Mandel E M, Bluestone C D, Cantekin E I, Ghorbanian S N, Rockette H E
Ann Otol Rhinol Laryngol Suppl. 1981 May-Jun;90(3 Pt 3):48-52. doi: 10.1177/00034894810903s212.
A double-blind randomized clinical trial was conducted comparing cefaclor and amoxicillin for the treatment of acute otitis media with effusion in 110 children (150 ears). Each child underwent unilateral or bilateral tympanocentesis and then randomly received a 14-day course of either amoxicillin or cefaclor. Of 57 children in the cefaclor group, only 3 children (5.3%) had persistent or recurrent symptoms during the 14-day course of treatment, as compared to 5 of 53 children (9.4%) in the amoxicillin group, but this difference is not significant. After completion of the 14 days of therapy, 45 of 76 ears (59.2%) of the children in the cefaclor group were effusion-free, as compared to only 28 of 64 ears (43.7%) of the children in the amoxicillin group. When adjusted for age and race, this difference is statistically significant (p = .03). However, the difference between the effect of the two antimicrobials is not statistically significant in children. Cefaclor is a reasonable choice for antimicrobial therapy for acute otitis media with effusion, and from these study findings, it appears that cefaclor may be more effective than amoxicillin in resolving the middle ear effusion at the completion of 14-day therapy.
进行了一项双盲随机临床试验，比较头孢克洛和阿莫西林对110名儿童（150只耳朵）急性分泌性中耳炎的治疗效果。每个儿童均接受单侧或双侧鼓膜穿刺术，然后随机接受为期14天的阿莫西林或头孢克洛治疗。在头孢克洛组的57名儿童中，只有3名儿童（5.3%）在14天的治疗过程中出现持续或反复症状，而阿莫西林组的53名儿童中有5名（9.4%）出现此类症状，但这种差异并不显著。在完成14天的治疗后，头孢克洛组76只耳朵中的45只（59.2%）儿童的中耳无积液，而阿莫西林组64只耳朵中只有28只（43.7%）儿童的中耳无积液。在对年龄和种族进行调整后，这种差异具有统计学意义（p = 0.03）。然而，两种抗菌药物疗效之间的差异在儿童中无统计学意义。头孢克洛是治疗急性分泌性中耳炎抗菌治疗的合理选择，从这些研究结果来看，在14天治疗结束时，头孢克洛在消除中耳积液方面可能比阿莫西林更有效。
