Bergeron M G, Ahronheim G, Richard J E, Riding K, Cron C, Bryer D, Macdonald N, Bouchard M, Young J, Dempsey E E
Pediatr Infect Dis J. 1987 Jul;6(7):654-60. doi: 10.1097/00006454-198707000-00007.
A prospective double blind trial compared the fixed combination of erythromycin-sulfisoxazole (E/S) with cefaclor in the treatment of acute otitis media. One hundred nineteen children in six centers across Canada were studied. Diagnostic tympanocentesis of 134 ears yielded 135 bacterial isolates: Streptococcus pneumoniae (42%); Haemophilus influenzae (21%); Branhamella catarrhalis (10%); Streptococcus pyogenes (5%); and other bacteria (22%). Seventy-seven percent of strains of B. catarrhalis and 14% of strains of H. influenzae were beta-lactamase producers. E/S exhibited greater in vitro activity against H. influenzae and B. catarrhalis. Twenty-three patients had bacteriologically sterile middle ear fluid. The overall clinical outcome at Days 10 and 31 was identical in both treatment groups. Otoscopic findings improved more rapidly in the E/S group than in the cefaclor group at 10 and 31 days (P less than or equal to 0.04). In cases where pre-treatment middle ear fluid was negative on routine bacterial culture, complete cure at 10 days was observed in 75% of patients treated with E/S but only in 14% of those treated with cefaclor (P = 0.02). Side effects were infrequent and comparable between the test drugs. E/S is at least as effective as cefaclor in the management of acute otitis media and may be superior, particularly for cases not yielding bacteria on routine culture.
一项前瞻性双盲试验比较了红霉素 - 磺胺异恶唑（E/S）固定组合与头孢克洛治疗急性中耳炎的疗效。对加拿大六个中心的119名儿童进行了研究。对134只耳朵进行诊断性鼓膜穿刺术，共分离出135株细菌：肺炎链球菌（42%）；流感嗜血杆菌（21%）；卡他莫拉菌（10%）；化脓性链球菌（5%）；其他细菌（22%）。77%的卡他莫拉菌菌株和14%的流感嗜血杆菌菌株是β - 内酰胺酶产生菌。E/S对流感嗜血杆菌和卡他莫拉菌表现出更强的体外活性。23例患者中耳液细菌学检查无菌。两个治疗组在第10天和第31天的总体临床结果相同。在第10天和第31天，E/S组耳镜检查结果比头孢克洛组改善得更快（P≤0.04）。在治疗前中耳液常规细菌培养为阴性的病例中，接受E/S治疗的患者75%在10天内完全治愈，而接受头孢克洛治疗的患者只有14%（P = 0.02）。两种受试药物的副作用都很少见且相当。E/S在治疗急性中耳炎方面至少与头孢克洛一样有效，并且可能更具优势，特别是对于常规培养未检出细菌的病例。
