Sih T, Moura R, Caldas S, Schwartz B
Department of Otolaryngology, Faculdade de Medicina, Universidade de Sao Paulo, Brasil.
Int J Pediatr Otorhinolaryngol. 1993 Jan;25(1-3):19-24. doi: 10.1016/0165-5876(93)90006-o.
We enrolled 60 children with recurrent acute otitis media (AOM) in a study of the effectiveness of antimicrobial prophylaxis. All children were entered into the study following an acute episode of infection treated with amoxicillin (AMX) for 10 days. Following therapy, the children were re-examined, and then randomly assigned to receive either trimethoprim-sulfamethoxazole (TMP-SMX), amoxicillin (AMX) or a placebo (PLA). Twenty children were included in each group. Each drug was administered once a day at bedtime, at 1/3 the therapeutic dose, for 3 months. Children were re-evaluated with pneumootoscopy during episodes of acute illness and with pneumootoscopy and impedance tympanometry (TYMP) at monthly intervals. We observed a significantly increased rate of recurrent AOM in children receiving placebo compared with those who received antibiotics (50% vs. 17% P < 0.005). Both prophylactic antibiotics were equally effective in preventing recurrent AOM (recurrence rate 20% TMP-SMX, 15% AMX). We also observed that recurrences in children receiving placebo occurred earlier in the study period than in those receiving antibiotics. These results suggest that antimicrobial prophylaxis in children with recurrent acute otitis media is effective in reducing subsequent disease. The similar efficacy of both antibiotics tested suggests that the less expensive agent should be used.
我们招募了60名复发性急性中耳炎（AOM）患儿，进行一项抗菌预防有效性的研究。所有患儿在接受阿莫西林（AMX）治疗10天的急性感染发作后进入研究。治疗后，对患儿进行复查，然后随机分配接受甲氧苄啶-磺胺甲恶唑（TMP-SMX）、阿莫西林（AMX）或安慰剂（PLA）。每组纳入20名患儿。每种药物每天睡前以治疗剂量的1/3给药，持续3个月。在急性疾病发作期间通过耳镜检查对患儿进行重新评估，并每月通过耳镜检查和鼓室声导抗测试（TYMP）进行评估。我们观察到，与接受抗生素治疗的患儿相比，接受安慰剂治疗的患儿复发性AOM的发生率显著增加（50%对17%，P<0.005）。两种预防性抗生素在预防复发性AOM方面同样有效（复发率TMP-SMX为20%，AMX为15%）。我们还观察到，接受安慰剂治疗的患儿在研究期间比接受抗生素治疗的患儿复发更早。这些结果表明，对复发性急性中耳炎患儿进行抗菌预防可有效减少后续疾病。两种受试抗生素的疗效相似，这表明应使用成本较低的药物。
