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高剂量螨提取物舌下免疫疗法治疗哮喘的疗效:台湾一项多中心、双盲、随机、安慰剂对照研究

Efficacy of sublingual immunotherapy with high-dose mite extracts in asthma: a multi-center, double-blind, randomized, and placebo-controlled study in Taiwan.

作者信息

Niu Chen-Kuang, Chen Wu-Yuan, Huang Jing-Long, Lue Ko-Huang, Wang Jiu-Yao

机构信息

Division of Pediatric Pulmonology, Kaohsiung Chang Gung Children's Hospital, Department of Pediatrics, Medical College, Kaohsiung Medical University Hospital, Taiwan, ROC.

出版信息

Respir Med. 2006 Aug;100(8):1374-83. doi: 10.1016/j.rmed.2005.11.016. Epub 2006 Jan 5.

DOI:10.1016/j.rmed.2005.11.016
PMID:16403616
Abstract

Sublingual immunotherapy (SLIT) has been recommended as a viable alternative to subcutaneous injection therapy in the treatment of airway allergies, though more data is needed from well-controlled studies for documenting its efficacy in different ethnic populations. Ninety-seven children (age range 6-12 years), mild-to-moderate asthma with a single sensitization to mite allergen, were enrolled from 5 medical centers in Taiwan to evaluate the efficacy and safety of SLIT with standardized mite extracts, which contain Dermatophagoides pteronyssinus (D.p.) and Dermatophagoides farinae (D.f.). Patients were double blinded and randomly assigned to either a SLIT or placebo group. Following 24 weeks of study period, symptom and medication scores, lung function tests, skin prick tests, total serum IgE, and specific IgE to D.p. and D.f. were recorded. The results showed that there was statistically significant difference between these two groups in the analysis of daily (P=0.011), nighttime (P=0.028), and daytime (P=0.009) asthmatic scores after 24 weeks of treatment. Patients receiving SLIT improved their forced vital capacity (FVC), forced expiratory volume in 1s (FEV1), and peak expiratory flow (PEF) as compared to baseline (P=0.042, P=0.048, and P=0.001, respectively). No differences were found in skin prick test, total serum IgE and specific IgE to D.p. and D.f. Tolerance with high-dose SLIT was good with few minor adverse events reported. Our results indicated that a 24-week SLIT is of clinical benefit to mite-sensitive asthmatic children in Taiwan.

摘要

舌下免疫疗法(SLIT)已被推荐作为皮下注射疗法的一种可行替代方法,用于治疗气道过敏,不过仍需要来自严格对照研究的更多数据,以证明其在不同种族人群中的疗效。从台湾的5个医疗中心招募了97名儿童(年龄范围6至12岁),他们患有轻度至中度哮喘且对螨过敏原单一致敏,以评估使用标准化螨提取物(其中包含屋尘螨和粉尘螨)进行舌下免疫疗法的疗效和安全性。患者被双盲并随机分配到舌下免疫疗法组或安慰剂组。在24周的研究期后,记录症状和用药评分、肺功能测试、皮肤点刺试验、总血清IgE以及对屋尘螨和粉尘螨的特异性IgE。结果显示,在治疗24周后,两组在每日(P = 0.011)、夜间(P = 0.028)和白天(P = 0.009)哮喘评分的分析中存在统计学显著差异。与基线相比,接受舌下免疫疗法的患者其用力肺活量(FVC)、1秒用力呼气容积(FEV1)和呼气峰值流速(PEF)均有所改善(分别为P = 0.042、P = 0.048和P = 0.001)。在皮肤点刺试验、总血清IgE以及对屋尘螨和粉尘螨的特异性IgE方面未发现差异。高剂量舌下免疫疗法的耐受性良好,报告的轻微不良事件较少。我们的结果表明,24周的舌下免疫疗法对台湾对螨敏感的哮喘儿童具有临床益处。

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