Bielory Leonard, Blaiss Michael, Fineman Stanley M, Ledford Dennis K, Lieberman Phil, Simons F Estelle R, Skoner David P, Storms William W
Department of Medicine, UMDNJ-New Jersey Medical School, Newark, USA.
Ann Allergy Asthma Immunol. 2006 Apr;96(4):514-25. doi: 10.1016/S1081-1206(10)63545-4.
The Joint Task Force for the American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology was charged with formulating a position paper regarding the potential release of intranasal corticosteroids for over-the-counter use. We took the position that safety issues regarding this proposal would be our sole concern. We reviewed the literature to evaluate the frequency and severity of potential adverse events related to the administration of intranasal corticosteroids. We limited this review to 5 areas: (1) effects on growth, (2) ocular effects, (3) effects on bone, (4) effects on the hypothalamic-pituitary-adrenal axis, and (5) local adverse effects. After review of the available data, we concluded that intranasal corticosteroids should remain prescription-only drugs. Patients receiving an intranasal corticosteroid should be instructed in its use and that use should be monitored by a physician or an appropriately trained medical provider (eg, nurse practitioner or physician assistant) under the direct supervision of a physician. This conclusion was reached based on the evidence that corticosteroids administered by any route, including the intranasal route, have the potential to cause adverse effects in all the areas noted herein. Our conclusion was strengthened by the fact that these adverse effects can be insidious and therefore not evident for many years; there is the potential for overuse; patients could also have access to other forms of topically administered corticosteroids, thus increasing their total dose; and individuals vary in their susceptibility to corticosteroid-induced adverse effects. We were also influenced to take this position knowing that generally reassuring data regarding the use of respiratory tract-administered corticosteroids are based on mean data and that all such studies have shown outliers in whom adverse effects were evident. Thus, as stated, we recommend that intranasal corticosteroids remain prescription-only drugs.
美国过敏、哮喘与免疫学会和美国过敏、哮喘与免疫学院联合特别工作组负责起草一份关于鼻用皮质类固醇可能转为非处方药的立场文件。我们认为该提议的安全性问题将是我们唯一关注的问题。我们查阅了文献，以评估与鼻用皮质类固醇给药相关的潜在不良事件的发生频率和严重程度。我们将此次文献查阅限制在五个方面：（1）对生长的影响，（2）眼部影响，（3）对骨骼的影响，（4）对下丘脑-垂体-肾上腺轴的影响，以及（5）局部不良反应。在审查现有数据后，我们得出结论，鼻用皮质类固醇应继续作为处方药使用。接受鼻用皮质类固醇治疗的患者应接受用药指导，且用药应由医生或经过适当培训的医疗服务提供者（如执业护士或医师助理）在医生的直接监督下进行监测。得出这一结论的依据是，包括鼻内途径在内的任何途径给药的皮质类固醇都有可能在本文所述的所有方面引起不良反应。这些不良反应可能隐匿，多年都不明显；存在过度使用的可能性；患者还可能接触到其他形式的局部用皮质类固醇，从而增加其总剂量；而且个体对皮质类固醇引起的不良反应的易感性各不相同，这些事实进一步强化了我们的结论。我们之所以采取这一立场，还因为了解到关于呼吸道给药皮质类固醇使用的一般令人放心的数据是基于均值数据，而且所有此类研究都显示存在明显不良反应的异常值。因此，如前所述，我们建议鼻用皮质类固醇继续作为处方药使用。
