Anti-Allergic Agents

抗过敏药
  • 文章类型: Journal Article
    大疱性类天疱疮(BP)是一种影响老年人群的慢性自身免疫性疾病,其特征是表皮下紧张性大疱的形成。治疗选择包括局部类固醇,全身性类固醇,免疫抑制剂,和抗菌药物,并且有新的证据表明奥马珠单抗的疗效.在这项研究中,我们的目的是证明奥马珠单抗治疗BP的疗效,我们还报告了治疗相关的不良事件.回顾性队列研究包括2016年至2023年在我们诊所大疱性疾病科随访的BP患者。接受奥马珠单抗的患者被纳入研究。通过BP疾病面积指数活动和损伤评分评估所有患者的治疗反应,治疗量表评分,类固醇剂量减少,和瘙痒的存在/不存在。此外,比较了治疗开始前和最后一次就诊时患者的总IgE水平.有15名(男性/女性=8/7)BP患者接受奥马珠单抗治疗。奥马珠单抗治疗允许类固醇剂量减少,中位数为1个月。奥马珠单抗(25.5mg,95%置信区间17.2-33.9,P<.001)与治疗开始相比,在最后一次就诊时提供了显着的类固醇剂量减少。奥马珠单抗导致BP疾病面积指数活动评分下降80.8(95%置信区间71.8-89.8,P<.001)。此外,与基线相比,奥马珠单抗导致IgE水平显着下降(1102.5±834.5vs834.6±613.6,P=.002)。在这项研究中,奥马珠单抗治疗是一种有效和安全的选择,在BP患者的高基线IgE水平,难治或不能耐受其他免疫抑制治疗。
    Bullous pemphigoid (BP) is a chronic autoimmune disease affecting the elderly population and characterized by the formation of subepidermal tense bullae. Treatment options include topical steroids, systemic steroids, immunosuppressants, and antimicrobials, and there is emerging evidence of the efficacy of omalizumab. In this study, we aimed to demonstrate omalizumab\'s efficacy for treating BP, and we also reported treatment-related adverse events. The retrospective cohort study included patients with BP who were followed up in our clinic\'s bullous diseases department between 2016 and 2023. Patients who received omalizumab were included in the study. Treatment responses of all patients were assessed by BP Disease Area Index activity and damage scores, treatment scale scoring, steroid dose reduction, and the presence/absence of pruritus. Also, total IgE levels of patients before the treatment onset and at the last visit were compared. There were 15 (male/female = 8/7) BP patients receiving omalizumab treatment. Omalizumab therapy allowed steroid dose reduction at a median of 1 month. Omalizumab (25.5 mg, 95% confidence interval 17.2-33.9, P < .001) provided a significant steroid dose reduction at the last visit compared to the beginning of treatment. Omalizumab resulted in a decrease in BP Disease Area Index activity score of 80.8 (95% confidence interval 71.8-89.8, P < .001). Also, omalizumab caused significant decline in IgE levels compared to baseline (1102.5 ± 834.5 vs 834.6 ± 613.6, P = .002). In this study, omalizumab treatment was an effective and safe option in BP patients with high baseline IgE levels who are refractory to or cannot tolerate other immunosuppressive therapies.
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  • 文章类型: Journal Article
    目的:慢性诱导性荨麻疹(CIndU)是一组长期持续且具有挑战性的疾病,以明确触发因素引起的复发性风团和血管性水肿为特征。在这次审查中,我们讨论了关于CIndU发病机制的最新发现,诊断和治疗,我们讨论了新的潜在靶点,这些靶点可能导致对CIndU患者开发更有效的治疗方法。
    背景:在过去的几十年中,已经报道了对其发病机理的理解有意义的进展。NovelCIndU特异性患者报告的结果指标可以更紧密和更好地评估患者。CIndU是一种难以治疗的疾病,严重损害受影响患者的生活质量(QoL)。激发试验允许诊断CIndU亚型。CIndU唯一许可和推荐的治疗方法是第二代非镇静H1抗组胺药,在许多情况下缺乏疗效。已在所有类型的CIndU中评估了奥马珠单抗的标签外使用,总体结果良好。目前在慢性自发性荨麻疹中评估的有前途的新兴疗法为CIndU的新疗法铺平了道路。
    OBJECTIVE: Chronic inducible urticaria (CIndU) is a group of long-persisting and challenging to manage diseases, characterized by recurrent wheals and angioedema induced by definite triggers. In this review, we address recent findings on CIndU pathogenesis, diagnosis as well as its treatment, and we discuss novel potential targets that may lead to the development of more effective therapies for CIndU patients.
