Kerwin Edward M, Oppenheimer John J, LaForce Craig, Parasuraman Bhash, Miller Christopher J, O'Dowd Liza, Goldman Mitchell
Clinical Research Institute of Southern Oregon PC, Medford, Oregon 97504, USA.
Ann Allergy Asthma Immunol. 2009 Jul;103(1):62-72. doi: 10.1016/S1081-1206(10)60145-7.
The goal of asthma therapy is to control symptoms using minimal pharmacologic intervention.
To evaluate the efficacy and tolerability of once-daily budesonide/formoterol vs once-daily budesonide in patients stable with twice-daily budesonide/formoterol.
This double-blind, 12-week study enrolled 619 patients 12 years and older with mild to moderate asthma. After 4 to 5 weeks of twice-daily budesonide/formoterol pressurized metered-dose inhaler (pMDI), 80/4.5 microg x 2 inhalations (320/18 microg/d), stable patients were randomized 1:1:1:1 to 2 inhalations twice daily of budesonide/formoterol pMDI, 80/4.5 microg (320/18 microg/d), or 2 inhalations once daily (evening) of budesonide/formoterol pMDI, 160/4.5 microg or 80/4.5 microg (320/9 microg or 160/9 microg/d), or budesonide pMDI, 160 microg (320 microg/d).
All budesonide/formoterol groups maintained significantly more favorable evening predose forced expiratory volume in 1 second (FEV1), morning peak expiratory flow (PEF), daytime/nighttime asthma symptoms, nighttime rescue medication use, and rescue medication-free days vs budesonide. Variables evaluated during the end of the once-daily dosing interval (evening predose FEV1, evening PEF, daytime asthma symptoms, and daytime rescue medication use) significantly favored twice-daily budesonide/formoterol vs all treatments. Twice-daily budesonide/formoterol demonstrated significantly more favorable results for symptom-free and asthma control days vs all treatments and awakening-free nights vs budesonide. Asthma Quality of Life Questionnaire and Asthma Control Questionnaire results significantly favored twice-daily budesonide/formoterol vs budesonide (P < or = .018). All treatments were well tolerated.
Pulmonary function and asthma control were more effectively maintained with all budesonide/formoterol regimens vs once-daily budesonide and with twice-daily budesonide/formoterol at twice the daily formoterol dose vs both once-daily budesonide/formoterol doses.
哮喘治疗的目标是使用最少的药物干预来控制症状。
评估对于使用每日两次布地奈德/福莫特罗病情稳定的患者，每日一次布地奈德/福莫特罗与每日一次布地奈德的疗效和耐受性。
这项双盲、为期12周的研究纳入了619名12岁及以上的轻至中度哮喘患者。在使用每日两次布地奈德/福莫特罗压力定量吸入器（pMDI），80/4.5微克×2吸（320/18微克/天）4至5周后，病情稳定的患者按1:1:1:1随机分组，分别接受每日两次吸入布地奈德/福莫特罗pMDI，80/4.5微克（320/18微克/天），或每日一次（晚上）吸入布地奈德/福莫特罗pMDI，160/4.5微克或80/4.5微克（320/9微克或160/9微克/天），或布地奈德pMDI，160微克（320微克/天）。
与布地奈德相比，所有布地奈德/福莫特罗组在晚上给药前1秒用力呼气容积（FEV1）、早晨呼气峰值流速（PEF）、白天/夜间哮喘症状、夜间急救药物使用以及无急救药物天数方面均保持明显更有利的情况。在每日一次给药间隔结束时评估的变量（晚上给药前FEV1、晚上PEF、白天哮喘症状和白天急救药物使用）显示，与所有治疗相比，每日两次布地奈德/福莫特罗明显更有利。与所有治疗相比，每日两次布地奈德/福莫特罗在无症状和哮喘控制天数方面显示出明显更有利的结果，与布地奈德相比在无觉醒夜间方面更有利。哮喘生活质量问卷和哮喘控制问卷结果显示，与布地奈德相比，每日两次布地奈德/福莫特罗明显更有利（P≤0.018）。所有治疗耐受性良好。
与每日一次布地奈德相比，所有布地奈德/福莫特罗方案在维持肺功能和哮喘控制方面更有效，与每日一次布地奈德/福莫特罗的两种剂量相比，每日两次布地奈德/福莫特罗且福莫特罗剂量加倍在维持肺功能和哮喘控制方面更有效。
