North West London Hospitals NHS Trust, Central Middlesex Hospital, London, NW10 7NS, United Kingdom.
J Cyst Fibros. 2011 Jan;10(1):25-30. doi: 10.1016/j.jcf.2010.09.003.
Once daily dosing of aminoglycosides is widely used but is limited by the inconvenience of the slow infusion it requires and the associated three-times daily infusion of a beta-lactam. Twice daily tobramycin can be given as a slow IV bolus and may be more convenient. This study compares twice with three-times daily dosing of both tobramycin and ceftazidime.
This was a randomised, open-label, parallel group trial. CF patients presenting with an infective exacerbation were randomised to either twice or three-times daily ceftazidime and tobramycin. Markers of treatment efficacy and safety were measured in the two groups. The primary outcome measure was improvement in FEV1.
146 patients were randomised into the study. There was no significant difference in the two groups for improvement in FEV1% predicted (9.93% and 7.98% for twice daily and three-times daily respectively) and similar times to next exacerbation. There were no differences in the incidence of treatment failure, nephrotoxicity and ototoxicity.
This study confirms that twice daily dosing of both tobramycin and ceftazidime is safe and effective and may be considered more convenient than current dosing schedules.
氨基糖苷类药物每日一次给药已被广泛应用，但由于其需要缓慢输注，且与之相关的β-内酰胺类药物需要每日三次输注，因此存在不便。每日两次给予妥布霉素可以作为缓慢的静脉推注，可能更为方便。本研究比较了每日两次和每日三次给予妥布霉素和头孢他啶的效果。
这是一项随机、开放标签、平行组试验。出现感染性加重的 CF 患者被随机分为每日两次或三次给予头孢他啶和妥布霉素。两组均测量了治疗效果和安全性的标志物。主要结局指标为 FEV1 的改善。
146 例患者被随机纳入研究。两组患者的 FEV1%预计值改善无显著差异（每日两次组为 9.93%，每日三次组为 7.98%），下一次加重的时间也相似。两组在治疗失败、肾毒性和耳毒性的发生率方面无差异。
本研究证实，每日两次给予妥布霉素和头孢他啶是安全有效的，并且可能比目前的给药方案更为方便。
