Panpanich R, Lerttrakarnnon P, Laopaiboon M
Faculty of Medicine, Community Medicine, Chiang Mai University, 110 Intawaroros, Chiang Mai, North, Thailand 50200.
Cochrane Database Syst Rev. 2008 Jan 23(1):CD001954. doi: 10.1002/14651858.CD001954.pub3.
Acute lower respiratory tract infections (LRTI) range from acute bronchitis and acute exacerbations of chronic bronchitis to pneumonia. Approximately five million people die of acute respiratory tract infections annually. Among these, pneumonia represents the most frequent cause of mortality, hospitalization and medical consultation. Azithromycin is a new macrolide antibiotic, structurally modified from erythromycin and noted for its activity against some gram-negative organisms associated with respiratory tract infections, particularly Haemophilus influenzae (H. influenzae).
To compare the effectiveness of azithromycin to amoxycillin or amoxycillin/clavulanic acid (amoxyclav) in the treatment of LRTI, in terms of clinical failure, incidence of adverse events and microbial eradication.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007 Issue 2), MEDLINE (January 1966 to July 2007), and EMBASE (January 1974 to July 2007).
Randomized and quasi-randomized controlled trials, comparing azithromycin to amoxycillin or amoxycillin/clavulanic acid in participants with clinical evidence of acute LRTI: acute bronchitis, pneumonia, and acute exacerbation of chronic bronchitis were studied.
The criteria for assessing study quality were generation of allocation sequence, concealment of treatment allocation, blinding, and completeness of the trial. All types of acute LRTI were initially pooled in the meta-analyses. The heterogeneity of results was investigated by the forest plot and Chi-square test. Index of I-square (I(2)) was also used to measure inconsistent results among trials. Subgroup and sensitivity analyses were conducted.
Fifteen trials were analysed. The pooled analysis of all trials showed that there was no significant difference in the incidence of clinical failure on about day 10 to 14 between the two groups (relative risk (RR), random-effects 1.09; 95% confidence interval (CI) 0.64 to 1.85). Sensitivity analysis showed a reduction of clinical failure in azithromycin-treated participants (RR 0.55; 95% CI 0.25 to 1.21) in three adequately concealed studies, compared to RR 1.32; 95% CI 0.70 to 2.49 in 12 studies with inadequate concealment. Twelve trials reported the incidence of microbial eradication and there was no significant difference between the two groups (RR 0.95; 95% CI 0.87 to 1.03). The reduction of adverse events in the azithromycin group was RR 0.76 (95% CI 0.57 to 1.00).
AUTHORS' CONCLUSIONS: There is unclear evidence that azithromycin is superior to amoxicillin or amoxyclav in treating acute LRTI. In patients with acute bronchitis of a suspected bacterial cause, azithromycin tends to be more effective in terms of lower incidence of treatment failure and adverse events than amoxicillin or amoxyclav. Future trials of high methodological quality are needed.
急性下呼吸道感染(LRTI)涵盖急性支气管炎、慢性支气管炎急性加重以及肺炎。每年约有500万人死于急性呼吸道感染。其中,肺炎是导致死亡、住院和就医的最常见原因。阿奇霉素是一种新型大环内酯类抗生素,由红霉素结构改造而来,以其对一些与呼吸道感染相关的革兰氏阴性菌,特别是流感嗜血杆菌(H. influenzae)的活性而闻名。
比较阿奇霉素与阿莫西林或阿莫西林/克拉维酸(阿莫西林克拉维酸钾)在治疗LRTI方面的有效性,包括临床治疗失败情况、不良事件发生率和微生物清除情况。
我们检索了Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2007年第2期)、MEDLINE(1966年1月至2007年7月)以及EMBASE(1974年1月至2007年7月)。
随机和半随机对照试验,比较阿奇霉素与阿莫西林或阿莫西林/克拉维酸在有急性LRTI临床证据的参与者中的疗效:研究了急性支气管炎、肺炎和慢性支气管炎急性加重。
评估研究质量的标准包括分配序列的产生、治疗分配的隐藏、盲法以及试验的完整性。所有类型的急性LRTI最初都纳入荟萃分析。通过森林图和卡方检验研究结果的异质性。I²指数也用于衡量试验间结果的不一致性。进行了亚组分析和敏感性分析。
分析了15项试验。所有试验的汇总分析表明,两组在第10至14天左右的临床治疗失败发生率无显著差异(相对风险(RR),随机效应1.09;95%置信区间(CI)0.64至1.85)。敏感性分析显示,在三项隐藏充分的研究中,阿奇霉素治疗的参与者临床治疗失败率降低(RR 0.55;95%CI 0.25至1.21),而在12项隐藏不充分的研究中RR为1.32;95%CI 0.70至2.49。12项试验报告了微生物清除率,两组之间无显著差异(RR 0.95;95%CI 0.87至1.03)。阿奇霉素组不良事件减少的RR为0.76(95%CI 0.57至1.00)。
阿奇霉素在治疗急性LRTI方面优于阿莫西林或阿莫西林克拉维酸钾的证据尚不明确。在疑似细菌感染引起的急性支气管炎患者中,阿奇霉素在治疗失败率和不良事件发生率方面往往比阿莫西林或阿莫西林克拉维酸钾更有效。需要开展更高方法学质量的未来试验。