Efficacy of oral long-term N-acetylcysteine in chronic bronchopulmonary disease:: A meta-analysis of published double-blind, placebo-controlled clinical trials
Efficacy of oral long-term N-acetylcysteine in chronic bronchopulmonary disease:: A meta-analysis of published double-blind, placebo-controlled clinical trials
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DOI：
10.1016/s0149-2918(00)88479-9
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发表时间：
2000-02-01
影响因子：
3.2
通讯作者：
Leuenberger, P
中科院分区：
文献类型：
--
作者：
Grandjean, EM;Berthet, P;Leuenberger, P
目的：本荟萃分析旨在基于合格临床试验评估长期口服N-乙酰半胱氨酸（NAC）治疗慢性支气管炎（CB）的可能预防获益。NAC治疗急性加重没有investigated.Background：长期口服NAC治疗已在CB患者的一些研究进行了调查。NAC防止急性加重和症状的CB在一些，但不是所有的trials.Methods：包括在本分析的试验是从MEDLINE（R）检索期间从1980年1月1日至1995年6月30日，在最初的搜索中检索到的文章中的参考文献，并咨询2位专家。选择基于以下标准：已发表、双盲、安慰剂对照、慢性支气管肺疾病、治疗持续时间大于或等于2个月，以及足以计算结果变量的数据，该结果变量允许直接比较NAC组和安慰剂组的研究（效应量）。8项试验中有7项的主要终点是急性加重的发生率，另一项是临床评估。在7项研究中，入选标准基于医学研究理事会的CB标准，在一些试验中还有额外的标准。对于元分析，个别试验的终点转化为一个共同的outcome.Results的效果大小：初步确定的21项试验，8个合格的纳入。8份文件中的参考文献和与专家的协商产生了另外8份出版物，其中1份符合列入标准。NAC口服给药，每日剂量为400 mg（1项研究）、600 mg（5项研究）或1200 mg（1项研究）。另一项试验使用600 mg每周3次的剂量。治疗持续时间为3个月（1项研究）、25个月（2项研究）或6个月（7项研究）。该荟萃分析的结果显示，与安慰剂相比，NAC的效应量具有统计学显著性。效应量的总体值为-1.37（95% CI，-1.5至-1.25）。敏感性分析没有显著改变这些结果。在以急性加重次数作为临床终点的试验亚组分析中，（95% CI，-0.50至-0.18）（即与安慰剂相比，急性加重次数减少23%）。结论：这些结果表明，口服NAC的长期过程中，防止CB的急性加重，从而可能降低发病率和医疗保健费用。
Objective: This meta-analysis was performed to assess the possible prophylactic benefit of prolonged treatment with oral N-acetylcysteine (NAC) in chronic bronchitis (CB) based on qualifying clinical trials. Treatment of acute exacerbations with NAC was not investigated.Background: Prolonged treatment with oral NAC has been investigated in a number of studies of patients with CB. NAC prevented acute exacerbations and symptoms of CB in some but not all trials.Methods: The trials included in this analysis were selected from a MEDLINE(R) search of the period from January 1, 1980, through June 30, 1995; references in the articles retrieved in the initial search; and consultation with 2 experts. Selection was based on the following criteria: published, double-blind, placebo-controlled, chronic bronchopulmonary disease, duration of therapy greater than or equal to 2 months, and data sufficient to calculate an outcome variable permitting direct comparison of studies (effect size) for both NAC and placebo groups. The primary end point was the incidence of acute exacerbations in 7 of 8 trials and clinical assessment in the other. In 7 studies, inclusion criteria were based on Medical Research Council criteria for CB, with an additional criterion in some trials. For the mete-analysis, the end points of individual trials were transformed into an effect size as a common outcome.Results: Of 21 trials initially identified, 8 qualified for inclusion. References from the 8 papers and consultation with the experts produced 8 additional publications, 1 of which qualified for inclusion. NAC was administered orally at a daily dose of 400 mg (1 study), 600 mg (5 studies), or 1200 mg (1 study). One other trial used a dose of 600 mg 3 times per week. The duration of treatment was 3 months (1 study), 25 months (2 studies), or 6 months (7 studies). The results of this meta-analysis showed a statistically significant effect size for NAC compared with placebo. The overall value of effect size was -1.37 (95% CI, -1.5 to -1.25). Sensitivity analyses did not significantly alter these results. In a subset analysis of trials with the number of acute exacerbations as a clinical end point, a mean difference of -0.32 clinical event (95% CI, -0.50 to -0.18) was found (ie, a 23% decrease in the number of acute exacerbations compared with placebo).Conclusion: These findings suggest that a prolonged course of oral NAC prevents acute exacerbations of CB, thus possibly decreasing morbidity and health care costs.