Fogarty Charles M, Kohno Shigeru, Buchanan Patricia, Aubier Michel, Baz Malik
Spartanburg Pharmaceutical Research, 126 Dillon Street, Spartanburg, SC 29307, USA.
J Antimicrob Chemother. 2003 Apr;51(4):947-55. doi: 10.1093/jac/dkg153. Epub 2003 Mar 13.
The incidence of community-acquired respiratory tract infections caused by Streptococcus pneumoniae exhibiting antibacterial resistance has increased dramatically in recent years. Telithromycin is the first of a new class of antibacterials, the ketolides, which have been developed specifically to provide effective treatment for these infections. Data were analysed from 3935 patients who had participated in one Japanese Phase II study and 11 US/global Phase III studies in three indications: community-acquired pneumonia, acute exacerbations of chronic bronchitis or acute sinusitis. Patients received either telithromycin 800 mg once daily or a comparator antibacterial. S. pneumoniae isolates considered to be causative for infection were tested for susceptibility to penicillin G and erythromycin A. In per-protocol analyses, telithromycin showed a high level of clinical efficacy against S. pneumoniae, with clinical cure rates of 92.8% for all isolates, 91.7% for those with reduced susceptibility to penicillin G and 86.0% for those with reduced susceptibility to erythromycin A. Bacterial eradication rates were consistent with the clinical outcomes. High rates of clinical cure and bacterial eradication were also observed for infections caused by isolates demonstrating high-level resistance to erythro-mycin A [MICs >/= 512 mg/L: 100% (13/13) clinical cure, 100% (13/13) bacterial eradication]. These results support the use of telithromycin as a first-line oral therapy for the treatment of community-acquired respiratory tract infections caused by S. pneumoniae with reduced susceptibility to penicillin G and erythromycin A.
近年来,由肺炎链球菌引起的具有抗菌耐药性的社区获得性呼吸道感染的发病率急剧上升。泰利霉素是新型抗菌药物(酮内酯类)中的首个药物,专门研发用于有效治疗这些感染。对参与一项日本II期研究和11项美国/全球III期研究的3935例患者的数据进行了分析,研究涉及三个适应症:社区获得性肺炎、慢性支气管炎急性加重或急性鼻窦炎。患者接受每日一次800mg泰利霉素或一种对照抗菌药物治疗。对被认为是感染病原体的肺炎链球菌分离株进行青霉素G和红霉素A敏感性测试。在符合方案分析中,泰利霉素对肺炎链球菌显示出高水平的临床疗效,所有分离株的临床治愈率为92.8%,对青霉素G敏感性降低的分离株为91.7%,对红霉素A敏感性降低的分离株为86.0%。细菌清除率与临床结果一致。对于由对红霉素A显示高水平耐药性的分离株引起的感染(最低抑菌浓度≥512mg/L:临床治愈率100%(13/13),细菌清除率100%(13/13)),也观察到了高临床治愈率和细菌清除率。这些结果支持将泰利霉素作为一线口服疗法,用于治疗对青霉素G和红霉素A敏感性降低的肺炎链球菌引起的社区获得性呼吸道感染。