Steurer M, Schenk P
Department of Otorhinolaryngology, Head and Neck Surgery, General Hospital of Vienna, University of Vienna Medical School, Austria.
Eur Arch Otorhinolaryngol. 2000;257(3):140-8. doi: 10.1007/s004050050211.
Cefdinir is a new, extended-spectrum, orally active, third-generation cephalosporin that is resistant to bacterial beta-lactamase production. To evaluate efficacy and safety of the antibiotic in maxillary sinusitis, its use was compared with amoxicillin/clavulanate (amox/clav), which is a well-accepted beta-lactamase-resistant antibiotic. In this investigator-blinded multicenter phase III clinical study, 569 patients were randomly assigned to one of three treatment regimens: one daily dose of cefdinir 600 mg (OD), cefdinir 300 mg every 12 h (BD), and amox/clav 500/125 mg every 8 h. All antibiotics were administered orally for 10 days. Maxillary sinusitis was documented by typical clinical signs and symptoms and was confirmed by X-ray imaging. Before treatment, the genus and species of any pathogens were determined from sinus aspirates. Cultures were tested for beta-lactmase production and in vitro resistance to cefdinir and amox/clav. The effectiveness of antibiotic treatment was evaluated 7-14 days after therapy and whether or not recurrent clinical symptoms or persistent infection was determined 21-35 days post-therapy. The appearance of any adverse events was classified as associated or not associated with the medication of the study. Present findings showed that the in vitro susceptibility of pathogens to cefdinir and amox/clav was similar. Cefdinir OD or BD was therapeutically as effective as or better than amox/clav, although cefdinir BD was not as useful as amox/clav clinically. Cefdinir OD and BD and amox/clav were well tolerated. The statistical incidence of adverse events was the same among the three treatment groups, although cefdinir OD treatment had significantly fewer treatment discontinuations due to adverse events than BD and amox/clav.
头孢地尼是一种新型的、广谱的、口服有效的第三代头孢菌素，对细菌产生的β-内酰胺酶具有抗性。为了评估该抗生素在上颌窦炎中的疗效和安全性，将其使用情况与阿莫西林/克拉维酸（amox/clav）进行了比较，后者是一种广泛认可的抗β-内酰胺酶抗生素。在这项研究者设盲的多中心III期临床研究中，569名患者被随机分配到三种治疗方案之一：每日一次服用头孢地尼600mg（OD）、每12小时服用头孢地尼300mg（BD）以及每8小时服用amox/clav 500/125mg。所有抗生素均口服给药10天。上颌窦炎通过典型的临床体征和症状记录，并通过X线成像确诊。治疗前，从鼻窦抽吸物中确定任何病原体的属和种。对培养物进行β-内酰胺酶产生情况以及对头孢地尼和amox/clav的体外耐药性检测。在治疗后7 - 14天评估抗生素治疗的有效性，并在治疗后21 - 35天确定是否出现复发性临床症状或持续性感染。任何不良事件的出现被分类为与研究用药相关或不相关。目前的研究结果表明，病原体对头孢地尼和amox/clav的体外敏感性相似。头孢地尼OD或BD在治疗上与amox/clav一样有效或更好，尽管头孢地尼BD在临床上不如amox/clav有用。头孢地尼OD、BD和amox/clav耐受性良好。三个治疗组中不良事件的统计学发生率相同，尽管由于不良事件导致的治疗中断，头孢地尼OD治疗组明显少于BD组和amox/clav组。
