Allergen injection immunotherapy for seasonal allergic rhinitis
Editorial Group: Cochrane Ear, Nose and Throat Disorders Group
Published Online: 24 JAN 2007
Assessed as up-to-date: 13 NOV 2006
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
How to Cite
Calderon MA, Alves B, Jacobson M, Hurwitz B, Sheikh A, Durham S. Allergen injection immunotherapy for seasonal allergic rhinitis. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD001936. DOI: 10.1002/14651858.CD001936.pub2.
- Publication Status: Edited (no change to conclusions)
- Published Online: 24 JAN 2007
Allergic rhinitis is the most common of the allergic diseases. Despite improved understanding of the pathophysiology of allergic rhinitis and advances in its pharmacological treatment, its prevalence has increased worldwide. For patients whose symptoms remain uncontrolled despite medical treatment, allergen injection immunotherapy is advised. An allergen-based treatment may reduce symptoms, the need for medication and modify the natural course of this disease.
To evaluate the efficacy and safety of subcutaneous specific allergen immunotherapy, compared with placebo, for reducing symptoms and medication requirements in seasonal allergic rhinitis patients.
We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1 2006), MEDLINE (1950 to 2006), EMBASE (1974 to 2006), Pre-MEDLINE, KOREAMED, INDMED, LILACS, PAKMEDINET, Scisearch, mRCT and the National Research Register. The date of the last search was February 2006.
All studies identified by the searches were assessed to identify randomised controlled trials involving participants with symptoms of seasonal allergic rhinitis and proven allergen sensitivity, treated with subcutaneous allergen specific immunotherapy or corresponding placebo.
Data collection and analysis
Two independent authors identified all studies reporting double-blind, placebo controlled randomised trials of specific immunotherapy in patients with seasonal allergic rhinitis due to tree, grass or weed pollens. Two authors independently performed quality assessment of studies. Data from identified studies were abstracted onto a standard extraction sheet and subsequently entered into RevMan 4.2.8. Analysis was performed using the Standardised Mean Difference (SMD) method and a random-effects model; P values < 0.05 were considered statistically significant. The primary outcome measures were symptom scores, medication use, quality of life and adverse events.
We retrieved 1111 publications of which 51 satisfied our inclusion criteria. In total there were 2871 participants (1645 active, 1226 placebo), each receiving on average 18 injections. Duration of immunotherapy varied from three days to three years. Symptom score data from 15 trials were suitable for meta-analysis and showed an overall reduction in the immunotherapy group (SMD -0.73 (95% CI -0.97 to -0.50, P < 0.00001)). Medication score data from 13 trials showed an overall reduction in the immunotherapy group (SMD of -0.57 (95% CI -0.82 to -0.33, p<0.00001)). Clinical interpretation of the effect size is difficult. Adrenaline was given in 0.13% (19 of 14085 injections) of those on active treatment and in 0.01% (1 of 8278 injections) of the placebo group for treatment of adverse events. There were no fatalities.
This review has shown that specific allergen injection immunotherapy in suitably selected patients with seasonal allergic rhinitis results in a significant reduction in symptom scores and medication use. Injection immunotherapy has a known and relatively low risk of severe adverse events. We found no long-term consequences from adverse events.
Plain language summary
Immunotherapy by allergen injections for seasonal allergic rhinitis ('hay fever')
Seasonal allergic rhinitis ('hay fever') is a global health problem and its prevalence has increased considerably in the last two decades. Treatment includes allergen avoidance, drugs such as antihistamine tablets and nasal sprays, and immunotherapy (vaccination). For those patients whose symptoms remain uncontrolled despite drug treatment, specific allergen immunotherapy (SIT) is advised.
Specific allergen immunotherapy is most commonly administered as subcutaneous (under the skin) injections by specialists requiring a building-up period followed by a maintenance period of three to five years. Immunotherapy may also be delivered by the oral, nasal or sublingual route and these will be studied in separate Cochrane reviews, as will immunotherapy for perennial (all year round) allergic rhinitis. In this review we aimed to evaluate the efficacy and safety of injection immunotherapy, compared with placebo, for reducing symptoms and the need for medication.
We identified randomised, double-blind, placebo controlled trials of specific allergen immunotherapy in patients with seasonal allergic rhinitis due to tree, grass or weed pollens. Fifty-one studies satisfied our inclusion criteria. In total there were 2871 participants (1645 in the treatment groups and 1226 in the placebo), each receiving on average 18 injections. The duration of treatment varied from three days to three years.
This review has shown that injection immunotherapy in suitably selected patients with hay fever results in significant reductions in symptom scores and medication use. Injection immunotherapy has a known and relatively low risk of severe adverse events. We found no long-term consequences from adverse events and no fatalities.
我們搜尋數個資料庫，最新的數據為2006年2月的資料： Ear, Nose and Throat Disorders Group Trials Register Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1 2006) MEDLINE (1950 to 2006) EMBASE (1974 to 2006) PreMEDLINE KOREAMED INDMED LILACS PAKMEDINET Scisearch mRCT National Research Register.
所有研究都是利用randomised controlled trials來分析，主要是利用皮下過敏原減敏治療或是安慰劑針對季節性過敏性鼻炎治療，之後的症狀及過敏源的敏感性來做評估
兩個獨立作者分別利用dobuleblind，placebo controlled randomised trials的方式，探求減敏治療對於樹木、雜草、花粉引起季節性過敏性鼻炎的療效。來自兩位作者的數據帶入RevMan 4.2.8軟體，利用Standardised Mean Difference method，randomeffects model；P value<0.05來做統計分析，結果評量是利用病人的臨床症狀、藥物使用及副作用、生活品質做評估
我們找到1111篇資料，其中51個滿足我們的條件。總共2871病人收錄進來，1645病人接受減敏治療，1226病人接受安慰劑治療，平均接受18次注射，治療期間為3天至3年，15個試驗結果減敏治療症狀分數都減低 (SMD −0.73 (95% CI −0.97 – −05.0， P < 0.00001))，13個試驗藥物分數結果也是減低 (SMD OF −0.57 (95% CI −0.82 – −0.33， p<0.00001))。臨床上要解釋成效是比較困難的。adrenaline曾因為藥物副作用而給予減敏治療的病人約0.13%(19/14085次注射)，給予安慰劑病人約0.01%(1/8278次注射)，其中沒有病人死亡
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌
利用過敏原注射治療季節性過敏性鼻炎是一個全球性的健康問題，且其盛行率在最近20年也是逐漸增加，治療包含避開過敏原及藥物治療像是抗組織胺、鼻噴劑、免疫治療等等。如果一般治療無法控制時，特殊的過敏原免疫治療是可以考慮的，最常使用的治療方式為皮下注射，且必須治療3 – 5年，免疫治療也可經口、鼻、舌下的方式給予，這些治療方式也將會再做進一步的研究，且會推廣至經年性的過敏性鼻炎。在這篇研究我們主要目標為評估注射型免疫治療的安全及效度，減少症狀及藥物需求，我們利用radomised，dobuleblind，placebo controlled trials的方式探求減敏治療對於樹木、雜草、花粉引起季節性過敏性鼻炎的療效。51個研究符合我們的條件，共2871病人參與治療(1645病人接受減敏治療，1226病人接受安慰劑治療)，平均18次注射，治療期間3天 – 3年。研究結果發現篩選過的花粉熱病人在注射型免疫治療後的藥物及症狀有減緩的趨勢，這種治療方式不會有嚴重的副作用且不曾有死亡的病歷