Thamboo Andrew, Manji Jamil, Szeitz András, Santos Rachelle Dar, Hathorn Iain, Gan Eng Cern, Alsaleh Saad, Javer Amin R
Division of Otolaryngology, niversity of British Columbia, St. Paul's Sinus Centre, Vancouver, British Columbia, Canada.
Int Forum Allergy Rhinol. 2014 May;4(5):397-402. doi: 10.1002/alr.21280. Epub 2014 Jan 21.
Budesonide is a potent corticosteroid commonly prescribed for management of inflammation in chronic rhinosinusitis (CRS). The standard for prescribing budesonide is via impregnated nasal saline irrigation (INSI), although recently the mucosal atomization device (MAD) has emerged as a theoretically superior method of distributing medication into the sinuses. The MAD atomizes medication into small droplets and this is thought to enhance absorption and improve bioavailability. However, no studies have shown whether enhanced absorption and improved bioavailability of budesonide via MAD causes adrenal suppression. The objective of this study is to determine whether budesonide via MAD affects the hypothalamic-pituitary-adrenal (HPA) axis.
Twenty CRS patients were recruited from a tertiary rhinology clinic and randomized to take budesonide (1 mg) via MAD or via INSI twice a day for 60 days. The adrenocorticotropic hormone (ACTH) stimulation test and 22-item Sinonasal Outcomes Test (SNOT-22) questionnaire were administered on days 1, 30, and 60 of the study. Plasma budesonide and cortisol levels were simultaneously quantified using a high-performance liquid chromatography-tandem mass spectrometry technique.
There was no indication of adrenal suppression in either group (n = 20) based on ACTH stimulation test results nor was there significant plasma budesonide levels detected in either group. Quality of life, as indicated by SNOT-22, did not differ between groups at 60 days (p = 0.404; 95% confidence interval [CI], -37.2 to 15.9), but SNOT-22 scores for patients using MAD did show statistically significant improvement at 60 days compared to baseline (p = 0.02).
The MAD is likely a safe and effective method of delivering budesonide to the sinuses in the short term.
布地奈德是一种强效皮质类固醇，常用于治疗慢性鼻-鼻窦炎（CRS）的炎症。布地奈德的标准给药方式是通过浸渍式鼻腔盐水冲洗（INSI），不过最近黏膜雾化装置（MAD）已成为一种理论上更优的将药物输送至鼻窦的方法。MAD将药物雾化成小液滴，据信这可增强吸收并提高生物利用度。然而，尚无研究表明通过MAD增强布地奈德的吸收和生物利用度是否会导致肾上腺抑制。本研究的目的是确定通过MAD使用布地奈德是否会影响下丘脑-垂体-肾上腺（HPA）轴。
从一家三级鼻科诊所招募了20名CRS患者，随机分为两组，一组通过MAD、另一组通过INSI每天两次服用布地奈德（1毫克），持续60天。在研究的第1天、第30天和第60天进行促肾上腺皮质激素（ACTH）刺激试验和22项鼻鼻窦结局测试（SNOT-22）问卷。使用高效液相色谱-串联质谱技术同时定量血浆布地奈德和皮质醇水平。
根据ACTH刺激试验结果，两组（n = 20）均未显示肾上腺抑制迹象，两组也均未检测到显著的血浆布地奈德水平。SNOT-22表明，60天时两组的生活质量无差异（p = 0.404；95%置信区间[CI]，-37.2至15.9），但与基线相比，使用MAD的患者在60天时SNOT-22评分确实有统计学上的显著改善（p = 0.02）。
短期内，MAD可能是一种将布地奈德输送至鼻窦的安全有效的方法。
