PDF(Pubmed)
Abstract：
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 Dermatophagoides pteronyssinus (Derp) and Dermatophagoides farina (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.
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 Dermatophagoides pteronyssinus (Derp) and Dermatophagoides farina (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.
摘要：
■小儿过敏性鼻结膜炎已成为公众关注的问题，发病率逐年增加。常规皮下免疫治疗(SCIT)治疗时间长,成本高，合规性差。这种新型免疫疗法通过将过敏原直接注入颈部淋巴结，显著缩短了治疗过程。这可以为儿童带来更快的临床益处。
■通过与SCIT的比较，本研究旨在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。将50例尘螨过敏的过敏性鼻结膜炎患儿随机分为ICLIT组和SCIT组,接受三次宫颈淋巴管内注射尘螨过敏原或三年皮下注射，分开。主要结果包括总鼻部症状评分（TNSS），总眼部症状评分（TOSS），总症状评分（TSS），药物总评分（TMS），和总生活质量评分。次要结果包括治疗期间的疼痛感知和不良反应。其他次要结果是翼状螨（Derp）和粉尘螨（Derf）特异性IgE水平的变化。
■两组患者的TNSS均显著降低,TOSS,TSS,TMS,治疗36个月后的总生活质量评分（p<0.0001）。与SCIT相比，ICLIT可迅速改善过敏症状(p<0.0001)。两组近期疗效一致(p=0.07),SCIT组远期疗效较好(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,ICLIT和SCIT组的血清Derp和Derf特异性IgE水平在3年后下降(p<0.0001)。
■ICLIT可以显著改善儿科患者的过敏症状，在有效性和安全性方面具有优势，除了提高生活质量，包括缩短治疗时间，药物使用频率和疼痛感知。
■https://www.chictr.org.cn/,标识符ChiCTR1800017130。
■通过与SCIT的比较，本研究旨在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。将50例尘螨过敏的过敏性鼻结膜炎患儿随机分为ICLIT组和SCIT组,接受三次宫颈淋巴管内注射尘螨过敏原或三年皮下注射，分开。主要结果包括总鼻部症状评分（TNSS），总眼部症状评分（TOSS），总症状评分（TSS），药物总评分（TMS），和总生活质量评分。次要结果包括治疗期间的疼痛感知和不良反应。其他次要结果是翼状螨（Derp）和粉尘螨（Derf）特异性IgE水平的变化。
■两组患者的TNSS均显著降低,TOSS,TSS,TMS,治疗36个月后的总生活质量评分（p<0.0001）。与SCIT相比，ICLIT可迅速改善过敏症状(p<0.0001)。两组近期疗效一致(p=0.07),SCIT组远期疗效较好(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,ICLIT和SCIT组的血清Derp和Derf特异性IgE水平在3年后下降(p<0.0001)。
■ICLIT可以显著改善儿科患者的过敏症状，在有效性和安全性方面具有优势，除了提高生活质量，包括缩短治疗时间，药物使用频率和疼痛感知。
■https://www.chictr.org.cn/,标识符ChiCTR1800017130。
