Henry Dan C, Kapral Dolores, Busman Todd A, Paris Maria M
Foothill Family Clinic, 2295 Foothill Drive, Salt Lake City, UT 84109, USA.
Clin Ther. 2004 Dec;26(12):2026-33. doi: 10.1016/j.clinthera.2004.12.004.
Treatment guidelines for acute bacterial rhinosinusitis (ABRS) recommend 10 to 14 days of therapy with high-dose amoxicillin, amoxicillin/clavulanate, cefdinir, cefpodoxime, cefuroxime, a macrolide, or a newer fluoroquinolone, among other agents.
This study compared the clinical efficacy and tolerability of cefdinir and levofloxacin in patients with a diagnosis of acute rhinosinusitis of presumed bacterial origin.
In this multicenter, double-blind, noninferiority study, ambulatory adult patients who had signs and symptoms for >7 to 21 days before the screening visit and radiographic findings consistent with acute rhinosinusitis were randomized to receive cefdinir 600 mg or levofloxacin 500 mg, each once daily for 10 days. Clinical and radiologic response rates were determined at the test-of-cure (TOC) visit, which took place 9 to 14 days after the completion of treatment.
Two hundred seventy-one patients (138 cefdinir, 133 levofloxacin) were enrolled and randomized to treatment at 27 study centers in the United States and Poland between November 2003 and March 2004. Of these, 241 (123 cefdinir, 118 levofloxacin) were clinically evaluable. The cefdinir group consisted of 75 women and 48 men, of whom 117 were white and 6 black; their mean (SD) age was 42.5 (14.3) years. The levofloxacin group consisted of 71 women and 47 men, of whom 111 were white and 7 black; their mean age was 40.4 (13.6) years. The 2 groups were similar in terms of presenting signs and symptoms and baseline radiographic findings. The most common presenting symptoms were sinus pain, sinus pressure, and purulent nasal discharge, each of which was reported by > or =89% of patients. Clinical cure rates at the TOC visit in the cefdinir and levofloxacin groups were 83% (102/123) and 86% (101/118), respectively (95% Cl for the difference in cure rates, -12.3 to 7.0). Cefdinir and levofloxacin were comparable in the treatment of infections classified as moderate to severe. The incidence of drug-related adverse events was generally comparable in the 2 treatment groups, although there were significant differences between cefdinir and levofloxacin in the incidence of vaginal moniliasis in women (11% vs 0%, respectively; P = 0.003), drug-related diarrhea (8% vs 1%; P = 0.005), and insomnia (0% vs 4%; P = 0.027). Only 2% of patients discontinued therapy prematurely as a result of a drug-related adverse event.
In this population of patients with ABRS, the extended-spectrum cephalosporin cefdinir was as efficacious as the fluoroquinolone levofloxacin, suggesting that cefdinir may be a suitable alternative to the currently recommended fluoroquinolones.
急性细菌性鼻窦炎（ABRS）的治疗指南推荐使用高剂量阿莫西林、阿莫西林/克拉维酸、头孢地尼、头孢泊肟酯、头孢呋辛、大环内酯类药物或新型氟喹诺酮类药物等进行10至14天的治疗。
本研究比较头孢地尼和左氧氟沙星对诊断为疑似细菌性起源的急性鼻窦炎患者的临床疗效和耐受性。
在这项多中心、双盲、非劣效性研究中，将在筛查访视前有7至21天体征和症状且影像学检查结果符合急性鼻窦炎的门诊成年患者随机分为两组，分别接受600毫克头孢地尼或500毫克左氧氟沙星治疗，均每日一次，共10天。在治疗结束后9至14天进行的治愈检验（TOC）访视时确定临床和影像学反应率。
2003年11月至2004年3月期间，在美国和波兰的27个研究中心共纳入271例患者（138例接受头孢地尼治疗，133例接受左氧氟沙星治疗）并随机分组接受治疗。其中，241例（123例头孢地尼组，118例左氧氟沙星组）可进行临床评估。头孢地尼组包括75名女性和48名男性，其中117人为白人，6人为黑人；其平均（标准差）年龄为42.5（14.3）岁。左氧氟沙星组包括71名女性和47名男性，其中111人为白人，7人为黑人；其平均年龄为40.4（13.6）岁。两组在呈现的体征和症状以及基线影像学检查结果方面相似。最常见的症状是鼻窦疼痛、鼻窦压痛和脓性鼻涕，每组中≥89%的患者报告有这些症状。头孢地尼组和左氧氟沙星组在TOC访视时的临床治愈率分别为83%（102/123）和86%（101/118）（治愈率差异的95%置信区间为-12.3至7.0）。头孢地尼和左氧氟沙星在治疗中度至重度感染方面具有可比性。两个治疗组药物相关不良事件的发生率总体相当，尽管头孢地尼和左氧氟沙星在女性阴道念珠菌病发生率（分别为11%和0%；P = 0.003）、药物相关腹泻发生率（8%和1%；P = 0.005）以及失眠发生率（0%和4%；P = 0.027）方面存在显著差异。仅2%的患者因药物相关不良事件提前停药。
在这组ABRS患者中，广谱头孢菌素头孢地尼与氟喹诺酮类左氧氟沙星疗效相当，这表明头孢地尼可能是当前推荐的氟喹诺酮类药物的合适替代品。
