Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial.

Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial.
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DOI:
10.1016/s0140-6736(08)61448-8
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发表时间:
2008-09-20
期刊:
影响因子:
168.9
通讯作者:
Busse, William W.
Busse, William W.
中科院分区:
医学1区
文献类型:
--
作者:
Szefler, Stanley J.;Mitchell, Herman;Sorkness, Christine A.;Gergen, Peter J.;O'Connor, George T.;Morgan, Wayne J.;Kattan, Meyer;Pongracic, Jacqueline A.;Teach, Stephen J.;Bloomberg, Gordon R.;Eggleston, Peyton A.;Gruchalla, Rebecca S.;Kercsmar, Carolyn M.;Liu, Andrew H.;Wildfire, Jeremy J.;Curry, Matthew D.;Busse, William W.

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关于呼出的一氧化氮在临床哮喘管理中的作用的初步证据是模棱两可的。本研究评估了eNO作为哮喘指南为基础的临床护理在内城青少年和年轻人中的辅助作用。一项随机、双盲、平行组试验在546名12-20岁的市中心参与者中进行,这些参与者患有持续性哮喘(Clinicaltrials.gov标识符:NCT 00114413)。在46周双盲治疗策略之前,初始控制方案的3周导入表征期。参与者被随机分配到仅基于NAEPP指南的治疗(参考组)或指南加FENO测量(FENO组)。主要结局是哮喘症状天数,次要结局是急性哮喘加重。在46周的治疗期间,哮喘症状天数、肺功能、计划外护理访视和住院治疗在治疗组之间没有差异(FENO组的平均哮喘症状天数为1.93 [95% CI 1.74-2.11],对照组为1.89 [1.71-1.74];差异0.04 [-0.29-0.22],p=0.7796)。FENO组接受的吸入性皮质类固醇剂量显著高于参照组(差异为118.9 mcg/天,95% CI:48.5-189.3,P=0.0010)。随机分组后,两组的哮喘症状均较低,57%(306/534)的参与者在至少80%的访视中控制良好。一个协调的哮喘管理计划促进了大多数参与者的良好控制。添加FENO作为对照指标,导致吸入皮质类固醇剂量增加,但症状性哮喘控制无临床重要改善。
Preliminary evidence is equivocal regarding the role of exhaled nitric oxide in clinical asthma management. This study evaluates the usefulness of eNO as an adjunct to asthma guidelines-based clinical care among inner-city adolescents and young adults. A randomized, double-blind, parallel-group trial was conducted with 546 inner-city participants, aged 12–20 years, with persistent asthma (Clinicaltrials.gov Identifier: NCT00114413). A run-in characterization period of 3 weeks on an initial controller regimen preceded a 46-week double-blind treatment strategy. Participants were randomized to either, treatment based on NAEPP guidelines alone (Reference Group) or the guidelines plus FENO measurements (FENO Group). Primary outcome was asthma symptom days and secondary outcome was acute asthma exacerbations. During the 46-week treatment period, the number of asthma symptom days, pulmonary function, unscheduled care visits, and hospitalizations did not differ between the treatment groups (mean asthma symptom days were 1.93 [95% CI 1.74-2.11] in the FENO group vs. 1.89 [1.71-1.74] in the control group; difference 0.04 [-0.29-0.22], p=0.7796). The FENO Group received a significantly higher inhaled corticosteroid dose (118.9 mcg/day difference, 95% CI: 48.5-189.3, P=0.0010) as compared to the Reference Group. Asthma symptoms remained low in both groups following randomization with 57% (306/534) of the participants well controlled for at least 80% of visits.. A coordinated asthma management program facilitated achieving good control in the majority of participants. The addition of FENO as a control indicator resulted in a higher dose of inhaled corticosteroids without a clinically important improvement in symptomatic asthma control.