妥布霉素吸入干粉产品TOBI Podhaler获准用于囊性纤维化患者

圣路易斯(MD Consult)-2013年3月22日，美国食品药品管理局(FDA)和诺华公司宣布，TOBI Podhaler(妥布霉素吸入干粉)已获准用于发生肺部铜绿假单胞菌(Pa)感染的囊性纤维化(CF)患者。TOBI Podhaler可通过袖珍干粉吸入器将抗生素妥布霉素送入肺内，因而比关联产品TOBI使用更便利，后者通过雾化器给药。

据诺华公司介绍，Pa感染是CF患者肺功能丧失的首要病因。尚不清楚对于年龄＜6岁的患者、肺功能超出特定范围的患者，以及肺部存在洋葱伯克霍尔德菌，TOBI Podhaler是否也安全、有效。

TOBI Podhaler在1个纳入674例年龄≥6岁、合并肺部Pa感染的CF患者的3期临床项目中得到了评估。其中425例患者接受了至少1剂TOBI Podhaler。2项试验对比评估了TOBI Podhaler与安慰剂的疗效，第3项试验则对比评估了TOBI Podhaler与安慰剂的安全性。各项研究均采用获准的剂量112 mg、2次/d(每剂包含4粒28 mg胶囊)，每个疗程包含28天治疗期和随后28 天停药期。疗效评估结果显示，TOBI Podhaler可比安慰剂更有效地改善肺功能。

在临床研究中接受TOBI Podhaler治疗的患者的常见不良反应包括咳嗽、咳血、肺紊乱(肺或CF急性加重)、气促、发热、咽痛、发声困难和头痛。

TOBI Podhaler不需要采用冰箱保存，而且与雾化Pa治疗不同的是，不需要动力源用于驱动给药装置。用于TOBI给药的雾化器必须每天用沸水消毒10分钟，而一次性Podhaler装置仅需在每次使用后用干布擦拭干净、并且每周更换即可。

TOBI Podhaler有望于2013年第二季度在美国上市。

爱思唯尔版权所有  未经授权请勿转载

ST LOUIS (MD Consult) - On March 22, 2013, the US Food and Drug Administration (FDA) and Novartis annnounced the approval of TOBI Podhaler (tobramycin inhalation powder) for the management of patients with cystic fibrosis (CF) who are experiencing bacterial lung infections attributed to Pseudomonas aeruginosa (Pa). TOBI Podhaler delivers the antibiotic tobramycin into the lungs via a pocket-sized dry powder inhaler, which offers better portability than the related product TOBI, which is delivered via nebulizer.

According to Novartis, Pa infections are the leading cause of loss of lung function in patients with CF. It is not known whether TOBI Podhaler is safe and effective in patients younger than 6 years, in patients whose lung function is outside of a certain range, or in patients whose lungs contain Burkholderia cepacia.

TOBI Podhaler was studied in a phase 3 clinical program involving 674 patients with CF aged 6 years and older with Pa in their lungs, of whom 425 patients received at least 1 dose of TOBI Podhaler. Two trials evaluated the efficacy of TOBI Podhaler versus placebo, whereas a third trial assessed the safety of TOBI Podhaler versus TOBI. All studies evaluated TOBI Podhaler at the approved dose of 112 mg twice daily (the contents of 4 28-mg capsules per dose) in cycles of 28 days on, immediately followed by 28 days off treatment. Results of the efficacy studies showed that the use if TOBI Podhaler improved lung function compared with placebo.

Common adverse effects reported in patients treated with TOBI Podhaler during the clinical studies included cough, hemoptysis, lung disorder (pulmonary or CF exacerbations), shortness of breath, pyrexia, oropharyngeal pain, dysphonia, and headache.

TOBI Podhaler does not need to be stored in a refrigerator and, unlike nebulized Pa treatments, does not require a power source to operate the delivery device. The nebulizer used to administer TOBI must be disinfected in boiling water for 10 minutes every other treatment day, whereas the disposable Podhaler device must only be wiped clean with a dry cloth after each use, and is then replaced weekly.

TOBI Podhaler is anticipated to be available in the US in the second quarter of 2013.