Clinical Efficacy of Tosufloxacin Tosilate Hydrate for the Treatment of Acute Otitis Media in Children
Clinical Efficacy of Tosufloxacin Tosilate Hydrate for the Treatment of Acute Otitis Media in Children
复制标题
甲苯磺酸妥舒沙星水合物治疗小儿急性中耳炎的临床疗效
DOI：
10.5631/jibirin.105.381
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发表时间：
2012
期刊：
影响因子：
--
通讯作者：
S. Sawada
中科院分区：
文献类型：
--
作者：
N. Yamanaka;R. Sugita;Y. Uno;S. Matsubara;Y. Hayashi;S. Sawada
最近，小儿急性中耳炎的问题受到了特别关注。顽固性急性中耳炎儿童患者数量的增加已成为耳鼻喉科诊所和医院临床环境中的一个严重问题。中耳炎临床数据的这种变化可能是由于社会环境的影响，包括越来越多的幼儿被托儿所照顾，以及耐药细菌的增加。 2006年出版并于2009年修订的小儿急性中耳炎治疗临床指南中，提出了根据症状评分和鼓膜检查结果对严重程度进行分类，并推荐了以严重程度为导向的治疗算法。针对耐药菌的泛滥，我们也强调了正确使用抗菌药物的重要性，并推动根据指南推荐的评分系统正确评估各类抗菌药物的临床疗效。在这项研究中，我们采用评分系统的严重程度分类来检查托舒沙星 (TFLX) 细颗粒剂（6 毫克/公斤，每日两次）（一种新型儿科喹诺酮类抗菌药物）在 106 名 15 岁或以下被诊断患有中度或重度急性小儿中耳炎的儿童中的有效性和细菌学功效。我们得到了以下结果。根据评分导向评估，TFLX 的临床有效率为 98.1%（104/106），根据治疗医生的常规判断，TFLX 的临床有效率为 97.2%（103/106）。本研究检出的细菌病原体为流感嗜血杆菌37.7%（40/106）、肺炎链球菌32.1%（34/106）和卡他莫拉菌6.6%（7/106）。 TFLX给药完成时，细菌消除率为95.8%（69/72）。只有一名患者出现轻度腹泻作为药物不良反应。
Special attention has been focused on the recent problem of pediatric acute otitis media. The increase in the number of pediatric patients with intractable acute otitis media has been a serious problem in the clinical setting of ENT clinics and hospitals. Such a change in the clinical figures of otitis media may be due to the social environment, including the tendency for more very young children to be looked after at nurseries, and the increase in drug-resistant bacteria. In the clinical guidelines for the treatment of pediatric acute otitis media, published in 2006 and revised in 2009, a classification of severity according to scoring of symptoms and tympanic membrane findings was proposed and a severity-oriented treatment algorithm was recommended. In response to the proliferation of drug-resistant bacteria, we have also emphasized the importance of the proper use of antimicrobials and have promoted a correct assessment of the clinical efficacy of various antimicrobial agents according to the scoring system recommended by the guidelines. In this study, we employed this severity classification by the scoring system to examine the usefulness and bacteriological efficacy of tosufloxacin (TFLX) fine granules (6 mg/kg bid), a novel pediatric quinolone antimicrobial, in 106 children aged 15 or under diagnosed with moderate or severe acute pediatric otitis media. We obtained the following results. The clinical response rate to TFLX was 98.1% (104/106) according to the score-oriented evaluation and 97.2% (103/106) as conventionally judged by the treating physicians. Bacterial pathogens detected in this study were Haemophilus influenzae 37.7% (40/106), Streptococcus pneumoniae 32.1% (34/106) and Moraxella catarrhalis 6.6% (7/106). At the time of completion of TFLX administration, the rate of bacterial elimination was 95.8% (69/72). Only one patient experienced mild diarrhea as an adverse drug reaction.