重症未控制哮喘患者吸入制剂依从性和吸入技术的反馈：一项随机临床研究
2018/01/19
摘要
在重症哮喘中，哮喘控制不佳可以反映药物依从性或吸入技术或者难治性哮喘。本研究旨在评价进行吸入药物使用反馈是否有助于鉴别难治性哮喘并提高吸入技术和依从性。重症未控制哮喘患者纳入随访区域随机分组。集中患教组反复接受吸入性药物使用，依从性和疾病管理等训练。干预组则接受相同的治疗，并进行反馈训练。首要研究终点为吸入制剂当前依从性。次要研究终点为预先设定的临床各项指标。研究终点评定对于研究分组事先不知情。通过意向性治疗和符合方案集的为基础进行分析。在第3个月，治疗反馈组（n=111）平均依从性较加强教育组显著提高（意向性治疗，n=107;73% v.s. 63%; 95%CI 2.8%-17.6%, P=0.02）。研究结束时，54名（38%）患者哮喘病情稳定或改善，52名（35%）未控制或依从性较差；40名（27%）未控制但依从性较好。重复反馈可以显著提高吸入制剂依从性。在依从性和吸入制剂评估后，仅40名（27%）患者为难治性哮喘切依从性好，需要叠加治疗。
A randomised clinical trial of feedback on inhaler adherence and technique in patients with severe uncontrolled asthma.
Eur Respir J. 2018 Jan 4;51(1). pii: 1701126. doi: 10.1183/13993003.01126-2017. Print 2018 Jan.
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.
在重症哮喘中，哮喘控制不佳可以反映药物依从性或吸入技术或者难治性哮喘。本研究旨在评价进行吸入药物使用反馈是否有助于鉴别难治性哮喘并提高吸入技术和依从性。重症未控制哮喘患者纳入随访区域随机分组。集中患教组反复接受吸入性药物使用，依从性和疾病管理等训练。干预组则接受相同的治疗，并进行反馈训练。首要研究终点为吸入制剂当前依从性。次要研究终点为预先设定的临床各项指标。研究终点评定对于研究分组事先不知情。通过意向性治疗和符合方案集的为基础进行分析。在第3个月，治疗反馈组（n=111）平均依从性较加强教育组显著提高（意向性治疗，n=107;73% v.s. 63%; 95%CI 2.8%-17.6%, P=0.02）。研究结束时，54名（38%）患者哮喘病情稳定或改善，52名（35%）未控制或依从性较差；40名（27%）未控制但依从性较好。重复反馈可以显著提高吸入制剂依从性。在依从性和吸入制剂评估后，仅40名（27%）患者为难治性哮喘切依从性好，需要叠加治疗。
（上海交通大学医学院附属瑞金医院呼吸与危重症医学科 周剑平 万欢英 摘译）
（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.
Eur Respir J. 2018 Jan 4;51(1). pii: 1701126. doi: 10.1183/13993003.01126-2017. Print 2018 Jan.
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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