEF25-75，每组15、30和45分钟。在研究期间监测氧饱和度和心率。
结果：共93例患者（吸入SABA组；n=48vs.安慰剂组；n=45）在110名入选患者中完成了研究。患者的基线人口统计学特征包括年龄，性别,诊断年龄,父母哮喘,过敏性鼻炎和特应性皮炎的病史，目前的哮喘治疗，各组IgE和皮肤点刺试验相似。（p>0.05）当在研究期间的每个时间间隔比较肺功能参数时，在FVC中没有发现统计学意义，FEV1,FEV1/FVC,各组中PEF和用力呼气流量在25%和75%之间(FEF25-75)。（p>.05）两组之间的心率和氧饱和度变化也没有差异。（p>0.05）结论：单剂量的吸入SABA提供了类似的短期支气管扩张剂效果的背对背施用吸入SABA的AAE儿童谁表现出对SABA的FEV1≥12％的初始反应。
