Creticos Peter Socrates, Pfaar Oliver
Division of Allergy & Clinical Immunology, Johns Hopkins University School of Medicine, Baltimore, MD 21224, USA.
Creticos Research Group, Crownsville, MD 21032, USA.
Immunotherapy. 2018 Jun;10(7):605-616. doi: 10.2217/imt-2017-0186. Epub 2018 Apr 10.
Sublingual tablet immunotherapy provides an attractive alternative approach to allergen immunotherapy, as the allergen is administered as a rapidly dissolving sublingual tablet. Part I of this two-part series on the ragweed sublingual tablet describes the dose-ranging clinical work, the safety studies and the clinical outcomes from the pivotal trials which provide clear evidence for statistically significant and clinically meaningful benefit in the treatment of patients suffering from ragweed-induced seasonal allergic rhinitis-conjunctivitis with or without milder asthma. The robust results observed in the clinical trials performed with the ragweed sublingual tablet are defined by the quality of their study design, their use of a standardized allergen extract, their consistent reproducibility in demonstrating therapeutic efficacy and their properly quantified and graded safety data.
舌下片剂免疫疗法为变应原免疫疗法提供了一种有吸引力的替代方法，因为变应原是以快速溶解的舌下片剂形式给药的。关于豚草舌下片剂的这个两部分系列文章的第一部分描述了剂量范围的临床研究、安全性研究以及关键试验的临床结果，这些试验为治疗患有豚草诱导的季节性变应性鼻炎 - 结膜炎（伴或不伴有轻度哮喘）的患者提供了具有统计学显著性和临床意义的益处的明确证据。在用豚草舌下片剂进行的临床试验中观察到的强有力结果取决于其研究设计的质量、使用标准化变应原提取物、在证明治疗效果方面的一致可重复性以及适当量化和分级的安全性数据。
