一项关于重症未控制哮喘患者随机临床试验对于吸入剂依从性和技术的反馈
2018/04/04
摘要
在严重哮喘患者中，较差的疾病控制水平的原因可能是用药依从性或吸入技术的问题，也可能是因为难治性哮喘疾病本身的原因。本研究旨在通过对吸入剂的反馈干预识别出难治性哮喘并增强吸入剂使用技术和依从性。重症未控制哮喘患者采用逐层分层随机区组设计，强化教育组接受了吸入器使用、治疗依从性和疾病管理的训练。干预组接受了相同的干预，并通过（生物）反馈指导培训加强了干预。主要终点是实际吸入器坚持率，次要终点包括对临床结局的预定义评估。成果评估者对团队分配不知情。（生物）反馈组（n = 111）第三个月的平均依从率高于增强教育组（n = 107; 73％vs 63％; 95％CI 2.8％-17.6％; p = 0.02）。在研究结束时，54名患者（38％）哮喘稳定或改善; 52人（35％）无法控制，但依从性较差; 40人（27％）无法控制，但依从性较好。重复的反馈显着改善了吸入器的依从性。在遵守和吸入技术评估程序后，只有40例（27％）哮喘患者病情仍无法控制，因此可能需要其他辅助治疗。
A randomised clinical trial of feedback on inhaler adherence and technique in patients with severe uncontrolled asthma.
Sulaiman I, Greene G, MacHale E, Seheult J, Mokoka M, D'Arcy S, Taylor T, Murphy DM, Hunt E, Lane SJ, Diette GB, FitzGerald JM, Boland F, Sartini Bhreathnach A, Cushen B, Reilly RB, Doyle F, Costello RW.
Abstract
In severe asthma, poor control could reflect issues of medication adherence or inhaler technique, or that the condition is refractory. This study aimed to determine if an intervention with (bio)feedback on the features of inhaler use would identify refractory asthma and enhance inhaler technique and adherence.Patients with severe uncontrolled asthma were subjected to a stratified-by-site random block design. The intensive education group received repeated training in inhaler use, adherence and disease management. The intervention group received the same intervention, enhanced by (bio)feedback-guided training. The primary outcome was rate of actual inhaler adherence. Secondary outcomes included a pre-defined assessment of clinical outcome. Outcome assessors were blinded to group allocation. Data were analysed on an intention-to-treat and per-protocol basis.The mean rate of adherence during the third month in the (bio)feedback group (n=111) was higher than that in the enhanced education group (intention-to-treat, n=107; 73% versus 63%; 95% CI 2.8%-17.6%; p=0.02). By the end of the study, asthma was either stable or improved in 54 patients (38%); uncontrolled, but poorly adherent in 52 (35%); and uncontrolled, but adherent in 40 (27%).Repeated feedback significantly improved inhaler adherence. After a programme of adherence and inhaler technique assessment, only 40 patients (27%) were refractory and adherent, and might therefore need add-on therapy.
在严重哮喘患者中，较差的疾病控制水平的原因可能是用药依从性或吸入技术的问题，也可能是因为难治性哮喘疾病本身的原因。本研究旨在通过对吸入剂的反馈干预识别出难治性哮喘并增强吸入剂使用技术和依从性。重症未控制哮喘患者采用逐层分层随机区组设计，强化教育组接受了吸入器使用、治疗依从性和疾病管理的训练。干预组接受了相同的干预，并通过（生物）反馈指导培训加强了干预。主要终点是实际吸入器坚持率，次要终点包括对临床结局的预定义评估。成果评估者对团队分配不知情。（生物）反馈组（n = 111）第三个月的平均依从率高于增强教育组（n = 107; 73％vs 63％; 95％CI 2.8％-17.6％; p = 0.02）。在研究结束时，54名患者（38％）哮喘稳定或改善; 52人（35％）无法控制，但依从性较差; 40人（27％）无法控制，但依从性较好。重复的反馈显着改善了吸入器的依从性。在遵守和吸入技术评估程序后，只有40例（27％）哮喘患者病情仍无法控制，因此可能需要其他辅助治疗。
(中日友好医院呼吸与危重症医学科 王圆方 摘译 林江涛 审校)
(Eur Respir J. 2018 Jan 4;51(1). pii: 1701126. doi: 10.1183/13993003.01126-2017. Print 2018 Jan.)
(Eur Respir J. 2018 Jan 4;51(1). pii: 1701126. doi: 10.1183/13993003.01126-2017. Print 2018 Jan.)
A randomised clinical trial of feedback on inhaler adherence and technique in patients with severe uncontrolled asthma.
Sulaiman I, Greene G, MacHale E, Seheult J, Mokoka M, D'Arcy S, Taylor T, Murphy DM, Hunt E, Lane SJ, Diette GB, FitzGerald JM, Boland F, Sartini Bhreathnach A, Cushen B, Reilly RB, Doyle F, Costello RW.
Abstract
In severe asthma, poor control could reflect issues of medication adherence or inhaler technique, or that the condition is refractory. This study aimed to determine if an intervention with (bio)feedback on the features of inhaler use would identify refractory asthma and enhance inhaler technique and adherence.Patients with severe uncontrolled asthma were subjected to a stratified-by-site random block design. The intensive education group received repeated training in inhaler use, adherence and disease management. The intervention group received the same intervention, enhanced by (bio)feedback-guided training. The primary outcome was rate of actual inhaler adherence. Secondary outcomes included a pre-defined assessment of clinical outcome. Outcome assessors were blinded to group allocation. Data were analysed on an intention-to-treat and per-protocol basis.The mean rate of adherence during the third month in the (bio)feedback group (n=111) was higher than that in the enhanced education group (intention-to-treat, n=107; 73% versus 63%; 95% CI 2.8%-17.6%; p=0.02). By the end of the study, asthma was either stable or improved in 54 patients (38%); uncontrolled, but poorly adherent in 52 (35%); and uncontrolled, but adherent in 40 (27%).Repeated feedback significantly improved inhaler adherence. After a programme of adherence and inhaler technique assessment, only 40 patients (27%) were refractory and adherent, and might therefore need add-on therapy.
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一项关于管理孕期哮喘（MAP）的试验：FeNO水平和后代儿童哮喘的相关性研究
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吸入糖皮质激素与成人哮喘控制哮喘：12年随访研究
