Observation on the Efficacy of Sublingual Immunotherapy With Dust Mite Allergen for Perennial Allergic Rhinitis and the Mechanism of Action on ILCs With ILC1s and ILC2s and ILC3s

People's Hospital of Anshun City of Guizhou Province1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2022年12月1日最近更新: 2022年10月6日

适应症

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1
主要终点: Change in the Serum levels of IgE

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Allergic rhinitis is a common and recurrent ear, nose and throat (ENT) disease. It is a chronic or seasonal condition affecting 10% to 20% of the world's population. It is considered one of the most difficult diseases to treat globally and has become a major global health problem.

SUblingual immunotherapy (SIT) is currently considered to be an effective pairings therapy that can alter the natural progression of allergic rhinitis through immunomodulatory mechanisms. Immunotherapy is more suitable for patients with moderate to severe intermittent or persistent allergic rhinitis, especially for those with poor drug treatment. This treatment can significantly reduce the severity of allergic rhinitis, reduce the use of allergy medications, and improve the quality of life for many patients.

In the development of allergic rhinitis, the regulation of immune balance in Th1 / Th2 / Th17 cells is currently considered to be an important approach in the treatment of allergic rhinitis. But a growing body of evidence suggests that an intrinsic immune response is also the pathogenesis of allergic rhinitis. Innate lymphocytes are involved in mucosal immune formation, lymphocyte development, tissue damage repair and epithelial barrier protection, and play an important role in fighting infection, regulating inflammation and maintaining immune homeostasis. Three subsets of intrinsic lymphocytes (ILC1s, ILC2s, ILC3s) have been proposed to functionally approximate Th1, Th2, and Th17 in helper T lymphocytes (Th), but the results are inconclusive and the mechanism of ILCs role in AR progression is not fully elucidated.

Therefore, the purpose of this study was to investigate the efficacy and mechanism of subglossal immunotherapy for perennial allergic rhinitis, and to reveal the correlation between ILCs (ILC1s, ILC2s, ILC3s) and Th1 / Th2 / Th17 cell immunity, and to provide a basis for clinical studies of allergic rhinitis.

详细描述

Allergic rhinitis (AR) has become a major chronic respiratory inflammatory disease and is considered to be one of the global refractory diseases. and it has become an important global health problem.

The treatment of AR mainly includes environmental control, drug therapy, immunotherapy, etc. Studies have shown that the positive rate of dust mite allergen skin prick test in AR patients can reach 70%. Dust mites are considered to be the main allergens causing allergic diseases such as allergic rhinitis and asthma, which are ubiquitous in clinical living environments. Since it is difficult for patients to completely avoid exposure to dust mites in real life, it has attracted more and more attention of scholars to change the allergic constitution of patients by Specific immunotherapy SIT.

Specific immunotherapy is currently considered to be a more certain therapeutic approach in addition to allergen avoidance, which is the etiological treatment for IgE-mediated type I allergic disease. To gradually increase the dose of allergen extracts, gradually induced the body's immune tolerance, achieve when again contact allergens in patients with symptoms significantly reduce, or even not occur, the effect of this effect at the end of the treatment with sustainable for several years, is considered the only can be adjusted by the immune mechanism to change the allergic disease effective method for treatment of natural processes, Its safety and efficacy have been proved in clinical treatment by modifying immune function to change disease progression. Currently, SIT mainly consists of Subcutaneous immunotherapy (SCIT) and Sublingual immunotherapy (SLIT), which is divided into dose accumulation and dose maintenance phases. Standardized allergenic vaccines should be used for immunotherapy. This therapy can significantly reduce the severity of AR, reduce the use of anti-allergic drugs, and improve the quality of life of many patients. Especially for children, immunotherapy can not only reduce allergic symptoms, but also prevent the development of allergic rhinitis to asthma and other severe sensitization reactions. According to the AR recognition guidelines, immunotherapy is more suitable for patients with moderate-severe intermittent or persistent AR, especially for those with poor drug treatment effect.

Compared with SCIT, SLIT is relatively simple to operate, non-invasive, well tolerated and safe. The risk of systemic adverse reactions is low. In addition, allergen vaccines can be administered at home by patients or guardians under the guidance of doctors, which reduces the frequency of hospital visits, thus being highly recommended by clinical practice.

The allergen vaccine of SLIT is mainly dust mite drops in China. The application of Sublingual immunotherapy of dust mite allergen in the clinical treatment of AR began in 1986. The way of administration of Sublingual immunotherapy is different from subcutaneous immunotherapy: allergen vaccine is placed under the tongue, swallowed after several minutes of absorption, and the vaccine is ingested into the body through the oral mucosa. In 1993, the European Society of Clinical Immunology and Allergy proposed that sublingual immunotherapy was safer and more effective than subcutaneous immunotherapy. In 1998, SLIT was proposed by WHO to be used for adult allergic rhinitis. In 2001, the ARIA group of the World Health Organization pointed out that SLIT can effectively treat AR and patients can reduce the use of drugs, which has led to SLIT receiving increasing attention worldwide. In 2013, the World Allergy Organization (WAO) not only affirmed the clinical efficacy and safety of SLIT in its position paper, but also recommended SLIT as an initial and early clinical treatment for allergic diseases. Its application does not need to be based on the premise of drug treatment failure. Allergen-specific immunotherapy was proposed as the first-line therapy for AR in the 2015 new edition of Chinese guidelines, which is recommended for clinical use.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Because this test method is not consistent, so this topic will be using single blind method (blind) for the patients, but we will strictly implement spirit blinded phase separation principle, made random don't participate in the experiment, a researcher at the table, will conform to the criteria for the diagnosis of allergic rhinitis patients, according to the medical order, to give corresponding treatment, in the process of experiment, Research implementers do not participate in the statistics of experimental data; The efficacy evaluation index will be evaluated by a third party, blinded to the statistical analysis of the data, and the blind bottom was known only to the study designer and kept by a special person.

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Those who meet the above diagnostic criteria;
•The course of disease is at least one year;
•Over 18 years old to under 65 years old, both sexes;
•Did not receive specific immunotherapy in the past 1 month or did not use any drugs for AR in the past 1 week;
•Those with normal cognitive function agree to participate in this study and sign the informed consent form.

排除标准

•Those who do not meet the above diagnostic and inclusion criteria;
•Patients with severe nasal septum deviation, chronic rhinosinusitis, bronchial asthma, nasal polyps, upper respiratory tract infection, lung infection and other diseases;
•Patients with severe dysfunction of heart, liver, kidney or autoimmune diseases;
•pregnant or lactating women;
•Allergic constitution and allergic to the experimental drugs and ingredients;
•Patients with drug addiction history;
•Patients with major neuropsychiatric diseases who cannot take medication regularly;
•Patients who are participating in other clinical trials. Patients who met any of the above criteria were excluded.