首页> 美国卫生研究院文献>Antimicrobial Agents and Chemotherapy >Absence of Cochleotoxicity Measured by Standard and High-Frequency Pure Tone Audiometry in a Trial of Once- versus Three-Times-Daily Tobramycin in Cystic Fibrosis Patients
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Absence of Cochleotoxicity Measured by Standard and High-Frequency Pure Tone Audiometry in a Trial of Once- versus Three-Times-Daily Tobramycin in Cystic Fibrosis Patients

机译:囊性纤维化患者每日一次和每日三次妥布霉素试验中通过标准和高频纯音测听法测量的耳蜗毒性缺乏

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摘要

We undertook assessment of hearing in patients with cystic fibrosis who were taking part in a large randomized controlled trial of once- versus three-times-daily tobramycin for pulmonary exacerbations of cystic fibrosis (the TOPIC study). All patients were eligible to have standard pure tone audiometry performed across the frequency range of 0.25 to 8 kHz. High-frequency pure tone audiometry over 10 to 16 kHz was also performed with a subset of patients. Audiometry was undertaken at the start of tobramycin treatment, at the end of a 14-day course of treatment, and at follow-up 6 to 8 weeks later. We enrolled 244 patients, of whom 219 (125 children and 94 adults) completed treatment. Nineteen patients were excluded from analysis due to abnormal baseline audiometry. Complete pre- and posttreatment standard audiological data were obtained for 168/219 patients. We found no significant differences in hearing thresholds when they were assessed at the baseline, at the end of treatment, and at follow-up 6 to 8 weeks later were compared. In addition, no significant differences in hearing thresholds were detected between treatment regimens. Similar results were obtained for the subset of 63/168 patients who underwent high-frequency audiometry. We conclude that for a single 14-day course of tobramycin treatment in patients with cystic fibrosis with no preexisiting auditory deficit, no measurable effect on hearing was apparent with either once- or three-times-daily treatment. Estimation of the cumulative cochleotoxic risk in cystic fibrosis patients due to repeated aminoglycoside therapy, as evidenced by the patients excluded from this study due to hearing loss, also requires further characterization.
机译:我们对参加大型大型随机对照试验的囊性纤维化患者的听力进行了评估,该试验每天一次或每日3次妥布霉素治疗,导致肺部囊性纤维化急性加重(TOPIC研究)。所有患者都有资格在0.25至8 kHz的频率范围内执行标准纯音测听。还对一部分患者进行了10至16 kHz的高频纯音测听。在妥布霉素治疗开始时,治疗14天疗程结束时以及在随访6至8周后进行听力测定。我们招募了244名患者,其中219名(125名儿童和94名成人)完成了治疗。由于基线测听异常,将19名患者排除在分析之外。获得了168/219例患者的完整治疗前和治疗后标准听力学数据。在基线,治疗结束时和随访6至8周后进行评估时,我们发现听力阈值无显着差异。此外,治疗方案之间未发现听力阈值有显着差异。对于63/168位接受高频测听的患者,也获得了相似的结果。我们得出的结论是,对于患有囊性纤维化患者且没有既存的听觉缺陷的妥布霉素单次治疗14天疗程,每天一次或每天三次治疗对听觉没有明显的可测量影响。如因听力损失而被本研究排除的患者所证明的那样,由于重复的氨基糖苷类药物治疗引起的囊性纤维化患者累积的耳蜗毒性风险的估算也需要进一步表征。

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