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妥布霉素吸入粉剂:在囊性纤维化患者治疗慢性铜绿假单胞菌感染中的应用评价。

Tobramycin inhalation powder: a review of its use in the treatment of chronic Pseudomonas aeruginosa infection in patients with cystic fibrosis.

机构信息

Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand,

出版信息

Drugs. 2013 Nov;73(16):1815-27. doi: 10.1007/s40265-013-0141-0.

Abstract

Inhaled tobramycin, an aminoglycoside antibacterial, has been in widespread use in the form of a nebulized solution against Pseudomonas aeruginosa for many years. More recently, tobramycin inhalation powder (TIP; TOBI(®) Podhaler(™)) was formulated using PulmoSphere(™) technology for administration as a dry powder via the T-326 Inhaler. This technology enables the administration of an intrapulmonary drug dose that is similar to that achieved with nebulized tobramycin inhalation solution (TIS), but reduces the administration time for TIP to one-third of that for TIS. TIP is approved in several countries, including the EU and US, for use in cystic fibrosis (CF) patients aged ≥6 years with P. aeruginosa infection. In well designed clinical trials in CF patients, the antipseudomonal efficacy of intermittent twice-daily TIP 112 mg was greater than that of placebo in one trial (a second trial was unable to recruit sufficient patient numbers for meaningful analyses), and non-inferior to that of intermittent twice-daily nebulized TIS 300 mg/5 mL with regard to lung function and sputum density of P. aeruginosa. In addition, patients using TIP were more satisfied with their treatment than those using nebulized TIS, largely as a result of improved overall convenience. TIP is generally well tolerated, with a similar safety profile to that of TIS, except for a higher incidence of cough. In conclusion, TIP administered via the T-326 Inhaler is an effective antipseudomonal agent with non-inferior efficacy and generally similar tolerability to that of nebulized TIS in CF patients with chronic P. aeruginosa infection. Compared with nebulized TIS, TIP has a faster delivery and is more portable and convenient.

摘要

吸入用妥布霉素是一种氨基糖苷类抗菌药物,多年来一直以雾化溶液的形式广泛用于治疗铜绿假单胞菌。最近,妥布霉素吸入粉剂(TIP;TOBI(®) Podhaler(™))采用 PulmoSphere(™)技术配制,以干粉形式通过 T-326 吸入器给药。该技术可使肺部药物剂量与雾化妥布霉素吸入溶液(TIS)相似,但可将 TIP 的给药时间缩短至 TIS 的三分之一。TIP 在多个国家获得批准,包括欧盟和美国,用于治疗年龄≥6 岁的囊性纤维化(CF)患者的铜绿假单胞菌感染。在 CF 患者的精心设计临床试验中,TIP 112 mg 每日两次间歇性给药在一项试验中的抗假单胞菌疗效优于安慰剂(第二项试验因无法招募到足够数量的患者而无法进行有意义的分析),并且在肺功能和铜绿假单胞菌痰密度方面与每日两次间歇性雾化 TIS 300 mg/5 mL 非劣效。此外,与使用雾化 TIS 的患者相比,使用 TIP 的患者对其治疗的满意度更高,这主要是因为总体便利性得到了改善。TIP 通常具有良好的耐受性,安全性与 TIS 相似,除了咳嗽发生率较高。总之,通过 T-326 吸入器给予 TIP 是一种有效的抗假单胞菌药物,在慢性铜绿假单胞菌感染的 CF 患者中,其疗效与雾化 TIS 非劣效,且总体耐受性相似。与雾化 TIS 相比,TIP 具有更快的给药速度,并且更便于携带和使用。

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