吸入用（妥布霉素）和静脉注射用妥布霉素在患有囊性纤维化的幼儿中的安全性。
Safety of inhaled (Tobi®) and intravenous tobramycin in young children with cystic fibrosis.
作者信息
Hennig Stefanie, McKay Karen, Vidmar Suzanna, O'Brien Katie, Stacey Sonya, Cheney Joyce, Wainwright Claire E
机构信息
School of Pharmacy, The University of Queensland, Brisbane QLD 4072, Australia.
Department of Respiratory Medicine, The Children's Hospital at Westmead, Westmead, NSW 2145, Australia; Discipline of Paediatrics and Child Health, The University of Sydney, Australia.
出版信息
J Cyst Fibros. 2014 Jul;13(4):428-34. doi: 10.1016/j.jcf.2014.01.014. Epub 2014 Feb 22.
BACKGROUND
Use of inhaled tobramycin therapy for treatment of Pseudomonas aeruginosa infections in young children with cystic fibrosis (CF) is increasing. Safety data for pre-school children are sparse.
METHODS
The aim of this study was to assess the safety of tobramycin solution for inhalation (TOBI®-TSI) administered twice daily for 2 months/course concurrently to intravenous (IV) tobramycin during P. aeruginosa eradication therapy in children (0-5 years). Audiological assessment and estimation of glomerular filtration rate (GFR) was measured prior to any exposure and end of the study.
RESULTS
Data were available from 142 patients who were either never exposed to aminoglycosides (n=39), exposed to IV aminoglycosides only (n=36) or exposed to IV+TSI (n=67). Median exposure to TSI was 113 days [59, 119]. Comparison of effects on audiometry results and GFR, showed no detectable difference between the groups.
CONCLUSIONS
Use of TSI and IV tobramycin in pre-school children with CF was not associated with detectable renal toxicity or ototoxicity.
背景
吸入用妥布霉素治疗囊性纤维化（CF）幼儿铜绿假单胞菌感染的应用正在增加。学龄前儿童的安全性数据稀少。
方法
本研究的目的是评估在儿童（0至5岁）铜绿假单胞菌根除治疗期间，每日两次、每次疗程2个月同时吸入妥布霉素溶液（TOBI®-TSI）与静脉注射（IV）妥布霉素的安全性。在任何暴露前和研究结束时进行听力评估和肾小球滤过率（GFR）估计。
结果
142例患者的数据可用，这些患者从未接触过氨基糖苷类药物（n = 39）、仅接触过静脉注射氨基糖苷类药物（n = 36）或接触过静脉注射+TSI（n = 67）。TSI的中位暴露时间为113天[59, 119]。对听力测定结果和GFR的影响比较显示，各组之间无明显差异。
结论
在患有CF的学龄前儿童中使用TSI和静脉注射妥布霉素与可检测到的肾毒性或耳毒性无关。
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