[A preliminary study on the short-term effectiveness and safety of sublingual immunotherapy-spray for patients with respiratory allergy]

Zhonghua Yu Fang Yi Xue Za Zhi. 2024 Dec 6;58(12):1921-1925. doi: 10.3760/cma.j.cn112150-20240921-00761.
[Article in Chinese]

Abstract

To investigate the short-term effectiveness and safety of sublingual allergen immunotherapy with allergen sprays (SLIT-sprays) in Chinese patients with allergic rhinitis (AR) with or without asthma using real-world data. The retrospective cohort study included 100 patients who received SLIT-sprays in the ENT departments in Hainan Shulan (Boao) Hospital and Boao Super Hospital between October 2023 and August 2024. A questionnaire survey was conducted to collect clinical data on the effectiveness and safety of SLIT-sprays, examining the types and incidence of adverse events (AEs) during treatment, treatments after the occurrence of AEs, and changes in Visual Analog Scale (VAS) scores before and after SLIT-sprays. Self-reports from 100 patients were collected. The results showed that the average treatment duration for the 100 patients was (90.7±58.9) days, median 78.5 days. Using changes in VAS scores as the effectiveness assessment, the average VAS score increased by 4.2 (95%CI: 4.06-4.34). The incidence of AEs during the SLIT-sprays was 17.0% (17/100), all of which were mild to moderate local reactions, with no serious AEs reported. There were no significant differences in AE incidence among patients with different diseases (AR or AR with asthma and asthma alone) (χ2=1.831,P>0.05), different age group (χ2=1.477,P>0.05), different types of allergen extracts (χ2=1.613,P>0.05), or the number of allergen extracts used (patients using one or two allergen extracts) (Fisher's exact test,P>0.05). In conclusion, Chinese patients showed good safety and tolerability to SLIT-sprays, with all AEs being mild to moderate local reactions and no serious or systemic AEs occurring. Patients reported positive subjective evaluations of the early treatment effects.

探讨应用真实世界数据研究呼吸道过敏性疾病患者采用过敏原舌下喷雾剂免疫治疗的短期有效性和安全性。本回顾性队列研究纳入2023年10月至2024年8月期间在海南树兰(博鳌)医院和博鳌超级医院接受过敏原舌下喷雾剂免疫治疗的100例患者,采用问卷调查患者使用过敏原舌下喷雾剂免疫治疗临床有效性和安全性数据,观察治疗期间不良事件类型、发生率、出现不良反应后的处理以及治疗前后视觉模拟量表(VAS)评分的变化。结果显示100例患者平均治疗时间为(90.7±58.9)d、中位数时间78.5 d,以VAS评分的改变作为有效性的评估依据,100例患者VAS评分平均增加4.2(95%CI:4.06~4.34)。舌下喷雾剂免疫治疗不良事件按病例计算发生率为17.0%(17/100),均为轻中度局部反应,没有严重不良反应发生。不同疾病(过敏性鼻炎、鼻炎合并哮喘及单纯哮喘患者)(χ2=1.831,P>0.05)、不同年龄(儿童、青少年或成人)(χ2=1.477,P>0.05)、不同过敏原制剂种类(χ2=1.613,P>0.05)、过敏原制剂数量(患者采用1种或2种过敏原制剂)(Fisher精确检验,P>0.05),不良事件的发生率上均无显著差异。综上,初步研究显示呼吸道过敏性疾病患者对过敏原舌下喷雾剂的安全性和耐受性良好,患者对早期治疗效果的主观评价正面。.

Publication types

  • English Abstract

MeSH terms

  • Administration, Sublingual
  • Adult
  • Allergens
  • Asthma / therapy
  • Female
  • Humans
  • Male
  • Middle Aged
  • Respiratory Hypersensitivity / therapy
  • Retrospective Studies
  • Rhinitis, Allergic / therapy
  • Sublingual Immunotherapy* / methods
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Allergens