Department of Medicine, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, ON, Canada; The Research Institute of St Joe's Hamilton, Hamilton, ON, Canada.
Department of Medicine, McMaster University, Hamilton, ON, Canada.
J Allergy Clin Immunol Pract. 2022 Sep;10(9):2386-2394. doi: 10.1016/j.jaip.2022.05.015. Epub 2022 May 25.
Current forms of peanut oral immunotherapy (OIT) are associated with side effects, and there is a lack of evidence addressing how to mitigate them.
To determine whether premedication with desloratadine and ranitidine results in fewer side effects during peanut OIT/desensitization.
A total of 43 patients with peanut allergy (mean age, 7.6 ± 2.1 years, 37% females, 63% males, baseline eliciting dose, 33 ± 26 mg) were randomized to OIT with or without concomitant H and H antihistamine blockade, or double-placebo. Patients, study staff/investigators, and statisticians were blinded. The primary outcomes were the frequency and severity of OIT-induced adverse events. The secondary outcomes were quality of life and eliciting doses to blinded food challenge.
Adverse reactions occurred more in the OIT groups compared with the double-placebo group (OIT with antihistamines vs double-placebo hazard ratio, 3.75 [95% CI, 2.79-4.72]; OIT with placebo antihistamines vs double-placebo, hazard ratio, 4.62 [95% CI, 3.61-5.62]). Patients given antihistamines cotreatment with OIT had a similar risk of adverse events compared with those who did not use antihistamines with OIT (hazard ratio, 1.23 [95% CI, 0.49-1.97]). OIT with and without antihistamines accelerated the incidence rate of adverse events compared with double-placebo (4.8 and 6.4 events per patient vs 3.5 per patient, incidence rate ratio, 2.49 [95% CI, 1.36-4.56] and 2.04 [95% CI, 1.01-4.15], respectively). Antihistamines pretreatment modestly reduced the frequency of moderate to severe adverse reactions among OIT-treated groups (1.9 per patient vs 4.2 per patient, incidence rate ratio, 0.46 [95% CI, 0.24-0.89]), primarily urticaria (0.6 vs 2.1 per patient) followed by abdominal pain (2.6 vs 4.2 per patient), but increased neuropsychiatric adverse events (primarily tiredness and sedation, 2.3 vs 0.7 per patient). Eliciting doses after treatment were similar in all groups. Quality of life improved similarly regardless of treatment with peanut OIT or placebo OIT.
Peanut OIT with antihistamines modestly reduce the skin and gastrointestinal components of the high incidence of adverse reactions during OIT, and there are no clear differences in improvement in quality of life whether treated with OIT, OIT with antihistamines, or placebo OIT despite OIT being effective in inducing desensitization. Safer food allergy treatment approaches that importantly improve quality of life need to be proved in future robust randomized trials.
目前的花生口服免疫治疗（OIT）形式存在副作用，并且缺乏减轻这些副作用的证据。
确定在花生 OIT/脱敏过程中预先使用地氯雷他定和雷尼替丁是否会减少副作用。
共有 43 名花生过敏患者（平均年龄 7.6 ± 2.1 岁，37%为女性，63%为男性，基线激发剂量为 33 ± 26mg）被随机分为接受 OIT 治疗或同时接受 H1 和 H2 抗组胺药阻断治疗或接受双安慰剂治疗的组。患者、研究人员和统计人员均设盲。主要结局是 OIT 诱导的不良事件的频率和严重程度。次要结局是生活质量和盲法食物挑战的激发剂量。
与双安慰剂组相比，OIT 组发生不良反应的频率更高（OIT 加抗组胺药组与双安慰剂组的危险比为 3.75 [95%CI，2.79-4.72]；OIT 加安慰剂抗组胺药组与双安慰剂组的危险比为 4.62 [95%CI，3.61-5.62]）。接受 OIT 联合抗组胺药治疗的患者与未使用 OIT 联合抗组胺药治疗的患者发生不良反应的风险相似（危险比为 1.23 [95%CI，0.49-1.97]）。与双安慰剂组相比，OIT 联合或不联合抗组胺药治疗均加速了不良反应的发生率（OIT 联合和不联合抗组胺药组的患者中，不良反应的发生率分别为每例患者 4.8 和 6.4 次，双安慰剂组为每例患者 3.5 次，发病率比分别为 2.49 [95%CI，1.36-4.56]和 2.04 [95%CI，1.01-4.15]）。抗组胺药预处理适度减少了 OIT 治疗组中中度至重度不良反应的频率（OIT 治疗组为每例患者 1.9 次，双安慰剂组为每例患者 4.2 次，发病率比为 0.46 [95%CI，0.24-0.89]），主要为荨麻疹（OIT 治疗组为每例患者 0.6 次，双安慰剂组为每例患者 2.1 次）和腹痛（OIT 治疗组为每例患者 2.6 次，双安慰剂组为每例患者 4.2 次），但增加了神经精神不良事件（主要为疲劳和镇静，OIT 治疗组为每例患者 2.3 次，双安慰剂组为每例患者 0.7 次）。治疗后激发剂量在所有组中相似。无论接受花生 OIT 治疗还是安慰剂 OIT 治疗，生活质量均得到相似改善。尽管 OIT 有效诱导脱敏，但仍需要在未来的大型随机试验中证明改善生活质量的更安全的食物过敏治疗方法。
