Reiber Rainer, Keller Martina, Keller Winfried, Wolf Hendrik, Schnitker Jörg, Wüstenberg Eike
HNO-Praxis, 73614 Schorndorf, Germany.
HNO-Gemeinschaftspraxis, 78166 Donaueschingen, Germany.
Clin Transl Allergy. 2016 Mar 8;6:9. doi: 10.1186/s13601-016-0097-8. eCollection 2015.
The majority of allergic patients are poly-sensitized. For causal treatment by allergy immunotherapy (AIT) a single or few allergen products containing the clinically most relevant allergens are applied, but few data on tolerability of multiple application of AIT is available. The aim of our study was to investigate safety and tolerability in patients who started treatment by sublingual immunotherapy (SLIT) with the standardised SQ(®) grass SLIT-tablet and were treated with concomitant AIT products.
In a non-interventional, open-label, observational study in Germany treatment of patients with the SQ(®) grass SLIT-tablet and concomitant AIT (SCIT or SLIT) was documented between January 2012 and January 2014. Patients were followed at visits at first administration of the SQ(®) grass SLIT-tablet and after 1-3 months of treatment. Tolerability of the treatment with the SQ(®) grass SLIT-tablet and concomitant AIT were assessed by the physician and administration of AIT and adverse events (AEs) were recorded by the patients in diaries. AEs and adverse drug reactions (ADRs) were coded by using the Medical Dictionary for Regulatory Activities.
In total, 181 patients were documented by 48 allergists and 160 patients treated with a concomitant AIT (SCIT 130, SLIT 30). AEs were reported in 58 (36.3 %) patients with concomitant AIT, and AEs considered related with the SQ(®) grass SLIT-tablet in 49 (30.6 %) and with concomitant AIT in 18 (11.3 %) patients. Treatment was discontinued due to ADRs in 12 (7.5 %) patients and severity of ADRs was assessed mild or moderate in 29 (18.1 %), and severe in 20 (12.5 %) patients. Most common reactions were localised at the application site of the SQ(®) grass SLIT-tablet as oral pruritus, throat irritation, oedema mouth and paraesthesia oral; no serious ADRs were reported. Overall tolerability of the SQ(®) grass SLIT-tablet if given with concomitant AIT was assessed as "good" or "very good" by 91.0 % of patients and 91.6 % of physicians.
In comparison to data from previous studies no increase in frequency of AEs or change in the tolerability profile was observed when SLIT with the SQ(®) grass SLIT-tablet was administered with concomitant SCIT or SLIT.
大多数过敏患者为多敏状态。为通过变应原免疫疗法（AIT）进行病因治疗，会应用一种或几种含有临床上最相关变应原的变应原产品，但关于多次应用AIT耐受性的数据较少。我们研究的目的是调查开始接受标准化SQ（®）草花粉舌下免疫治疗（SLIT）片剂治疗并同时使用AIT产品的患者的安全性和耐受性。
在德国进行的一项非干预性、开放标签、观察性研究中，记录了2012年1月至2014年1月期间使用SQ（®）草花粉SLIT片剂及同时进行AIT（皮下免疫治疗或SLIT）的患者的治疗情况。在首次给予SQ（®）草花粉SLIT片剂时及治疗1 - 3个月后对患者进行随访。医生评估SQ（®）草花粉SLIT片剂及同时进行AIT治疗的耐受性，患者在日记中记录AIT的用药情况及不良事件（AE）。使用《药物监管活动医学词典》对AE和药物不良反应（ADR）进行编码。
共有48位过敏症专科医生记录了181例患者，其中160例患者同时接受了AIT（皮下免疫治疗130例，SLIT 30例）。58例（36.3%）同时接受AIT的患者报告了AE，49例（30.6%）患者的AE被认为与SQ（®）草花粉SLIT片剂有关，18例（11.3%）患者的AE与同时进行的AIT有关。12例（7.5%）患者因ADR停药，29例（18.1%）患者的ADR严重程度被评估为轻度或中度，20例（12.5%）患者为重度。最常见的反应发生在SQ（®）草花粉SLIT片剂的用药部位，如口腔瘙痒、咽喉刺激、口腔水肿和口腔感觉异常；未报告严重ADR。91.0%的患者和91.6%的医生将SQ（®）草花粉SLIT片剂与同时进行的AIT联合使用时的总体耐受性评估为“良好”或“非常良好”。
与先前研究的数据相比，当使用SQ（®）草花粉SLIT片剂进行SLIT并同时进行皮下免疫治疗或SLIT时，未观察到AE频率增加或耐受性特征改变。
