Calver A D, Walsh N S, Quinn P F, Baran C, Lonergan V, Singh K P, Orzolek W S
West Vaal Hospital, Orkney, South Africa.
Clin Infect Dis. 1997 Apr;24(4):570-4. doi: 10.1093/clind/24.4.570.
In this double-blind study, 557 patients with lower respiratory tract infection were randomly assigned to receive amoxicillin/clavulanate orally either every 12 hours (875/125 mg) or every 8 hours (500/125 mg) for 7-15 days. For the 455 patients evaluable for clinical efficacy at the end of therapy, clinical success was similar in the two groups: 93% and 94% in the 12-hour and 8-hour groups, respectively (P = .42). Bacteriologic success at the end of therapy was also comparable: 97% and 91% in the 12-hour and 8-hour groups, respectively (P = .86). The occurrence of adverse events related to treatment was similar for the two groups, but fewer patients in the 12-hour group reported moderate or severe diarrhea. Amoxicillin/clavulanate (875/125 mg) given every 12 hours is as effective and safe as every-8-hours administration of the combination (500/125 mg) for the treatment of lower respiratory tract infection.
在这项双盲研究中,557例下呼吸道感染患者被随机分配,分别每12小时口服阿莫西林/克拉维酸(875/125毫克)或每8小时口服(500/125毫克),疗程为7至15天。在治疗结束时可评估临床疗效的455例患者中,两组的临床成功率相似:12小时给药组和8小时给药组分别为93%和94%(P = 0.42)。治疗结束时的细菌学成功率也相当:12小时给药组和8小时给药组分别为97%和91%(P = 0.86)。两组与治疗相关的不良事件发生率相似,但12小时给药组报告中度或重度腹泻的患者较少。每12小时给予阿莫西林/克拉维酸(875/125毫克)治疗下呼吸道感染的疗效和安全性与每8小时给予该组合(500/125毫克)相当。