Leach Chet L, Davidson Patricia J, Hasselquist Bruce E, Boudreau Robert J
3M Pharmaceuticals, St. Paul, Minnesota, USA.
J Aerosol Med. 2005 Winter;18(4):379-85. doi: 10.1089/jam.2005.18.379.
The objective of this study was to determine the lung delivery of HFA-134a-beclomethasone dipropionate (HFA-BDP) from a breath-activated inhaler (QVAR Autohaler) compared with proper and improper press and breathe (QVAR P&B) metered dose inhaler (MDI) technique. The hypothesis was that that the smaller particles of BDP from HFA-BDP would stay suspended longer in the inspiratory air of patients and thus reduce the deleterious effects of inhaler discoordination. The study was an open label, four period, cross-over design. Asthmatic patients (n = 7) with a history of asthma symptoms, an FEV-1 of >70% of predicted normal, and a history of reversibility to a beta-agonist of >or=12% were utilized. BDP was radiolabeled with technetium-99m and delivered from the QVAR Autohaler or QVAR P&B device in patients trained to reproducibly utilize coordinated and discoordinated P&B MDI technique. Patients using Autohaler MDI exhibited 60% lung deposition of BDP. Patients using coordinated technique with the P&B MDI exhibited 59% lung deposition. Patients trained to consistently actuate the P&B MDI before inhaling exhibited 37% lung deposition. Patients trained to consistently actuate the P&B MDI late in the inspiration (i.e., 1.5 sec into a 3-sec inspiration) exhibited 50% lung deposition. In conclusion, the breath-activated Autohaler automatically provided optimal BDP lung deposition of 60%. Patients with good P&B MDI technique also received optimal lung deposition of 59%. The degree of lung deposition was decreased as patients demonstrated poor inhaler technique. However patients with poor technique still received a large lung dose of BDP (i.e., >or=37%) compared with lung deposition values of 4-7% for CFC-BDP MDIs previously published and confirmed in this study.
本研究的目的是确定与正确和不正确的按压与呼吸(QVAR P&B)定量吸入器(MDI)技术相比,来自呼吸激活吸入器(QVAR Autohaler)的氢氟烷烃-134a-丙酸倍氯米松(HFA-BDP)的肺部递送情况。假设是HFA-BDP中较小的倍氯米松颗粒会在患者的吸气空气中悬浮更长时间,从而减少吸入器不协调的有害影响。该研究采用开放标签、四周期、交叉设计。使用有哮喘症状病史、第一秒用力呼气量(FEV-1)大于预测正常值的70%且对β受体激动剂可逆性大于或等于12%的哮喘患者(n = 7)。用锝-99m对倍氯米松进行放射性标记,并通过QVAR Autohaler或QVAR P&B装置递送给经过训练可重复使用协调和不协调的按压与呼吸MDI技术的患者。使用Autohaler MDI的患者显示倍氯米松的肺部沉积率为60%。使用P&B MDI协调技术的患者显示肺部沉积率为59%。经过训练在吸气前始终启动P&B MDI的患者显示肺部沉积率为37%。经过训练在吸气后期(即3秒吸气过程中的1.5秒)始终启动P&B MDI的患者显示肺部沉积率为50%。总之,呼吸激活的Autohaler自动提供了60%的最佳倍氯米松肺部沉积率。具有良好P&B MDI技术的患者也获得了59%的最佳肺部沉积率。随着患者吸入技术变差,肺部沉积程度降低。然而,与先前发表并在本研究中得到证实的氯氟烃-倍氯米松MDI的4-7%的肺部沉积值相比,技术较差的患者仍获得了大量的肺部倍氯米松剂量(即大于或等于37%)。