    BACKGROUND: Meaningful advances in the understanding of its pathogenesis have been reported in the last decades. Novel CIndU-specific patient-reported outcome measures enable a closer and better evaluation of patients. CIndU is a hard-to-treat disease that highly impairs quality of life (QoL) of affected patients. Provocation tests allow to diagnose CIndU subtypes. The only licensed and recommended treatment for CIndU are second generation non-sedating H1-antihistamines, which lack efficacy in many cases. Omalizumab off-label use has been assessed in all types of CIndU with overall good outcomes. Promising emerging therapies currently assessed in chronic spontaneous urticaria are paving the path for novel treatments for CIndU.
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  • 文章类型: Journal Article
    虽然一些研究已经检查了T细胞和相关细胞因子在慢性自发性荨麻疹(CSU)发展中的作用,针对奥马珠单抗治疗期间细胞因子水平变化的研究有限.这项研究的主要目的是研究CSU患者的炎性细胞因子谱(包括IL-4,IL-5,IL-10,IL-13,IL-17,IL-31,IL-33和TNFα)接受奥马珠单抗治疗。使用ELISA测量细胞因子的血浆水平。在CSU治疗前进行测量,在奥马珠单抗治疗的第3个月和第6个月,一次进入对照组。使用每周荨麻疹活动评分(UAS7)评估患者疾病的严重程度,使用荨麻疹控制测试(UCT)评估疾病控制。纳入了31名CSU患者和56名年龄和性别匹配的健康对照。与健康对照组相比,CSU患者的血浆IL-4和IL-33水平显着降低(分别为p=0.001;p=0.038)。在奥马珠单抗治疗期间,与基线相比,IL-4水平在第3个月显示显着增加(p=0.01),与第3个月和基线相比,第6个月和IL-5水平显着降低(第6个月与基线;p=0.006,第6个月vs.第3个月;p=0.001)。奥马珠单抗的一种潜在作用机制可能涉及其对CSU患者2型炎性细胞因子的调节作用。这一发现部分解释了抗IL-4/13治疗在慢性自发性荨麻疹中的功效。有必要进一步研究针对CSU中2型炎症细胞因子的药物。
    While several studies have examined the role of T cells and related cytokines in the development of chronic spontaneous urticaria (CSU), there is a limited amount of research focusing on the changes in cytokine levels during omalizumab treatment. The primary objective of this study was to investigate the inflammatory cytokine profile (including IL-4, IL-5, IL-10, IL-13, IL-17, IL-31, IL-33, and TNFα) among CSU patients undergoing to omalizumab treatment. Plasma levels of cytokines were measured using ELISA. Measurements were taken before CSU treatment, at the 3rd and 6th months of omalizumab treatment, and once in the control group. The severity of the patients\' disease was assessed using the weekly Urticaria Activity Score(UAS7), and disease control was evaluated using the Urticaria Control Test(UCT). Thirty-one CSU patients and 56 age- and gender-matched healthy controls were included. Plasma levels of IL-4 and IL-33 were significantly lower in patients with CSU compared to healthy controls (p = 0.001; p = 0.038, respectively). During omalizumab treatment, IL-4 levels showed a significant increase in the 3rd month compared to baseline (p = 0.01), and IL-5 levels significantly decreased in the 6th month compared to both the 3rd month and baseline (6th month vs. baseline; p = 0.006, 6th month vs. 3rd month; p = 0.001). One potential mechanism of action for omalizumab may involve its regulatory effects on type 2 inflammatory cytokines in CSU patients. This finding partially explains the efficacy of anti-IL-4/13 treatments in chronic spontaneous urticaria. Further investigations on drugs targeting type 2 inflammatory cytokines in CSU are warranted.
