Abstract：
OBJECTIVE: 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).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
目的：这项前瞻性研究旨在通过评估舌下免疫疗法（SLIT）在诊断为过敏性鼻炎（AR）伴/不伴结膜炎（AR/C）的患者中使用含屋尘螨（HDM）提取物的疫苗的持续有效性和安全性，提供进一步的支持性证据。
方法：对HDM过敏的AR/C患者（n=111，SLIT组：57，对照组：54）于2020年10月至12月接受标准SLIT滴剂或对症药物治疗。研究人员指示患者参加年度医院就诊，以评估各种参数，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）和总药物评分（TMS）。在学习期间,所有参与者都被要求在日记卡上保留任何不良事件(AE)的全面记录,然后通过电话传达给调查人员。
结果：在基线（2020年），TNSS,TOSS,TMS,VAS,SLIT组和对照组的RQLQ评分具有可比性(P>0.05)。经过一年的治疗（2021年），与基线相比,两组所有评分均显著降低(P<0.001).在治疗的第二年（2022年）结束时，与2021年相比，SLIT组的TNSS和RQLQ评分继续显著降低（P<0.05）。第三年（2023年），对照组显示TNSS反弹，TOSS,TMS,和RQLQ分数，与2022年或2021年相比差异显著(P<0.05)。此外,与对照组相比,SLIT组RQLQ所有领域的评分均显著较低(P<0.001).对症治疗影响鼻部症状评分，眼部症状,实际问题,和情感领域在2023年与2021年或2022年相比显著(P<0.05)。在SLIT组中，TNSS没有显著差异，TMS,VAS,在整个治疗的三年中，单敏和多敏患者的RQLQ评分均观察到（P>0.05）。所有AE均为轻度至中度。
结论：HDM-SLIT的3年疗程在AR/C患者中显示出显着的治疗效果和良好的安全性。重要的是,我们的研究提供了初步证据，表明AR/C对生活质量（QoL）的更大影响可能主要源于鼻部症状，眼部症状,实际问题,和情感幸福。
方法：对HDM过敏的AR/C患者（n=111，SLIT组：57，对照组：54）于2020年10月至12月接受标准SLIT滴剂或对症药物治疗。研究人员指示患者参加年度医院就诊，以评估各种参数，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）和总药物评分（TMS）。在学习期间,所有参与者都被要求在日记卡上保留任何不良事件(AE)的全面记录,然后通过电话传达给调查人员。
结果：在基线（2020年），TNSS,TOSS,TMS,VAS,SLIT组和对照组的RQLQ评分具有可比性(P>0.05)。经过一年的治疗（2021年），与基线相比,两组所有评分均显著降低(P<0.001).在治疗的第二年（2022年）结束时，与2021年相比，SLIT组的TNSS和RQLQ评分继续显著降低（P<0.05）。第三年（2023年），对照组显示TNSS反弹，TOSS,TMS,和RQLQ分数，与2022年或2021年相比差异显著(P<0.05)。此外,与对照组相比,SLIT组RQLQ所有领域的评分均显著较低(P<0.001).对症治疗影响鼻部症状评分，眼部症状,实际问题,和情感领域在2023年与2021年或2022年相比显著(P<0.05)。在SLIT组中，TNSS没有显著差异，TMS,VAS,在整个治疗的三年中，单敏和多敏患者的RQLQ评分均观察到（P>0.05）。所有AE均为轻度至中度。
结论：HDM-SLIT的3年疗程在AR/C患者中显示出显着的治疗效果和良好的安全性。重要的是,我们的研究提供了初步证据，表明AR/C对生活质量（QoL）的更大影响可能主要源于鼻部症状，眼部症状,实际问题,和情感幸福。
