布地奈德搏动喷雾器雾化治疗上呼吸道疾病的强化治疗选择

IF 0.6 Q3 OTORHINOLARYNGOLOGY
Bolesław Samoliński, Konrad Furmańczyk, Andrzej Emeryk, Tomasz R Sosnowski, Paweł Bijoś
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引用次数: 0

摘要

& lt; b>介绍:& lt; / b>T2免疫反应相关气道炎症(如嗜酸性粒细胞炎症)的主要治疗方法是局部糖皮质激素治疗。然而,其有效性受到药物渗透到鼻周腔的挑战的限制。新一代脉动喷雾器的推出部分解决了这个问题。脉动喷雾器(振动气溶胶)增强雾化药物进入鼻窦的渗透,从而为慢性鼻窦炎的治疗开辟了新的治疗选择。因此,布地奈德用于慢性鼻窦炎伴鼻息肉的适应症已被批准。& lt; br> & lt; br> & lt; b>目的:& lt; / b>本研究的目的是比较使用PARI SINUS2雾化器系统(由PARI LC SPRINT SINUS雾化器和PARI SINUS2压缩机组成)给药的试验药物(TD)和参比药物(RD)的分散悬浮液的空气动力学粒径分布(APSD)。使用PARI SINUS2喷雾器系统管理的TD和RD分散悬浮液的APSD的比较。使用6个PARI SINUS2喷雾器系统对每种配方进行12次雾化测试,每个系统重复两次。研究方法为文献综述和自己的研究。通过PARI SINUS2雾化系统雾化2 mL TD和RD悬浮液后,使用下一代撞击器(NGI)和激光衍射光谱仪进行APSD研究。统计分析包括描述性统计以及平均值差异的90%和95%置信区间以及被检查参数的平均值比率。& lt; br> & lt; br> & lt; b>结果:& lt; / b>TD非常适合雾化程序。两种配方(TD和RD)在不同水平的NGI级联撞击器上的气溶胶液滴分布表现出显著的变化。在TD的情况下,更容易产生更大的液滴,这促进了药物在冲击器上层的沉积。布地奈德的两种形式的等效,RD和TD,在治疗慢性鼻窦炎鼻息肉使用脉动雾化器被证明。这些适应症得到了药品、医疗器械和杀菌剂产品注册办公室(URPLWMiPB)的认可,并添加到TD的产品信息中。& lt; br> & lt; br> & lt; b>结论:& lt; / b>布地奈德两种制剂均有效。布地奈德通过振动雾化管理是有效的治疗慢性鼻窦炎鼻息肉。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Enhanced Therapeutic Options for Budesonide Nebulisation via Pulsating Nebuliser in Upper Respiratory Tract Diseases

Introduction: The primary treatment method for T2 immune response-related airway inflammations, such as eosinophilic inflammation, is topical glucocorticosteroid therapy. However, its effectiveness is limited by the challenge of drug penetration into the perinasal cavity. The introduction of a new generation of pulsating nebulizers has partially addressed this issue. Pulsating nebulizers (vibrating aerosol) enhance the penetration of nebulized medication into the paranasal sinuses, thereby opening a new therapeutic option for the treatment of chronic sinusitis. Consequently, a new regulatory indication has been approved for the use of budesonide in chronic rhinosinusitis with nasal polyps. Aim: The aim of the study was to compare the aerodynamic particle size distribution (APSD) of the dispersed suspensions of the test drug (TD) and the reference drug (RD) administered using the PARI SINUS2 nebulizer system, consisting of the PARI LC SPRINT SINUS nebulizer and the PARI SINUS2 compressor. Material and methods: Comparison of the APSD of the dispersed suspensions of the TD and the RD administered using the PARI SINUS2 nebulizer system. Twelve nebulizations of each formulation were tested using six PARI SINUS2 nebulizer systems, with two repetitions per system. The methods were review of studies and own research. The APSD study was conducted using a next-generation impactor (NGI) and a laser diffraction spectrometer after nebulization of 2 mL suspensions of TD and RD via the PARI SINUS2 nebulizer system. Statistical analyses included descriptive statistics as well as 90% and 95% confidence intervals for the difference in means and the ratio of means of the examined parameters. Results: The TD was well-suited to the nebulization procedure. Both formulations (TD and RD) exhibited significant variability in the aerosol droplet distribution at different levels of the NGI cascade impactor. In the case of TD, larger droplets were more easily generated, which promoted deposition of the drug at the upper levels of the impactor. The equivalence of the two forms of budesonide, RD and TD, in the treatment of chronic rhinosinusitis with nasal polyps using a pulsating nebulizer was demonstrated. These indications were acknowledged by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB) and added to the Product Information of TD. Conclusions: Both budesonide formulations were effective. Budesonide administered via vibrational nebulization is effective in the treatment of chronic rhinosinusitis with nasal polyps.

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来源期刊
Polish Journal of Otolaryngology
Polish Journal of Otolaryngology OTORHINOLARYNGOLOGY-
CiteScore
1.30
自引率
16.70%
发文量
15
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