Gotfried Mark, Busman Todd A, Norris Sandra, Notario Gerard F
University of Arizona, Pulmonary Associates, Phoenix, AZ 85020, USA.
Curr Med Res Opin. 2007 Feb;23(2):459-66. doi: 10.1185/030079906X162827.
Clarithromycin is commonly dosed for 7 or more days in patients with acute bacterial exacerbation of chronic bronchitis (ABECB). Studies with other antibiotics have shown equivalent efficacy, reduced/similar frequency of adverse events, improved adherence and patient satisfaction, and lower treatment costs with a shorter treatment course.
The study population was derived from two multicenter, randomized, double-blind (North America)/single-blind (France) comparative trials in which outpatients at least 35 years old with a presumptive diagnosis of obstructive ABECB were randomized to receive clarithromycin extended-release (ER) 1000 mg once daily for 5 days or a comparator agent--clarithromycin immediate-release (IR) 500 mg twice daily for 7 days (in North America) or telithromycin 800 mg once daily for 5 days (in France).
A total of 818 patients were randomized (411 to clarithromycin ER and 407 to a comparator agent). The clinical cure rate in clinically evaluable patients at the follow-up visit was 90% each for the clarithromycin ER group (318/353) and the comparator group (318/355). The patient bacteriological cure rate and the overall target pathogen eradication rate in clinically and bacteriologically evaluable patients were each 92% for the clarithromycin ER group (155/168 and 189/205, respectively) and 93% for the comparator group (147/158 and 183/197, respectively) at the follow-up visit. The study drugs were generally well tolerated, with < 2% of patients discontinuing their treatment prematurely due to a drug-related adverse event. The incidence of drug-related adverse events was 18% (73/411) in the clarithromycin ER group and 24% (97/407) in the comparator group. Clarithromycin ER-treated patients reported statistically significantly fewer episodes of abdominal pain than did patients treated with a comparator agent (0.2% vs. 1.7%, respectively; p = 0.037). This combined analysis is limited by differing blinding methods, comparator agents, and their duration of administration. Furthermore, many patients were excluded from the clinically and bacteriologically evaluable group due to lack of a pretreatment target pathogen.
A once daily, 5-day clarithromycin ER regimen appears to be a suitable choice for treating patients with ABECB.
在慢性支气管炎急性细菌感染加重（ABECB）患者中，克拉霉素通常给药7天或更长时间。对其他抗生素的研究表明，较短疗程具有同等疗效、不良事件发生率降低/相似、依从性和患者满意度提高以及治疗成本更低。
研究人群来自两项多中心、随机、双盲（北美）/单盲（法国）对照试验，其中至少35岁、初步诊断为阻塞性ABECB的门诊患者被随机分组，分别接受每日1次、每次1000mg克拉霉素缓释剂（ER），疗程5天，或对照药物——北美为每日2次、每次500mg克拉霉素速释剂（IR），疗程7天，法国为每日1次、每次800mg泰利霉素，疗程5天。
共有818例患者被随机分组（411例接受克拉霉素ER，407例接受对照药物）。在随访时，临床可评估患者中，克拉霉素ER组（318/353）和对照组（318/355）的临床治愈率均为90%。在随访时，临床和细菌学可评估患者中，克拉霉素ER组（分别为155/168和189/205）的患者细菌学治愈率和总体目标病原体根除率均为92%，对照组（分别为147/158和183/197）均为93%。研究药物总体耐受性良好，因药物相关不良事件而提前停药的患者<2%。克拉霉素ER组药物相关不良事件的发生率为18%（73/411），对照组为24%（97/407）。与接受对照药物治疗的患者相比，接受克拉霉素ER治疗的患者报告的腹痛发作次数在统计学上显著更少（分别为0.2%对1.7%；p=0.037）。由于盲法、对照药物及其给药持续时间不同，该综合分析受到限制。此外，由于缺乏治疗前目标病原体，许多患者被排除在临床和细菌学可评估组之外。
每日1次、疗程5天的克拉霉素ER方案似乎是治疗ABECB患者的合适选择。
