A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy.
A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy.
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一项随机，双盲，安慰剂对照的舌下和口服免疫疗法的试点研究，用于治疗花生过敏。
DOI：
10.1016/j.jaci.2014.11.005
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发表时间：
2015-05
期刊：
影响因子：
--
通讯作者：
Wood RA
中科院分区：
文献类型：
--
作者：
Narisety SD;Frischmeyer-Guerrerio PA;Keet CA;Gorelik M;Schroeder J;Hamilton RG;Wood RA
虽然口服和舌下免疫疗法(OIT和SIT)治疗花生过敏已经出现了令人振奋的结果，但这些方法的直接比较是有限的。本研究旨在比较花生口服免疫疗法和舌下免疫疗法的安全性、有效性和机制相关性。在这项双盲研究中，花生过敏儿童被随机分成两组，分别接受主动OIT/安慰剂OIT或主动OIT/安慰剂Sit。剂量增加到3.7毫克/天(Sit)或2000毫克/天(Oit)，受试者在维持6个月和12个月后再次接受挑战。在解除失明后，根据方案修改治疗方案，提供额外6个月的治疗。在12个月或18个月通过挑战的受试者被停止治疗4周，并重新接受挑战。21名年龄在7-13岁的受试者被随机分组。5名患者在失明阶段停止治疗。在剩下的16个人中，所有人在12个月后的挑战阈值都增加了10倍。OIT活动组的阈值升高幅度更大(141倍对22倍，P=0.01)。在皮试和花生特异性IgE和IgG4组内发现了显著的变化，总体上OIT的影响更大。OIT的不良反应一般较轻，但更常见(P<；0.001)，包括中度反应和需要药物治疗的剂量。四名受试者在研究完成时持续无反应。OIT在治疗花生过敏方面似乎比SIT有效得多，但也与显著更多的不良反应和早期研究退出有关。在回避4周后，只有一小部分受试者持续无反应。
Although promising results have emerged regarding oral and sublingual immunotherapy (OIT and SLIT) for the treatment of peanut allergy, direct comparisons of these approaches are limited. This study was conducted to compare the safety, efficacy, and mechanistic correlates of peanut oral and sublingual immunotherapy. In this double-blind study, children with peanut allergy were randomized to receive active SLIT/placebo OIT or active OIT/placebo SLIT. Doses were escalated to 3.7mg/day (SLIT) or 2000mg/day (OIT), and subjects were re-challenged after 6 and 12 months of maintenance. After unblinding, therapy was modified per protocol to offer an additional 6 months of therapy. Subjects who passed challenges at 12 or 18 month were taken off treatment for 4 weeks and re-challenged. Twenty-one subjects, age 7–13 years, were randomized. Five discontinued therapy during the blinded phase. Of the remaining 16, all had a >10-fold increase in challenge threshold after 12 months. The increased threshold was significantly greater in the active OIT group (141-fold versus 22-fold, P=0.01). Significant within group changes in skin tests and peanut-specific IgE and IgG4 were found with overall greater effects with OIT. Adverse reactions were generally mild but more common with OIT (P<0.001), including moderate reactions and doses requiring medication. Four subjects had sustained unresponsiveness at study completion. OIT appeared far more effective than SLIT for the treatment of peanut allergy, but was also associated with significantly more adverse reactions and early study withdrawal. Sustained unresponsiveness after 4 weeks of avoidance was seen in only a small minority of subjects.
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影响因子：
8
作者：
Sicherer, SH;Burks, AW;Sampson, HA
通讯作者：
Sampson, HA
影响因子：
14.2
作者：
Vickery, Brian P.;Scurlock, Amy M.;Burks, A. Wesley
通讯作者：
Burks, A. Wesley
影响因子：
12.4
作者：
Clark, A. T.;Islam, S.;Ewan, P. W.
通讯作者：
Ewan, P. W.
影响因子：
14.2
作者：
Sicherer, Scott H.
通讯作者：
Sicherer, Scott H.
影响因子：
14.2
作者：
Gorelik, Mark;Narisety, Satya D.;Frischmeyer-Guerrerio, Pamela A.
通讯作者：
Frischmeyer-Guerrerio, Pamela A.