Nalepa Piotr, Dobryniewska Malgorzata, Busman Todd, Notario Gerard
Krakow, Poland.
Curr Med Res Opin. 2003;19(5):411-20. doi: 10.1185/030079903125002018.
The objective of this study was to compare the efficacy and safety of two clarithromycin formulations given for 5 days to patients with acute bacterial exacerbation of chronic bronchitis (ABECB).
This was a double-blind, randomized, multicenter study of ambulatory patients between 40 and 75 years of age with a medical history of chronic bronchitis, chronic obstructive pulmonary disease and a presumptive diagnosis of ABECB who met Anthonisen Type 1 criteria (increased dyspnea, increased sputum volume and increased sputum purulence). Eligible patients received a 5-day course of clarithromycin extended-release (ER) 500 mg once daily or clarithromycin immediate-release (IR) 250 mg twice daily. Clinical cure, bacteriological cure and pathogen eradication rates were determined at the end of therapy and at a follow-up visit.
Clinical cure rates were similar at the test-of-cure visit for evaluable patients in the clarithromycin ER group (97%, 298/307) and clarithromycin IR group (98%, 300/307) (95% CI (-3.2, 1.9)). The bacteriological cure rate was 89% and the pathogen eradication rate was 90% in both treatment groups. Resolution or improvement in cough, sputum production, sputum volume and sputum appearance was observed in > 90% of evaluable patients in each treatment group. The incidence of study drug-related adverse events was 6.6% (23/351) in the clarithromycin ER group and 5.4% (19/352) in the clarithromycin IR group. The most frequently occurring study drug-related adverse events were abdominal pain, diarrhea and taste perversion.
Clarithromycin ER 500 mg once daily for 5 days is equivalent to clarithromycin IR 250 mg twice daily for 5 days in treating adults with ABECB. Both regimens were effective in resolving clinical signs and symptoms of ABECB and eradicating the target pathogens, and were well tolerated.
本研究的目的是比较两种克拉霉素制剂对慢性支气管炎急性细菌加重期(ABECB)患者进行5天治疗的疗效和安全性。
这是一项针对40至75岁有慢性支气管炎、慢性阻塞性肺疾病病史且初步诊断为ABECB并符合安东尼森1型标准(呼吸困难加重、痰量增加和痰液脓性增加)的门诊患者的双盲、随机、多中心研究。符合条件的患者接受为期5天的克拉霉素缓释(ER)500mg每日一次疗程或克拉霉素速释(IR)250mg每日两次疗程。在治疗结束时和随访时确定临床治愈率、细菌学治愈率和病原体清除率。
在可评估患者的治愈检查访视中,克拉霉素ER组(97%,298/307)和克拉霉素IR组(98%,300/307)的临床治愈率相似(95%CI(-3.2,1.9))。两个治疗组的细菌学治愈率均为89%,病原体清除率均为90%。每个治疗组中超过90%的可评估患者咳嗽、咳痰、痰量和痰液外观得到缓解或改善。克拉霉素ER组研究药物相关不良事件的发生率为6.6%(23/351),克拉霉素IR组为5.4%(19/352)。最常发生的研究药物相关不良事件是腹痛、腹泻和味觉异常。
对于治疗ABECB的成人患者,每日一次500mg克拉霉素ER治疗5天等同于每日两次250mg克拉霉素IR治疗5天。两种方案在解决ABECB的临床体征和症状以及根除目标病原体方面均有效,且耐受性良好。