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舌下免疫治疗喷雾剂用于呼吸道过敏患者的短期有效性和安全性的初步研究

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

作者信息

Dai X Y, Lou H D, Wang X Y, Chen S, Zhang J, Ding H B, Li J, Cheng L

机构信息

Department of Respiration, International center for Allergy Treatment, Shulan (Boao) Hospital, Boao571437, China.

Allergy Center, Boao Super Hospital, Boao571437, China.

出版信息

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

DOI:10.3760/cma.j.cn112150-20240921-00761
PMID:39710470
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% 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) (χ=1.831,>0.05), different age group (χ=1.477,>0.05), different types of allergen extracts (χ=1.613,>0.05), or the number of allergen extracts used (patients using one or two allergen extracts) (Fisher's exact test,>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.

摘要

利用真实世界数据,调查舌下变应原免疫疗法(SLIT)喷雾剂在中国过敏性鼻炎(AR)伴或不伴哮喘患者中的短期有效性和安全性。这项回顾性队列研究纳入了2023年10月至2024年8月期间在海南博鳌超级医院附属海南博鳌一龄医院耳鼻喉科接受SLIT喷雾剂治疗的100例患者。通过问卷调查收集SLIT喷雾剂有效性和安全性的临床数据,检查治疗期间不良事件(AE)的类型和发生率、AE发生后的治疗情况以及SLIT喷雾剂前后视觉模拟量表(VAS)评分的变化。收集了100例患者的自我报告。结果显示,100例患者的平均治疗时长为(90.7±58.9)天,中位数为78.5天。以VAS评分变化作为有效性评估指标,平均VAS评分增加了4.2(95%可信区间4.06 - 4.34)。SLIT喷雾剂治疗期间AE的发生率为17.0%(17/100),均为轻度至中度局部反应,未报告严重AE。不同疾病(AR或AR伴哮喘以及单纯哮喘)、不同年龄组(χ=1.477,P>0.05)、不同变应原提取物类型(χ=1.613,P>0.05)或使用的变应原提取物数量(使用一种或两种变应原提取物的患者)之间的AE发生率无显著差异(Fisher精确检验,P>0.05)。总之,中国患者对SLIT喷雾剂显示出良好的安全性和耐受性,所有AE均为轻度至中度局部反应,未发生严重或全身性AE。患者对早期治疗效果的主观评价为阳性。

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