哮喘患者是否感知吸入治疗即刻起效？两个临床试验检测评价时间对患者感知的影响
2010/02/02
背景：感知维持治疗即刻起效能正向强化哮喘治疗，且能改善哮喘患者对治疗的依从性。处在临床试验的各个治疗组间也需要对这种效应进行精确比较。
方法：本项随机对照研究检测评价时间（研究1：每日和每周；研究2：服药前和服药后）是否对患者感知药物即刻起效（感知）及对自身感知的满意度（满意度）产生影响。此项为期2周的美国多中心双盲平行组研究入选年龄≥18岁的轻度至中度哮喘患者。患者随机给予下述2种方案之一：布地奈德/福莫特罗压力计量吸入器(pMDI) 80/4.5 μg x 2揿(160/9μg)每日2次，或布地奈德pMDI 80μg x 2揿(160μg) 每日2次。同时，将患者进一步随机分组，以交叉的方式完成前期有效性感知和满意度调查（每天和每周，n=123；或服药前和服药后，n=134）.同时评价患者用药后的感知及其价值。
结果：患者的感知不论是每日还是每周，或是用药前还是用药后，均未见显著差异。满意度显著性差异仅见于研究1：每周评价有显著性差异（P<0.05）。敏感性分析显示治疗组未见显著差异（P= 0.162）。两项研究中，大部分患者（87％）感知吸入治疗即刻起效（136/157），而且具有正向气道感觉。大部分患者认为，感知哮喘治疗即刻起效能确保或帮助其管理哮喘。
结论：评价时间对患者感知哮喘治疗是否即刻有效无显著影响。两组每周和每日评价的满意度差异具有一致性。这表明两种治疗均有效，无偏倚。患者认为，对维持治疗即刻起效的感知使患者感觉更容易呼吸，这种感知对患者的自我治疗有利。
（林江涛 审校）
J Asthma. 2009 Dec;46(10):1006-1012.
Can patients with asthma feel inhaler therapy working right away? Two clinical trials testing the effect of timing of assessment on patient perception.
Leidy NK, Gutierrez B,Lampl K, Uryniak T, O’Brien CD.
Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland 20814, USA.
BACKGROUND: Feeling a maintenance therapy work right away may provide positive reinforcement and may offer one way to improve adherence in patients with asthma. Precise measurement is required to accurately compare the presence of this effect across clinical trial treatment groups.
METHODS: Two randomized, controlled studies tested whether timing of assessment (daily vs weekly, study 1; and predose vs postdose, study 2) influenced patients’ reports of whether they can feel a medication working right away (perception), and their satisfaction with this perception (satisfaction). These 2-week US-based multicenter double-blind, parallel-group studies included patients > or = 18 years of age with mild to moderate persistent asthma. In each, patients were randomized to one of two drugs with different onset profiles: budesonide/formoterol pressurized metered-dose inhaler (pMDI) 80/4.5 microg x 2 inhalations (160/9 microg) twice daily or budesonide pMDI 80 microg x 2 inhalations (160 microg) twice daily. Patients were further randomized to complete previously validated perception and satisfaction questions in a cross-over fashion, either daily and weekly (N = 123) or predose and postdose (N = 134). Patient surveys also assessed perceptions of the onset of effect of medication and their value of these perceptions.
RESULTS: No significant differences were observed in patients’ reports of perception, either daily versus weekly or predose versus postdose. A statistically significant difference in satisfaction was found in study 1 only, favoring weekly recall (p < 0.05), with sensitivity analysis showing no difference by treatment group (p = 0.162). Across both studies, most patients (87%) who perceived their inhaler working right away (136 of 157 patients) identified positive airway sensations. Most patients reported that feeling their medication work right away is reassuring and would help them manage their asthma.
CONCLUSION: Assessment timing has no effect on patient response to the perception of feeling a medication working right away. Differences found in satisfaction levels reported with weekly versus daily recall were consistent across treatment groups, indicating that no bias was introduced in favor of either treatment group. Patients characterized the perception of feeling a maintenance therapy working right away as easier breathing and reported this perception as beneficial to patient self-care.
