{"title":"针对过敏性鼻炎的大规模多中心随机安慰剂对照皮下屋尘螨过敏原免疫疗法(HDM SCIT):MITAR 研究。","authors":"Narissara Suratannon, Ticha Limsuwan, Pongsakorn Tantilipikorn, Pantipa Chatchatee, Atik Saengapaswiriya, Tadech Boonpiyathad, Torpong Thongngarm, Boonsam Roongpuvapaht, Hiroshi Chantaphakul, Prapasri Kulalert, Sanguansak Thanaviratananich, Pasuree Sangsupawanich, Supranee Fooanant, Wiparat Manuyakorn, Supinda Chusakul, Orathai Piboonpochanun, Tanakorn Apornpong, Jongkonnee Wongpiyabovorn, Kiat Ruxrungtham","doi":"10.12932/AP-221123-1735","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Previous house dust mite subcutaneous immunotherapy (HDM SCIT) placebo-controlled trials have small sample sizes and lack a consensus on baseline treatment.</p><p><strong>Objective: </strong>To determine the efficacy of HDM SCIT in moderate-to-severe allergic rhinitis (AR) patients treated with an intranasal corticosteroid at baseline.</p><p><strong>Methods: </strong>We conducted a randomized, placebo-controlled trial comparing HDM SCIT against placebo in Dermatophagoides pteronyssinus (Der p) sensitized. All patients received standard of care according to Allergic Rhinitis and its Impact on Asthma (ARIA) guideline, including an intranasal steroid (INCS) at baseline. The primary endpoint was the comparison of a composite score, combining the total nasal symptom score and medication score, assessed at the twelfth month post-treatment.</p><p><strong>Results: </strong>Of the 144 subjects, 108 received HDM-SCIT and 36 received a placebo. The median age was 30 years (range 11-61), with 60% being female. The mean Der p wheal diameter was 9.4 mm (SD 4.4). After one year of treatment, the composite score median (IQR) in the HDM SCIT group and the placebo group was 0.75 (0.50-1.13) and 0.63 (0.50-1.25), respectively (p > 0.05). Both groups exhibited a significant mean change in the composite score from baseline (p < 0.001), but there was no significant difference between the groups. The median (IQR) serum Der p-specific immunoglobulin G4 level significantly increased only in the HDM SCIT arm (p ≤ 0.001).</p><p><strong>Conclusion: </strong>One-year HDM SCIT significantly reduced both symptoms and medication use in HDM-allergic rhinitis patients. However, the changes were not significantly different from those in the placebo group, who also received an INCS at baseline. A longer-term study is warranted to assess disease modification factors.</p>","PeriodicalId":8552,"journal":{"name":"Asian Pacific journal of allergy and immunology","volume":"42 3","pages":"233-245"},"PeriodicalIF":2.3000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A large scale multicentre randomized, placebo-controlled subcutaneous house dust mite allergen immunotherapy (HDM SCIT) in allergic rhinitis: MITAR Study.\",\"authors\":\"Narissara Suratannon, Ticha Limsuwan, Pongsakorn Tantilipikorn, Pantipa Chatchatee, Atik Saengapaswiriya, Tadech Boonpiyathad, Torpong Thongngarm, Boonsam Roongpuvapaht, Hiroshi Chantaphakul, Prapasri Kulalert, Sanguansak Thanaviratananich, Pasuree Sangsupawanich, Supranee Fooanant, Wiparat Manuyakorn, Supinda Chusakul, Orathai Piboonpochanun, Tanakorn Apornpong, Jongkonnee Wongpiyabovorn, Kiat Ruxrungtham\",\"doi\":\"10.12932/AP-221123-1735\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Previous house dust mite subcutaneous immunotherapy (HDM SCIT) placebo-controlled trials have small sample sizes and lack a consensus on baseline treatment.</p><p><strong>Objective: </strong>To determine the efficacy of HDM SCIT in moderate-to-severe allergic rhinitis (AR) patients treated with an intranasal corticosteroid at baseline.</p><p><strong>Methods: </strong>We conducted a randomized, placebo-controlled trial comparing HDM SCIT against placebo in Dermatophagoides pteronyssinus (Der p) sensitized. All patients received standard of care according to Allergic Rhinitis and its Impact on Asthma (ARIA) guideline, including an intranasal steroid (INCS) at baseline. The primary endpoint was the comparison of a composite score, combining the total nasal symptom score and medication score, assessed at the twelfth month post-treatment.</p><p><strong>Results: </strong>Of the 144 subjects, 108 received HDM-SCIT and 36 received a placebo. The median age was 30 years (range 11-61), with 60% being female. The mean Der p wheal diameter was 9.4 mm (SD 4.4). After one year of treatment, the composite score median (IQR) in the HDM SCIT group and the placebo group was 0.75 (0.50-1.13) and 0.63 (0.50-1.25), respectively (p > 0.05). Both groups exhibited a significant mean change in the composite score from baseline (p < 0.001), but there was no significant difference between the groups. The median (IQR) serum Der p-specific immunoglobulin G4 level significantly increased only in the HDM SCIT arm (p ≤ 0.001).