Immunological response to Chinese herbal medicine in food allergy

食物过敏中草药的免疫反应

• 批准号: 7885428
• 负责人: Julie Wang
• 金额: $ 12.89万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-10 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7885428
• 关键词: Accident and Emergency department; Accounting; Address; Adult; Adverse effects; Affect; Aftercare; Allergic; Allergic Disease; Allergic Reaction; Allergy to peanuts; Anaphylaxis; Animal Model; Anti-Allergic Agents; Anti-Inflammatory Agents; Anti-inflammatory; Basophils; Binding; Cell surface; Cells; Child; China; Chinese Herbs; Chinese Traditional Medicine; Chronic; Clinical; Complex; Controlled Clinical Trials; Country; Data; Disease; Disease remission; Double-Blind Method; Epitopes; Expenditure; Fishes; Flow Cytometry; Food; Food Allergy Herbal Formula-1; Food Hypersensitivity; Goals; Health; Healthcare; Herb; Herbal Medicine; Hospitals; Human; Hypersensitivity; IgE; Immunoassay; Immunoglobulin G; Immunologics; In Vitro; Individual; Investigation; Life; Measures; Milk Hypersensitivity; Modeling; Mononuclear; Mus; Nut Hypersensitivity; Nuts; Oral; Outcome; Patients; Peanuts - dietary; Peptides; Peripheral; Phase I Clinical Trials; Phytotherapy; Placebo Control; Prevalence; Principal Investigator; Process; Production; Property; Protocols documentation; Quality of life; Randomized; Safety; Shellfish; Signal Transduction; Specificity; Surface; Tablets; Testing; Traditional Medicine; Trees; United States; Visit; Wheat; aqueous; base; clinical effect; clinical efficacy; dietary supplements; egg; food allergen; mast cell; pancreatic secretory trypsin inhibitor I; response; soy

DESCRIPTION (provided by applicant): Food allergy affects as many as 6% of young children and 3-4% of adults.(1,2) Peanut allergy is the leading cause of food-induced anaphylaxis treated in hospital emergency departments in the United States (3) and peanut and tree nut allergies account for approximately 80% of fatal and near-fatal anaphylactic reactions.(4-6) While the majority of children outgrow their allergy to milk, egg, wheat, and soy, allergies to peanut, tree nuts, fish and shellfish are often life-long. Currently, there are no treatments that can cure or provide long-term remission from food allergy. Traditional Chinese Medicine (TCM) has been used to treat various diseases for thousands of years. Chinese herbal medicine, particularly in the form of formulas that are composed of several herbs, is one of the major components in the practice of TCM. The Food Allergy Herbal Formula (FAHF-2) is a 9 herb formula (7-14) that has been demonstrated to be safe and effective in a murine model of peanut allergy.(15,16) Furthermore, FAHF-2 appears to be safe and well-tolerated in food-allergic patients. This protection from anaphylaxis in the murine model is associated with decreased IgE, increased lgG2a, decreased peripheral basophils, and decreased cell surface expression of FceRI on mast cells and basophils. Thus, we hypothesize that FAHF-2 is a safe and effective herbal therapy for food allergy and this protection is associated with suppression of food specific IgE while increasing food-specific IgG (and lgG4), decreased IgE epitope diversity, and suppression of basophil numbers and function. These aims will be investigated in a double-blind, randomized, placebo-controlled clinical trial, using standard protocols, including double-blind, placebo-controlled oral food challenges, to evaluate clinical outcomes including long-term efficacy. RELEVANCE: The goal of this study will be to validate the clinical efficacy of Chinese herbal medicine in food allergies and to elucidate the mechanisms of action of this herbal formula. This potential therapy has significant advantages over other treatments currently under investigation because it is administered orally, has a high safety profile, and may provide long-term protection from anaphylaxis.

描述（由申请人提供）：食物过敏影响多达6%的幼儿和3-4%的成人。（1，2）花生过敏是美国医院急诊室治疗的食物诱导过敏反应的主要原因（3），花生和树坚果过敏约占致命和近致命过敏反应的80%。(4-6)虽然大多数儿童对牛奶、鸡蛋、小麦和大豆的过敏会随着年龄的增长而消失，但对花生、坚果、鱼类和贝类的过敏往往是终生的。目前，没有治疗方法可以治愈或提供长期缓解食物过敏。中国传统医学（TCM）已被用于治疗各种疾病数千年。中草药，特别是由几种草药组成的配方形式，是中医实践的主要组成部分之一。食物过敏草药配方（FAHF-2）是一个9草药配方（7-14），已被证明是安全和有效的花生过敏小鼠模型。(15此外，FAHF-2在食物过敏患者中似乎是安全的且耐受性良好。在鼠模型中，这种对过敏反应的保护与IgE降低、IgG 2a增加、外周嗜碱性粒细胞减少以及肥大细胞和嗜碱性粒细胞上FceRI的细胞表面表达降低相关。因此，我们假设FAHF-2是一种安全有效的食物过敏草药疗法，这种保护作用与抑制食物特异性IgE，同时增加食物特异性IgG（和IgG 4），降低IgE表位多样性，抑制嗜碱性粒细胞数量和功能有关。将在一项双盲、随机、安慰剂对照临床试验中研究这些目标，使用标准方案，包括双盲、安慰剂对照口服食物挑战，以评价包括长期疗效在内的临床结局。 相关性：本研究的目的是验证中草药在食物过敏中的临床疗效，并阐明该草药配方的作用机制。与目前正在研究的其他治疗方法相比，这种潜在的治疗方法具有显著的优势，因为它是口服给药，具有高安全性，并且可以提供长期的过敏保护。