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  • 文章类型: Journal Article
    背景和目的:儿童慢性荨麻疹指南包含通常基于成人研究的建议。诊断途径尚未标准化,抗H1,奥马珠单抗的有效性,孟鲁司特,在儿科人群中很少报道全身性糖皮质激素。研究之间的慢性荨麻疹缓解率差异很大。这项研究的目的是提高我们对小儿慢性荨麻疹的认识。材料与方法:本研究纳入37例慢性荨麻疹患儿,年龄0~18岁。人口统计参数,病史,临床特征,收集实验室数据和治疗信息.儿童接受推荐剂量的第二代H1抗组胺药治疗,增加了两倍。奥马珠单抗用于难治性抗H1患者。对严重加重的患者进行为期三天的全身性糖皮质激素治疗。孟鲁司特对一些儿童进行了治疗。结果:常见无血管性水肿的病例。32例(86.48%)儿童出现自发性慢性荨麻疹,可诱导2(5.41%),由1中的寄生虫和2中的血管诱导。治疗慢性荨麻疹的潜在原因没有益处,除了消灭脆弱的Dientamoeba。45.9%的病例在三年内解决了慢性荨麻疹。9名儿童(24.32%)存在过敏性疾病,3名(8.11%)存在自身免疫性疾病。所有儿童均接受许可剂量或更高剂量的抗H1治疗。在29名(78.38%)患者中观察到抗H1的部分或完全反应。孟鲁司特没有任何好处。所有接受奥马珠单抗治疗的儿童均有反应。全身性糖皮质激素已成功用于治疗急性发作。结论:我们的发现表明,在没有临床怀疑的情况下,不应常规进行实验室检查。然而,合并症,如甲状腺自身免疫性疾病和乳糜泻,建议在慢性荨麻疹过程中进行监测。可以从慢性荨麻疹的诊断框架中诊断这些临床状况。增加抗H1和奥马珠单抗的剂量对标准治疗耐药的儿童有效,但我们仍需要进一步研究以产生以患者为中心的标准治疗。
    Background and Objectives: The guidelines for chronic urticaria in children contain recommendations that are often based on adult studies. The diagnostic pathway has not been standardized and the effectiveness of anti-H1, omalizumab, montelukast, and systemic glucocorticoids is rarely reported in the pediatric population. There is a wide variation in the rate of remission of chronic urticaria between studies. The aim of this study is to enhance our understanding of pediatric chronic urticaria. Materials and Methods: This study enrolled 37 children with chronic urticaria aged from 0 to 18 years. Demographic parameters, medical history, clinical features, laboratory data and treatment information were collected. Children were treated with the recommended dosage of second-generation H1-antihistamines, which was increased by up to twofold. Omalizumab was added for refractory anti-H1 patients. A three-day course with systemic glucocorticoids was administered for severe exacerbations. Montelukast was administered to some children. Results: Wheals without angioedema were common. Chronic urticaria was spontaneous in 32 children (86.48%), inducible in 2 (5.41%), induced by a parasite in 1 and vasculitic in 2. Treatment of the potential causes of chronic urticaria was of no benefit, except for eradication of Dientamoeba fragilis. Chronic urticaria was resolved within three years in 45.9% of cases. Allergic diseases were present in nine children (24.32%) and autoimmune diseases were present in three (8.11%). All children were treated with anti-H1 at the licensed dose or at a higher dose. A partial or complete response to anti-H1 was observed in 29 (78.38%) patients. Montelukast showed no benefit. All children treated with omalizumab responded. Systemic glucocorticoids were successfully used to treat exacerbations. Conclusions: Our findings indicate that laboratory tests should not be routinely performed in children with chronic urticaria without clinical suspicion. However, comorbidities such as thyroid autoimmune disease and coeliac disease are suggested to be monitored over the chronic urticaria course. These clinical conditions could be diagnosed from the diagnostic framework of chronic urticaria. Increasing the dosage of anti-H1 and omalizumab was effective in children resistant to standard treatment but we still need further studies to generate a standard patient-centered treatment.
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  • 文章类型: Journal Article
    背景:奥马珠单抗是唯一获得许可的慢性特发性荨麻疹(CIU)的三线治疗药物。奥马珠单抗的最佳剂量仍存在争议。因此,本研究旨在评估不同剂量奥马珠单抗治疗CIU患者的疗效和安全性.
