Cipla Ltd, Medical Services , Tower A, 13th Floor, Peninsula Business Park, Ganaptrao Kadam Marg, Lower Parel, Mumbai 400013 , India
Expert Opin Drug Deliv. 2015 Aug;12(8):1301-10. doi: 10.1517/17425247.2015.1000858. Epub 2015 Jan 7.
An important factor responsible for suboptimal treatment in patients with obstructive airway diseases, which is often overlooked, is running out of medication. Addition of a dose counter to a pressurized metered-dose inhaler (pMDI) allows the patient to reliably track number of actuations, identify when the label claim number of actuations has been reached, and when a new inhaler needs to be purchased.
This article discusses the conventional methods for tracking doses in pMDIs, rationale of using dose counters, published evidence of studies, including performance and patient satisfaction with the use of pMDIs with dose counter. A section on the FDA guidance on dose counters and on Cipla's dose counters is also included.
It has been several years since the US FDA guidance on integration of dose-counting mechanisms into pMDIs and some time since pMDIs with dose counters have been available (albeit not with all pMDIs); but their importance has not been fully realized. This can be due to factors such as lack of adequate understanding about dose tracking, limited pMDIs being available with integrated dose counters and absence of a clear consolidation of the need, advantages, guidelines, types and characteristics of dose counters in published articles.
在患有阻塞性气道疾病的患者中，药物用尽是导致治疗效果不理想的一个重要因素，而这往往被忽视。在压力定量吸入器（pMDI）上添加一个剂量计数器，可让患者可靠地跟踪使用次数，确定达到标签声称的使用次数，以及何时需要购买新的吸入器。
本文讨论了 pMDI 中跟踪剂量的常规方法、使用剂量计数器的基本原理、已发表的研究证据，包括使用带剂量计数器的 pMDI 的性能和患者满意度。还包括关于 FDA 对剂量计数器的指导意见以及 Cipla 剂量计数器的一个部分。
自美国 FDA 发布关于将剂量计数机制集成到 pMDI 中的指导意见以来已经有几年了，而且带有剂量计数器的 pMDI 也已经上市（尽管并非所有 pMDI 都有）；但它们的重要性尚未得到充分认识。这可能是由于对剂量跟踪的理解不足、具有集成剂量计数器的 pMDI 数量有限以及在已发表的文章中没有明确整合对剂量计数器的需求、优势、指南、类型和特点等因素所致。
