Oshawa Clinic, Oshawa, Ontario, Canada.
Clin Drug Investig. 1998;15(2):81-90. doi: 10.2165/00044011-199815020-00002.
The objective of this multicentre, randomised, open-label, general practice (GP) study was to evaluate the efficacy and tolerability of cefprozil (Cefzil(trade mark), Bristol-Myers Squibb) compared with that of cefuroxime axetil (Ceftin((R)), Glaxo Wellcome) in the treatment of adult subjects with acute sinusitis. Typical of the GP setting, diagnosis was made based solely on clinical signs and symptoms of acute disease. Sinus radiography was performed post-randomisation. A total of 381 adolescent and adult patients were randomly assigned to 10 days' treatment with either cefprozil, 500mg orally twice daily (n = 191), or cefuroxime axetil, 250mg orally twice daily (n = 190). Based on predefined criteria, treatments were found to be equally effective in terms of proportions of patients in the per-protocol population that were cured, improved or failed (p = 0.20). Similar results were observed when the evaluation was performed on the subset of patients with radiographic evidence of sinusitis and when the evaluation was based on the investigator's judgement. Similar rates of adverse events were observed in the two treatment groups. In summary, cefprozil 500mg twice daily is as well tolerated and as effective as cefuroxime axetil 250mg twice daily for the treatment of adolescent and adult patients with clinical signs and symptoms of acute sinusitis.
这项多中心、随机、开放性、普通科(GP)研究的目的是评估头孢丙烯(Cefzil(商标),百时美施贵宝)与头孢呋辛酯(Ceftin(R),葛兰素威康)在治疗成人急性鼻窦炎患者方面的疗效和耐受性。普通科的治疗特点是仅根据急性疾病的临床体征和症状进行诊断。随机分组后进行鼻窦放射检查。共有 381 名青少年和成年患者被随机分配接受 10 天的治疗,分别为口服头孢丙烯 500mg,每日 2 次(n = 191)或口服头孢呋辛酯 250mg,每日 2 次(n = 190)。根据预先设定的标准,基于方案人群中治愈、改善或失败的患者比例,两种治疗方法在疗效方面没有差异(p = 0.20)。在有放射学证据的鼻窦炎患者亚组中进行评估和根据研究者的判断进行评估时,观察到类似的结果。两组的不良事件发生率相似。综上所述,头孢丙烯 500mg,每日 2 次与头孢呋辛酯 250mg,每日 2 次一样耐受良好,且对于治疗有急性鼻窦炎临床体征和症状的青少年和成年患者有效。