Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy.
Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy.
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DOI：
10.1016/j.jaci.2015.04.029
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发表时间：
2015-10
期刊：
影响因子：
--
通讯作者：
Li XM
中科院分区：
文献类型：
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作者：
Wang J;Jones SM;Pongracic JA;Song Y;Yang N;Sicherer SH;Makhija MM;Robison RG;Moshier E;Godbold J;Sampson HA;Li XM
FAHF-2是一种基于传统中药的9味草药配方，可在小鼠模型中阻断花生过敏反应。在I期研究中，发现FAHF-2是安全的，并且耐受性良好。评价FAHF-2治疗食物过敏的安全性和有效性。在这项双盲、随机、安慰剂对照研究中，68名年龄在12-45岁的受试者接受FAHF-2（n=46）或安慰剂（n=22），这些受试者对花生、树坚果、芝麻、鱼和/或贝类过敏，并通过基线双盲、安慰剂对照食物激发（DBPCFC）确认。治疗6个月后，受试者接受DBPCFC。对于那些表现出诱发剂量增加的患者，在停止治疗后3个月进行重复DBPCFC。治疗耐受性良好，无严重不良事件。通过意向治疗分析，安慰剂组在治疗结束时具有较高的诱发剂量和累积剂量（p=0.05）DBPCFC。治疗反应所需的肾上腺素无差异（p=0.55）。活性组和安慰剂组之间的过敏原特异性IgE和IgG 4、PBMC产生的细胞因子或嗜碱性粒细胞活化无显著差异。对用FAHF-2和食物过敏原孵育的受试者基线PBMC进行的体外免疫学研究产生了比未处理的细胞显著更少的IL-5、更大的IL-10和增加的T细胞数量。值得注意的是，44%的受试者在至少三分之一的研究期间药物依从性较差。FAHF-2是一种用于食物过敏个体的安全草药，并显示出良好的体外免疫调节作用;然而，在使用的剂量和持续时间下，未证明改善对食物过敏原耐受性的功效。
FAHF-2 is a 9-herb formula based on Traditional Chinese Medicine that blocks peanut anaphylaxis in a murine model. In Phase I studies, FAHF-2 was found to be safe, and well tolerated. To evaluate the safety and effectiveness of FAHF-2 as a treatment for food allergy. In this double-blind, randomized, placebo-controlled study, 68 subjects, 12-45 years of age, with allergies to peanut, tree nut, sesame, fish, and/or shellfish, confirmed by baseline double-blind, placebo controlled food challenge (DBPCFC), received FAHF-2 (n=46) or placebo (n=22). After 6 months of therapy, subjects underwent DBPCFC. For those who demonstrated increases in eliciting dose, a repeat DBPCFC was performed 3 months after stopping therapy. Treatment was well-tolerated with no serious adverse events. By intent-to-treat analysis, the placebo group had a higher eliciting dose and cumulative dose (p=0.05) at the end of treatment DBPCFC. There was no difference in the requirement for epinephrine to treat reactions (p=0.55). There were no significant differences in allergen-specific IgE and IgG4, cytokine production by PBMCs or basophil activation between active and placebo groups. In vitro immunological studies performed on subject baseline PBMCs incubated with FAHF-2 and food allergen produced significantly less IL-5, greater IL-10 and increased numbers of Tregs than untreated cells. Notably, 44% of subjects had poor drug adherence for at least one-third of the study period. FAHF-2 is a safe herbal medication for food allergic individuals and shows favorable in vitro immunomodulatory effects; however, efficacy for improving tolerance to food allergens is not demonstrated at the dose and duration used.