sublingual immunotherapy

舌下免疫治疗
  • 文章类型: Journal Article
    过敏性鼻炎(AR)是由环境过敏原引发的I型超敏反应引起的上呼吸道慢性炎症。AR与显著的发病率相关,并影响患者的生活质量,情感幸福,生产力,和认知功能。随着AR患病率和发病率在全球范围内显著增加,在阿拉伯联合酋长国(UAE)也注意到类似的观察结果,AR成为潜在的公共卫生问题.UAE的AR管理主要由非过敏专家提供,依赖一线治疗,如鼻内类固醇和抗组胺药,通常具有次优和短期疗效。过敏原免疫疗法(AIT)是目前唯一可用的皮下或舌下过敏原免疫疗法形式的疾病修饰治疗选择,已被证明具有长期益处。本文旨在提供有关使用AIT管理阿联酋AR的建议,同时考虑阿联酋医疗保健系统的现状和当地经验。
    Allergic rhinitis (AR) is a chronic inflammatory condition of the upper airways caused by a type I hypersensitivity reaction triggered by environmental allergens. AR is associated with significant morbidity and affects patients\' quality of life, emotional well-being, productivity, and cognitive functioning. As AR prevalence and morbidity have increased significantly worldwide, similar observations have been noted in the United Arab Emirates (UAE) with AR becoming a potential public health issue. Management of AR in the UAE is mainly provided by non-allergy specialists relying on first-line treatments such as intranasal steroids and antihistamines, with often suboptimal and short-term efficacy. Allergen Immunotherapy (AIT) is the only currently available disease-modifying treatment option in the form of either subcutaneous or sublingual allergen immunotherapy that has been proven to have long-term benefits. This article aims to provide recommendations regarding the use of AIT for managing AR in the UAE, considering both the current landscape in the Emirati healthcare system and local experience.
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  • 文章类型: Journal Article
    哮喘是全球儿童常见的慢性疾病。过敏原特异性免疫治疗,如皮下(SCIT)和舌下(SLIT)治疗,通过增加过敏原耐受性是有希望的。这项荟萃分析比较了SLIT和SCIT在小儿哮喘中的疗效和安全性。
    我们搜索了PubMed,科克伦图书馆,和Embase用于比较哮喘儿童SLIT和SCIT的随机对照试验和病例对照研究。使用随机效应模型进行Meta分析,并通过R软件4.3.2版和RevMan5.4版进行计算。使用NOS和Cochrane偏差风险工具评估研究质量和偏差风险。
    文献检索共产生1787条记录,筛选和评估后,有7项研究符合纳入标准。SLIT和SCIT之间的总哮喘症状评分(TASS)没有显着差异(平均差异-0.05[95%CI:-0.21;0.10])。然而,SLIT组哮喘改善率较高(风险比0.77[95%CI:0.64;0.93]).FEV1改善没有显着差异(平均差-1.60[95%CI:-6.27;3.08])。治疗之间的不良事件相似(风险比0.56[95%CI:0.11;2.82])。
    SLIT和SCIT对于治疗小儿哮喘通常同样有效和安全。由于其非侵入性施用,SLIT可能是优选的。需要对长期效果和量身定制的治疗方法进行更多研究。
    UNASSIGNED: Asthma is a common chronic condition in children globally. Allergen-specific immunotherapy, such as subcutaneous (SCIT) and sublingual (SLIT) therapies, are promising by increasing allergen tolerance. This meta-analysis compares the efficacy and safety of SLIT and SCIT in pediatric asthma.
    UNASSIGNED: We searched PubMed, Cochrane Library, and Embase for randomized controlled trials and case-control studies comparing SLIT and SCIT in asthmatic children. Meta-analysis was conducted using random-effects models with calculations via R software version 4.3.2 and RevMan version 5.4. Study quality and bias risk were assessed using the Newcastle-Ottawa Scale and Cochrane Risk of Bias Tool.
    UNASSIGNED: The literature search yielded a total of 1787 records, with 7 studies meeting the inclusion criteria after screening and assessments. There was no significant difference in the Total Asthma Symptoms Score between SLIT and SCIT (mean difference -0.05 [95% CI: -0.21; 0.10]). However, asthma improvement rates were higher in the SLIT group (risk ratio 0.77 [95% CI: 0.64; 0.93]). FEV1 improvement showed no significant difference (mean difference -1.60 [95% CI: -6.27; 3.08]). Adverse events were similar between the treatments (risk ratio 0.56 [95% CI: 0.11; 2.82]).
