Westerman E M, De Boer A H, Le Brun P P H, Touw D J, Roldaan A C, Frijlink H W, Heijerman H G M
Apotheek Haagse Ziekenhuizen, P.O. Box 43100, 2504 AC The Hague, The Netherlands.
J Cyst Fibros. 2007 Jul;6(4):284-92. doi: 10.1016/j.jcf.2006.10.010. Epub 2006 Dec 20.
Dry powder inhalation (DPI) may be an alternative to nebulisation of drugs in the treatment of chest infections in cystic fibrosis (CF) patients. In a pilot study the feasibility of a colistin dry powder inhaler (prototype Twincer) by a single dose in CF-patients was assessed and compared to nebulised colistin.
Ten CF-patients, chronically infected with P. aeruginosa, participated in a randomised cross over study. On two visits to the outpatient clinic, patients inhaled colistin sulphomethate as 25 mg dry powder (Twincer) or as 158 mg nebulised solution (Ventstream nebuliser, PortaNeb compressor). Pulmonary function tests were performed before, 5 and 30 min after inhalation. Serum samples were drawn prior to each dose and at 15, 45 min, 1.5; 2.5; 3.5 and 5.5 h after inhalation.
The DPI was well tolerated by the patients: no significant reduction in FEV1 was observed. Relative bioavailability of DPI to nebulisation was approx. 140% based on actual dose and approx. 270% based on drug dose label claim.
The colistin DPI (Twincer inhaler) is well tolerated and appreciated by CF-patients. Optimisation with respect to particle size and internal resistance of the inhaler is necessary to attain equivalent pulmonary deposition to liquid nebulisation.
干粉吸入(DPI)可能是囊性纤维化(CF)患者胸部感染治疗中雾化给药的一种替代方法。在一项初步研究中,评估了黏菌素干粉吸入器(原型Twincer)在CF患者中单次给药的可行性,并与雾化黏菌素进行了比较。
10名长期感染铜绿假单胞菌的CF患者参与了一项随机交叉研究。在两次门诊就诊时,患者吸入25mg黏菌素甲磺酸盐干粉(Twincer)或158mg雾化溶液(Ventstream雾化器,PortaNeb压缩机)。在吸入前、吸入后5分钟和30分钟进行肺功能测试。在每次给药前以及吸入后15、45分钟、1.5、2.5、3.5和5.5小时采集血清样本。
患者对DPI耐受性良好:未观察到FEV1有显著降低。基于实际剂量,DPI相对于雾化的相对生物利用度约为140%;基于药物剂量标签声明,约为270%。
黏菌素DPI(Twincer吸入器)耐受性良好,CF患者对其评价较高。为了实现与液体雾化相当的肺部沉积,有必要对吸入器的颗粒大小和内部阻力进行优化。