Bachand R T
Abbott International Ltd, Abbott Park, Illinois 60064-3500.
J Antimicrob Chemother. 1991 Feb;27 Suppl A:75-82. doi: 10.1093/jac/27.suppl_a.75.
This double-blind, randomized 17-centre clinical trial compared the safety and efficacy of clarithromycin (2 x 125 mg capsules) 12-hourly and penicillin VK (2 x 125 mg tablets in capsules) 6-hourly in the treatment of proven Group A, beta-haemolytic streptococcal pharyngitis. One hundred and twenty-eight patients (clarithromycin: 65, penicillin VK: 63) were enrolled in the study and included in the safety analysis. Clinical and bacteriological evaluations were performed on treatment days 5-7, and within two to ten and 15 to 56 days post-treatment. The post-treatment clinical success and bacteriological cure rates for clarithromycin were 95% (41/43) and 88% (38/43), respectively, with both rates 91% (43/47) for penicillin VK. Three clarithromycin patients withdrew because of adverse events, but only one of these events was possibly drug related. More clarithromycin patients (19/65) reported digestive system related adverse events than did penicillin VK patients (8/63); however, there was no significant difference between treatment groups in the overall number of patients reporting adverse events. Clarithromycin (250 mg, 12-hourly) is a safe and effective as penicillin VK (250 mg, 6-hourly) in the treatment of streptococcal pharyngitis.
这项双盲、随机、17中心的临床试验比较了每12小时服用一次克拉霉素(2粒125毫克胶囊)和每6小时服用一次青霉素V钾(胶囊中的2片125毫克片剂)治疗确诊的A组β溶血性链球菌咽炎的安全性和有效性。128名患者(克拉霉素组:65例,青霉素V钾组:63例)纳入研究并进行安全性分析。在治疗第5至7天以及治疗后2至10天和15至56天进行临床和细菌学评估。克拉霉素治疗后的临床成功率和细菌学治愈率分别为95%(41/43)和88%(38/43),青霉素V钾的这两项比率均为91%(43/47)。3名克拉霉素治疗的患者因不良事件退出,但其中只有1例不良事件可能与药物有关。报告消化系统相关不良事件的克拉霉素患者(19/65)比青霉素V钾患者(8/63)多;然而,在报告不良事件的患者总数方面,治疗组之间没有显著差异。克拉霉素(250毫克,每12小时一次)在治疗链球菌咽炎方面与青霉素V钾(250毫克,每6小时一次)一样安全有效。