    UNASSIGNED: SLIT and SCIT were generally similarly effective and safe for treating pediatric asthma. SLIT may be preferred due to its noninvasive administration. More research is needed on long-term effects and tailored treatment approaches.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    背景:雪松季节性过敏性鼻炎的传统治疗方法包括第二代抗组胺药,鼻皮质类固醇,和舌下免疫疗法(SLIT)。奥马珠单抗(Xolair®),抗免疫球蛋白E(IgE)单克隆抗体,是对现有疗法无反应的严重病例的另一种选择。许多研究已经证明了奥马珠单抗对雪松季节性过敏性鼻炎的治疗效果;然而,大多数报告的结果仅在随访4周后.因此,这项研究评估了奥马珠单抗在整个雪松花粉季节的临床疗效。受试者和方法:本研究包括2021年至2023年来自我们部门和南上大阪医院耳鼻咽喉科的患者,这些患者年龄≥12岁,血清总IgE水平为30-1,500IU/mL,30-150公斤的基准体重,和持续严重的鼻部症状,尽管常规治疗。在招募时服用口服类固醇或服用少于两个奥马珠单抗剂量的患者被排除在外。46名患者(26名男性,20名女性;平均年龄,19.1±11.2年)符合这些标准,并根据其IgE水平和体重每2或4周接受皮下奥马珠单抗。使用总鼻部症状评分(TNSS)和日本标准生活质量问卷(JRQLQNo.1)用于过敏性鼻炎。结果:36例患者随访8周,13例12周。TNSS在4周时从6.6显著提高到4.5,4.2在8周时,在12周时为4.1(p<0.05)。鼻腔分泌物,打喷嚏,鼻塞,眼睛发痒,泪液和泪液显着改善(p<0.05)。生活质量评分在日常活动中得到改善,睡眠,从第4周到第12周的身体健康。讨论:与以前的发现一致,奥马珠单抗可显著改善严重雪松季节性变应性鼻炎患者的鼻和眼部症状及生活质量。尽管许多患者由于高昂的费用在八周后停用该药,该药物在预防症状复发方面的有效性表明潜在的长期益处。联合奥马珠单抗与SLIT在结果上没有显着差异;然而,需要进一步的药物经济学研究来评估成本-效果.结论:奥马珠单抗是治疗严重雪松季节性变应性鼻炎的有效方法,提供显著的症状缓解和生活质量改善。进一步的研究应该调查其长期疗效和安全性,包括潜在的不良反应和抗奥马珠单抗抗体的开发。
    BACKGROUND: Traditional treatments for cedar seasonal allergic rhinitis include second-generation antihistamines, nasal corticosteroids, and sublingual immunotherapy (SLIT). Omalizumab (Xolair®), an anti-immunoglobulin E (IgE) monoclonal antibody, is an additional option for severe cases unresponsive to existing therapies. Numerous studies have demonstrated the therapeutic effectiveness of omalizumab for cedar seasonal allergic rhinitis; however, most reported results after only up to four weeks of follow-up. Therefore, this study evaluates the clinical efficacy of omalizumab throughout one whole cedar pollen season.   Subjects and methods: This study included patients from our department and the Otorhinolaryngology Department of Minami Osaka Hospital between 2021 and 2023 who were ≥ 12 years old and had serum total IgE levels of 30-1,500 IU/mL, a baseline weight of 30-150 kg, and persistent severe nasal symptoms despite conventional treatments. Patients taking oral steroids at the time of enrollment or had fewer than two omalizumab doses were excluded. Forty-six patients (26 males, 20 females; mean age, 19.1 ± 11.2 years) met these criteria and received subcutaneous omalizumab every 2 or 4 weeks based on their IgE levels and weight. Symptoms were assessed at baseline and 4, 8, and 12 weeks post-administration using the Total Nasal Symptom Score (TNSS) and the Japanese Standard Quality of Life Questionnaire (JRQLQ No. 1) for allergic rhinitis.   Results: Thirty-six patients were followed up for 8 weeks and 13 for 12 weeks. TNSS significantly improved from 6.6 to 4.5 at 4 weeks, 4.2 at 8 weeks, and 4.1 at 12 weeks (p<0.05). Nasal discharge, sneezing, nasal obstruction, itchy eyes, and tearfulness showed significant improvements (p<0.05). Quality of life scores improved in daily activities, sleep, and physical health from week 4 to week 12.   Discussion: Consistent with previous findings, omalizumab significantly improved nasal and ocular symptoms and quality of life in patients with severe cedar seasonal allergic rhinitis. Despite many patients discontinuing the drug after eight weeks due to high costs, the drug\'s effectiveness in preventing symptom recurrence suggests potential long-term benefits. Combining omalizumab with SLIT showed no significant differences in outcomes; however, further pharmacoeconomic studies are warranted to evaluate cost-effectiveness.   Conclusion: Omalizumab proved to be an effective treatment for severe cedar seasonal allergic rhinitis, providing significant symptom relief and quality of life improvements. Further studies should investigate its long-term efficacy and safety, including potential adverse effects and the development of anti-omalizumab antibodies.
