A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack

A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack
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DOI:
10.1378/chest.123.4.1018
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发表时间:
2003-04-01
期刊:
影响因子:
9.6
通讯作者:
Shpirer, I
Shpirer, I
中科院分区:
医学1区
文献类型:
--
作者:
Soroksky, A;Stav, D;Shpirer, I

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研究目的:无创通气已被证明对因肺水肿和慢性阻塞性肺病恶化而导致的急性呼吸衰竭患者有效。然而,它在急性哮喘发作中的作用尚不确定。该试点研究的目的是比较传统哮喘治疗与鼻双水平压力通气 (BPV) [BiPAP;伟康公司;宾夕法尼亚州默里斯维尔]加常规治疗入院急诊室的严重哮喘发作患者。设计:一项前瞻性、随机、安慰剂对照研究。地点:一所大学医院的急诊科。患者:从急诊室就诊的 124 名哮喘患者中招募了 30 名严重哮喘发作患者。 15 名患者被随机分配接受 BPV 加常规治疗,15 名患者接受单独常规治疗。两组入院时具有相似的临床特征。 BPV 组招募时的平均 (+/- SD) FEV1 为 37.3 +/- 10.7%,对照组为 33.8 +/- 10.2%(p = 不显着)。干预和测量:BPV组应用预定吸气和呼气压力的BPV 3小时;在对照组中,使用亚治疗压力的类似假装置3小时。在基线、研究方案期间和完成时获得床边肺功能测试结果和生命体征。结果:BPV 的使用显着改善了肺功能测试结果。 BPV 组中 80% 的患者达到预定的主要终点(与基线相比,FEV1 增加至少 50%),而对照组患者只有 20% (p < 0.004)。 BPV 组 FEV1 平均升高 53.5 +/- 23.4%,常规治疗组升高 28.5 +/- 22.6% (p = 0.006)。次要终点住院率的意向治疗分析包括 33 名患者。 BPV 组 17 名患者中有 3 名 (17.6%) 需要住院治疗,而对照组 16 名患者中有 10 名 (62.5%) 需要住院治疗 (p = 0.0134)。结论:在选定的哮喘严重发作患者中,在常规治疗的基础上加用 BPV 可以改善肺功能,更快缓解发作,并显着减少住院需要。
Study objective: Noninvasive ventilation has been shown to be effective in patients with acute respiratory failure due to pulmonary edema and exacerbations of COPD. Its role in an acute asthmatic attack, however, is uncertain. The purpose of this pilot study was to compare conventional asthma treatment with nasal bilevel pressure ventilation (BPV) [BiPAP; Respironics; Murrysville, PA] plus conventional treatment in patients with a severe asthmatic attack admitted to the emergency department.Design: A prospective, randomized, placebo-controlled study.Setting: An emergency department at a university hospital.Patients: Thirty patients with a severe asthma attack were recruited from a larger group of 124 asthmatic patients seen in the emergency department. Fifteen patients were randomly assigned to BPV plus conventional therapy and 15 patients to conventional therapy alone. The two groups had similar clinical characteristics on hospital admission. Mean (+/- SD) FEV1 on recruitment was 37.3 +/- 10.7% in the BPV group and 33.8 +/- 10.2% in the control group (p = not significant). Interventions and measurements: BPV with predetermined inspiratory and expiratory pressures was applied for 3 h in the BPV group; in the control group, a similar sham device with subtherapeutic pressures was applied for 3 h. Bedside lung function test results and vital signs were obtained at baseline, and during and at the completion of the study protocol.Results: The use of BPV significantly improved lung function test results. Eighty percents of the patients in the BPV group reached the predetermined primary end points (an increase of at least 50% in FEV1 as compared to baseline), vs 20% of control patients (p < 0.004). Mean rise in FEV1 was 53.5 +/- 23.4% in the BPV group and 28.5 +/- 22.6% in the conventional treatment group (p = 0.006). The intention-to-treat analysis of the secondary end point rate of hospitalization included 33 patients. Hospitalization was required for 3 of 17 patients (17.6%) in the BPV group, as compared with 10 of 16 patients (62.5%) in the control group (p = 0.0134).Conclusion: In selected patients with a severe asthma attack, the addition of BPV to conventional treatment can improve lung function, alleviate the attack faster, and significantly reduce the need for hospitalization.