Henry D C, Sydnor A, Settipane G A, Allen J, Burroughs S, Cobb M M, Holley H P
Foothill Family Clinic, Salt Lake City, Utah, USA.
Clin Ther. 1999 Jul;21(7):1158-70. doi: 10.1016/s0149-2918(00)80019-3.
This double-masked, multicenter, randomized clinical trial compared the efficacy and tolerability of cefuroxime axetil and amoxicillin/clavulanate in the treatment of acute bacterial maxillary sinusitis. A total of 263 patients with acute bacterial maxillary sinusitis were randomly assigned to receive 10 days of treatment with either cefuroxime axetil 250 mg twice daily (n = 132) or amoxicillin/clavulanate 500/125 mg 3 times daily (n = 131). Patients' responses to treatment were assessed once during treatment (6 to 8 days after the start of treatment), at the end of treatment (1 to 3 days posttreatment), and at follow-up (26 to 30 days after cessation of treatment). Clinical success, defined as cure or improvement, was equivalent in the cefuroxime axetil and amoxicillin/ clavulanate groups at the end-of-treatment and follow-up assessments. Patients in both groups showed improvements in symptoms of acute sinusitis at the during-treatment visit. Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events than treatment with cefuroxime axetil (29% vs 17%), primarily reflecting a higher incidence of gastrointestinal adverse events (23% vs 11%), particularly diarrhea. Two patients in the cefuroxime axetil group and 8 patients in the amoxicillin/clavulanate group withdrew from the study due to adverse events (P = 0.06). These results indicate that cefuroxime axetil 250 mg twice daily is as effective as amoxicillin/clavulanate 500 mg 3 times daily in the treatment of acute sinusitis and produces fewer gastrointestinal adverse events. cefuroxime axetil, amoxicillin/clavulanate, acute sinusitis.
这项双盲、多中心、随机临床试验比较了头孢呋辛酯和阿莫西林/克拉维酸治疗急性细菌性上颌窦炎的疗效和耐受性。共有263例急性细菌性上颌窦炎患者被随机分配，接受为期10天的治疗，其中132例患者每日两次服用250mg头孢呋辛酯，131例患者每日三次服用500/125mg阿莫西林/克拉维酸。在治疗期间（治疗开始后6至8天）、治疗结束时（治疗后1至3天）和随访时（停止治疗后26至30天）对患者的治疗反应进行评估。在治疗结束和随访评估中，头孢呋辛酯组和阿莫西林/克拉维酸组的临床成功率（定义为治愈或改善）相当。两组患者在治疗期间的急性鼻窦炎症状均有所改善。与头孢呋辛酯治疗相比，阿莫西林/克拉维酸治疗的药物相关不良事件发生率显著更高（29%对17%），主要反映出胃肠道不良事件发生率更高（23%对11%），尤其是腹泻。头孢呋辛酯组有2例患者和阿莫西林/克拉维酸组有8例患者因不良事件退出研究（P = 0.06）。这些结果表明，每日两次服用250mg头孢呋辛酯在治疗急性鼻窦炎方面与每日三次服用500mg阿莫西林/克拉维酸效果相当，且胃肠道不良事件更少。头孢呋辛酯、阿莫西林/克拉维酸、急性鼻窦炎。
