Treatment of idiopathic bronchiectasis with aerosolized recombinant human DNase I
Treatment of idiopathic bronchiectasis with aerosolized recombinant human DNase I
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DOI：
10.1378/chest.113.5.1329
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发表时间：
1998-05-01
期刊：
影响因子：
9.6
通讯作者：
Fick, RB
中科院分区：
文献类型：
--
作者：
O'Donnell, AE;Barker, AF;Fick, RB
试验目的：研究雾化重组人DNA酶I治疗特发性支气管扩张症的安全性和有效性。设计：双盲、随机、安慰剂对照、多中心研究。人群：来自北美、英国和爱尔兰23个中心的349例病情稳定的特发性支气管扩张症成人门诊患者。干预和测量：研究患者接受雾化rhDNA酶或安慰剂，每日两次，持续24周。主要终点是肺部急性加重的发生率和治疗期间FEV 1较基线的平均百分比变化。结果：肺部急性加重更频繁，FEV 1下降更大，接受rhDNase的患者与安慰剂相比，在这24-week trial.Conclusions：rhDNase是无效的，在这组成人门诊患者在稳定的条件下，特发性支气管扩张症的潜在危害。这与先前发表的结果形成对比，这些结果证明了rhDNase在囊性纤维化支气管扩张症患者中的疗效。
Study objective: To study the safety and efficacy of aerosolized recombinant human DNase I in the treatment of idiopathic bronchiectasis.Design: Double-blind, randomized, placebo-controlled, multicenter study.Populations: Three hundred forty-nine adult outpatients in stable condition with idiopathic bronchiectasis from 23 centers in North America, Great Britain, and Ireland.Interventions and measurements: Study patients received aerosolized rhDNase or placebo twice daily for 24 weeks. Primary end points were incidence of pulmonary exacerbations and mean percent change in FEV1 from baseline over the treatment period.Results: Pulmonary exacerbations were more frequent and FEV1 decline was greater in patients who received rhDNase compared with placebo during this 24-week trial.Conclusions: rhDNase was ineffective and potentially harmful in this group of adult outpatients in stable condition with idiopathic bronchiectasis. This contrasts with previously published results that demonstrated efficacy of rhDNase in patients with cystic fibrosis bronchiectasis.