J Asthma. 2009 Dec;46(10):1006-12.
方法：本项随机对照研究检测评价时间（研究1：每日和每周；研究2：服药前和服药后）是否对患者感知药物即刻起效（感知）及对自身感知的满意度（满意度）产生影响。此项为期2周的美国多中心双盲平行组研究入选年龄≥18岁的轻度至中度哮喘患者。患者随机给予下述2种方案之一：布地奈德/福莫特罗压力计量吸入器(pMDI) 80/4.5 μg x 2揿(160/9μg)每日2次，或布地奈德pMDI 80μg x 2揿(160μg) 每日2次。同时，将患者进一步随机分组，以交叉的方式完成前期有效性感知和满意度调查（每天和每周，n=123；或服药前和服药后，n=134）.同时评价患者用药后的感知及其价值。
结果：患者的感知不论是每日还是每周，或是用药前还是用药后，均未见显著差异。满意度显著性差异仅见于研究1：每周评价有显著性差异（P<0.05）。敏感性分析显示治疗组未见显著差异（P= 0.162）。两项研究中，大部分患者（87％）感知吸入治疗即刻起效（136/157），而且具有正向气道感觉。大部分患者认为，感知哮喘治疗即刻起效能确保或帮助其管理哮喘。
结论：评价时间对患者感知哮喘治疗是否即刻有效无显著影响。两组每周和每日评价的满意度差异具有一致性。这表明两种治疗均有效，无偏倚。患者认为，对维持治疗即刻起效的感知使患者感觉更容易呼吸，这种感知对患者的自我治疗有利。
（林江涛 审校）
J Asthma. 2009 Dec;46(10):1006-1012.
Can patients with asthma feel inhaler therapy working right away? Two clinical trials testing the effect of timing of assessment on patient perception.
Leidy NK, Gutierrez B,Lampl K, Uryniak T, O’Brien CD.
Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland 20814, USA.
BACKGROUND: Feeling a maintenance therapy work right away may provide positive reinforcement and may offer one way to improve adherence in patients with asthma. Precise measurement is required to accurately compare the presence of this effect across clinical trial treatment groups.
METHODS: Two randomized, controlled studies tested whether timing of assessment (daily vs weekly, study 1; and predose vs postdose, study 2) influenced patients’ reports of whether they can feel a medication working right away (perception), and their satisfaction with this perception (satisfaction). These 2-week US-based multicenter double-blind, parallel-group studies included patients > or = 18 years of age with mild to moderate persistent asthma. In each, patients were randomized to one of two drugs with different onset profiles: budesonide/formoterol pressurized metered-dose inhaler (pMDI) 80/4.5 microg x 2 inhalations (160/9 microg) twice daily or budesonide pMDI 80 microg x 2 inhalations (160 microg) twice daily. Patients were further randomized to complete previously validated perception and satisfaction questions in a cross-over fashion, either daily and weekly (N = 123) or predose and postdose (N = 134). Patient surveys also assessed perceptions of the onset of effect of medication and their value of these perceptions.
RESULTS: No significant differences were observed in patients’ reports of perception, either daily versus weekly or predose versus postdose. A statistically significant difference in satisfaction was found in study 1 only, favoring weekly recall (p < 0.05), with sensitivity analysis showing no difference by treatment group (p = 0.162). Across both studies, most patients (87%) who perceived their inhaler working right away (136 of 157 patients) identified positive airway sensations. Most patients reported that feeling their medication work right away is reassuring and would help them manage their asthma.
CONCLUSION: Assessment timing has no effect on patient response to the perception of feeling a medication working right away. Differences found in satisfaction levels reported with weekly versus daily recall were consistent across treatment groups, indicating that no bias was introduced in favor of either treatment group. Patients characterized the perception of feeling a maintenance therapy working right away as easier breathing and reported this perception as beneficial to patient self-care.
J Asthma. 2009 Dec;46(10):1006-12.
