Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.
JAMA. 2013 Mar 27;309(12):1278-88. doi: 10.1001/jama.2013.2049.
Allergic rhinitis affects up to 40% of the US population. To desensitize allergic individuals, subcutaneous injection immunotherapy or sublingual immunotherapy may be administered. In the United States, sublingual immunotherapy is not approved by the Food and Drug Administration. However, some US physicians use aqueous allergens, off-label, for sublingual desensitization.
To systematically review the effectiveness and safety of aqueous sublingual immunotherapy for allergic rhinoconjunctivitis and asthma.
The databases of MEDLINE, EMBASE, LILACS, and the Cochrane Central Register of Controlled Trials were searched through December 22, 2012. English-language randomized controlled trials were included if they compared sublingual immunotherapy with placebo, pharmacotherapy, or other sublingual immunotherapy regimens and reported clinical outcomes. Studies of sublingual immunotherapy that are unavailable in the United States and for which a related immunotherapy is unavailable in the United States were excluded. Paired reviewers selected articles and extracted the data. The strength of the evidence for each comparison and outcome was graded based on the risk of bias (scored on allocation, concealment of intervention, incomplete data, sponsor company involvement, and other bias), consistency, magnitude of effect, and the directness of the evidence.
Sixty-three studies with 5131 participants met the inclusion criteria. Participants' ages ranged from 4 to 74 years. Twenty studies (n = 1814 patients) enrolled only children. The risk of bias was medium in 43 studies (68%). Strong evidence supports that sublingual immunotherapy improves asthma symptoms, with 8 of 13 studies reporting greater than 40% improvement vs the comparator. Moderate evidence supports that sublingual immunotherapy use decreases rhinitis or rhinoconjunctivitis symptoms, with 9 of 36 studies demonstrating greater than 40% improvement vs the comparator. Medication use for asthma and allergies decreased by more than 40% in 16 of 41 studies of sublingual immunotherapy with moderate grade evidence. Moderate evidence supports that sublingual immunotherapy improves conjunctivitis symptoms (13 studies), combined symptom and medication scores (20 studies), and disease-specific quality of life (8 studies). Local reactions were frequent, but anaphylaxis was not reported.
The overall evidence provides a moderate grade level of evidence to support the effectiveness of sublingual immunotherapy for the treatment of allergic rhinitis and asthma, but high-quality studies are still needed to answer questions regarding optimal dosing strategies. There were limitations in the standardization of adverse events reporting, but no life-threatening adverse events were noted in this review.
过敏性鼻炎影响了多达 40%的美国人口。为了脱敏过敏个体，可以进行皮下注射免疫疗法或舌下免疫疗法。在美国，舌下免疫疗法未获得食品和药物管理局的批准。然而，一些美国医生使用水性过敏原，进行标签外舌下脱敏治疗。
系统地回顾用于过敏性鼻结膜炎和哮喘的水性舌下免疫疗法的有效性和安全性。
通过 MEDLINE、EMBASE、LILACS 和 Cochrane 对照试验中心注册库搜索了截至 2012 年 12 月 22 日的数据库。如果研究比较了舌下免疫疗法与安慰剂、药物疗法或其他舌下免疫疗法方案，并报告了临床结果，则纳入了英语随机对照试验。排除了在美国不可用的舌下免疫疗法研究和在美国不可用相关免疫疗法的研究。配对审查员选择了文章并提取了数据。根据偏倚风险（分配、干预隐藏、数据不完整、赞助公司参与和其他偏倚）、一致性、效应大小和证据的直接性，对每一个比较和结果的证据强度进行了分级。
有 63 项研究（5131 名参与者）符合纳入标准。参与者的年龄从 4 岁到 74 岁不等。20 项研究（1814 名患者）仅招募了儿童。43 项研究（68%）的偏倚风险为中等。强有力的证据支持舌下免疫疗法可改善哮喘症状，13 项研究中有 8 项报告与对照组相比改善超过 40%。有中等质量证据支持舌下免疫疗法可减轻鼻炎或鼻结膜炎症状，36 项研究中有 9 项显示与对照组相比改善超过 40%。41 项舌下免疫疗法研究中有 16 项报告药物治疗哮喘和过敏的使用率降低了 40%以上，具有中等偏倚证据。有中等质量证据支持舌下免疫疗法可改善结膜炎症状（13 项研究）、联合症状和药物评分（20 项研究）和疾病特异性生活质量（8 项研究）。局部反应很常见，但没有报告过敏反应。
总体证据提供了中等质量水平的证据，支持舌下免疫疗法治疗过敏性鼻炎和哮喘的有效性，但仍需要高质量的研究来回答有关最佳剂量策略的问题。在不良事件报告的标准化方面存在局限性，但本综述中未发现危及生命的不良事件。
