Ulrik Charlotte Suppli, Claudius Birgitte Kjor, Tamm Michael, Harving Henrik, Siersted Hans Christian, Backer Vibeke, Hellquist Birthe, Dahl Ronald, Høgholm Asbjørn, Jøhnk Ida Karina
Cardiology and Respiratory Diseases, Hvidovre Hospital, Hvidovre, Denmark.
Clin Respir J. 2009 Jul;3(3):161-8. doi: 10.1111/j.1752-699X.2009.00129.x.
We investigated if a higher proportion of adults with previously uncontrolled asthma can achieve total control when given salmeterol/fluticasone propionate (50/250 microg) bid and compliance enhancement training (CET) compared to those given medication alone.
Open comparison of stable, but uncontrolled, adult asthmatics. After a 12-week treatment period on salmeterol/fluticasone propionate (period 1), patients who failed to achieve control were randomised to continuing treatment with or without CET for 12 weeks (period 2). The primary end point was the proportion achieving total control of their asthma in 7 of the last 8 consecutive weeks of period 2.
A total of 361 subjects (50.4% males, mean age 40.0 +/- 14.4 years) in 29 centres were included, of whom 75.9% were randomised into treatment period 2 (n = 140 in the intervention group). The proportion of subjects achieving total asthma control was 8.8% and 7.6%, respectively, in the intervention and control group [not significant (NS)]. Mean morning peak flow, forced expiratory volume in one second (FEV(1)), asthma symptom score and quality of life improved significantly over the study period in both treatment groups. Furthermore, proportion of days with use of rescue medication declined from 59.7% +/- 34.6% (55.7% +/- 35.3%) during screening to 20.3% +/- 29.2% (19.4% +/- 30.9%) during treatment period 2 (NS).
CET failed to increase the likelihood of achieving total control in asthmatics on salmeterol/fluticasone propionate compared to subjects receiving medication only. However, both groups had a significant improvement in asthma control. (Clinical Trials.gov number, NCT00351143)
我们研究了与仅接受药物治疗的成年人相比，之前哮喘未得到控制的成年人在使用沙美特罗/丙酸氟替卡松（50/250微克）每日两次并接受依从性增强训练（CET）时，是否有更高比例能够实现完全控制。
对病情稳定但未得到控制的成年哮喘患者进行开放比较。在接受沙美特罗/丙酸氟替卡松治疗12周（第1阶段）后，未实现控制的患者被随机分为继续接受治疗或不接受CET治疗12周（第2阶段）。主要终点是在第2阶段连续8周中的最后7周内实现哮喘完全控制的患者比例。
29个中心共纳入361名受试者（男性占50.4%，平均年龄40.0±14.4岁），其中75.9%被随机分配至治疗第2阶段（干预组140例）。干预组和对照组实现哮喘完全控制的受试者比例分别为8.8%和7.6%[无显著差异（NS）]。在研究期间，两个治疗组的平均晨起呼气峰流速、一秒用力呼气量（FEV₁）、哮喘症状评分和生活质量均有显著改善。此外，急救药物使用天数的比例从筛查期间的59.7%±34.6%（55.7%±35.3%）降至治疗第2阶段的20.3%±29.2%（19.4%±30.9%）（无显著差异）。
与仅接受药物治疗的受试者相比，CET未能增加使用沙美特罗/丙酸氟替卡松的哮喘患者实现完全控制的可能性。然而，两组的哮喘控制情况均有显著改善。（临床试验注册号，NCT00351143）
