小児急性中耳炎に対するトスフロキサシン細粒小児用15％の 有効性についての検討

―TFLXは小児急性中耳炎中等症例の鼓膜切開術を回避できるか―

抄録

We investigated whether it is possible to cure moderate pediatric acute otitis media without myringotomy by administering TFLX, a novel antibiotic agent.

1) From among 284 pediatric patients with acute otitis media, requiring treatment with the third choice medication during the period of this study in our hospital, 53 provided informed consent for treatment with TFLX.

2) TFLX 12 mg/kg was administered twice, in the morning and evening, to these 53 cases. Efficacy was assessed 3 ± 1 days after administration, and again at 5 ± 1 days. In addition, TFLX was discontinued in cases with a severity score of zero, at 3 ± 1 days after the start of administration.

3) At 3 ± 1 days and 5 ± 1 days after TFLX administration, a significant difference in score as compared with the previous TFLX administration indicated improvement. In addition, four cases had a score of zero at 3 ± 1 days among the 53 cases (7.5%) after TFLX administration, indicating rapid healing in response to TFLX.

4) At 5 ± 1 days after TFLX administration, assessment showed healing (score of 0 points) or improvement (redness of the eardrum only) in 48 of the 53 cases (90.6%).

5) Five of the 53 cases (9.4%) did not obtain sufficient improvement with TFLX administration and required myringotomy. Previously, all 53 cases would have required myringotomy. Thus, TFLX administration could potentially reduce myringotomy by approximately 90%.

6) We aimed to determine whether TFLX can reduce the need for myringotomy in pediatric acute secondary otitis media cases, and confirmed TFLX to be an effective antimicrobial agent for this purpose.