Randomised, controlled trial of N-acetylcysteine for treatment of acute exacerbations of chronic obstructive pulmonary disease [ISRCTN21676344].

Randomised, controlled trial of N-acetylcysteine for treatment of acute exacerbations of chronic obstructive pulmonary disease [ISRCTN21676344].
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DOI:
10.1186/1471-2466-4-13
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发表时间:
2004-12-06
影响因子:
3.1
通讯作者:
Young RP
Young RP
中科院分区:
医学3区
文献类型:
--
作者:
Black PN;Morgan-Day A;McMillan TE;Poole PJ;Young RP

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N-乙酰半胱氨酸(NAC)预防性治疗3个月或更长时间与慢性阻塞性肺疾病(COPD)加重频率降低相关。这就提出了一个问题,即在急性加重期间用NAC治疗是否会加速从加重中恢复。我们在一项随机、双盲、安慰剂对照试验中对此进行了研究。因COPD急性加重入院的受试者在入院后24小时内随机接受NAC 600 mg b.d.治疗。(n = 25)或匹配的安慰剂(n = 25)。治疗持续7天或直至出院(以先发生者为准)。合格受试者必须≥ 50岁,FEV 1 ≤ 60%预测值,FEV 1/VC ≤ 70%,吸烟史≥ 10包年。排除了患有哮喘、心力衰竭、肺炎和其他呼吸系统疾病的受试者。所有受试者同时接受泼尼松40 mg/天、沙丁胺醇5 mg q.i.d雾化吸入和适当抗生素治疗。每天同一时间雾化吸入沙丁胺醇后2 h测定FEV 1、VC、SaO 2和呼吸困难。呼吸困难用7分Likert量表测量。基线时,NAC组和对照组的FEV 1(%预测值)分别为22%和24%。两组间FEV 1、VC、SaO 2或呼吸困难的变化率无差异。两组的住院时间中位数也没有差异(两组均为6天)。在皮质类固醇和支气管扩张剂治疗基础上加用NAC不会改变COPD急性加重的结局。
Prophylactic treatment with N-acetylcysteine (NAC) for 3 months or more is associated with a reduction in the frequency of exacerbations of chronic obstructive pulmonary disease (COPD). This raises the question of whether treatment with NAC during an acute exacerbation will hasten recovery from the exacerbation. We have examined this in a randomised, double-blind, placebo controlled trial. Subjects, admitted to hospital with an acute exacerbation of COPD, were randomised within 24 h of admission to treatment with NAC 600 mg b.d. (n = 25) or matching placebo (n = 25). Treatment continued for 7 days or until discharge (whichever occurred first). To be eligible subjects had to be ≥ 50 years, have an FEV1 ≤ 60% predicted, FEV1/VC ≤ 70% and ≥ 10 pack year smoking history. Subjects with asthma, heart failure, pneumonia and other respiratory diseases were excluded. All subjects received concurrent treatment with prednisone 40 mg/day, nebulised salbutamol 5 mg q.i.d and where appropriate antibiotics. FEV1, VC, SaO2 and breathlessness were measured 2 hours after a dose of nebulised salbutamol, at the same time each day. Breathlessness was measured on a seven point Likert scale. At baseline FEV1 (% predicted) was 22% in the NAC group and 24% in the control group. There was no difference between the groups in the rate of change of FEV1, VC, SaO2 or breathlessness. Nor did the groups differ in the median length of stay in hospital (6 days for both groups). Addition of NAC to treatment with corticosteroids and bronchodilators does not modify the outcome in acute exacerbations of COPD.