Chen Hao, Chen Yanman, Vaishnani Deep K, Zhang Jiajia
Department of Thyroid, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China, 325000.
Department of Nursing, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China, 325000.
Drug Deliv Transl Res. 2025 May 22. doi: 10.1007/s13346-025-01882-0.
This study aimed to design and evaluate the clinical efficacy of a new patented portable multifunctional medical nebulizer. The portable multifunctional nebulizer, constructed using medical-grade PVC, incorporates four main systems: a nebulization system, a particle size adjustment mechanism, a heating unit, and a power storage system. This study employed a comparative experimental design. A conventional medical nebulizer, commonly used in a tertiary hospital, was selected as the control group, while the newly developed portable multifunctional nebulizer served as the experimental group. Each group underwent 30 experimental runs, with controlled variables across all tests. Key parameters assessed included initial mist emission time, nebulization rate, particle size distribution, medication splash loss, residual drug volume, and noise levels. The particle size distribution was measured using dynamic light scattering (DLS) technology, while medication loss was calculated by capturing mist spillover and measuring residual drug volume. Noise levels during stable nebulization were recorded using a sound level meter. The experimental group demonstrated the production of smaller, more uniform nebulized particles, reduced medication splash loss, decreased residual drug volume, and lower noise emissions. Statistically significant differences (P < 0.05) were observed across all parameters when compared to the control group. The multifunctional medical nebulizer consistently generates particles within a size range of 120-160 nm, improving drug delivery to target organs, minimizing medication loss, and reducing operational noise. This innovative design represents a significant advancement in the clinical application of respiratory therapy.
本研究旨在设计并评估一种新型专利便携式多功能医用雾化器的临床疗效。该便携式多功能雾化器采用医用级聚氯乙烯制成，包含四个主要系统：雾化系统、粒径调节机制、加热单元和蓄电系统。本研究采用对比实验设计。选择一家三级医院常用的传统医用雾化器作为对照组，而新开发的便携式多功能雾化器作为实验组。每组进行30次实验运行，所有测试中的变量均得到控制。评估的关键参数包括初始喷雾发射时间、雾化率、粒径分布、药物飞溅损失、残留药量和噪音水平。粒径分布采用动态光散射（DLS）技术测量，药物损失通过捕获喷雾溢出并测量残留药量来计算。稳定雾化期间的噪音水平使用声级计记录。实验组产生的雾化颗粒更小、更均匀，药物飞溅损失减少，残留药量降低，噪音排放更低。与对照组相比，所有参数均观察到具有统计学意义的差异（P < 0.05）。这种多功能医用雾化器始终能产生粒径在120 - 160纳米范围内的颗粒，改善药物向靶器官的递送，将药物损失降至最低，并降低运行噪音。这种创新设计代表了呼吸治疗临床应用的重大进步。
