Karpel Jill, D'urzo Anthony, Lockey Richard F
North Shore University Hospital-Manhasset, Manhasset, NY, USA.
J Asthma. 2008 Nov;45(9):747-53. doi: 10.1080/02770900802220611.
Results from two clinical trials of mometasone furoate administered via a dry powder inhaler (MF-DPI) were reviewed to evaluate the consistency of effects of MF-DPI administered once-daily in the evening (QD PM) or twice-daily (BID) on health-related quality of life (HRQOL) in adults with persistent asthma previously treated with inhaled corticosteroids. HRQOL data were collected from two 12-week, randomized, double-blind trials: in study 1 (n = 268), patients received MF-DPI 400 microg QD PM (1 inhalation), MF-DPI 200 microg BID, or placebo; in study 2 (n = 400), patients received MF-DPI 200 microg QD PM, MF-DPI 400 microg QD PM (1 inhalation), MF-DPI 200 microg BID, MF-DPI 400 microg QD PM (2 inhalations of 200 microg), or placebo. In both studies, HRQOL was assessed using the Medical Outcomes Survey 36-item Short Form (SF-36) and an asthma-specific module. MF-DPI was associated with consistent, statistically significant improvements in asthma-specific total scores, breathlessness, asthma concerns, and physical symptoms compared with placebo in both trials (p < 0.05 vs. placebo). MF-DPI improved SF-36 Physical Component Summary scores at all doses except 200 microg QD PM. In conclusion, the results from two placebo-controlled trials suggest that MF-DPI 400 microg/d, administered once or twice-daily, produces consistent, statistically, and clinically significant improvement in HRQOL measures in patients with persistent asthma.
对两项通过干粉吸入器给药的糠酸莫米松(MF-DPI)临床试验结果进行了回顾,以评估每日一次晚上给药(QD PM)或每日两次给药(BID)的MF-DPI对先前接受吸入性糖皮质激素治疗的持续性哮喘成年患者健康相关生活质量(HRQOL)影响的一致性。HRQOL数据来自两项为期12周的随机双盲试验:在研究1(n = 268)中,患者接受400微克QD PM的MF-DPI(1次吸入)、200微克BID的MF-DPI或安慰剂;在研究2(n = 400)中,患者接受200微克QD PM的MF-DPI、400微克QD PM的MF-DPI(1次吸入)、200微克BID的MF-DPI、400微克QD PM(2次200微克吸入)或安慰剂。在两项研究中,均使用医学结局调查36项简表(SF-36)和一个哮喘特异性模块评估HRQOL。在两项试验中,与安慰剂相比,MF-DPI在哮喘特异性总分、呼吸急促、哮喘相关问题和身体症状方面均有一致的、具有统计学意义的改善(与安慰剂相比,p < 0.05)。除200微克QD PM外,MF-DPI在所有剂量下均改善了SF-36身体成分汇总得分。总之,两项安慰剂对照试验的结果表明,每日一次或两次给药400微克/天的MF-DPI可使持续性哮喘患者的HRQOL指标产生一致的、具有统计学和临床意义的改善。