</p><p><strong>Conclusion: </strong>One-year HDM SCIT significantly reduced both symptoms and medication use in HDM-allergic rhinitis patients. However, the changes were not significantly different from those in the placebo group, who also received an INCS at baseline. A longer-term study is warranted to assess disease modification factors.</p>\",\"PeriodicalId\":8552,\"journal\":{\"name\":\"Asian Pacific journal of allergy and immunology\",\"volume\":\"42 3\",\"pages\":\"233-245\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Asian Pacific journal of allergy and immunology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.12932/AP-221123-1735\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Asian Pacific journal of allergy and immunology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.12932/AP-221123-1735","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ALLERGY","Score":null,"Total":0}
引用次数: 0
摘要
背景:以往的屋尘螨皮下免疫疗法(HDM SCIT)安慰剂对照试验样本较少,且对基线治疗缺乏共识:以往的屋尘螨皮下免疫疗法(HDM SCIT)安慰剂对照试验的样本量较小,而且对基线治疗缺乏共识:目的:确定家尘螨皮下免疫疗法对中重度过敏性鼻炎(AR)患者的疗效:我们进行了一项随机安慰剂对照试验,比较了HDM SCIT与安慰剂对Dermatophagoides pteronyssinus (Der p)致敏患者的疗效。所有患者均按照过敏性鼻炎及其对哮喘的影响(ARIA)指南接受标准治疗,包括在基线时使用鼻内类固醇(INCS)。主要终点是在治疗后第十二个月评估鼻部症状总分和药物治疗得分的综合得分比较:144名受试者中,108人接受了HDM-SCIT治疗,36人接受了安慰剂治疗。中位年龄为 30 岁(11-61 岁不等),60% 为女性。平均 Der p 乳泡直径为 9.4 毫米(标准偏差为 4.4)。治疗一年后,HDM SCIT 组和安慰剂组的综合评分中位数(IQR)分别为 0.75(0.50-1.13)和 0.63(0.50-1.25)(P > 0.05)。两组的综合评分平均值与基线相比均有显著变化(P < 0.001),但组间无明显差异。只有 HDM SCIT 组的血清 Der p 特异性免疫球蛋白 G4 的中位数(IQR)水平显著升高(p ≤ 0.001):结论:为期一年的HDM SCIT明显减轻了HDM过敏性鼻炎患者的症状和用药量。结论:为期一年的HDM SCIT能明显减轻HDM过敏性鼻炎患者的症状和用药量,但这些变化与安慰剂组没有明显差异,安慰剂组在基线时也接受了INCS。有必要进行更长期的研究,以评估疾病改变因素。
A large scale multicentre randomized, placebo-controlled subcutaneous house dust mite allergen immunotherapy (HDM SCIT) in allergic rhinitis: MITAR Study.
Background: Previous house dust mite subcutaneous immunotherapy (HDM SCIT) placebo-controlled trials have small sample sizes and lack a consensus on baseline treatment.
Objective: To determine the efficacy of HDM SCIT in moderate-to-severe allergic rhinitis (AR) patients treated with an intranasal corticosteroid at baseline.
Methods: We conducted a randomized, placebo-controlled trial comparing HDM SCIT against placebo in Dermatophagoides pteronyssinus (Der p) sensitized. All patients received standard of care according to Allergic Rhinitis and its Impact on Asthma (ARIA) guideline, including an intranasal steroid (INCS) at baseline. The primary endpoint was the comparison of a composite score, combining the total nasal symptom score and medication score, assessed at the twelfth month post-treatment.
Results: Of the 144 subjects, 108 received HDM-SCIT and 36 received a placebo. The median age was 30 years (range 11-61), with 60% being female. The mean Der p wheal diameter was 9.4 mm (SD 4.4). After one year of treatment, the composite score median (IQR) in the HDM SCIT group and the placebo group was 0.75 (0.50-1.13) and 0.63 (0.50-1.25), respectively (p > 0.05). Both groups exhibited a significant mean change in the composite score from baseline (p < 0.001), but there was no significant difference between the groups. The median (IQR) serum Der p-specific immunoglobulin G4 level significantly increased only in the HDM SCIT arm (p ≤ 0.001).
Conclusion: One-year HDM SCIT significantly reduced both symptoms and medication use in HDM-allergic rhinitis patients. However, the changes were not significantly different from those in the placebo group, who also received an INCS at baseline. A longer-term study is warranted to assess disease modification factors.
期刊介绍:
The Asian Pacific Journal of Allergy and Immunology (APJAI) is an online open access journal with the recent impact factor (2018) 1.747
APJAI published 4 times per annum (March, June, September, December). Four issues constitute one volume.
APJAI publishes original research articles of basic science, clinical science and reviews on various aspects of allergy and immunology. This journal is an official journal of and published by the Allergy, Asthma and Immunology Association, Thailand.
The scopes include mechanism, pathogenesis, host-pathogen interaction, host-environment interaction, allergic diseases, immune-mediated diseases, epidemiology, diagnosis, treatment and prevention, immunotherapy, and vaccine. All papers are published in English and are refereed to international standards.