Zhuhai Campus of Zunyi Medical University, Zhuhai, China.
Department of Otolaryngology, First People's Hospital of Foshan, Foshan, China.
Front Immunol. 2023 Aug 1;14:1144813. doi: 10.3389/fimmu.2023.1144813. eCollection 2023.
Pediatric allergic rhinoconjunctivitis has become a public concern with an increasing incidence year by year. Conventional subcutaneous immunotherapy (SCIT) has long treatment time, high cost and poor compliance. The novel immunotherapy significantly shortens the course of treatment by directly injecting allergens into cervical lymph nodes, which can perform faster clinical benefits to children.
By comparing with SCIT, this study aimed to evaluate the long-term efficacy and safety of intra-cervical lymphatic immunotherapy (ICLIT).
This is a prospective randomized controlled study. A total of 50 allergic rhinoconjunctivitis children with dust mite allergy was randomly divided into ICLIT group and SCIT group, receiving three cervical intralymphatic injections of dust mite allergen or three years of subcutaneous injection, separately. Primary outcomes included total nasal symptom scores (TNSS), total ocular symptom scores (TOSS), total symptom scores (TSS), total medication scores (TMS), and total quality of life score. Secondary outcomes included pain perception and adverse reactions during treatment. Other secondary outcome was change in (Derp) and (Derf) -specific IgE level.
Both groups had significantly decreased TNSS, TOSS, TSS, TMS, and total quality of life score after 36 months of treatment (p<0.0001). Compared with SCIT, ICLIT could rapidly improve allergic symptoms (p<0.0001). The short-term efficacy was consistent between the two groups (p=0.07), while the long-term efficacy was better in SCIT group (p<0.0001). The pain perception in ICLIT group was lower than that in SCIT group (p<0.0001). ICLIT group was safer. Specifically, the children had only 3 mild local adverse reactions without systemic adverse reactions. The SCIT group had 14 systemic adverse reactions. At last, the serum Derp and Derf-specific IgE levels in ICLIT and SCIT groups decreased 3 years later (p<0.0001).
ICLIT could ameliorate significantly the allergic symptoms in pediatric patients with an advantage in effectiveness and safety, besides an improved life quality including shortened period of treatment, frequency of drug use and pain perception.
https://www.chictr.org.cn/, identifier ChiCTR1800017130.
小儿变应性鼻结膜炎发病率逐年上升，已成为公众关注的问题。传统的皮下免疫治疗（SCIT）治疗时间长、费用高、依从性差。新型免疫治疗通过直接将过敏原注入颈淋巴结，显著缩短了治疗过程，为儿童更快地带来临床获益。
通过与 SCIT 比较，评估颈内淋巴免疫治疗（ICLIT）的长期疗效和安全性。
这是一项前瞻性随机对照研究。共纳入 50 例尘螨过敏的变应性鼻结膜炎患儿，随机分为 ICLIT 组和 SCIT 组，分别接受 3 次颈内淋巴注射尘螨过敏原或 3 年的皮下注射。主要结局指标包括总鼻症状评分（TNSS）、总眼症状评分（TOSS）、总症状评分（TSS）、总用药评分（TMS）和总生活质量评分。次要结局指标包括治疗期间的疼痛感知和不良反应。其他次要结局指标是 Derp 和 Derf 特异性 IgE 水平的变化。
两组治疗 36 个月后 TNSS、TOSS、TSS、TMS 和总生活质量评分均显著降低（p<0.0001）。与 SCIT 相比，ICLIT 能迅速改善过敏症状（p<0.0001）。两组短期疗效相当（p=0.07），但 SCIT 组长期疗效更好（p<0.0001）。ICLIT 组疼痛感知低于 SCIT 组（p<0.0001）。ICLIT 组更安全。具体来说，患儿仅有 3 例轻度局部不良反应，无全身不良反应。SCIT 组有 14 例全身不良反应。最后，3 年后 ICLIT 和 SCIT 组的血清 Derp 和 Derf 特异性 IgE 水平均降低（p<0.0001）。
ICLIT 可显著改善小儿患者的过敏症状，具有疗效和安全性优势，且治疗周期、用药频率和疼痛感知均得到改善，生活质量提高。
https://www.chictr.org.cn/，编号 ChiCTR1800017130。
