Yanagihara Katsunori, Izumikawa Koichi, Higa Futoshi, Tateyama Masao, Tokimatsu Issei, Hiramatsu Kazufumi, Fujita Jiro, Kadota Jun-ichi, Kohno Shigeru
Azithromycin Community-acquired Pneumonia Management Study Group, Nagasaki.
Intern Med. 2009;48(7):527-35. doi: 10.2169/internalmedicine.48.1482. Epub 2009 Apr 1.
The growing problem of drug resistance among respiratory pathogens in community-acquired pneumonia (CAP), particularly Streptococcus pneumoniae, (S. pneumoniae) has complicated initial empiric therapy of CAP. This study was undertaken to evaluate the efficacy and tolerability of a 3-day course of azithromycin in adults with mild to moderately severe CAP, and to determine whether in vitro macrolide resistance among strains of S. pneumoniae is related to clinical efficacy/failure.
An open-label, non-comparative study was undertaken at 3 university-affiliated hospitals in Japan. Patients were eligible if they were 18 years or older and had mild or moderately severe CAP. All patients received azithromycin 500 mg/day for three days, and clinical and microbiological responses were evaluated 1 and 2 weeks after initiating therapy.
A total of 78 patients received the study medication, 59 of whom had sufficient data available for efficacy analysis. Overall, a good clinical response with azithromycin was achieved in 49 patients (83.1%) and a microbiological response was achieved in 78.3%. Azithromycin resistance, based on CLSI criteria, was demonstrated in 85.7% (12/14) of S. pneumoniae isolates, and the presence of ermB genes was found in 50.0% (7/14). However, among patients in whom S. pneumoniae was isolated (n=17), a good clinical response was achieved in 76.5% (13/17), and the microbiological response rate was 64.3% (9/14). Furthermore, 6 of 7 patients in whom high-level resistance was documented (MICs >256 microg/mL and carrying ermB genes) exhibited good clinical responses. Azithromycin was well tolerated; adverse events, mainly of a gastrointestinal nature, were recorded in 6 patients (7.7%).
Most patients responed well to azithromycin, indicating that azithromycin might be clinically effective for the treatment of CAP with macrolide-resistant S. pneumoniae. However, a larger study is necessary to prove the efficacy against macrolide-resistant S. pneumoniae.
社区获得性肺炎（CAP）呼吸道病原体，尤其是肺炎链球菌（S. pneumoniae）的耐药问题日益严重，这使得CAP的初始经验性治疗变得复杂。本研究旨在评估阿奇霉素3日疗程对轻至中度严重CAP成人患者的疗效和耐受性，并确定肺炎链球菌菌株的体外大环内酯耐药性是否与临床疗效/治疗失败相关。
在日本3家大学附属医院进行了一项开放标签、非对照研究。年龄在18岁及以上且患有轻或中度严重CAP的患者符合入选标准。所有患者接受阿奇霉素500mg/天，共3天，并在开始治疗后1周和2周评估临床和微生物学反应。
共有78例患者接受了研究药物治疗，其中59例有足够的数据可用于疗效分析。总体而言，49例患者（83.1%）对阿奇霉素有良好的临床反应，微生物学反应率为78.3%。根据CLSI标准，85.7%（12/14）的肺炎链球菌分离株显示对阿奇霉素耐药，50.0%（7/14）的菌株存在ermB基因。然而，在分离出肺炎链球菌的患者中（n = 17），76.5%（13/17）有良好的临床反应，微生物学反应率为64.3%（9/14）。此外，7例记录有高水平耐药（MICs>256μg/mL且携带ermB基因）的患者中有6例有良好的临床反应。阿奇霉素耐受性良好；6例患者（7.7%）记录有不良事件，主要为胃肠道性质。
大多数患者对阿奇霉素反应良好，表明阿奇霉素可能对治疗耐大环内酯肺炎链球菌的CAP具有临床疗效。然而，需要更大规模的研究来证明其对耐大环内酯肺炎链球菌的疗效。
