Zeckel M L, Jacobson K D, Guerra F J, Therasse D G, Farlow D
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.
Clin Ther. 1992 Mar-Apr;14(2):214-29.
In this single-blind study, 579 patients with chronic bronchitis were randomly assigned to receive 400 mg of loracarbef twice daily or 500/125 mg of amoxicillin/clavulanate thrice daily for seven days. Treatment efficacy was evaluated in 129 of the loracarbef-treated patients and 120 amoxicillin/clavulanate-treated patients in whom pretreatment positive cultures of pathogens susceptible to both antibiotics were isolated. Three organisms predominated in either pure or mixed cultures in 57.0% of the evaluable patients: Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella (Branhamella) catarrhalis; H influenzae was isolated in 25.0% of the patients with single pathogens. Among the evaluable patients, favorable clinical responses (cure or improvement) were noted in 93.8% of the loracarbef-treated patients and in 95.0% of the amoxicillin/clavulanate-treated patients. A favorable bacteriologic response (pathogen eliminated or presumed eliminated) was found in 82.2% of loracarbef-treated patients and 90.0% of amoxicillin/clavulanate-treated patients. Six patients in the loracarbef group and 14 in the amoxicillin/clavulanate group discontinued treatment because of adverse events. The events were judged to be drug related in four loracarbef-treated patients and in 11 amoxicillin/clavulanate-treated patients. The incidence of diarrhea and other gastrointestinal symptoms was significantly more frequent in the amoxicillin/clavulanate group (13.5% and 5.6%) than in the loracarbef group (4.5% and 1.7%), while the incidence of severe headaches was significantly more frequent in the loracarbef than the amoxicillin/clavulanate group (7.2% vs 3.1%). It is concluded that loracarbef and amoxicillin/clavulanate are safe and effective in the treatment of acute bacterial exacerbations of chronic bronchitis.
在这项单盲研究中，579例慢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129例接受氯碳头孢治疗的患者和120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，这些患者在治疗前分离出了对两种抗生素敏感的病原体阳性培养物。在57.0%的可评估患者中，三种微生物在纯培养或混合培养中占主导地位：流感嗜血杆菌、肺炎链球菌或卡他莫拉菌（布兰汉菌属）；25.0%的单一病原体患者分离出流感嗜血杆菌。在可评估患者中，氯碳头孢治疗组93.8%的患者和阿莫西林/克拉维酸治疗组95.0%的患者出现了良好的临床反应（治愈或改善）。氯碳头孢治疗组82.2%的患者和阿莫西林/克拉维酸治疗组90.0%的患者出现了良好的细菌学反应（病原体清除或推测清除）。氯碳头孢组有6例患者、阿莫西林/克拉维酸组有14例患者因不良事件而停药。4例接受氯碳头孢治疗的患者和11例接受阿莫西林/克拉维酸治疗的患者的不良事件被判定与药物有关。阿莫西林/克拉维酸组腹泻和其他胃肠道症状的发生率（分别为13.5%和5.6%）显著高于氯碳头孢组（分别为4.5%和1.7%），而氯碳头孢组严重头痛的发生率显著高于阿莫西林/克拉维酸组（7.2%对3.1%）。结论是，氯碳头孢和阿莫西林/克拉维酸在治疗慢性支气管炎急性细菌感染方面是安全有效的。
