Murray John J, Emparanza Paz, Lesinskas Eugenijus, Tawadrous Margaret, Breen Jeanne D
Vanderbilt Medical School, Nashville, Tennessee, USA.
Otolaryngol Head Neck Surg. 2005 Aug;133(2):194-200. doi: 10.1016/j.otohns.2005.04.020.
To compare the efficacy and safety of a single 2.0-g dose of a novel azithromycin microsphere formulation with that of 10 days of levofloxacin, 500 mg/d, when used to treat adults with uncomplicated acute bacterial maxillary sinusitis (ABS).
An international, multicenter, randomized, double-blind, double-dummy trial. Eligible outpatients > or =18 years of age with clinical and radiographic evidence of ABS underwent maxillary sinus aspiration before randomization. Primary endpoint was clinical efficacy at the test-of-cure visit (day 17-24).
Clinical success rates were 94.5% (242/256) in azithromycin-microspheres-treated patients and 92.8% (233/251) in the levofloxacin group. In patients with documented Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, clinical cure rates were 97.3% (36/37), 96.3% (26/27), and 100% (8/8), respectively, for the azithromycin group and 92.3% (36/39), 100% (30/30), and 90.9% (10/11), respectively, for the levofloxacin group.
Single-dose azithromycin microspheres provided clinical and bacteriologic efficacy and safety comparable to 10 days of levofloxacin.
A novel microsphere formulation of azithromycin given as a single dose was safe and effective for the treatment of ABS.
比较单次服用2.0克新型阿奇霉素微球制剂与连续10天每天服用500毫克左氧氟沙星治疗无并发症的成人急性细菌性上颌窦炎（ABS）的疗效和安全性。
一项国际多中心随机双盲双模拟试验。年龄≥18岁、有ABS临床和影像学证据的合格门诊患者在随机分组前接受上颌窦穿刺。主要终点是治疗结束访视（第17 - 24天）时的临床疗效。
阿奇霉素微球治疗组的临床成功率为94.5%（242/256），左氧氟沙星组为92.8%（233/251）。在有肺炎链球菌、流感嗜血杆菌或卡他莫拉菌记录的患者中，阿奇霉素组的临床治愈率分别为97.3%（36/37）、96.3%（26/27）和100%（8/8），左氧氟沙星组分别为92.3%（36/39）、100%（30/30）和90.9%（10/11）。
单剂量阿奇霉素微球的临床和细菌学疗效及安全性与10天左氧氟沙星相当。
新型单剂量阿奇霉素微球制剂治疗ABS安全有效。