    方法:从数据库创建到2023年4月8日搜索了四个数据库。使用了几个关键词,如奥马珠单抗和荨麻疹来检索相关研究。荟萃分析结果在R4.2.1软件和Stata15.1软件中进行分析。Cochrane偏差风险工具Ver。2用于评价随机对照试验(RCTs)的偏倚风险。
    结果:总计,包括2331例患者。采用五项指标进行评估,包括每周瘙痒严重程度评分(ISS7),每周蜂巢严重程度评分(HSS7),每周荨麻疹活动评分(UAS7),皮肤病生活质量指数(DLQI)和不良事件(AE)。300毫克剂量的奥马珠单抗是治疗U的最佳剂量,然后是150mg剂量。此外,在HSS7中,600mg奥马珠单抗仅显示与安慰剂的显著差异。在AE中没有观察到显著的统计学差异。Meta回归分析显示,时间,作为协变量,在奥马珠单抗150mg与安慰剂的比较中具有统计学意义。
    结论:300mg奥马珠单抗是治疗U患者的最佳剂量,150mg剂量也表现出良好的疗效。需要进一步的研究来探讨不同剂量奥马珠单抗治疗CIU患者的疗效和安全性。
    BACKGROUND: Omalizumab is the only licensed drug that serves as a third-line treatment for chronic idiopathic urticaria (CIU). The optimum doses of omalizumab remain controversial. Therefore, this study aims to estimate the efficacy and safety of different doses of omalizumab in the treatment of CIU patients.
    METHODS: Four databases were searched from the database\'s creation to April 8, 2023. Several keywords such as omalizumab and urticarias were used to retrieve related studies. The meta-analytical outcomes were analyzed in R 4.2.1 software and Stata 15.1 software. Cochrane risk-of-bias tool Ver. 2 was used to evaluate the risk of bias in randomized controlled trials (RCTs).
    RESULTS: In total, 2331 patients were included. Five indexes were employed to assess, including weekly Itch Severity Score (ISS7), weekly Hive Severity Score (HSS7), weekly Urticaria Activity Score (UAS7), Dermatology Life Quality Index (DLQI), and adverse events (AE). A 300 mg dose of omalizumab was the optimum dose to treat CIU, followed by the 150 mg dose. Furthermore, 600 mg of omalizumab only showed a significant difference from the placebo in HSS7. No significant statistical difference was observed in AE. Meta-regression analysis revealed that time, as a covariate, was statistically significant in the comparison of omalizumab 150 mg with placebo.
    CONCLUSIONS: 300 mg of omalizumab was the optimum dosage to treat CIU patients, with a 150 mg dose also exhibiting good efficacy. Further studies are required to explore the efficacy and safety of different doses of omalizumab in the treatment of CIU patients.
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  • 文章类型: Journal Article
    背景:本研究的目的是评估奥马珠单抗作为慢性荨麻疹(CU)治疗干预的临床有效性和安全性。
    方法:从2023年3月1日至2023年9月30日,包括96名CU患者的队列数据,在我们医疗机构的过敏诊所接受了奥马珠单抗治疗,是系统地编译的。奥马珠单抗给药后,使用7日荨麻疹活动评分和荨麻疹对照试验评估治疗效果.
    结果:根据统计分析,治疗干预的平均持续时间为2.4±1.3个月,相应的平均累积剂量为765±450mg。在接受随访期超过3个月的42例CU患者中,据观察,治疗导致症状完全缓解,无复发病例记录.值得注意的是,出现合并症的患者和未出现合并症的患者在治疗持续时间和累积剂量方面存在统计学差异(p<0.01,95%CI:0.280-1.326;p<0.01,95%CI:0.597-2.997).此外,合并变应性鼻炎组和非合并变应性鼻炎组患者的治疗持续时间和累积剂量存在显着差异(p&lt;0.01,95%CI:0.204-1.305;p=0.01,95%CI:0.326-2.860)。
    结论:奥马珠单抗通过有效控制症状并促进皮肤病变的消退,在中国患者中证明了治疗CU的有效性。评估其治疗功效通常需要12周的治疗期。此外,CU与其他过敏性疾病的共同发生是调整奥马珠单抗给药方案的相关考虑因素.
    BACKGROUND: The purpose of this study was to assess the clinical effectiveness and safety profile of omalizumab as a therapeutic intervention for chronic urticaria (CU).
    METHODS: From March 1, 2023, to September 30, 2023, data on a cohort comprising 96 patients with CU, who underwent treatment with omalizumab at our medical institution\'s allergy clinic, were systematically compiled. Subsequent to the administration of omalizumab, the therapeutic efficacy was assessed utilizing the 7-day urticaria activity score and the urticaria control test.
