Hosie J, Quinn P, Smits P, Sides G
Health Centre, Sligo, Ireland.
J Antimicrob Chemother. 1995 Jul;36(1):173-83. doi: 10.1093/jac/36.1.173.
The safety and efficacy of dirithromycin and clarithromycin were compared in a single-blind, multicentre study of patients with acute bacterial exacerbation of chronic bronchitis (AECB). Patients received either dirithromycin, 500 mg once daily for 5 days, or clarithromycin, 250 mg twice daily for 7 days. A total of 212 patients entered the study, of whom 191 qualified for efficacy analysis. Favourable post-therapy clinical and bacteriological response rates for qualified patients (95 dirithromycin and 96 clarithromycin) were similar: 89.5% and 68.8% for dirithromycin vs 94.8% and 71.9% for clarithromycin. At late post-therapy evaluation, favourable clinical and bacteriological response rates were achieved in 98.8% and 96.2% of dirithromycin patients and 95.3% and 93.3% of clarithromycin patients, respectively. These differences were neither statistically nor clinically significantly different. Both drugs had similar efficacy against Haemophilus influenzae and both were well tolerated. Dirithromycin, administered as a single daily dose for just 5 days resulted in complete compliance in all but four patients. In clarithromycin-treated patients, requiring a 7-day course of twice-daily treatment, compliance was less satisfactory, with 12 patients failing to comply, though the between-group difference was not statistically significant. It can be concluded that 5 days of dirithromycin, 500 mg once daily is as safe and effective as 7 days of clarithromycin, 250 mg, twice daily in the treatment of AECB.
在一项针对慢性支气管炎急性细菌性加重（AECB）患者的单盲、多中心研究中，比较了地红霉素和克拉霉素的安全性和有效性。患者分别接受地红霉素（每日一次，500mg，共5天）或克拉霉素（每日两次，250mg，共7天）治疗。共有212名患者进入研究，其中191名符合疗效分析标准。符合标准的患者（95名接受地红霉素治疗，96名接受克拉霉素治疗）治疗后良好的临床和细菌学反应率相似：地红霉素组为89.5%和68.8%，克拉霉素组为94.8%和71.9%。在治疗后期评估中，地红霉素组分别有98.8%和96.2%的患者获得了良好的临床和细菌学反应率，克拉霉素组分别为95.3%和93.3%。这些差异在统计学和临床上均无显著意义。两种药物对流感嗜血杆菌的疗效相似，且耐受性良好。地红霉素每日单剂量给药仅5天，除4名患者外，所有患者均完全依从。在接受克拉霉素治疗的患者中，需要每日两次给药7天，依从性较差，有12名患者未依从，尽管组间差异无统计学意义。可以得出结论，在治疗AECB方面，每日一次500mg的地红霉素治疗5天与每日两次250mg的克拉霉素治疗7天一样安全有效。
