Haczyński J, Bardadin J, Gryczyńska D, Gryczyński M, Gołabek W, Kawalski H, Kaźmierczak H, Krecicki T, Kubik P, Namysłowski G, Popiel L
Medical Department, Eli Lilly Polska, Warsaw, Poland.
Med Sci Monit. 2001 Sep-Oct;7(5):1016-22.
Acute pharyngotonsillitis (APT) is one of the most common inflammatory processes of adults and children in an outpatient setting. Increasing failure rates, hypersensitivity to penicillin, the required multiple daily doses and common side effects lead to poor patients compliance and thus inadequate treatment duration, providing therefore ground for considering alternative antimicrobial agents.
This multicenter, randomized, single blind study was undertaken in order to compare efficacy and safety of cefaclor (375 mg BID) and amoxicillin/clavulanate (625 mg BID) in 10 days treatment regiment of ambulatory patients with APT. A total of 200 patients (age range between 12-65 years) with symptoms of APT and positive antigen strep test were enrolled into the study. Clinical and bacteriological responses were assessed after the end of treatment (14th-18th day) and at the follow-up visit (38th-45th day). All GABHS strains, isolated from throat cultures, were tested for in vitro sensitivity to the antibiotics used in the study and no strain was found resistant to both antibiotics.
The results indicated that both antibiotics had high--almost 99% effectiveness at the post therapy visit. On the follow up visit an increased tendency of relapses was observed in the amoxicillin/clavulanate treated group, compared to cefaclor treated group (8.33% vs 3.29%). Relative risk of relapse in patients treated with amoxicillin/clavulanate was 2.6 greater compared to cefaclor. There were significantly higher rates of gastrointestinal adverse events in group treated with amoxicillin/clavulanate (29/97 patients; 29.89%) compared to cefaclor (16/95 patients; 16.84%) - p< 0.03. Frequency of other adverse events did not differ significantly between the groups.
Cefaclor and amoxicillin/clavulonate provide a clinically and bacteriologically effective treatment for patients with pharyngotonsillitis caused by GABHS, but cefaclor treatment is significantly safer in regard to gastrointestinal side effects.
急性咽喉扁桃体炎（APT）是门诊成人和儿童中最常见的炎症性疾病之一。青霉素治疗失败率上升、对青霉素过敏、每日需多次给药以及常见的副作用导致患者依从性差，从而使治疗疗程不足，因此有理由考虑使用替代抗菌药物。
本多中心、随机、单盲研究旨在比较头孢克洛（375毫克，每日两次）和阿莫西林/克拉维酸（625毫克，每日两次）在门诊APT患者10天治疗方案中的疗效和安全性。共有200名有APT症状且抗原链球菌试验呈阳性的患者（年龄在12 - 65岁之间）纳入研究。在治疗结束后（第14 - 18天）和随访时（第38 - 45天）评估临床和细菌学反应。从咽拭子培养物中分离出的所有A组β溶血性链球菌（GABHS）菌株均进行了对研究中所用抗生素的体外敏感性测试，未发现对两种抗生素均耐药的菌株。
结果表明，两种抗生素在治疗后访视时的有效性都很高，几乎达到99%。在随访时，与头孢克洛治疗组相比，阿莫西林/克拉维酸治疗组观察到复发趋势增加（8.33%对3.29%）。阿莫西林/克拉维酸治疗患者的复发相对风险比头孢克洛高2.6倍。与头孢克洛组（16/95例患者；16.84%）相比，阿莫西林/克拉维酸治疗组胃肠道不良事件发生率显著更高（29/97例患者；29.89%） - p < 0.03。两组间其他不良事件的发生率无显著差异。
头孢克洛和阿莫西林/克拉维酸对由A组β溶血性链球菌引起的咽喉扁桃体炎患者提供了临床和细菌学有效的治疗，但头孢克洛治疗在胃肠道副作用方面明显更安全。
