2nd Medical Department, District Hospital, Lüdenscheid, Germany.
Clin Drug Investig. 1998;15(1):13-20. doi: 10.2165/00044011-199815010-00002.
The efficacy and tolerability of oral cefixime 400mg once daily for 5 days was compared with standard 10-day therapy in a multicentre, double-blind, randomised, controlled clinical trial of 222 patients with acute exacerbations of chronic bronchitis. Clinical and bacteriological efficacy were assessed after 6, 11 and 30 days. A total of 167 patients were evaluable for efficacy on a per-protocol basis. Clinical efficacy (cure or improvement based on the quality and quantity of expectorated sputum and symptoms of dyspnoea) at day 11 was statistically equivalent (p < 0.01) between the treatment groups, with a successful clinical response achieved in 91% (5-day) and 89% (10-day) of patients. Bacteriological efficacy was also similar with 5- and 10-day treatment. During treatment, more patients reported an adverse event possibly or probably related to the study medication in the 10-day than in the 5-day treatment group (19 vs 14%). However, this difference was not statistically significant. Oral cefixime 400mg once daily is an effective and well tolerated treatment for acute exacerbations of chronic bronchitis. Short-term (5-day) therapy offers clinical efficacy similar to that of standard (10-day) therapy.
一项多中心、双盲、随机、对照临床试验比较了口服头孢克肟 400mg 每日 1 次、连用 5 天与标准 10 天疗法治疗慢性支气管炎急性加重的疗效和耐受性，共有 222 例患者参与该试验。在第 6、11 和 30 天分别评估临床和细菌学疗效。167 例患者按方案进行疗效评估。第 11 天时，根据痰的质量和数量以及呼吸困难症状，治疗组的临床疗效（治愈或改善）具有统计学等效性（p<0.01），91%（5 天）和 89%（10 天）的患者获得了成功的临床应答。5 天和 10 天治疗的细菌学疗效也相似。在治疗期间，报告与研究药物可能或很可能相关的不良事件的患者在 10 天治疗组多于 5 天治疗组（19 例比 14 例）。然而，这种差异没有统计学意义。口服头孢克肟 400mg 每日 1 次是一种有效且耐受性良好的慢性支气管炎急性加重的治疗方法。短期（5 天）治疗可提供与标准（10 天）治疗相似的临床疗效。
