Department of Otolaryngology Head and Neck Surgery, Yongchuan Hospital of Chongqing Medical University, Chongqing, China.
Department of Otolaryngology Head and Neck Surgery, Yongchuan Hospital of Chongqing Medical University, Chongqing, China.
Am J Otolaryngol. 2024 Sep-Oct;45(5):104418. doi: 10.1016/j.amjoto.2024.104418. Epub 2024 Jul 21.
This prospective study aims to provide further supportive evidence by assessing the sustained effectiveness and safety of sublingual immunotherapy (SLIT) using a vaccine containing house dust mite (HDM) extracts in patients diagnosed with allergic rhinitis (AR) with/without conjunctivitis (AR/C).
AR/C patients (n = 111, SLIT group: 57, control group: 54) allergic to HDM were treated with standardized SLIT drops or symptomatic drugs from October to December in 2020. The patients were directed by the investigators to attend annual hospital visits for the assessment of various parameters including the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), visual analog scale (VAS), total nasal symptom score (TNSS), total ocular symptom score (TOSS) and total medication score (TMS). During the study period, all participants were mandated to maintain comprehensive records of any adverse events (AEs) on diary cards, which were then communicated to the investigators via telephone.
At baseline (2020), TNSS, TOSS, TMS, VAS, and RQLQ scores were comparable between SLIT and control groups (P > 0.05). After one year of treatment (2021), significant reduction in all scores compared to the baseline for both groups (P < 0.001). At the end of the second year of treatment (2022), TNSS and RQLQ score in the SLIT group continued to decrease significantly compared to 2021 (P < 0.05). In the third year (2023), the control group showed a rebound in TNSS, TOSS, TMS, and RQLQ scores, significant differences compared to 2022 or 2021 (P < 0.05). Besides, the SLIT group had significantly lower scores across all domains of RQLQ compared to the control group (P < 0.001). Symptomatic treatment influenced the scores of Nasal Symptoms, Eye Symptoms, Practical Problems, and Emotions domains significantly in 2023 compared to 2021 or 2022 (P < 0.05). Within the SLIT group, no significant differences in TNSS, TMS, VAS, and RQLQ scores were observed between monosensitized and polysensitized patients throughout the three years of treatment (P > 0.05). All AEs were mild to moderate.
The 3-year course of HDM-SLIT has shown significant therapeutic efficacy and a favorable safety profile in patients with AR/C. Importantly, our study presents initial evidence suggesting that the greater impact of AR/C on quality of life (QoL) may primarily stem from nasal symptoms, eye symptoms, practical issues, and emotional well-being.
本前瞻性研究旨在通过评估含有屋尘螨(HDM)提取物的舌下免疫疗法(SLIT)对过敏性鼻炎(AR)伴/不伴结膜炎(AR/C)患者的持续有效性和安全性,提供进一步的支持性证据。
2020 年 10 月至 12 月,对 111 例 HDM 过敏的 AR/C 患者(SLIT 组 57 例,对照组 54 例)进行标准化 SLIT 滴剂或对症药物治疗。研究者指导患者每年到医院就诊,评估各种参数,包括鼻结膜炎生活质量问卷(RQLQ)、视觉模拟量表(VAS)、总鼻部症状评分(TNSS)、总眼部症状评分(TOSS)和总用药评分(TMS)。在研究期间,所有参与者都被要求在日记卡上记录任何不良事件(AE),然后通过电话告知研究者。
在基线(2020 年)时,SLIT 组和对照组的 TNSS、TOSS、TMS、VAS 和 RQLQ 评分无统计学差异(P>0.05)。治疗 1 年后(2021 年),两组各项评分均较基线显著下降(P<0.001)。治疗 2 年后(2022 年),SLIT 组的 TNSS 和 RQLQ 评分与 2021 年相比继续显著下降(P<0.05)。在第 3 年(2023 年),对照组的 TNSS、TOSS、TMS 和 RQLQ 评分较 2022 年或 2021 年出现反弹,与同期相比差异有统计学意义(P<0.05)。此外,SLIT 组在 RQLQ 的所有领域的评分均显著低于对照组(P<0.001)。在 2023 年,与 2021 年或 2022 年相比,对症治疗显著影响了鼻部症状、眼部症状、实际问题和情绪领域的评分(P<0.05)。在 SLIT 组中,3 年的治疗过程中,单敏和多敏患者的 TNSS、TMS、VAS 和 RQLQ 评分无显著差异(P>0.05)。所有的 AE 均为轻度至中度。
3 年的 HDM-SLIT 治疗对 AR/C 患者显示出显著的治疗效果和良好的安全性。重要的是,我们的研究初步表明,AR/C 对生活质量(QoL)的影响更大,可能主要源于鼻部症状、眼部症状、实际问题和情绪健康。