A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response.

A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response.
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DOI:
10.1016/j.jaci.2010.12.1111
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发表时间:
2011-03
期刊:
The Journal of allergy and clinical immunology
影响因子:
--
通讯作者:
Burks AW
Burks AW
中科院分区:
其他
文献类型:
--
作者:
Varshney P;Jones SM;Scurlock AM;Perry TT;Kemper A;Steele P;Hiegel A;Kamilaris J;Carlisle S;Yue X;Kulis M;Pons L;Vickery B;Burks AW

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开放标签口服免疫疗法(OIT)方案已用于治疗少数花生过敏患者。花生 OIT 尚未在双盲、安慰剂对照试验中进行评估。通过双盲、安慰剂对照研究探讨 OIT 治疗花生过敏的安全性和有效性。在这项多中心研究中,1-16 岁的花生过敏儿童接受了含花生粉或安慰剂的 OIT 治疗。最初的升级、积累和维持阶段之后是大约一年的口服食物挑战。定期进行滴定皮肤点刺试验(SPT)和实验室研究。二十八名受试者参加了这项研究。由于过敏副作用,三名花生 OIT 受试者在研究早期退出。在双盲安慰剂对照食物挑战期间,所有剩余的花生 OIT 受试者 (N=16) 摄入的最大累积剂量为 5000 mg(约 20 颗花生),而安慰剂受试者 (N=9) 摄入的中位累积剂量为 280 mg(范围为 0-1900 mg)[p<0.001]。与安慰剂组相比,花生 OIT 组的 SPT 大小 (p<0.001)、IL-5 (p=0.01) 和 IL-13 (p=0.02) 减少,花生特异性 IgG4 增加 (p<0.001)。花生 OIT 受试者的花生特异性 IgE 最初有所增加 (p<0.01),但到 OFC 时与基线相比没有显着变化。在花生 OIT 受试者中,OFC 时 FoxP3 hi:FoxP3 中间 CD4+CD25+ T 细胞的比例增加 (p=0.04)。这些结果最终证明花生 OIT 可诱导脱敏和并发免疫调节。目前的研究仍在继续,正在评估花生 OIT 导致长期免疫耐受的假设。
Open-label oral immunotherapy (OIT) protocols have been used to treat small numbers of patients with peanut allergy. Peanut OIT has not been evaluated in double-blind, placebo-controlled trials. To investigate the safety and effectiveness of OIT for peanut allergy in a double blind, placebo-controlled study. In this multicenter study, peanut-allergic children ages 1-16 years received OIT with peanut flour or placebo. Initial escalation, build-up, and maintenance phases were followed by an oral food challenge at approximately one year. Titrated skin prick tests (SPT) and laboratory studies were performed at regular intervals. Twenty-eight subjects were enrolled in the study. Three peanut OIT subjects withdrew early in the study due to allergic side effects. During the double-blind, placebo-controlled food challenge, all remaining peanut OIT subjects (N=16) ingested the maximum cumulative dose of 5000 mg (approximately 20 peanuts), while placebo subjects (N=9) ingested a median cumulative dose of 280 mg (range, 0-1900 mg) [p<0.001]. In contrast to the placebo group, the peanut OIT group showed reductions in SPT size (p<0.001), IL-5 (p=0.01), and IL-13 (p=0.02) and increases in peanut-specific IgG4 (p<0.001). Peanut OIT subjects had initial increases in peanut-specific IgE (p<0.01) but did not show significant change from baseline by the time of OFC. The ratio of FoxP3 hi: FoxP3 intermediate CD4+CD25+ T cells increased at the time of OFC (p=0.04) in peanut OIT subjects. These results conclusively demonstrate that peanut OIT induces desensitization and concurrent immune modulation. The present study continues and is evaluating the hypothesis that peanut OIT causes long-term immune tolerance.
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