Beghi G, Berni F, Carratù L, Casalini A, Consigli G, D'Antò M, Gioia V, Molino A, Paizis G, Vaghi A
Pneumology Dept., S. Corona Hospital, Garbagnate, Milan, Italy.
J Chemother. 1995 Apr;7(2):146-52. doi: 10.1179/joc.1995.7.2.146.
An open randomized trial was conducted in 142 hospitalized and out-patients with acute purulent exacerbation of chronic bronchitis to compare the clinical efficacy and tolerability of azithromycin (n = 69) and amoxicillin/clavulanic acid (n = 73). Azithromycin (500 mg) was administered as a single dose for three days and amoxicillin/clavulanic acid (amoxicillin 875 mg-clavulanic acid 125 mg) was given b.i.d. for 8 days (8.16 +/- 1.18). Before therapy and 24-48 hours after the end of treatment, sputum culture (by positioning five orthodontal swabs at the opening of salivary gland ducts after a washing of the oral cavity with sterile saline solution to avoid oral contamination), chest X-rays, arterial blood gas analysis, trials of respiratory functions and routine blood tests were performed. In the azithromycin group (69 patients) the efficacy rate was 67.6% (46 patients: 34 cured and 12 improved); in 22 patients (32.4%) the treatment failed; 1 patient was not evaluated because of no follow-up. The overall efficacy rate in the amoxicillin/clavulanic acid group (73 patients) was 97.3% (71 patients: 60 cured and 11 improved); in 1 patient (1.4%) the treatment failed and 1 patient was a drop-out for side effects. All pathogens isolated before treatment were susceptible to the antibiotics administered. At the end of treatment microbiological efficacy was 67.1% in the azithromycin group and 98.6% in the amoxicillin/clavulanic acid group. The tolerability was judged good in both treatment groups. Side effects were observed in 1 patient treated with amoxicillin/clavulanic acid (diarrhea), which imposed interruption of treatment, and in 2 patients from the azithromycin group (gastralgia and biochemical laboratory tests: renal function).(ABSTRACT TRUNCATED AT 250 WORDS)
对142例慢性支气管炎急性化脓性加重期的住院患者和门诊患者进行了一项开放性随机试验，以比较阿奇霉素（n = 69）和阿莫西林/克拉维酸（n = 73）的临床疗效和耐受性。阿奇霉素（500毫克）单剂量给药3天，阿莫西林/克拉维酸（阿莫西林875毫克 - 克拉维酸125毫克）每日两次给药8天（8.16 +/- 1.18）。在治疗前以及治疗结束后24 - 48小时，进行痰培养（用无菌生理盐水冲洗口腔后，将五支正畸拭子置于唾液腺导管开口处，以避免口腔污染）、胸部X光检查、动脉血气分析、呼吸功能试验和血常规检查。阿奇霉素组（69例患者）有效率为67.6%（46例患者：34例治愈，12例好转）；22例患者（32.4%）治疗失败；1例患者因未随访未评估。阿莫西林/克拉维酸组（73例患者）总有效率为97.3%（71例患者：60例治愈，11例好转）；1例患者（1.4%）治疗失败，1例患者因副作用退出。治疗前分离出的所有病原体均对所用抗生素敏感。治疗结束时，阿奇霉素组微生物学有效率为67.1%，阿莫西林/克拉维酸组为98.6%。两个治疗组的耐受性均判定为良好。阿莫西林/克拉维酸治疗的1例患者出现副作用（腹泻），导致治疗中断，阿奇霉素组有2例患者出现副作用（胃痛和生化实验室检查：肾功能）。（摘要截断于250字）
