舌下过敏原免疫治疗：来自随机试验、真实世界研究和荟萃分析的证据。

文献信息

中文摘要

背景： 过敏原免疫治疗是IgE介导的呼吸道过敏唯一可能改变疾病进程的治疗。在可用的给药途径中，舌下免疫治疗（SLIT）因其良好的安全性特征和更高的患者接受度而受到重视。
目的： 本叙述性综述通过整合随机对照试验、大型观察性队列和荟萃分析的证据，批判性地评价SLIT对季节性和常年性呼吸道过敏的临床疗效、真实世界效果和长期疾病修饰潜力，并关注过敏原和产品特异性结局以及与年龄相关的差异。
结果： 稳健的RCT证据支持草类和HDM SLIT片剂在症状和药物使用方面具有临床意义的减少，关键试验中在3年疗程后持续获益长达1-2年。真实世界队列证实了这些发现，并额外报告SLIT后新发哮喘风险降低和长期药物配发减少。SLIT用于哮喘的证据显示在某些试验中加重风险降低，尽管其对日常控制的影响不太一致。儿科试验通常反映成人结局，具有良好的安全性和有效性，尤其是标准化片剂；然而，试验间的异质性和历史上的方法学局限性仍是重要的注意事项。荟萃分析证实了总体疗效，但强调了研究间存在显著异质性以及产品特异性评价的重要性。
结论： SLIT可能是呼吸道过敏性鼻炎的一种有效、耐受良好、可改变疾病进程的选择，并在选定的哮喘结局方面显示出前景。最佳获益需要标准化、剂量充分的制剂和持续依从（≥3年）。未来研究应优先开展产品特异性、样本量充分且结局标准化的试验，以完善患者选择和长期疾病修饰终点。

英文摘要

BACKGROUND: Allergen immunotherapy is the only potentially disease-modifying treatment for IgE-mediated respiratory allergy. Among the available routes, sublingual immunotherapy (SLIT) has gained prominence because of its favorable safety profile and greater patient acceptability.
OBJECTIVES: This narrative review critically appraises the clinical efficacy, real-world effectiveness, and long-term disease-modifying potential of SLIT for seasonal and perennial respiratory allergies by integrating evidence from randomized controlled trials, large observational cohorts, and meta-analyses, with attention to allergen- and product-specific outcomes and age-related differences.
RESULTS: Robust RCT evidence supports clinically meaningful reductions in symptoms and medication use with grass and HDM SLIT tablets, with sustained benefits observed up to 1-2 years after a 3-year treatment course in key trials. Real-world cohorts corroborate these findings and additionally report a reduced risk of new asthma onset and lower long-term medication dispensing after SLIT. Evidence for SLIT in asthma shows reductions in exacerbation risk in some trials, although its effects on day-to-day control are less consistent. Pediatric trials generally mirror adult outcomes, with favorable safety and efficacy, particularly for standardized tablets; however, heterogeneity across trials and historical methodological limitations remain important caveats. Meta-analyses confirm overall efficacy but highlight substantial between-study heterogeneity and the importance of product-specific evaluations.
CONCLUSIONS: SLIT could be an effective, well-tolerated, disease-modifying option for respiratory allergic rhinitis and shows promise for selected asthma outcomes. Optimal benefits require standardized, adequately dosed formulations and sustained adherence (≥3 years). Future research should prioritize product-specific, adequately powered trials with standardized outcomes to refine patient selection and long-term disease-modification endpoints.