Larenas-Linnemann Désirée
Pediatric Allergy and Asthma Clinic, Department of Investigation, Hospital Médica Sur, México City, México.
Ther Clin Risk Manag. 2016 May 27;12:831-50. doi: 10.2147/TCRM.S70363. eCollection 2016.
Due to differences between allergen immunotherapy (AIT) trials in patient populations, trial design (including primary efficacy variables), the definition of a pollen season, data analysis, and comparisons between AIT products with existing data, is not possible nor valid. The efficacy of two grass pollen AIT tablets, Oralair(®) and Grazax(®)/Grastek(®), should not be compared by looking at the percentage of score improvement in their respective trials. However, the evidence available concerning the efficacy and safety in trials can be compared by paying close attention to the scientific quality of the trials, details in the administration schedules, and safety issues. It can be concluded due to the high level of evidence available, that Oralair(®) is effective in a pre (2-months)-coseasonal schedule to reduce symptoms and medication use, and improve a patients' quality of life during the treatment season. For the long-term, where the quality of efficacy evidence is moderate at 2-year posttreatment due to a high dropout rate, the pre (4-months)-coseasonal schedule should be used. No clinical efficacy data exists for starting treatment in-season, but the clinical onset of action of Oralair(®) is detectable after only 1 month of treatment. In the pivotal trials in Europe and the USA, no tablet-related epinephrine was needed, though some rare severe local reactions have been reported. Research for Grazax(®)/Grastek(®) showed that the long-term efficacy needs a continuous 3-year administration (moderate-low quality evidence available), and in two patients, tablet-related epinephrine was given. Further details on the comparative efficacy of both tablets would only be possible if both were evaluated in the same, adequately powered trial.
由于变应原免疫疗法（AIT）在患者群体、试验设计（包括主要疗效变量）、花粉季节的定义、数据分析以及将AIT产品与现有数据进行比较等方面存在差异，因此无法进行比较，也没有实际意义。两种草花粉AIT片剂Oralair(®)和Grazax(®)/Grastek(®)的疗效不应通过各自试验中评分改善的百分比来比较。然而，通过密切关注试验的科学质量、给药方案细节和安全性问题，可以对试验中的疗效和安全性现有证据进行比较。由于现有证据水平较高，可以得出结论，Oralair(®)在（提前2个月）花粉季节前的给药方案中有效，可减轻症状、减少药物使用，并改善治疗季节患者的生活质量。从长期来看，由于高失访率，治疗后2年疗效证据质量中等，应采用（提前4个月）花粉季节前的给药方案。目前没有关于在花粉季节开始治疗的临床疗效数据，但Oralair(®)仅在治疗1个月后即可检测到临床起效。在欧洲和美国的关键试验中，虽然报告了一些罕见的严重局部反应，但未出现与片剂相关的肾上腺素使用情况。对Grazax(®)/Grastek(®)的研究表明，长期疗效需要连续给药3年（现有中等低质量证据），并且有两名患者使用了与片剂相关的肾上腺素。只有在同一充分有力的试验中对两种片剂进行评估，才有可能获得关于它们比较疗效的更多详细信息。
