Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study.
Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study.
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DOI：
10.1016/j.jaci.2011.06.015
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发表时间：
2011-12
期刊：
影响因子：
--
通讯作者：
Li XM
中科院分区：
文献类型：
--
作者：
Patil SP;Wang J;Song Y;Noone S;Yang N;Wallenstein S;Sampson HA;Li XM
食物过敏是西方国家常见且日益严重的健康问题。目前尚无有效的治疗方法，意外摄入可能会危及生命。食物过敏草药配方 2 (FAHF-2) 可在花生引起的过敏反应小鼠模型中阻止花生过敏反应。在针对食物过敏患者的急性 I 期研究中发现它是安全的且耐受性良好。在延长的 I 期临床试验中评估 FAHF-2 的安全性，并确定对食物过敏患者外周血嗜碱性粒细胞的潜在影响。开放标签研究中的患者每天服用 3 次 3.3 克（6 片）FAHF-2，持续 6 个月。在基线时和每隔 2 个月采集生命体征、体格检查、实验室数据、肺功能测试和心电图数据。在研究过程中，使用 CCR3/CD63 染色和流式细胞术评估嗜碱性粒细胞活化以及嗜碱性粒细胞和嗜酸性粒细胞数量。在 18 名入组患者中，14 名完成了研究。治疗前后的实验室参数、肺功能研究或心电图结果没有发现与药物相关的显着差异。第 6 个月时，响应离体刺激，嗜碱性粒细胞 CD63 表达显着降低 (p<.010)。治疗后嗜酸性粒细胞和嗜碱性粒细胞数量也有减少的趋势。 FAHF-2 安全、耐受性良好，并且在一项扩展的 I 期临床研究中对嗜碱性粒细胞具有抑制作用。有必要进行受控的 II 期研究。在一项针对食物过敏患者的为期 6 个月的临床试验中，FAHF-2 是安全的、耐受性良好的，并且可以抑制嗜碱性粒细胞的数量和活化。 FAHF-2可能为食物过敏患者提供安全的免疫治疗选择。在一项针对食物过敏患者的为期六个月的 I 期开放标签临床试验中，FAHF-2 是安全且耐受性良好的。 FAHF-2 的免疫学有益作用是减少嗜碱性粒细胞数量和抑制活化。
Food allergy is a common and increasing health concern in westernized countries. No effective treatment is available and accidental ingestion can be life threatening. Food allergy herbal formula-2 (FAHF-2) blocks peanut anaphylaxis in a murine model of peanut-induced anaphylaxis. It was found to be safe, and well tolerated in an acute phase I study of food allergic patients. To assess the safety of FAHF-2 in an extended phase I clinical trial and determine potential effects on peripheral blood basophils from food allergic patients. Patients in an open-label study received 3.3 grams (6 tablets) of FAHF-2 three times a day for 6 months. Vital signs, physical examinations, laboratory data, pulmonary function tests and electrocardiographic data were acquired at baseline and at 2 month intervals. During the course of the study, basophil activation and basophil and eosinophil numbers were evaluated using CCR3/ CD63 staining and flow cytometry. Of eighteen patients enrolled, 14 completed the study. No significant drug-associated differences in laboratory parameters, pulmonary function studies, or electrocardiographic findings before and after treatment were found. There was a significant reduction (p<.010) in basophil CD63 expression in response to ex vivo stimulation at month 6. There was also a trend towards a reduction of eosinophil and basophil numbers after treatment. FAHF-2 was safe, well-tolerated, and had an inhibitory effects on basophils in an extended phase I clinical study. A controlled phase II study is warranted. FAHF-2 was safe, well-tolerated and inhibited basophils numbers and activation in a 6 month clinical trial for food allergic patients. FAHF-2 may provide a safe immunotherapeutic option for food allergic patients. FAHF-2 was safe and well-tolerated in a six-month phase-I open label clinical trial for food allergy patients. Immunological beneficial effects of FAHF-2 were decreased basophil numbers and inhibition of activation.
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DOI：
10.1097/aci.0b013e328329226f
发表时间：
2009-04
影响因子：
2.8
作者：
Li XM
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