Roger Reig Albert, Padró Casas Clara, Gutiérrez Fernández Diego, Orta Cuevas José Carlos, Sánchez López Germán, Corzo Higueras José Luis
Allergy Unit, Hospital Universitari Germans Trias i Pujol, Carretera de Canyet, s/n, 08916, Badalona, Spain.
Servicio Neumologia-Alergia, Hospital Puerta del Mar, Cádiz, Spain.
Drugs Real World Outcomes. 2021 Jun;8(2):241-251. doi: 10.1007/s40801-021-00233-y. Epub 2021 Feb 16.
Convenient dosing is a key component of treatment adherence and thus efficacy and safety. Aqueous sublingual immunotherapy (SLIT) formulations can be administered with a dosing pump that delivers 200 µL of volume per actuation.
The objective of this study was to describe the use of Staloral 300 Rapid in its new dosing pump presentation and to evaluate the safety and satisfaction from both the patient and doctor.
We performed a retrospective non-interventional study in a population (aged 5 years or over) of individuals with allergic rhinitis or allergic asthma who were being treated with aqueous 300 index of reactivity SLIT formulations of various allergens (grass pollen, tree pollen, house dust mites). Based on a detailed, SLIT-specific, patient self-questionnaire (Quartis) and the inspection of medical records, we assessed the characteristics of the SLIT, safety, patient satisfaction and willingness to continue SLIT. The physician's satisfaction with the treatment was measured on a 0-100 visual analogue scale. Adverse events were coded with the Medical Dictionary for Regulatory Activities.
A total of 801 valid patients were included (52.4% male; mean ± standard deviation age: 25.9 ± 17.2 years; mean time since diagnosis: 4.56 ± 4.68 years; mean time using the previous dosing pump: 19.2 ± 13.0 months; time using the 200-µL dosing pump: 14.95 ± 3.80 months). Among the study population, 317 subjects comprised the paediatric subgroup (57%: male; mean age: 9.8 ± 2.5 years). Overall, 54 patients (6.7%) reported a total of 68 adverse events (including 51 gastrointestinal adverse events). The large majority of adverse events were mild, local and transient and did not require treatment. There were no severe adverse events. The level of patient satisfaction with the ease of SLIT administration was high (84.3% overall, and 82.6% in the paediatric subgroup). The mean ± standard deviation visual analogue scale score for physician satisfaction with the treatment was 70.6 ± 25.1 out of 100.
Administration of 300 index of reactivity SLIT with a 200-µL dosing pump is safe, well tolerated and associated with good levels of patient satisfaction.
方便给药是治疗依从性的关键组成部分，进而关乎疗效和安全性。舌下免疫疗法（SLIT）水性制剂可通过给药泵给药，每次按压可输送200微升药液。
本研究旨在描述新型给药泵包装的Staloral 300 Rapid的使用情况，并评估患者和医生的安全性及满意度。
我们对一组年龄在5岁及以上、患有过敏性鼻炎或过敏性哮喘且正在接受多种过敏原（草花粉、树花粉、屋尘螨）300反应指数的SLIT水性制剂治疗的人群进行了一项回顾性非干预性研究。基于一份详细的、针对SLIT的患者自我问卷（Quartis）以及病历检查，我们评估了SLIT的特点、安全性、患者满意度以及继续接受SLIT治疗的意愿。医生对治疗的满意度采用0至100的视觉模拟量表进行测量。不良事件使用《药物监管活动医学词典》进行编码。
共纳入801例有效患者（男性占52.4%；平均年龄±标准差：25.9±17.2岁；自诊断以来的平均时间：4.56±4.68年；使用前一种给药泵的平均时间：19.2±13.0个月；使用200微升给药泵的时间：14.95±3.80个月）。在研究人群中，317名受试者组成儿童亚组（男性占57%；平均年龄：9.8±2.5岁）。总体而言，54例患者（6.7%）共报告了68起不良事件（包括51起胃肠道不良事件）。绝大多数不良事件为轻度、局部性且短暂性，无需治疗。未发生严重不良事件。患者对SLIT给药便利性的满意度较高（总体为84.3%，儿童亚组为82.6%）。医生对治疗满意度的视觉模拟量表平均得分±标准差为70.6±25.1（满分100分）。
使用200微升给药泵给予300反应指数的SLIT是安全的，耐受性良好，且患者满意度较高。
