Yepes-Nuñez Juan Jose, Zhang Yuan, Roqué i Figuls Marta, Bartra Tomas Joan, Reyes Juan Manuel, Pineda de la Losa Fernando, Enrique Ernesto
Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West. HSC-2C21, Hamilton, ON, Canada, L8S 4K1.
Cochrane Database Syst Rev. 2015 Nov 9;2015(11):CD010522. doi: 10.1002/14651858.CD010522.pub2.
Food allergy is an abnormal immunological response following exposure (usually ingestion) to a food. Elimination of the allergen is the principle treatment for food allergy, including allergy to fruit. Accidental ingestion of allergenic foods can result in severe anaphylactic reactions. Allergen-specific immunotherapy (SIT) is a specific treatment, when the avoidance of allergenic foods is problematic. Recently, studies have been conducted on different types of immunotherapy for the treatment of food allergy, including oral (OIT) and sublingual immunotherapy (SLIT).
To determine the efficacy and safety of oral and sublingual immunotherapy in children and adults with food allergy to fruits, when compared with placebo or an elimination strategy.
The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, and AMED were searched for published results along with trial registries and the Journal of Negative Results in BioMedicine for grey literature. The date of the most recent search was July 2015.
Randomised controlled trials (RCTs) comparing OIT or SLIT with placebo or an elimination diet were included. Participants were children or adults diagnosed with food allergy who presented immediate fruit reactions.
We used standard methodological procedures expected by the Cochrane Collaboration. We assessed treatment effect through risk ratios (RRs) for dichotomous outcomes.
We identified two RCTs (N=89) eligible for inclusion. These RCTs addressed oral or sublingual immunotherapy, both in adults, with an allergy to apple or peach respectively. Both studies enrolled a small number of participants and used different methods to provide these differing types of immunotherapy. Both studies were judged to be at high risk of bias in at least one domain. Overall, the quality of evidence was judged to be very low due to the small number of studies and participants and possible bias. The studies were clinically heterogeneous and hence we did not pool the results. A study comparing SLIT with placebo for allergy to peach did not detect a significant difference between the number of patients desensitised at six months following a double-blind placebo-controlled food challenge (RR 1.16, 95% confidence interval (CI) 0.49 to 2.74). The second study, comparing OIT versus no treatment for apple allergy, found an effect on desensitisation in favour of the intervention using an oral provocation test at eight months, but results were imprecise (RR 17.50, 95% CI 1.13 to 270.19). Neither study reported data on evidence of immunologic tolerance. In both studies, the incidence of mild and moderate adverse events was higher in the intervention groups than in the controls. In the study comparing SLIT with placebo, patients in the intervention group experienced significantly more local adverse reactions than participants in the control group (RR 3.21, 95% CI 1.51 to 6.82), though there was not a significant difference in the number of participants experiencing systemic adverse reactions (RR 0.81, 95% CI 0.22 to 3.02). In the study of OIT, two of the 25 participants in the intervention group reported relevant side effects, whereas no participants in the control group reported relevant side effects.
AUTHORS' CONCLUSIONS: There is insufficient evidence for using OIT or SLIT to treat allergy to fruit, specifically related to peach and apple. Mild or moderate adverse reactions were reported more frequently in people receiving OIT or SLIT. However, these reactions could be treated successfully with medications.
食物过敏是指接触(通常为摄入)某种食物后出现的异常免疫反应。消除过敏原是食物过敏(包括水果过敏)的主要治疗方法。意外摄入致敏食物可导致严重的过敏反应。当避免食用致敏食物存在问题时,特异性免疫疗法(SIT)是一种针对性治疗方法。最近,针对不同类型的免疫疗法治疗食物过敏开展了多项研究,包括口服免疫疗法(OIT)和舌下免疫疗法(SLIT)。
比较口服和舌下免疫疗法与安慰剂或排除策略相比,在对水果过敏的儿童和成人中的疗效和安全性。
检索Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE、CINAHL和AMED以获取已发表的结果,同时检索试验注册库以及《生物医学阴性结果杂志》以获取灰色文献。最近一次检索日期为2015年7月。
纳入比较OIT或SLIT与安慰剂或排除饮食的随机对照试验(RCT)。参与者为被诊断为食物过敏且对水果出现速发型反应的儿童或成人。
我们采用了Cochrane协作网期望的标准方法程序。我们通过二分类结局的风险比(RR)评估治疗效果。
我们确定了两项符合纳入标准的RCT(N = 89)。这些RCT分别针对对苹果或桃子过敏的成人进行口服或舌下免疫疗法研究。两项研究纳入的参与者数量均较少,且采用不同方法提供不同类型的免疫疗法。两项研究在至少一个领域均被判定存在高偏倚风险。总体而言,由于研究和参与者数量较少以及可能存在的偏倚,证据质量被判定为非常低。这些研究在临床上具有异质性,因此我们未合并结果。一项比较SLIT与安慰剂治疗桃子过敏的研究,在双盲安慰剂对照食物激发试验后6个月,未发现脱敏患者数量有显著差异(RR 1.16,95%置信区间(CI)0.49至2.74)。第二项研究比较OIT与不治疗苹果过敏的情况,在8个月时通过口服激发试验发现干预措施对脱敏有效果,但结果不精确(RR 17.50,95% CI 1.13至270.19)。两项研究均未报告免疫耐受证据的数据。在两项研究中,干预组轻度和中度不良事件的发生率均高于对照组。在比较SLIT与安慰剂的研究中,干预组患者出现的局部不良反应明显多于对照组参与者(RR 3.21,95% CI 1.51至6.82),尽管出现全身不良反应的参与者数量无显著差异(RR 0.81,95% CI 0.22至3.02)。在OIT研究中,干预组的25名参与者中有2名报告了相关副作用,而对照组没有参与者报告相关副作用。
没有足够证据支持使用OIT或SLIT治疗水果过敏,特别是与桃子和苹果相关的过敏。接受OIT或SLIT的人群中,轻度或中度不良反应报告更为频繁。然而,这些反应可用药物成功治疗。