JAMA:研究支持舌下免疫疗法治疗过敏性鼻炎和哮喘

2013-04-22 JAMA dxy

过敏性鼻炎困扰着多达百分之40的美国人口。通常予以皮下注射免疫治疗或舌下免疫治疗治疗。该疗法在欧洲已经获得使用但却没有在美国获得美国食品与药物管理局的批准。然而一些美国医生对标注外使用水溶性免疫原舌下免疫疗法治疗过敏性鼻炎表现出了相当大的兴趣。 发表在《美国医学会杂志》2013年4月期刊上的一则研究显示,在一项对一种针对过敏性鼻炎和哮喘的疗法所做的检查中,研究人员在先前的研究中发现了适度的证据以

过敏性鼻炎困扰着多达百分之40的美国人口。通常予以皮下注射免疫治疗或舌下免疫治疗治疗。该疗法在欧洲已经获得使用但却没有在美国获得美国食品与药物管理局的批准。然而一些美国医生对标注外使用水溶性免疫原舌下免疫疗法治疗过敏性鼻炎表现出了相当大的兴趣。

发表在《美国医学会杂志》2013年4月期刊上的一则研究显示,在一项对一种针对过敏性鼻炎和哮喘的疗法所做的检查中,研究人员在先前的研究中发现了适度的证据以支持应用舌下免疫疗法来治疗这些疾病的做法,舌下免疫疗法涉及在一个较长的治疗期内在舌下给予水溶性过敏原并通过局部吸收使过敏个体脱敏以减少其过敏症状。与皮下(皮肤下)免疫疗法相比,舌下免疫疗法容易进行,不需要注射,而且患者可在家中而不必前往诊所进行治疗。

巴尔的摩约翰霍普金斯大学医学院的Sandra Y. Lin,M.D.及其同事对以往的研究开展了一项系统性的回顾,旨在检查用水溶性舌下免疫疗法治疗过敏性鼻结膜炎和哮喘的有效性和安全性。研究者检索了MEDLINE, EMBASE, LILACS等数据库以及Cochrane对照试验注册数据,日期截止至2012年12月22日。研究纳入标准为英文随机对照试验研究,舌下免疫疗法与安慰剂,药物疗法或其他舌下免疫治疗方案及已报道临床结局的试验进行对照。在美国未被批准的舌下免疫治疗研究或未被批准的相关免疫治疗皆被排除。研究由两位评审员选择文章并析取数据。每一项对照试验和结局证据的有效性基于偏倚风险(分组评分,介入措施设盲,数据不完全,有关资助方,以及其他偏倚),一致性,有效性程度,以及是否直接证据等予以分类。

在对医学文献进行审阅之后,研究人员确认了有5131名参与者的63项研究符合进行综述的纳入标准。参与者的年龄范围在4-74岁之间。有20项研究(n=1,814位患者)仅包括儿童患者。有43项研究(68%)的偏倚风险居中。研究者发现,有强烈证据支持舌下免疫治疗可改善哮喘症状,13项研究中有8项报道与安慰剂相比,舌下免疫治疗改善程度超过百分之40。适度证据支持舌下免疫治疗可缓解鼻炎或鼻炎症状,36项研究中有9项证实与对照组相比,改善程度超过百分之40。研究者发现,41项研究中有16项有适度证据显示药物疗法可改善哮喘或变态反应至少百分之40。有13项研究显示适度证据支持舌下免疫治疗改善结膜炎症状,有20项研究支持改善症状和治疗得分,有8项研究支持改善疾病特异性生活质量。局部反应频繁出现,但未见过敏反应报道出现。

文章的作者得出结论:总体证据提供适中水平的证据,支持用舌下免疫疗法来治疗过敏性鼻炎和哮喘的做法,但仍需进行高质量研究以明确最佳剂量治疗策略的问题。这篇综述的局限之处在于不良反应报道的标准化,但并无危及生命的不良事件出现。

哮喘相关的拓展阅读:


Sublingual Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and Asthma:
A Systematic Review
Objective 
To systematically review the effectiveness and safety of aqueous sublingual immunotherapy for allergic rhinoconjunctivitis and asthma.
Evidence Acquisition 
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.
Results 
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.
Conclusions and Relevance 
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.

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