[A randomized controlled study on the long-term efficacy of intra-cervical lymphatic immunotherapy for adult allergic rhinitis].

Objective: To determine the long-term efficacy and safety of intra-cervical lymphatic immunotherapy (ICLIT) for adult allergic rhinitis (AR) by comparing it with subcutaneous immunotherapy (SCIT). Methods: A total of 100 adult AR patients with dust mite allergy in Department of Otorhinolaryngology, First People's Hospital of Foshan from Feb 2018 to Dec 2019 were randomly divided into two groups, 50 in SCIT group [including 42 males and 8 females, aging (32.55±9.72) years] and 50 in ICLIT group [including 45 males and 5 females, aging (31.33±9.84) years]. The changes in total symptom score (total system score, TSS), nasal symptom score (total nasal symptom score, TNSS), eye symptom score (total ocular scoring system, TOSS), drug score (total medication score, TMS), and quality of life score of the two groups of patients were evaluated before and after treatment, and the adverse reactions of all patients during the treatment period were recorded. The changes in the level of dust mite specific IgE (sIgE) in the serum were evaluated. GraphPad Prism 9.0 software was used for statistical analysis. Results: In the SCIT group, 38 patients completed treatment and follow-up, with a dropout rate of 24%. In the ICLIT group, 48 patients completed treatment and follow-up, with a dropout rate of only 4%. The scores of TSS, TNSS, TOSS, TMS, and quality of life in the ICLIT group before treatment were 32.1±3.0, 27.3±3.1, 4.8±2.8, 2.3±0.9, and 68.1±28.7, respectively; After 36 months of treatment, the scores were 21.8±11.4, 18.1±9.4, 3.7±2.9, 1.3±1.1, and 36.0±26.7, respectively, which were significantly lower than those before treatment (all P<0.001). After 36 months of treatment, the TSS of the ICLIT group improved by 10.3±11.2 compared to before, while the TSS of the SCIT group improved significantly by 21.9±11.0 compared to before, with statistically significant differences between the groups (P<0.001). No serious systemic adverse reactions occurred in both groups of patients. Conclusions: ICLIT treatment for adult AR has long-term efficacy, high safety, and high compliance, but its long-term efficacy is not as good as SCIT. ICLIT can be considered as a new complementary option for AR immunotherapy.目的： 通过与皮下免疫治疗（subcutaneous immunotherapy，SCIT）对比，明确经颈部淋巴结内免疫治疗（intra-cervical lymphatic immunotherapy，ICLIT）对于成人变应性鼻炎（AR）的远期疗效及安全性。 方法： 将2018年2月至2019年12月于佛山市第一人民医院耳鼻咽喉科接受治疗的100例尘螨过敏的成人AR患者随机分为两组，其中SCIT组50例［男42例，女8例，年龄（32.55±9.72）岁］，ICLIT组50例［男45例，女5例，年龄（31.33±9.84）岁］。评估两组患者治疗前后总症状评分（total system score，TSS）、鼻部症状评分（total nasal symptom score，TNSS）、眼部症状评分（total ocular scoring system，TOSS）、药物评分（total medication score，TMS）及生活质量评分的变化，记录所有患者在治疗期间的不良反应情况，并评估血清中尘螨特异性免疫球蛋白E（sIgE）的水平变化。使用GraphPad Prism 9.0软件进行数据分析。 结果： SCIT组中38例患者完成治疗及随访，脱落率为24%，ICLIT组中48例患者完成治疗及随访，脱落率仅为4%。ICLIT组患者的TSS、TNSS、TOSS、TMS和生活质量评分治疗前分别为（32.1±3.0）、（27.3±3.1）、（4.8±2.8）、（2.3±0.9）、（68.1±28.7）分；治疗36个月后分别为（21.8±11.4）、（18.1±9.4）、（3.7±2.9）、（1.3±1.1）、（36.0±26.7）分，均较治疗前明显下降，差异有统计学意义（P值均<0.001）。治疗36个月后，ICLIT组的TSS较治疗前改善（10.3±11.2）分，SCIT组的TSS较治疗前改善（21.9±11.0）分，组间差异有统计学意义（P<0.001）。两组患者均未发生严重全身不良反应。 结论： ICLIT治疗对成人AR远期疗效尚可，安全性高，依从性高，但其远期疗效不如SCIT。ICLIT是AR免疫治疗的一种新型补充选择。.