Blumer J L, Bertino J S, Husak M P
Pediatr Infect Dis. 1984 Jan-Feb;3(1):25-9. doi: 10.1097/00006454-198401000-00007.
The efficacy and safety of cefaclor and trimethoprim-sulfamethoxazole (TMP-SMX) were compared in 100 children with acute otitis media assigned to the two treatment groups in a double-blind, randomized fashion. Treatment was for 10 days. Each patient had a diagnostic tympanocentesis before starting therapy. Pathogens were isolated from the middle ear aspirate in 49% of the cases, and organisms considered nonpathogenic were isolated as pure cultures from an additional 19%. Of the 100 patients 4 of 50 in the cefaclor group and 2 of 50 in the TMP-SMX group were considered treatment failures. In three of the four failures with cefaclor, compliance with the first course of therapy could not be ascertained. All six patients showed a good therapeutic response to an additional 10-day course of cefaclor. We conclude that cefaclor and TMP-SMX have essentially equivalent efficacy in the treatment of acute otitis media.
采用双盲、随机方式将100名急性中耳炎患儿分为两组，比较头孢克洛和甲氧苄啶-磺胺甲恶唑（TMP-SMX）的疗效和安全性。治疗为期10天。每位患者在开始治疗前均进行了诊断性鼓膜穿刺术。49%的病例中耳吸出物中分离出病原体，另有19%的病例中分离出被认为是非致病性的微生物纯培养物。100名患者中，头孢克洛组50例中有4例、TMP-SMX组50例中有2例被视为治疗失败。在头孢克洛治疗失败的4例中，有3例无法确定是否遵守了第一个疗程的治疗。所有6例患者在额外接受10天的头孢克洛治疗后均显示出良好的治疗反应。我们得出结论，头孢克洛和TMP-SMX在治疗急性中耳炎方面疗效基本相当。
