Bateman E D, Bousquet J, Keech M L, Busse W W, Clark T J H, Pedersen S E
University of Cape Town, Cape Town, South Africa.
Eur Respir J. 2007 Jan;29(1):56-62. doi: 10.1183/09031936.00128505. Epub 2006 Oct 18.
The present study examined the association between guideline-derived asthma control and health-related quality of life, assessed using the Asthma Quality of Life Questionnaire (AQLQ), in patients with uncontrolled asthma whose treatment was directed towards achieving the highest possible level of control. The present randomised, double-blind, parallel-group study compared the efficacy of fluticasone propionate (FP) and salmeterol/fluticasone propionate combination (SFC) in achieving two composite, guideline-derived measures of control: total control (TC) and well-controlled (WC) asthma. Not achieving these levels was classed as not well-controlled (NWC). Doses were augmented until patients achieved TC or reached the maximum dose. This dose was maintained for the remainder of the study. AQLQ was assessed at baseline and at each clinic visit. AQLQ scores improved throughout the study, reaching near-maximal levels in patients achieving TC and WC, and 52-week mean scores in the three control groups were statistically significantly different. Clinically meaningful improvements (mean change from baseline) were: TC group (SFC 1.9, FP 1.8), WC (SFC 1.5, FP 1.5) and NWC (SFC 1.0, FP 0.9). In conclusion, the treatment aimed at controlling asthma improves the health-related quality of life to levels approaching normal. The difference in Asthma Quality of Life Questionnaire scores between total control and well-controlled confirms that patients distinguish even between these high levels of control.
本研究调查了在治疗目标为尽可能达到最高控制水平的未控制哮喘患者中,基于指南的哮喘控制与使用哮喘生活质量问卷(AQLQ)评估的健康相关生活质量之间的关联。本随机、双盲、平行组研究比较了丙酸氟替卡松(FP)和沙美特罗/丙酸氟替卡松联合制剂(SFC)在实现两种基于指南的综合控制指标方面的疗效:完全控制(TC)和良好控制(WC)哮喘。未达到这些水平被归类为控制不佳(NWC)。剂量逐步增加,直至患者达到TC或达到最大剂量。该剂量在研究的剩余时间内维持不变。在基线和每次门诊就诊时评估AQLQ。在整个研究过程中,AQLQ评分均有所改善,在达到TC和WC的患者中达到接近最大水平,三个对照组的52周平均评分在统计学上有显著差异。具有临床意义的改善(相对于基线的平均变化)为:TC组(SFC 1.9,FP 1.8),WC组(SFC 1.5,FP 1.5)和NWC组(SFC 1.0,FP 0.9)。总之,旨在控制哮喘的治疗可将健康相关生活质量提高到接近正常的水平。完全控制和良好控制之间的哮喘生活质量问卷评分差异证实,患者甚至能够区分这些高水平的控制状态。