An evidence-based analysis of house dust mite allergen immunotherapy: A call for more rigorous clinical studies
An evidence-based analysis of house dust mite allergen immunotherapy: A call for more rigorous clinical studies
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DOI：
10.1016/j.jaci.2013.09.004
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发表时间：
2013-12-01
影响因子：
14.2
通讯作者：
Demoly, Pascal
中科院分区：
文献类型：
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作者：
Calderon, Moises A.;Casale, Thomas B.;Demoly, Pascal
背景：根据meta分析和综述，皮下过敏原免疫治疗（SCIT）和舌下过敏原免疫治疗（SLIT）对屋尘螨（HDMs）诱发的变应性鼻炎（AR）和过敏性哮喘（AA）患者有益。然而，报告的效应大小在不同的研究中差异很大。目的：我们试图对市售的SCIT和SLIT制剂在hdm诱导AA和hdm诱导ar患者中的应用进行循证医学评估。方法：我们检索了双盲、安慰剂对照的随机临床试验，并分析了研究设计、剂量、方案、患者报告的结果、安全性报告和依从性。结果：44项研究符合我们的纳入标准。一些研究同时测试了SLIT和SCIT，或者同时对AA和AR结果进行评分；因此，我们回顾了35个AA患者治疗组（20个SCIT组和15个SLIT组）和23个AR患者治疗组（7个SCIT组和16个SLIT组）。治疗时间从6周到3年不等。对于SCIT， Der p 1主要过敏原的剂量（报告时）为维持剂量7至30 μ g，累积剂量为60至420 μ g。对于SLIT，维持剂量为0.8 ~ 70 μ g，累积剂量为60 ~ 23,695 μ g。安全数据经常缺失或报告不足。与安慰剂相比，SCIT的活跃症状评分在统计学上显著高于SLIT。结论：HDM SCIT和SLIT的基本治疗参数（如剂量和持续时间）尚无共识。迫切需要严格的、长期的、双盲的、安慰剂对照的随机临床试验，其疗效标准反映了hdm诱发的过敏性疾病的特殊特征。
Background: According to meta-analyses and reviews, subcutaneous allergen immunotherapy (SCIT) and sublingual allergen immunotherapy (SLIT) are beneficial in patients with allergic rhinitis (AR) and allergic asthma (AA) induced by house dust mites (HDMs). However, the reported effect sizes have varied greatly from one study to another.Objective: We sought to perform an evidence-based medicine assessment of commercially available SCIT and SLIT formulations in patients with HDM-induced AA and HDM-induced AR.Methods: We searched for double-blind, placebo-controlled randomized clinical trials and analyzed study designs, doses, regimens, patient-reported outcomes, safety reporting, and compliance.Results: Forty-four studies met our inclusion criteria. Some studies tested both SLIT and SCIT or scored both AA and AR outcomes; therefore we reviewed 35 treatment arms in patients with AA (20 for SCIT and 15 for SLIT) and 23 treatment arms in patients with AR (7 for SCIT and 16 for SLIT). The treatment duration ranged from 6 weeks to 3 years. For SCIT, the dose of Der p 1 major allergen (when reported) ranged from 7 to 30 mu g for maintenance doses and 60 to 420 mu g for cumulative doses. For SLIT, the doses of Der p 1 (when reported) were 0.8 to 70 mu g for maintenance doses and 60 to 23,695 mu g for cumulative doses. Safety data were often absent or poorly reported. A statistically significant active versus placebo symptom score was observed more frequently for SCIT than for SLIT.Conclusion: There is no consensus on basic treatment parameters (eg, dose and duration) in HDM SCIT and SLIT. There is an urgent need for rigorous, long-term, double-blind, placebo-controlled randomized clinical trials with an efficacy criterion that reflects the particular features of HDM-induced allergic disease.