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  • 文章类型: Journal Article
    屋尘螨(HDM)过敏原免疫疗法(AIT)在HDM致敏引发的常年性过敏性鼻炎(AR)和过敏性哮喘(AA)的治疗中具有既定作用。我们的目标是识别所有双盲,随机化,用于治疗人类AR和AA的HDMAIT的安慰剂对照试验,并总结目前生产并可用于临床的AIT产品的证据。共有56名合资格双盲,随机化,HDMAIT治疗人体AA和/或AR的安慰剂对照试验符合纳入标准,共调查了14种商业AIT产品;56项研究共纳入14,619例患者.在56项研究中,39项研究调查了产品的当前制造商推荐的维持剂量(MRMD),17人调查了其他剂量。我们确定了8项舌下免疫疗法(SLIT)产品的39项研究(12,539例随机患者)和皮下免疫疗法产品的17项研究(2,080例随机患者)。对于AR,3产品,ALK12标准化质量(SQ-HDM)SLIT平板电脑,ALK6SQ-HDM平板电脑,和SG300反应性SLIT平板电脑指数,进行了剂量发现研究(DFSs)和III期确定性研究(DSs),以证明产品MRMD的功效。对于AA,2产品,ALK12SQ-HDMSLIT平板电脑和ALK6SQ-HDM平板电脑,MRMD有DFSs和DSs。没有皮下免疫治疗产品具有支持MRMD的配对DFS和DS。总共排除了30项不再商业生产的产品研究。这项研究将有助于为HDM诱导的AR和AA的治疗提供临床护理和产品选择。
    House dust mite (HDM) allergen immunotherapy (AIT) has an established role in the treatment of perennial allergic rhinitis (AR) and allergic asthma (AA) triggered by HDM sensitization. We aimed to identify all double-blind, randomized, placebo-controlled trials of HDM AIT for the treatment of AR and AA in humans and to summarize the evidence for AIT products that are currently manufactured and available for clinical use. A total of 56 eligible double-blind, randomized, placebo-controlled trials of HDM AIT for the treatment of AA and/or AR in humans fit the inclusion criteria and investigated a total of 14 commercial AIT products; together, the 56 studies enrolled a total of 14,619 patients. Of the 56 studies, 39 studies investigated the current manufacturer-recommended maintenance dose (MRMD) of the product, and 17 investigated other doses. We identified 39 studies (12,539 patients randomized) for 8 sublingual immunotherapy (SLIT) products and 17 studies (2,080 patients randomized) for subcutaneous immunotherapy products. For AR, 3 products, the ALK 12 standardized-quality (SQ-HDM) SLIT tablet, the ALK 6 SQ-HDM tablet, and the SG 300 index of reactivity SLIT tablet, had both dose-finding studies (DFSs) and phase III definitive studies (DSs) to demonstrate efficacy of the MRMD of the product. For AA, 2 products, the ALK 12 SQ-HDM SLIT tablet and the ALK 6 SQ-HDM tablet, had both DFSs and DSs for the MRMD. No subcutaneous immunotherapy product had a paired DFS and DS supporting the MRMD. A total of 30 studies of products no longer commercially manufactured were excluded. This study will help to inform clinical care and product selection for the treatment of HDM-induced AR and AA.
