Gotfried Mark, Notario Gerard, Spiller Joy, Palmer Robert, Busman Todd
Pulmonary Associates, University of Arizona, Phoenix, AZ 85020, USA.
Curr Med Res Opin. 2005 Feb;21(2):245-54. doi: 10.1185/030079905X26243.
The objective of this study was to compare the efficacy, tolerability, and safety of two clarithromycin regimens, extended-release (ER) 1000 mg once daily for 5 days and immediate-release (IR) 500 mg twice daily for 7 days, in the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB).
This was a double-blind, randomized, parallel-group, multicenter study of ambulatory patients at least 40 years old with a presumptive diagnosis of ABECB, purulent sputum, and documented evidence of chronic obstructive pulmonary disease (COPD), including forced expiratory volume in one second (FEV(1)) < 70% of predicted value. Clinical cure, bacteriological cure, and target pathogen eradication rates were determined at a test-of-cure visit (study days 14-40). Safety was assessed based on the incidence of study drug-related adverse events.
A total of 485 patients were randomized (240 to ER and 245 to IR). Clinical cure rates were similar for evaluable patients treated with ER (84%, 157/187) and those treated with IR (84%, 172/204) (95% CI -7.9, 7.2). The bacteriological cure rates were 87% (82/94) and 89% (91/102), and the overall target pathogen eradication rates were 88% (107/122) and 89% (117/131) for the respective treatment groups. The incidence of adverse events was 13% (31/240) in the ER group and 18% (45/245) in the IR group. The rate of gastrointestinal adverse events was lower with ER (8%, 19/240) compared to IR (11%, 26/245). Clarithromycin ER-treated patients reported statistically significantly fewer adverse events due to abnormal taste than did clarithromycin IR-treated patients (3% and 8%, respectively, p = 0.012).
Both once-daily, 5-day, short-course therapy with clarithromycin ER and 7-day, twice-daily therapy with clarithromycin IR were effective in resolving clinical signs/symptoms of ABECB and eradicating the causative pathogens, with no statistically significant difference in clinical cure rate between the treatment groups. Clarithromycin ER was better tolerated, causing fewer gastrointestinal adverse events and statistically significantly fewer reports of abnormal taste as compared with clarithromycin IR.
本研究旨在比较两种克拉霉素治疗方案，即每日一次1000mg缓释（ER）制剂，连用5天，与每日两次500mg即释（IR）制剂，连用7天，治疗慢性支气管炎急性细菌感染（ABECB）的疗效、耐受性和安全性。
这是一项双盲、随机、平行组、多中心研究，研究对象为至少40岁、初步诊断为ABECB、有脓性痰液且有慢性阻塞性肺疾病（COPD）记录证据（包括一秒用力呼气量（FEV₁）<预测值的70%）的门诊患者。在治疗结束访视（研究第14 - 40天）时确定临床治愈率、细菌学治愈率和目标病原体根除率。根据研究药物相关不良事件的发生率评估安全性。
共485例患者被随机分组（240例接受ER治疗，245例接受IR治疗）。接受ER治疗的可评估患者（84%，157/187）和接受IR治疗的可评估患者（84%，172/204）的临床治愈率相似（95%CI -7.9，7.2）。各治疗组的细菌学治愈率分别为87%（82/94）和89%（91/102），总体目标病原体根除率分别为88%（107/122）和89%（117/131）。ER组不良事件发生率为13%（31/240），IR组为18%（45/245）。与IR组（11%，26/245）相比，ER组胃肠道不良事件发生率较低（8%，19/240）。接受克拉霉素ER治疗的患者因味觉异常报告的不良事件在统计学上显著少于接受克拉霉素IR治疗的患者（分别为3%和8%，p = 0.012）。
每日一次、为期5天的克拉霉素ER短程治疗和每日两次、为期7天的克拉霉素IR治疗在解决ABECB的临床体征/症状和根除致病病原体方面均有效，治疗组之间临床治愈率无统计学显著差异。与克拉霉素IR相比，克拉霉素ER耐受性更好，引起的胃肠道不良事件更少，且因味觉异常报告的不良事件在统计学上显著更少。