    RESULTS: Based on the statistical analysis, the mean duration of therapeutic intervention was 2.4 ± 1.3 months, with a corresponding mean cumulative dosage of 765 ± 450 mg. Of the subset of 42 patients with CU who were subjected to a follow-up period exceeding 3 months, it was observed that the treatment led to complete symptom remission, and no instances of recurrence were documented. Notably, there were statistically significant differences in the treatment duration and the cumulative dosage between patients who experienced co-morbid conditions and those who did not (p < 0.01, 95% CI: 0.280-1.326; p < 0.01, 95% CI: 0.597-2.997). Furthermore, there were significant differences in the treatment duration and cumulative dosage between patients in the combined allergic rhinitis group and those in the non-combined allergic rhinitis group (p < 0.01, 95% CI: 0.204-1.305; p = 0.01, 95% CI: 0.326-2.860).
    CONCLUSIONS: Omalizumab demonstrates efficacy in the management of CU among Chinese patients by exerting effective symptom control and facilitating the regression of skin lesions. The assessment of its therapeutic efficacy typically requires a 12-week treatment period. Moreover, the co-occurrence of CU with other allergic disorders serves as a pertinent consideration for the adjustment of omalizumab dosing regimens.
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  • 文章类型: Journal Article
    食物过敏在世界范围内很常见,已成为主要的公共卫生问题;据估计,全世界有超过2.2亿人患有食物过敏。另一方面,多酚,植物中发现的酚类物质,因其促进健康的功能而受到关注,包括抗过敏作用.在这项研究中,我们研究了来自22种不同蔬菜的80%乙醇提取物对RBL-2H3细胞脱粒过程的潜在抑制作用。我们的目标是确定可以预防和治疗I型过敏性疾病的蔬菜。我们发现紫苏和细香葱的提取物对脱颗粒有很强的抑制作用。此外,我们通过动物实验验证了各自的功效,这表明,在摄入紫苏和细香葱植物提取物的OVA过敏模型小鼠中,由卵清蛋白(OVA)负荷引起的过敏症状得到缓解。这些现象被认为是由诱导抑制构成高亲和力IgE受体的亚基的表达引起的。特别是FcεRI的α链,值得注意的是,可以每天食用的蔬菜的抗过敏作用有望导致发现基于这些蔬菜成分的新的抗即时过敏药物。
    Food allergies are common worldwide and have become a major public health concern; more than 220 million people are estimated to suffer from food allergies worldwide. On the other hand, polyphenols, phenolic substances found in plants, have attracted attention for their health-promoting functions, including their anti-allergic effects. In this study, we examined the potential inhibitory effects of 80% ethanol extracts from 22 different vegetables on the degranulation process in RBL-2H3 cells. Our aim was to identify vegetables that could prevent and treat type I allergic diseases. We found strong inhibition of degranulation by extracts of perilla and chives. Furthermore, we verified the respective efficacy via animal experiments, which revealed that the anaphylactic symptoms caused by ovalbumin (OVA) load were alleviated in OVA allergy model mice that ingested vegetable extracts of perilla and chives. These phenomena were suggested to be caused by induction of suppression in the expression of subunits that constitute the high-affinity IgE receptor, particularly the α-chain of FcεR I. Notably, the anti-allergic effects of vegetables that can be consumed daily are expected to result in the discovery of new anti-immediate allergenic drugs based on the components of these vegetables.
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  • 文章类型: Multicenter Study
    OBJECTIVE: To explore the clinical manifestations, endoscopic findings, histopathological changes, treatment, and prognosis of eosinophilic gastrointestinal disease (EGID) in children, with the aim of enhancing awareness among pediatricians about this condition.
    METHODS: Data of 267 children with EGID were prospectively collected from January 2019 to July 2022 at Jiangxi Children\'s Hospital, Hunan Children\'s Hospital, and Henan Children\'s Hospital. The age of onset, symptoms, physical signs, laboratory examination results, endoscopic findings, histopathological changes, and treatment outcomes were observed.
    RESULTS: Among the 267 children with EGID, the majority had mild (164 cases, 61.4%) or moderate (96 cases, 35.6%) clinical severity. The disease occurred at any age, with a higher prevalence observed in school-age children (178 cases). The main symptoms in infants were vomiting and hematemesis, while in toddlers, vomiting and bloody stools were prominent. Abdominal pain and vomiting were the primary symptoms in preschool and school-age children. Nearly half (49.4%) of the affected children showed elevated platelet counts on hematological examination, but there was no significant difference in platelet counts among children with mild, moderate, and severe EGID (P>0.05). Endoscopic findings in EGID children did not reveal significant specificity, and histopathological examination showed no specific structural damage. Among them, 85.0% (227 cases) received acid suppression therapy, 34.5% (92 cases) practiced dietary avoidance, 20.9% (56 cases) received anti-allergic medication, and a small proportion (24 cases, 9.0%) were treated with prednisone. Clinical symptoms were relieved in all patients after treatment, but three cases with peptic ulcers experienced recurrence after drug discontinuation.
