Zeckel M L, Johns D, Masica D N, Farlow D
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
Clin Ther. 1995 Mar-Apr;17(2):214-30. doi: 10.1016/0149-2918(95)80020-4.
Loracarbef is an oral synthetic beta-lactam antibiotic in the new carbacephem class. We conducted a multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of loracarbef 200 mg twice daily (BID) and 400 mg BID when given orally for 10 days to patients 12 years of age and older with acute maxillary sinusitis. Because sinus aspirates for culture are not routinely obtained in the management of acute maxillary sinusitis, antimicrobial therapy usually is selected empirically. This study was designed to provide data simulating the usual clinical practice of treatment without sinus aspiration. Two hundred nine patients who met the entry criteria, which included abnormal pretherapy sinus radiographs compatible with acute maxillary sinusitis and symptoms of fewer than 4 weeks' duration, qualified for the clinical analyses. Of the 106 clinically qualified patients assigned to the 200-mg BID group, favorable clinical responses (cure and improvement) were noted in 86 (81.1%) patients. Of the 103 clinically qualified patients assigned to the 400-mg BID group, 84 (81.6%) patients had favorable clinical responses. These results compare favorably with accepted clinical response rates of 70% to 80% for beta-lactams selected on an empiric basis. At the end of the treatment period, favorable radiologic responses (resolved and improved) and favorable clinical responses occurred in 55 (51.9%) of the 106 clinically qualified patients in the 200-mg BID group and in 57 (55.3%) of the 103 clinically qualified patients in the 400-mg BID group. Mean roentgenogram scores for the clinically qualified patients were 2.3 for both groups before therapy and 1.3 and 1.5 after therapy for the 200-mg BID and 400-mg BID groups, respectively. The mean change from pretherapy to posttherapy by patient was 1.0 for the 200-mg BID group and 0.8 for the 400-mg BID group. There were no statistically significant differences between treatment groups in the incidence of specific adverse events reported during therapy. These data suggest that loracarbef 200 mg BID is comparable in efficacy and safety to loracarbef 400 mg BID in the treatment of patients with acute maxillary sinusitis.
氯碳头孢是一种新型碳头孢烯类口服合成β-内酰胺抗生素。我们进行了一项多中心、随机、双盲、平行组研究，以比较每日两次口服200mg和400mg氯碳头孢，连续给药10天，治疗12岁及以上急性上颌窦炎患者的疗效和安全性。由于在急性上颌窦炎的治疗中通常不常规获取鼻窦抽吸物进行培养，抗菌治疗通常是经验性选择。本研究旨在提供模拟无鼻窦抽吸治疗的常规临床实践的数据。209例符合入选标准的患者，包括治疗前鼻窦X光片异常且符合急性上颌窦炎表现、症状持续时间少于4周，纳入临床分析。在分配到200mg每日两次组的106例符合临床标准的患者中，86例（81.1%）有良好的临床反应（治愈和改善）。在分配到400mg每日两次组的103例符合临床标准的患者中，84例（81.6%）有良好的临床反应。这些结果与经验性选择的β-内酰胺类药物公认的70%至80%的临床反应率相比具有优势。在治疗期结束时，200mg每日两次组的106例符合临床标准的患者中有55例（51.9%）出现良好的影像学反应（消退和改善）以及良好的临床反应，400mg每日两次组的103例符合临床标准的患者中有57例（55.3%）出现上述情况。符合临床标准的患者治疗前两组的平均X光片评分为2.3，治疗后200mg每日两次组和400mg每日两次组分别为1.3和1.5。患者从治疗前到治疗后的平均变化，200mg每日两次组为1.0，400mg每日两次组为0.8。治疗组之间在治疗期间报告的特定不良事件发生率方面无统计学显著差异。这些数据表明，在治疗急性上颌窦炎患者时，每日两次口服200mg氯碳头孢与每日两次口服400mg氯碳头孢在疗效和安全性方面相当。
