Urueta-Robledo Juan, Ariza Horacio, Jardim José R, Caballero Andrés, García-Calderón Andrés, Amábile-Cuevas Carlos F, Hernández-Oliva Gerardo, Vivar-Orozco Raul
Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico.
Respir Med. 2006 Sep;100(9):1504-11. doi: 10.1016/j.rmed.2006.01.013. Epub 2006 Feb 28.
We compared the efficacy and safety of moxifloxacin and levofloxacin for the treatment of patients with acute exacerbations of chronic bronchitis (AECB) using a prospective, randomized, double blind, parallel-group clinical trial design. A total of 563 patients with AECB were enrolled (437 efficacy-valid) at 34 centers in Mexico, Argentina, Brazil, Colombia, and Peru. Patients were randomized to oral therapy with either moxifloxacin 400 mg once daily for 5 days or levofloxacin 500 mg once daily for 7 days. Clinical success was achieved in 201 out of 221 (91.0%) patients in the moxifloxacin group, and in 203 out of 216 (94.0%) in the levofloxacin group, indicating that moxifloxacin is equivalently effective to levofloxacin. Bacteriologic eradication or presumed eradication was also similar in the two treatment groups: 92.8% in the moxifloxacin group and 93.8% in the levofloxacin group. Nausea was the most common drug-related adverse event in each treatment group. The rate of discontinuation because of adverse events was very low (2%). In conclusion, a 5-day course of moxifloxacin is clinically and bacteriologically equivalent to a 7-day course of levofloxacin in the treatment of patients with AECB. The short treatment duration with moxifloxacin may have compliance advantages over other currently used therapies in the 'real-life' clinical setting.
我们采用前瞻性、随机、双盲、平行组临床试验设计,比较了莫西沙星和左氧氟沙星治疗慢性支气管炎急性加重期(AECB)患者的疗效和安全性。在墨西哥、阿根廷、巴西、哥伦比亚和秘鲁的34个中心,共纳入了563例AECB患者(437例疗效有效)。患者被随机分为口服治疗组,一组每天一次口服400mg莫西沙星,共5天;另一组每天一次口服500mg左氧氟沙星,共7天。莫西沙星组221例患者中有201例(91.0%)临床治愈,左氧氟沙星组216例患者中有203例(94.0%)临床治愈,这表明莫西沙星与左氧氟沙星疗效相当。两个治疗组的细菌学根除或假定根除情况也相似:莫西沙星组为92.8%,左氧氟沙星组为93.8%。恶心是每个治疗组中最常见的药物相关不良事件。因不良事件停药的发生率非常低(2%)。总之,在治疗AECB患者时,5天疗程的莫西沙星在临床和细菌学方面与7天疗程的左氧氟沙星相当。在“现实生活”临床环境中,莫西沙星较短的治疗疗程可能比其他目前使用的疗法具有依从性优势。