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  • 文章类型: Journal Article
    目的:这项前瞻性研究旨在通过评估舌下免疫疗法(SLIT)在诊断为过敏性鼻炎(AR)伴/不伴结膜炎(AR/C)的患者中使用含屋尘螨(HDM)提取物的疫苗的持续有效性和安全性,提供进一步的支持性证据。
    方法:对HDM过敏的AR/C患者(n=111,SLIT组:57,对照组:54)于2020年10月至12月接受标准SLIT滴剂或对症药物治疗。研究人员指示患者参加年度医院就诊,以评估各种参数,包括鼻结膜炎生活质量问卷(RQLQ)。视觉模拟量表(VAS),总鼻部症状评分(TNSS),总眼部症状评分(TOSS)和总药物评分(TMS)。在学习期间,所有参与者都被要求在日记卡上保留任何不良事件(AE)的全面记录,然后通过电话传达给调查人员。
    结果:在基线(2020年),TNSS,TOSS,TMS,VAS,SLIT组和对照组的RQLQ评分具有可比性(P>0.05)。经过一年的治疗(2021年),与基线相比,两组所有评分均显著降低(P<0.001).在治疗的第二年(2022年)结束时,与2021年相比,SLIT组的TNSS和RQLQ评分继续显著降低(P<0.05)。第三年(2023年),对照组显示TNSS反弹,TOSS,TMS,和RQLQ分数,与2022年或2021年相比差异显著(P<0.05)。此外,与对照组相比,SLIT组RQLQ所有领域的评分均显著较低(P<0.001).对症治疗影响鼻部症状评分,眼部症状,实际问题,和情感领域在2023年与2021年或2022年相比显著(P<0.05)。在SLIT组中,TNSS没有显著差异,TMS,VAS,在整个治疗的三年中,单敏和多敏患者的RQLQ评分均观察到(P>0.05)。所有AE均为轻度至中度。
    结论:HDM-SLIT的3年疗程在AR/C患者中显示出显着的治疗效果和良好的安全性。重要的是,我们的研究提供了初步证据,表明AR/C对生活质量(QoL)的更大影响可能主要源于鼻部症状,眼部症状,实际问题,和情感幸福。
    OBJECTIVE: This prospective study aims to provide further supportive evidence by assessing the sustained effectiveness and safety of sublingual immunotherapy (SLIT) using a vaccine containing house dust mite (HDM) extracts in patients diagnosed with allergic rhinitis (AR) with/without conjunctivitis (AR/C).
    METHODS: AR/C patients (n = 111, SLIT group: 57, control group: 54) allergic to HDM were treated with standardized SLIT drops or symptomatic drugs from October to December in 2020. The patients were directed by the investigators to attend annual hospital visits for the assessment of various parameters including the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), visual analog scale (VAS), total nasal symptom score (TNSS), total ocular symptom score (TOSS) and total medication score (TMS). During the study period, all participants were mandated to maintain comprehensive records of any adverse events (AEs) on diary cards, which were then communicated to the investigators via telephone.
    RESULTS: At baseline (2020), TNSS, TOSS, TMS, VAS, and RQLQ scores were comparable between SLIT and control groups (P > 0.05). After one year of treatment (2021), significant reduction in all scores compared to the baseline for both groups (P < 0.001). At the end of the second year of treatment (2022), TNSS and RQLQ score in the SLIT group continued to decrease significantly compared to 2021 (P < 0.05). In the third year (2023), the control group showed a rebound in TNSS, TOSS, TMS, and RQLQ scores, significant differences compared to 2022 or 2021 (P < 0.05). Besides, the SLIT group had significantly lower scores across all domains of RQLQ compared to the control group (P < 0.001). Symptomatic treatment influenced the scores of Nasal Symptoms, Eye Symptoms, Practical Problems, and Emotions domains significantly in 2023 compared to 2021 or 2022 (P < 0.05). Within the SLIT group, no significant differences in TNSS, TMS, VAS, and RQLQ scores were observed between monosensitized and polysensitized patients throughout the three years of treatment (P > 0.05). All AEs were mild to moderate.
    CONCLUSIONS: The 3-year course of HDM-SLIT has shown significant therapeutic efficacy and a favorable safety profile in patients with AR/C. Importantly, our study presents initial evidence suggesting that the greater impact of AR/C on quality of life (QoL) may primarily stem from nasal symptoms, eye symptoms, practical issues, and emotional well-being.
