Daly K, Giebink G S, Batalden P B, Anderson R S, Le C T, Lindgren B
University of Minnesota Otitis Media Research Center, Minneapolis 55440.
Pediatr Infect Dis J. 1991 Jul;10(7):500-6. doi: 10.1097/00006454-199107000-00004.
This double blind, placebo-controlled trial was designed to determine whether intervention with a stepped regimen of trimethoprim-sulfamethoxazole (TMP-SMX) and prednisone would prevent high risk children from developing chronic otitis media with effusion (OME) and recurrent acute otitis media. Forty-two children were enrolled, assigned to treatment with active drug or placebo and then examined at 2-week intervals. They received TMP-SMX (or placebo) during the first 2 weeks, TMP-SMX and prednisone (or placebo) during Weeks 3 and 4 for persistent OME and TMP-SMX (or placebo) for Weeks 5 and 6 if OME was still unresolved. After treatment 48% of active drug and 14% of placebo subjects resolved OME bilaterally (P less than 0.05). Active drug subjects also had fewer acute otitis media episodes than placebo subjects while receiving study treatment (P less than 0.01). Although this treatment regimen produced short term OME resolution, long term benefits were not demonstrated.
这项双盲、安慰剂对照试验旨在确定采用甲氧苄啶-磺胺甲恶唑（TMP-SMX）和泼尼松阶梯疗法进行干预是否能预防高危儿童患中耳积液慢性中耳炎（OME）和复发性急性中耳炎。42名儿童入组，被分配接受活性药物或安慰剂治疗，然后每隔2周进行检查。他们在头2周接受TMP-SMX（或安慰剂），第3周和第4周针对持续性OME接受TMP-SMX和泼尼松（或安慰剂），如果OME仍未解决，则在第5周和第6周接受TMP-SMX（或安慰剂）。治疗后，48%接受活性药物治疗的受试者和14%接受安慰剂治疗的受试者双侧OME得到缓解（P<0.05）。在接受研究治疗期间，接受活性药物治疗的受试者急性中耳炎发作次数也比接受安慰剂治疗的受试者少（P<0.01）。虽然这种治疗方案能在短期内使OME得到缓解，但未显示出长期益处。