    CONCLUSIONS: Mild and moderate EGID are more common in children, with no specific endoscopic findings. Dietary avoidance, acid suppression therapy, and anti-allergic medication are the main treatment methods. The prognosis of EGID is generally favorable in children.
    目的: 探讨儿童嗜酸粒细胞性胃肠道疾病(eosinophilic gastrointestinal disease, EGID)的临床表现、内镜下改变、病理组织学改变、治疗及预后特点,以提高儿科医师对该疾病的认识。方法: 前瞻性收集2019年1月—2022年7月江西省儿童医院、湖南省儿童医院、河南省儿童医院确诊的267例EGID患儿资料,观察其发病年龄、症状、体征、实验室检查、内镜下改变、病理组织学改变及治疗的预后情况。结果: 267例EGID患儿中,临床分度以轻度(164例,61.4%)和中度(96例,35.6%)为主。各年龄均可发病,以学龄期儿童(178例)为主。婴儿期主要表现为呕吐、呕血,幼儿期主要表现为呕吐、便血,学龄前期和学龄期主要表现为腹痛、呕吐。血常规示近一半(49.4%)患儿出现血小板升高,但轻、中、重度EGID患儿血小板计数比较差异无统计学意义(P>0.05)。EGID患儿消化道内镜下无显著特异性改变,组织病理亦无特异性结构损伤。其中85.0%(227例)予以抑酸治疗,34.5%(92例)予以饮食回避,20.9%(56例)予以抗过敏药物治疗,少部分(24例,9.0%)使用泼尼松治疗。治疗后患儿临床症状均得到缓解,3例以消化性溃疡为表现者停药后症状出现反复。结论: 儿童EGID以轻、中度多见,内镜下改变无明显特异性,饮食回避及抑酸、抗过敏药物为主要治疗方法,预后良好。.
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  • 文章类型: Randomized Controlled Trial
    背景:食物过敏是常见的,并且与高发病率相关;唯一被批准的治疗方法是花生过敏的口服免疫疗法。
    方法:在本试验中,我们评估了奥马珠单抗,单克隆抗IgE抗体,对于多种食物过敏的患者,作为单一疗法是有效和安全的。1至55岁的人对花生和至少两种其他试验指定的食物(腰果,牛奶,鸡蛋,核桃,小麦,和榛子)进行筛选。纳入需要对100毫克或更少的花生蛋白和300毫克或更少的其他两种食物的食物挑战做出反应。参与者被随机分配,以2:1的比例,接受奥马珠单抗或安慰剂皮下给药(剂量基于体重和IgE水平),每2至4周16至20周,之后,挑战不断重复。主要终点是以600mg或更多的单剂量摄入花生蛋白,而没有剂量限制症状。三个关键的次要终点是腰果的消耗,牛奶,和鸡蛋,每次至少1000毫克,没有剂量限制症状。完成第一阶段的前60名参与者(其中59名是儿童或青少年)参加了为期24周的开放标签扩展。
    结果:在接受筛查的462人中,180例随机分组。分析人群包括177名儿童和青少年(1至17岁)。118名接受奥马珠单抗的参与者中,共有79名(67%)符合主要终点标准。59名参与者中有4名(7%)接受安慰剂(P<0.001)。关键次要终点的结果与主要终点的结果一致(腰果,41%vs.3%;牛奶,66%vs.10%;鸡蛋,67%vs.0%;所有比较均P<0.001)。两组之间的安全终点没有差异,除了奥马珠单抗组的注射部位反应更多。
    结论:在1岁以下患有多种食物过敏的人中,奥马珠单抗治疗16周在提高花生和其他常见食物过敏原的反应阈值方面优于安慰剂。(由国家过敏和传染病研究所等资助;ClinicalTrials.gov编号,NCT03881696。).
    Food allergies are common and are associated with substantial morbidity; the only approved treatment is oral immunotherapy for peanut allergy.