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  • 文章类型: Journal Article
    背景:评估舌下特异性免疫治疗(SLIT)在儿童过敏性鼻炎和哮喘青春期前后的临床疗效和肺功能。
    方法:这项回顾性分析包括136名年龄在4-18岁的过敏性哮喘和鼻炎患者,他们接受了两年的SLIT治疗。根据年龄将患者分为两组:青春期前组(4-10岁)和青春期组(11-18岁)。半年后,一年,和两年的缝纫,鼻部症状总评分(TNSS),总鼻炎药物评分(TRMS),日间哮喘症状评分(DASS),夜间哮喘症状评分(NASS),总哮喘药物评分(TAMS),哮喘控制测试(ACT),评估呼气峰流速(PEF%),并与治疗前基线进行比较.
    结果:在两组中,TNSS,TRMS,DASS,NASS,TAMS,ACT,PEF%在半年后显著提高,一年,和两年的SLIT治疗。经过半年的治疗,青春期前患者对TNSS的治疗效果更好,DASS,NASS,和TAMS与青春期组相比。治疗一年后,青春期组的TAMS高于青春期前组。最后,与青春期组相比,PEF%显示出更好的治疗效果.
    结论:SLIT治疗过敏性鼻炎和哮喘患儿青春期前后的鼻炎和哮喘症状可有效控制。减少对症药物的使用,显著改善患者的肺功能,对青春期前儿童哮喘的治疗效果优于青少年。
    BACKGROUND: To evaluate the clinical efficacy of sublingual-specific immunotherapy (SLIT) and pulmonary function in children with allergic rhinitis and asthma before and after puberty.
    METHODS: This retrospective analysis included 136 patients aged 4-18 years with allergic asthma and rhinitis who received two years of SLIT treatment. Patients were divided into two groups based on age: the prepubertal group (4-10 years old) and the pubertal group (11-18 years old). After half a year, one year, and two years of SLIT, the total nasal symptom score (TNSS), total rhinitis medication score (TRMS), daytime asthma symptom score (DASS), nighttime asthma symptom score (NASS), total asthma medication score (TAMS), asthma control test (ACT), and peak expiratory flow rate (PEF%) were evaluated and compared with the baseline before treatment.
    RESULTS: In both groups, TNSS, TRMS, DASS, NASS, TAMS, ACT, and PEF% improved significantly after half a year, one year, and two years of SLIT treatment. After half a year of treatment, prepubertal patients showed better therapy for TNSS, DASS, NASS, and TAMS compared to the pubertal group. The TAMS of the pubertal group was higher than that of the prepubertal group after one year of treatment. Finally, the PEF% showed better therapy compared to the pubertal group.
    CONCLUSIONS: SLIT treatment with Dermatophagoides farinae drops can effectively control the symptoms of rhinitis and asthma in children with allergic rhinitis and asthma before and after puberty, reduce the use of symptomatic drugs, significantly improve the pulmonary function of patients, and have better effects on asthma in prepubertal children than in adolescents.
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  • 文章类型: Journal Article
    背景:舌下免疫疗法(SLIT)治疗常年性变应性鼻炎(AR)尚未在学龄前儿童中进行广泛研究。我们调查了1-4岁儿童屋尘螨(HDM)SLIT片的疗效和安全性。
    方法:根据监护人的偏好,将1-4岁的AR儿童分为SLIT(n=22)和对照组(n=12)。SLIT组每天接受10,000JAU的HDMSLIT片剂,持续12个月,而对照组仅接受对症治疗。
    结果:SLIT组和对照组的基线中位年龄分别为41和34个月,分别,两组的AR症状评分中位数均为4分。与基线相比,12个月后,SLIT组的AR症状评分显着下降(评分:3,p=0.002),而对照组有增加的趋势(评分:6,p=.08)。对SLIT的不良反应轻微,发生在8例患者中(36%)。在SLIT组中,Dermatophagoides(D.)在前6个月中,Farinae特异性IgE(sIgE)水平升高,并在12个月时降低至基线水平。在对照组中,与基线相比,D.farinae-sIgE水平在12个月时显著增加(p=0.01)。仅在SLIT组中,与基线相比,在12个月时,D.farinae特异性IgG4和HDMIgE阻断因子水平显着增加(p<.001)。与对照组(0.7%)相比,SLIT组(0.3%)的喘息频率较低。
    结论:这项初步研究证明了疗效,安全,HDMSLIT片剂对AR学龄前儿童的免疫调节作用。
    BACKGROUND: Sublingual immunotherapy (SLIT) for perennial allergic rhinitis (AR) has not been extensively studied in preschoolers. We investigated the efficacy and safety of house dust mite (HDM) SLIT-tablet for children aged 1-4 years.
