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布地奈德-福莫特罗按需用药与布地奈德维持用药治疗轻度哮喘的比较
As-Needed Budesonide–Formoterol versus Maintenance Budesonide in Mild Asthma


Eric D. Bateman ... 呼吸系统疾病 • 2018.05.17
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• 类固醇联合长效支气管扩张药按需吸入用药治疗轻度哮喘 • 哮喘药物治疗的真实世界疗效比较试验

轻度哮喘患者吸入激素联合长效b受体激动剂应该按需应用还是维持使用

 

贾国华,陈亚红*

北京大学第三医院呼吸与危重症医学科

*通讯作者

 

全球哮喘防治创议(GINA)2018修订版和中国支气管哮喘防治指南(2016年版)均强调,哮喘的治疗目标在于:缓解和控制症状,维持正常的活动水平;预防哮喘急性发作,减少肺功能下降;尽可能减少治疗药物的副作用。

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摘要


背景

轻度哮喘患者通常依靠吸入短效β2受体激动剂缓解症状,并且对维持治疗的依从性较差。另一种治疗方法可能是让患者按需接受速效缓解剂加吸入型糖皮质激素成分治疗,以缓解症状,降低发作风险。

 

方法

我们在适合接受常规吸入型糖皮质激素治疗、12岁或以上的轻度哮喘患者中,开展了一项为期52周的双盲多中心试验。患者被随机分组,分别接受每日2次安慰剂治疗+布地奈德-福莫特罗(200 μg布地奈德和6 μg福莫特罗)按需治疗,或每日2次布地奈德(200 μg)维持治疗+特布他林(0.5 mg)按需治疗。主要分析根据年度重度发作率(预先设定的非劣效性界值为1.2),对布地奈德-福莫特罗按需治疗和布地奈德维持治疗进行了比较。根据哮喘控制问卷-5(Asthma Control Questionnaire-5,ACQ-5)的评分(范围为0[无损伤]~6[最大损伤]),评估了症状。

 

结果

总共4,215例患者被随机分组,4,176例(布地奈德-福莫特罗组2,089例和布地奈德维持组2,087例)被纳入全分析集。对于重度发作,布地奈德-福莫特罗按需治疗不劣于布地奈德维持治疗;年度重度发作率分别为0.11(95%置信区间[CI],0.10~0.13)和0.12(95% CI,0.10~0.14)(率比,0.97;单侧95% CI上限,1.16)。布地奈德-福莫特罗组中吸入型糖皮质激素的中位计量日剂量(66 μg)低于布地奈德维持组(267 μg)。两组至第一次发作的时间相似(风险比,0.96;95% CI,0.78~1.17)。ACQ-5评分的变化显示,差异为0.11个单位(95% CI,0.07~0.15),布地奈德维持治疗较好。

 

结论

在轻度哮喘患者中,52周治疗期间,在重度哮喘发作率方面,布地奈德-福莫特罗按需治疗不劣于每日2次布地奈德治疗,但在控制症状方面,布地奈德-福莫特罗按需治疗劣于每日2次布地奈德治疗。布地奈德-福莫特罗组患者的吸入型糖皮质激素暴露约为布地奈德维持组的1/4(由阿斯利康资助;SYGMA 2在ClinicalTrials.gov注册号为NCT02224157)。





作者信息

Eric D. Bateman, M.D., Helen K. Reddel, M.B., B.S., Ph.D., Paul M. O’Byrne, M.B., Peter J. Barnes, M.D., Nanshan Zhong, Ph.D., Christina Keen, M.D., Carin Jorup, M.D., Rosa Lamarca, Ph.D., Agnieszka Siwek-Posluszna, M.D., and J. Mark FitzGerald, M.D.
From the Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa (E.D.B.); Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); Firestone Institute for Respiratory Health, St. Joseph’s Healthcare and Department of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON (P.M.O.), and the Institute for Heart and Lung Health, University of British Columbia, Vancouver (J.M.F.) — both in Canada; Airway Disease Section, National Heart and Lung Institute, Imperial College, London (P.J.B.); State Key Laboratory of Respiratory Diseases, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China (N.Z.); AstraZeneca Research and Development, Gothenburg, Sweden (C.K., C.J.); AstraZeneca Research and Development, Barcelona (R.L.); and AstraZeneca Research and Development, Warsaw, Poland (A.S.-P.). Address reprint requests to Dr. Bateman at the University of Cape Town Lung Institute, George St., Cape Town 7700, South Africa, or at eric.bateman@uct.ac.za.

 

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