Anderson Sandra D, Fitch Kenneth, Perry Clare P, Sue-Chu Malcolm, Crapo Robert, McKenzie Donald, Magnussen Helgo
Department of Respiratory Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.
J Allergy Clin Immunol. 2003 Jan;111(1):45-50. doi: 10.1067/mai.2003.1.
There has been an increase in the number and percentage of athletes competing in Olympic Games notifying use of beta2-agonists, from 1.7% at Los Angeles (1984) to 5.5% at Sydney (2000). For Salt Lake City (2002), the International Olympic Committee requested objective evidence to use beta2-agonists for asthma or exercise-induced asthma (EIA).
The objective of this study was to evaluate the evidence submitted for approval to use a beta2-agonist.
Objective evidence for asthma or EIA included (1) an increase of 12% or more of the predicted FEV1 in response to bronchodilator, (2) a reduction in FEV1 of 10% or greater from baseline in response to exercise or eucapnic voluntary hyperpnea, (3) a PD20 FEV1 to methacholine or histamine at a dose of less than 200 microg (2 mg/mL) or less than 1320 microg (13.2 mg/mL) for those taking inhaled corticosteroids for 3 months.
There were 165 applications. Of these, 147 (89%) included evidence of a challenge, bronchodilator response, or both, and 163 test results were submitted. One hundred thirty (5.2%) applications were approved. For those with positive responses, the median value (1) was 16.2% of predicted FEV1 for response to a bronchodilator (n = 13), (2) was a 15.9% decrease in FEV1 for response to a physical challenge (n = 36), and, (3) for PD20 FEV1, was 173 microg for response to a pharmacologic challenge (n = 45).
The analysis demonstrated that it is feasible to request objective evidence to justify use of beta2-agonists on the medical grounds of asthma or EIA.
参加奥运会的运动员中,使用β2-激动剂的人数及比例有所增加,从1984年洛杉矶奥运会的1.7%增至2000年悉尼奥运会的5.5%。对于2002年盐湖城奥运会,国际奥委会要求提供使用β2-激动剂治疗哮喘或运动诱发哮喘(EIA)的客观证据。
本研究的目的是评估提交的使用β2-激动剂的批准证据。
哮喘或EIA的客观证据包括:(1)吸入支气管扩张剂后,预计第1秒用力呼气容积(FEV1)增加12%或更多;(2)运动或等容性主动过度通气后,FEV1较基线值降低10%或更多;(3)对于使用吸入性糖皮质激素3个月的患者,对乙酰甲胆碱或组胺的FEV1剂量反应(PD20 FEV1)小于200微克(2毫克/毫升)或小于1320微克(13.2毫克/毫升)。
共收到165份申请。其中,147份(89%)包括激发试验、支气管扩张剂反应或两者的证据,并提交了163份检测结果。130份申请(5.2%)获得批准。对于反应阳性者,(1)吸入支气管扩张剂后,FEV1预计值的中位数为16.2%(n = 13);(2)运动激发试验后,FEV1降低的中位数为15.9%(n = 36);(3)药物激发试验的PD20 FEV1中位数为173微克(n = 45)。
分析表明,要求提供客观证据以证明基于哮喘或EIA的医学理由使用β2-激动剂是可行的。