    METHODS: Children aged 1-4 years with AR were divided into SLIT (n = 22) and control (n = 12) groups based on their guardians\' preferences. The SLIT group received a daily dose of 10,000 JAU of HDM SLIT-tablet for 12 months, whereas the control group received symptomatic treatment only.
    RESULTS: The baseline median age was 41 and 34 months in the SLIT and control groups, respectively, and the median AR symptom score was 4 for both groups. Compared with baseline, the AR symptom score had decreased significantly in the SLIT group after 12 months (score: 3, p = .002), whereas it tended to increase in the control group (score: 6, p = .08). Adverse reactions to SLIT were mild and occurred in eight patients (36%). In the SLIT group, Dermatophagoides (D.) farinae-specific IgE (sIgE) levels increased during the first 6 months and decreased to baseline levels at 12 months. In the control group, D. farinae-sIgE levels had increased significantly at 12 months compared to baseline (p = .01). D. farinae-specific IgG4 and HDM IgE-blocking factor levels were significantly increased at 12 months compared to baseline in the SLIT group only (p < .001). A lower wheezing frequency was seen in the SLIT group (0.3%) compared to the control group (0.7%).
    CONCLUSIONS: This pilot study demonstrated the efficacy, safety, and immunomodulatory effects of HDM SLIT-tablet in preschoolers with AR.
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  • 文章类型: Journal Article
    舌下免疫疗法(SLIT)的依从性普遍较低,导致短期和长期临床疗效降低。依从性是决定过敏性鼻炎(AR)治疗成功的关键因素。
    分析屋尘螨(HDM)诱发的AR患者对SLIT的依从性以及冠状病毒病2019(COVID-19)对依从性的影响。
    回顾性分析了2018年7月至2022年4月期间开始SLIT的3117例HDM诱发AR患者的临床资料。我们评估了与大流行前相比,COVID-19大流行期间不合规的原因和不合规的变化。
    在3117名患者中,507名(16.27%)患者(年龄,5-67岁)被确定为不合规。不依从性的最常见原因是疗效差(27.22%)。在SLIT的24-36个月期间,不合规率最高(28.13%,153/544),其次是12-24个月(7.02%,91/1296)。青少年/成人的不依从性明显高于儿童(P=0.000)。尽管广义线性模型分析表明,在SLIT的3-6个月期间,依从性受到COVID-19大流行的影响,对SLIT的总体遵守没有受到大流行的显著影响,根据Kaplan-Meier生存分析。
    本研究中SLIT的不符合率较低,疗效差是不依从的最常见原因.青少年/成人的依从性低于儿童。COVID-19大流行没有显著影响SLIT的合规性,这是AR患者在重大公共卫生事件期间进行家庭治疗的适当策略。
    UNASSIGNED: Compliance to sublingual immunotherapy (SLIT) is generally low, resulting in reduced short- and long-term clinical efficacy. Compliance is a critical factor determining the success of allergic rhinitis (AR) treatment.
    UNASSIGNED: To analyze the compliance of patients with house dust mite (HDM)-induced AR to SLIT and the impact of coronavirus disease 2019 (COVID-19) on compliance.
    UNASSIGNED: The clinical data of 3117 patients with HDM-induced AR who started SLIT between July 2018 and April 2022 were retrospectively reviewed. We assessed the reasons for non-compliance and the changes in non-compliance during the COVID-19 pandemic compared to the pre-pandemic period.
    UNASSIGNED: Of 3117 patients, 507 (16.27%) patients (ages, 5-67 years) were identified as non-compliant. The most common reason for non-compliance was poor efficacy (27.22%). The non-compliance rate was highest during 24-36 months of SLIT (28.13%, 153/544), followed by 12-24 months (7.02%, 91/1296). Non-compliance was significantly higher in adolescents/adults than in children (P = 0.000). Although the generalized linear model analysis indicated that compliance was affected by the COVID-19 pandemic during 3-6 months of SLIT, the overall compliance to SLIT was not significantly affected by the pandemic, according to the Kaplan-Meier survival analysis.
    UNASSIGNED: The non-compliance rate of SLIT in this study was low, and poor efficacy was the most common reason for non-compliance. The compliance of adolescents/adults was lower than that of children. The COVID-19 pandemic did not significantly impact compliance to SLIT, which is an appropriate strategy for the home treatment of AR patients during major public health events.
