Dere W H, Farlow D, Therasse D G, Jacobson K D, Guerra F J
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.
Clin Ther. 1992 Mar-Apr;14(2):166-77.
In this single-blind study, 488 patients with acute bronchitis were randomly assigned to receive 400 mg of loracarbef twice daily or 500/125 mg of amoxicillin/clavulanate three times daily for seven days. Treatment efficacy was evaluated in 98 patients treated with loracarbef and in 99 treated with amoxicillin-clavulanate in whom pretreatment positive cultures of pathogens susceptible to both study drugs were found. Streptococcus pneumoniae, Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, and Klebsiella pneumoniae were isolated in pure or mixed cultures in 64% of the evaluable patients; S pneumoniae was found in 26%. Among the evaluable patients, the rate of favorable clinical responses (cure and improvement) in the loracarbef group (96 of 98 patients; 98.0%) was similar to that in the amoxicillin/clavulanate group (96 of 99 patients; 97.0%); the favorable bacteriologic response rates were also similar (93.7% vs 92.9%, respectively). Eight patients in the loracarbef group and nine in the amoxicillin/clavulanate group discontinued treatment because of adverse events. The events were presumed to be drug related in five of the loracarbef group and in seven of the amoxicillin/clavulanate group. During therapy, diarrhea was the most frequently reported event in both groups. However, it occurred in only 8.2% of the loracarbef-treated patients compared with 22.5% of the amoxicillin/clavulanate patients (P less than 0.001). It is concluded that both loracarbef and amoxicillin/clavulanate are safe and effective in the treatment of acute purulent bacterial bronchitis.
在这项单盲研究中，488例急性支气管炎患者被随机分配，分别接受每日两次400毫克氯碳头孢或每日三次500/125毫克阿莫西林/克拉维酸治疗，疗程均为7天。对98例接受氯碳头孢治疗且治疗前两种研究药物对其病原体均敏感的阳性培养结果的患者，以及99例接受阿莫西林-克拉维酸治疗的患者进行了治疗效果评估。在64%的可评估患者中，从纯培养或混合培养物中分离出肺炎链球菌、流感嗜血杆菌、卡他莫拉菌（卡他布兰汉菌）和肺炎克雷伯菌；肺炎链球菌的分离率为26%。在可评估患者中，氯碳头孢组（98例患者中的96例；98.0%）的良好临床反应率（治愈和改善）与阿莫西林/克拉维酸组（99例患者中的96例；97.0%）相似；良好的细菌学反应率也相似（分别为93.7%和92.9%）。氯碳头孢组有8例患者、阿莫西林/克拉维酸组有9例患者因不良事件而停药。氯碳头孢组有5例、阿莫西林/克拉维酸组有7例事件被认为与药物相关。治疗期间，腹泻是两组中报告最频繁的事件。然而，氯碳头孢治疗的患者中腹泻发生率仅为8.2%，而阿莫西林/克拉维酸治疗的患者中腹泻发生率为22.5%（P<0.001）。结论是氯碳头孢和阿莫西林/克拉维酸在治疗急性化脓性细菌性支气管炎方面均安全有效。