    In this trial, we assessed whether omalizumab, a monoclonal anti-IgE antibody, would be effective and safe as monotherapy in patients with multiple food allergies. Persons 1 to 55 years of age who were allergic to peanuts and at least two other trial-specified foods (cashew, milk, egg, walnut, wheat, and hazelnut) were screened. Inclusion required a reaction to a food challenge of 100 mg or less of peanut protein and 300 mg or less of the two other foods. Participants were randomly assigned, in a 2:1 ratio, to receive omalizumab or placebo administered subcutaneously (with the dose based on weight and IgE levels) every 2 to 4 weeks for 16 to 20 weeks, after which the challenges were repeated. The primary end point was ingestion of peanut protein in a single dose of 600 mg or more without dose-limiting symptoms. The three key secondary end points were the consumption of cashew, of milk, and of egg in single doses of at least 1000 mg each without dose-limiting symptoms. The first 60 participants (59 of whom were children or adolescents) who completed this first stage were enrolled in a 24-week open-label extension.
    Of the 462 persons who were screened, 180 underwent randomization. The analysis population consisted of the 177 children and adolescents (1 to 17 years of age). A total of 79 of the 118 participants (67%) receiving omalizumab met the primary end-point criteria, as compared with 4 of the 59 participants (7%) receiving placebo (P<0.001). Results for the key secondary end points were consistent with those of the primary end point (cashew, 41% vs. 3%; milk, 66% vs. 10%; egg, 67% vs. 0%; P<0.001 for all comparisons). Safety end points did not differ between the groups, aside from more injection-site reactions in the omalizumab group.
    In persons as young as 1 year of age with multiple food allergies, omalizumab treatment for 16 weeks was superior to placebo in increasing the reaction threshold for peanut and other common food allergens. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT03881696.).
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  • 文章类型: Case Reports
    背景:目前慢性荨麻疹的分类主要基于皮肤表现的临床表现。因此,治疗性治疗主要针对局部症状的即时缓解。我们认为,将治疗策略限制在皮肤病理学上可能是不够的,因为细胞激活和炎症可能是远程触发的。
    方法:在本系列中,两名患者用尽了目前治疗顽固性荨麻疹的所有方法,但仍有症状。第一个病例是26岁的白人女性,第二个病例是63岁的非洲裔美国女性。尽管使用了奥马珠单抗和抗组胺药治疗,但这两种情况下都有频繁的突发性荨麻疹,需要频繁的泼尼松脉冲疗程来控制荨麻疹。当发现炎症性气道疾病并使用吸入性皮质类固醇治疗时,在几年的观察中,无需高剂量免疫抑制即可更快地控制荨麻疹。巧合的是,在持续吸入糖皮质激素治疗的一例中,自身免疫性甲状腺炎和抗免疫球蛋白E免疫球蛋白G滴度显着下降。
    结论:我们提出了一种新的方法来控制这两种情况下的远端上皮部位炎症,从而在不需要全身性皮质类固醇或免疫抑制剂的情况下持续控制荨麻疹症状。如在乳糜泻和类风湿性关节炎等其他上皮炎症中观察到的,自身免疫抗体的变化可能是慢性下气道炎症引起的耐受性破坏的后果。
    BACKGROUND: Current classification of chronic urticaria is primarily based on clinical presentation of skin manifestations. Hence, therapeutic treatment is primarily aimed locally for immediate symptom relief. We reason that limiting therapeutic strategies to the skin pathology might be inadequate since cellular activation and inflammation might be triggered remotely.
    METHODS: In this series two patients had exhausted all current treatments for recalcitrant urticaria but remained symptomatic. The first case was 26-year-old Caucasian female and the second was 63-year-old African American female. Both cases had frequent breakthrough urticaria requiring frequent pulsating courses of prednisone to control urticaria despite treatment with omalizumab and antihistamines. When inflammatory airway disease was discovered and managed with inhaled corticosteroid, urticaria is controlled much faster without the need of high dose immunosuppression over several years of observation. Coincidentally, autoimmune thyroiditis and anti-immunogobulin-E immunoglobulin-G titers dropped significantly in one case with sustained inhaled corticosteroid therapy.
    CONCLUSIONS: We suggest a novel approach of controlling remote epithelial site inflammation in these two cases that resulted in sustained-control of urticaria symptoms without the need for systemic corticosteroids or immunosuppressant. The changes of autoimmune antibodies might be the consequences of tolerance breaking from chronic lower airway inflammation as observed in other epithelial inflammatory condition like in celiac disease and rheumatoid arthritis.
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