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  • 文章类型: Journal Article
    与甘露聚糖缀合的聚合类变应原免疫疗法代表靶向树突细胞的新方法。在这项研究中,我们旨在确定通过皮下或舌下途径施用的源自草花粉的甘露聚糖-类过敏结合物(Phleumpratense和Dactylisglomerata)的最佳剂量。
    随机,双盲,采用双假人设计的安慰剂对照试验,涉及西班牙12个中心的162名参与者。受试者被随机分配到九个不同的治疗组之一,每个人在4个月内接受500,1,000,3,000或5,000mTU/mL剂量的安慰剂或活性治疗.每位参与者接受5次皮下(SC)剂量,每次0.5mL,每30天,和0.2mL的每日舌下(SL)剂量。通过SC接受积极治疗的参与者,通过SL接受安慰剂。通过SL接受积极治疗的参与者,接受安慰剂SC。一组,作为控制,接受了BotSC和SL安慰剂。主要疗效结果是与基线相比,研究结束时滴定鼻激发试验(NPT)的改善。次要结果包括特异性抗体(IgG4,IgE)和细胞(IL-10产生和调节性T细胞)反应。记录并评估所有不良事件和副反应。
    后处理,活跃群体在NPT中表现出从33%到53%的改善,无论给药途径如何,最高剂量显示出最大的改善。相比之下,安慰剂组改善了12%.在3,000mTU/mL的剂量下观察到与安慰剂的显着差异(对于SL,p=0.049,SC的p=0.015)和5,000mTU/mL(SL的p=0.011,SC的p=0.015)。SC给药后观察到IgG4的剂量依赖性增加,以及两种给药途径中产生IL-10的细胞增加。没有严重的全身或局部不良反应记录。不需要肾上腺素。
    用甘露聚糖-类过敏结合物进行草花粉免疫疗法在达到主要结果方面是安全有效的。无论是通过皮下或舌下途径给药,剂量为3,000和5,000mTU/mL。
    https://www.临床试验登记。欧盟/ctr搜索(EudraCT),标识符2014-005471-88;https://www.clinicaltrials.gov,标识符NCT02654223。
    UNASSIGNED: Polymerized allergoids conjugated with mannan represent a novel approach of allergen immunotherapy targeting dendritic cells. In this study, we aimed to determine the optimal dose of mannan-allergoid conjugates derived from grass pollen (Phleum pratense and Dactylis glomerata) administered via either the subcutaneous or sublingual route.
    UNASSIGNED: A randomized, double-blind, placebo-controlled trial with a double-dummy design was conducted, involving 162 participants across 12 centers in Spain. Subjects were randomly allocated to one of nine different treatment groups, each receiving either placebo or active treatment at doses of 500, 1,000, 3,000, or 5,000 mTU/mL over four months. Each participant received five subcutaneous (SC) doses of 0.5 mL each, every 30 days, and a daily sublingual (SL) dose of 0.2 mL. Participants who received active treatment through SC, received placebo through SL. Participants who received active treatment through SL, received placebo SC. One Group, as control, received bot SC and SL placebo. The primary efficacy outcome was the improvement in titrated nasal provocation tests (NPT) at the end of the study compared to baseline. Secondary outcomes included specific antibody (IgG4, IgE) and cellular (IL-10 producing and regulatory T cell) responses. All adverse events and side reactions were recorded and assessed.
    UNASSIGNED: Post-treatment, the active groups showed improvements in NPT ranging from 33% to 53%, with the highest doses showing the greatest improvements regardless of the administration route. In comparison, the placebo group showed a 12% improvement. Significant differences over placebo were observed at doses of 3,000 mTU/mL (p=0.049 for SL, p=0.015 for SC) and 5,000 mTU/mL (p=0.011 for SL, p=0.015 for SC). A dose-dependent increase in IgG4 was observed following SC administration, and an increase in IL-10 producing cells for both routes of administration. No serious systemic or local adverse reactions were recorded, and no adrenaline was required.
    UNASSIGNED: Grass pollen immunotherapy with mannan-allergoid conjugates was found to be safe and efficacious in achieving the primary outcome, whether administered via the subcutaneous or sublingual routes, at doses of 3,000 and 5,000 mTU/mL.
    UNASSIGNED: https://www.clinicaltrialsregister.eu/ctr-search (EudraCT), identifier 2014-005471-88; https://www.clinicaltrials.gov, identifier NCT02654223.
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