Gan V N, Kusmiesz H, Shelton S, Nelson J D
Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas 75235-9063.
Antimicrob Agents Chemother. 1991 May;35(5):967-71. doi: 10.1128/AAC.35.5.967.
One hundred five infants and children with acute otitis media were randomized to therapy with loracarbef, an experimental carbacephem antibiotic, or amoxicillin-clavulanate (Augmentin), an approved drug for this disease. Ninety-two were evaluable (46 in each group). Middle ear fluid samples obtained for culture before therapy grew Haemophilus spp. in 30% of cases, pneumococci in 29% of cases, and Moraxella catarrhalis in 15% of cases. beta-Lactamase-producing bacteria were found in 37% of patients. Clinical failure occurred in four loracarbef-treated patients and one amoxicillin-clavulanate-treated patient (P = 0.361). Recurrence of acute otitis media was more common in the 2 to 3 weeks after loracarbef treatment (eight patients) than it was after amoxicillin-clavulanate therapy (three patients), but not significantly so (P = 0.197). Thus, combined failure and recurrence occurred in 12 loracarbef-treated patients and four amoxicillin-clavulanate-treated patients (P = 0.052). Gastrointestinal side effects occurred in 13 loracarbef-treated and 21 amoxicillin-clavulanate-treated patients (P = 0.13). Diaper rash was more common with amoxicillin-clavulanate (22 patients) than with loracarbef (10 patients; P = 0.016). Satisfactory results were achieved with both antibiotics, and adverse effects, although common, were minor.
105名患有急性中耳炎的婴幼儿被随机分为两组，分别接受实验性碳头孢烯类抗生素氯碳头孢或已获批准用于治疗该病的阿莫西林-克拉维酸（安灭菌）治疗。92名患者可进行评估（每组46名）。治疗前获取的中耳积液样本培养结果显示，30%的病例中培养出嗜血杆菌属，29%的病例中培养出肺炎球菌，15%的病例中培养出卡他莫拉菌。37%的患者体内发现产β-内酰胺酶细菌。氯碳头孢治疗组有4名患者临床治疗失败，阿莫西林-克拉维酸治疗组有1名患者临床治疗失败（P = 0.361）。氯碳头孢治疗后2至3周内急性中耳炎复发情况比阿莫西林-克拉维酸治疗后更为常见（氯碳头孢组8例，阿莫西林-克拉维酸组3例），但差异无统计学意义（P = 0.197）。因此，氯碳头孢治疗组共有12例治疗失败和复发，阿莫西林-克拉维酸治疗组有4例（P = 0.052）。氯碳头孢治疗组有13例出现胃肠道副作用，阿莫西林-克拉维酸治疗组有21例出现胃肠道副作用（P = 0.13）。阿莫西林-克拉维酸组尿布疹比氯碳头孢组更常见（阿莫西林-克拉维酸组22例，氯碳头孢组10例；P = 0.016）。两种抗生素均取得了满意的疗效，不良反应虽然常见，但程度较轻。
