Engelhard D, Cohen D, Strauss N, Sacks T G, Jorczak-Sarni L, Shapiro M
Department of Clinical Microbiology, Hadassah University Hospital, Jerusalem, Israel.
Lancet. 1989 Jul 15;2(8655):141-3. doi: 10.1016/s0140-6736(89)90192-x.
In a prospective study, 105 infants aged 3-12 months with acute otitis media were randomly assigned to one of three treatment groups: amoxycillin/clavulanate ('Augmentin') alone (36 patients), myringotomy plus placebo (35 patients), or augmentin plus myringotomy (34 patients). The last two groups were double-blinded. Bacterial pathogens, mainly Haemophilus influenzae (of which 20% were beta-lactamase producers) and Streptococcus pneumoniae, were isolated from 60% of the ear exudates and all isolates were sensitive to augmentin. Most of the infants improved clinically within 3-6 days irrespective of the treatment protocol. As judged by otoscopy, 60% of the patients receiving augmentin, with or without myringotomy, recovered completely compared with 23% of patients treated with myringotomy plus placebo. Treatment with augmentin was also more effective than myringotomy with regard to persistence of ear infection. In the myringotomy plus augmentin group closure of the incision and resolution of the discharge from the incision site was faster than in the myringotomy plus placebo group. The addition of myringotomy to augmentin did not seem to affect either the persistence of the infection after treatment or the residual middle ear effusion.
在一项前瞻性研究中，105名年龄在3至12个月的急性中耳炎婴儿被随机分配到三个治疗组之一：单独使用阿莫西林/克拉维酸（“奥格门汀”）（36例患者）、鼓膜切开术加安慰剂（35例患者）或奥格门汀加鼓膜切开术（34例患者）。后两组采用双盲法。主要从60%的耳分泌物中分离出细菌病原体，主要是流感嗜血杆菌（其中20%是β-内酰胺酶产生菌）和肺炎链球菌，所有分离菌株对奥格门汀敏感。无论治疗方案如何，大多数婴儿在3至6天内临床症状改善。通过耳镜检查判断，接受奥格门汀治疗的患者，无论是否进行鼓膜切开术，60%完全康复，而接受鼓膜切开术加安慰剂治疗的患者为23%。在耳部感染持续方面，奥格门汀治疗也比鼓膜切开术更有效。在鼓膜切开术加奥格门汀组，切口闭合和切口部位分泌物消退比鼓膜切开术加安慰剂组更快。在奥格门汀基础上加做鼓膜切开术似乎既不影响治疗后感染的持续时间，也不影响残留中耳积液情况。
