Marple Bradley F, Roberts Craig S, de Caprariis Pascal J, Reisman Arlene
Department of Otolaryngology-Head and Neck Surgery, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.
Clin Ther. 2007 Dec;29(12):2690-8. doi: 10.1016/j.clinthera.2007.12.030.
A previous study found that a single 2-g dose of azithromycin extended release (AZ-ER) was as efficacious as 10 days of levofloxacin (LFX) 500 mg QD in adults with acute bacterial rhinosinusitis (ABRS). The speed with which patients experience resolution of ABRS symptoms has not been reported.
The purpose of this study was to evaluate the resolution of ABRS symptoms after a single 2-g dose of AZ-ER compared with 10 days of LFX.
This was a retrospective analysis of data from a published international, randomized, double-blind, double-dummy clinical trial conducted between January 21, 2003, and February 20, 2004, that included 534 adult (age >or=18 years) outpatients with ABRS. All patients entering the study were required to have purulent nasal discharge, purulent drainage in the posterior pharynx, or purulent discharge from the maxillary sinus orifice and at least 1 of 3 other protocol-defined cardinal symptoms of ABRS (sinus pain, pressure, or tenderness) for >or=7 days. In addition, they were required to have at least 2 of the following 6 noncardinal symptoms at baseline: cough, fever, headache, nasal congestion, postnasal discharge, and leukocytosis. All patients who received medication were assessed for the occurrence of adverse events at study visits during and after therapy. At the ontreatment visit (between days 3 and 5), baseline symptoms were reassessed as resolved, improved, same, new, or worse. Resolution of symptoms was calculated as the proportion of patients with 3 or 4 cardinal symptoms either resolved (if present at baseline) or not new (if absent at baseline). Concomitant medications other than antibiotics were allowed as needed for symptomatic treatment.
Demographic characteristics were similar at baseline between the AZ-ER and LFX treatment arms (mean age, 38.4 and 39.5 years, respectively), although more women were randomized to receive LFX (62.9%) than AZ-ER (53.3%) (P = 0.025). More than 90% of patients in both arms had >or=3 ABRS symptoms at baseline. At the on-treatment visit, resolution of >or=3 ABRS symptoms was achieved in 88 of 270 AZ-ER patients (32.6%) and 61 of 261 LFX patients (23.4%) (P = 0.018). Resolution of individual symptoms in the AZ-ER and LFX groups at 3 to 5 days was as follows: sinus pain (92/253[36.4%] and 77/251 [30.7%]; P = NS), sinus pressure (97/243 [39.9%] and 68/244 [27.9%]; P = 0.005), sinus tenderness (83/218 [38.1%] and 73/214 [34.1%]; P = NS), and nasal discharge (57/270 [21.0%] and 49/264 [18.6%]; P = NS). Treatment-related adverse events were reported by 63 of 270 AZ-ER patients (23.3%) and 41 of 268 LFX patients (15.3%). Gastrointestinal disturbances were the most common adverse events, including nausea (4.4% and 3.4%) and abdominal pain (2.6% and 0.4%).
先前的一项研究发现，对于患有急性细菌性鼻窦炎（ABRS）的成年人，单次服用2克缓释阿奇霉素（AZ-ER）与连续10天每天服用500毫克左氧氟沙星（LFX）的疗效相当。但尚未有关于患者ABRS症状缓解速度的报道。
本研究旨在评估单次服用2克AZ-ER与服用10天LFX后ABRS症状的缓解情况。
这是一项对已发表的国际随机双盲双模拟临床试验数据的回顾性分析，该试验于2003年1月21日至2004年2月20日进行，纳入了534例成年（年龄≥18岁）ABRS门诊患者。所有进入研究的患者均需有脓性鼻涕、咽后壁脓性分泌物或上颌窦口脓性分泌物，以及至少一项ABRS的其他三项方案定义的主要症状（鼻窦疼痛、压痛或触痛）持续≥7天。此外，他们在基线时需至少有以下6项非主要症状中的2项：咳嗽、发热、头痛、鼻塞、鼻后滴漏和白细胞增多。所有接受药物治疗的患者在治疗期间及之后的研究访视中均评估不良事件的发生情况。在治疗访视时（第3至5天），将基线症状重新评估为已缓解、改善、相同、新发或加重。症状缓解率计算为具有3项或4项主要症状已缓解（若基线时存在）或未新发（若基线时不存在）的患者比例。除抗生素外，必要时可根据症状使用其他伴随药物进行对症治疗。
AZ-ER组和LFX治疗组在基线时的人口统计学特征相似（平均年龄分别为38.4岁和39.5岁），尽管随机接受LFX治疗的女性（62.9%）多于AZ-ER组（53.3%）（P = 0.025）。两组中超过90%的患者在基线时具有≥3项ABRS症状。在治疗访视时，270例AZ-ER患者中有88例（32.6%）实现了≥3项ABRS症状的缓解，261例LFX患者中有61例（23.4%）实现了缓解（P = 0.018）。AZ-ER组和LFX组在3至5天时各症状的缓解情况如下：鼻窦疼痛（92/253[36.4%]和77/251[30.7%]；P =无显著差异）、鼻窦压痛（97/243[39.9%]和68/244[27.9%]；P = 0.005）、鼻窦触痛（83/218[38.1%]和73/214[34.1%]；P =无显著差异）以及鼻涕（57/270[21.0%]和49/264[18.6%]；P =无显著差异）。270例AZ-ER患者中有63例（23.3%）报告了与治疗相关的不良事件，268例LFX患者中有41例（15.3%）报告了相关不良事件。胃肠道不适是最常见的不良事件，包括恶心（4.4%和3.4%）和腹痛（2.6%和0.4%）。
