Safety, tolerability, and immunologic effects of a food allergy herbal formula in food allergic individuals: a randomized, double-blinded, placebo-controlled, dose escalation, phase 1 study.
Safety, tolerability, and immunologic effects of a food allergy herbal formula in food allergic individuals: a randomized, double-blinded, placebo-controlled, dose escalation, phase 1 study.
复制标题
DOI：
10.1016/j.anai.2010.05.005
复制
发表时间：
2010-07
影响因子：
5.9
通讯作者：
Li, Xiu-Min
中科院分区：
文献类型：
--
作者：
Wang, Julie;Patil, Sangita P.;Yang, Nan;Ko, Jimmy;Lee, Joohee;Noone, Sally;Sampson, Hugh A.;Li, Xiu-Min
食物过敏是一种常见且严重的健康问题。一种名为食物过敏草药配方2（FAHF-2）的新草药产品已被证明在花生诱导的过敏反应小鼠模型中具有高安全性和有效的长期疗效。评价FAHF-2在食物过敏患者中的安全性和耐受性。在这项随机、双盲、安慰剂对照、剂量递增、I期试验中，患者接受3种剂量的FAHF-2或安慰剂之一：2.2 g（4片）、3.3 g（6片）或6.6 g（12片），每天3次，持续7天。4例活性药物组患者和2例安慰剂组患者在每个剂量水平接受治疗。监测生命体征、体格检查结果、实验室数据、肺功能检查结果和心电图数据。还进行了免疫调节研究。19名食物过敏的参与者被纳入研究。2例患者（FAHF-2组1例，安慰剂组1例）报告轻度胃肠道症状。1例患者因不太可能与研究药物相关的过敏反应退出研究。治疗访视前后的生命体征、体格检查结果、实验室数据、肺功能检查结果和心电图数据均无明显差异。7天后，在积极治疗组中发现白细胞介素（IL）5水平显著降低。用FAHF-2培养的外周血单核细胞的体外研究也证明了IL-5的显著降低以及培养上清液干扰素γ和IL-10水平的增加。FAHF-2在食物过敏患者中安全且耐受性良好。
Food allergy is a common and serious health problem. A new herbal product, called food allergy herbal formula 2 (FAHF-2), has been demonstrated to have a high safety profile and potent long-term efficacy in a murine model of peanut-induced anaphylaxis. To evaluate the safety and tolerability of FAHF-2 in patients with food allergy. In this randomized, double-blinded, placebo-controlled, dose escalation, phase 1 trial, patients received 1 of 3 doses of FAHF-2 or placebo: 2.2 g (4 tablets), 3.3 g (6 tablets), or 6.6 g (12 tablets) 3 times a day for 7 days. Four active and 2 placebo patients were treated at each dose level. Vital signs, physical examination results, laboratory data, pulmonary function test results, and electrocardiogram data were monitored. Immunomodulatory studies were also performed. Nineteen food allergic participants were included in the study. Two patients (1 in the FAHF-2 group and 1 in the placebo group) reported mild gastrointestinal symptoms. One patient withdrew from the study because of an allergic reaction that was unlikely related to the study medication. No significant differences were found in vital signs, physical examination results, laboratory data, pulmonary function test results, and electrocardiogram data obtained before and after treatment visits. Significantly decreased interleukin (IL) 5 levels were found in the active treatment group after 7 days. In vitro studies of peripheral blood mononuclear cells cultured with FAHF-2 also demonstrated a significant decrease in IL-5 and an increase in culture supernatant interferon γ and IL-10 levels. FAHF-2 appeared to be safe and well tolerated in patients with food allergy.
登录
查看更多内容
影响因子：
14.2
作者：
Bock, SA;Muñoz-Furlong, A;Sampson, HA
通讯作者：
Sampson, HA
影响因子：
4.3
作者：
Caldas, ED;Machado, LL
通讯作者：
Machado, LL
影响因子：
5.9
作者：
Ko, Jimmy;Lee, Jennifer I.;Sicherer, Scott H.
通讯作者：
Sicherer, Scott H.
影响因子：
5.9
作者：
Li, XM;Zhang, TF;Schofield, B
通讯作者：
Schofield, B
影响因子：
6.1
作者：
Dolan, SP;Nortrup, DA;Capar, SG
通讯作者：
Capar, SG