Miravitlles Marc, Molina Jesús, Brosa Max
Servei de Pneumologia, Institut Clínic del Tòrax (IDIBAPS), Hospital Clínic, Barcelona, España.
Arch Bronconeumol. 2007 Jan;43(1):22-8. doi: 10.1016/s1579-2129(07)60016-0.
As the research undertaken to date on the efficacy of the new antibiotics in the treatment of exacerbations of chronic bronchitis has taken the form of trials designed to demonstrate equivalence, we have no data on the advantages associated with the use of these new drugs with greater bactericidal activity. Our objective was to compare the clinical efficacy of moxifloxacin to that of the antibiotic regimens routinely used to treat such exacerbations by a systematic review of the literature and a meta-analysis.
A manual and electronic search was performed to identify all clinical trials carried out between January 1997 and July 2005 to compare moxifloxacin and the antibiotics that are currently the first line treatment for exacerbations of chronic bronchitis. Once it had been established that the designs of the trials included were acceptable, a meta-analysis of clinical outcomes was performed.
Of the 45 studies identified, 9 met the inclusion criteria. Of these, 5 were double-blind randomized trials and 4 were randomized open trials. The 9 trials comprised a total of 3905 patients. The aggregate standardized mean difference in clinical success rate was 1.5% (95% confidence interval, -0.4 to 3.4%). Bacterial eradication rates ranged from 68.4% to 96% for the standard regimens, and from 87.7% to 96% for moxifloxacin. No intergroup differences in the percentages of patients lost to follow-up were observed in any of the studies.
Although the trials reviewed were designed to demonstrate equivalence, meta-analysis revealed that the clinical success rate achieved with moxifloxacin tended to be higher than that obtained in the groups that received standard antibiotic treatment.
由于迄今开展的关于新型抗生素治疗慢性支气管炎急性加重疗效的研究采用的是旨在证明等效性的试验形式，我们尚无关于使用这些具有更强杀菌活性的新药所带来优势的数据。我们的目的是通过系统文献综述和荟萃分析，比较莫西沙星与常规用于治疗此类急性加重的抗生素方案的临床疗效。
进行了手工检索和电子检索，以确定1997年1月至2005年7月期间开展的所有比较莫西沙星与目前作为慢性支气管炎急性加重一线治疗药物的抗生素的临床试验。在确定纳入试验的设计可接受后，对临床结局进行了荟萃分析。
在检索到的45项研究中，9项符合纳入标准。其中，5项为双盲随机试验，4项为随机开放试验。这9项试验共纳入3905例患者。临床成功率的汇总标准化均差为1.5%（95%置信区间，-0.4至3.4%）。标准方案的细菌清除率为68.4%至96%，莫西沙星为87.7%至96%。在任何一项研究中均未观察到组间失访患者百分比的差异。
尽管所综述的试验旨在证明等效性，但荟萃分析显示，莫西沙星取得的临床成功率往往高于接受标准抗生素治疗的组。
