Taudorf E, Weeke B
Allergy. 1983 Nov;38(8):561-4. doi: 10.1111/j.1398-9995.1983.tb04140.x.
In 1900 it was claimed that oral administration of ragweed could be used for the hyposensitization of hay fever patients. Several uncontrolled trials have been published, all showing an effect of oral hyposensitization. Only one study was controlled and showed no effect of oral hyposensitization. It was decided to undertake controlled clinical trials to determine the safety and effectiveness of orally administered enteric-coated grass pollen tablets in patients with hay fever. The actual grass pollen dose in the first trial was 30 times the dose that is normally recommended for preseasonal oral pollen hyposensitization using pollen aqueous solution or pollen powder. The safety study will be described here. Twelve young adults with a history of grass pollen hay fever positive skin prick test and positive nasal provocation test with extracts of timothy grass pollen were randomly allocated to one of the treatment groups with four patients in each group taking enteric-coated Conjuvac Timothy tablets or enteric-coated Whole Timothy pollen tablets or enteric-coated placebo tablets. The study was double blind. Preseasonally, the patients received 342,500 PNU and in total they received 4,500,000 PNU during 6 months. The patients receiving active treatment did not have any side effects. No significant changes were shown in the skin and nasal reactivity to grass pollen during the study. Neither were there any changes in timothy-specific IgE, IgG, total IgE nor histamine liberation from basophils.
1900年，有人声称口服豚草可用于花粉症患者的减敏治疗。已经发表了几项非对照试验，均显示口服减敏有效果。只有一项研究是对照试验，结果显示口服减敏无效。因此决定进行对照临床试验，以确定口服肠溶草花粉片对花粉症患者的安全性和有效性。第一次试验中实际的草花粉剂量是使用花粉水溶液或花粉粉进行季节性前口服花粉减敏通常推荐剂量的30倍。这里将描述安全性研究。12名有草花粉花粉症病史、皮肤点刺试验阳性且对梯牧草花粉提取物鼻激发试验阳性的年轻成年人被随机分配到一个治疗组，每组4名患者，分别服用肠溶Conjuvac梯牧草片剂、肠溶全梯牧草花粉片剂或肠溶安慰剂片剂。该研究为双盲试验。在季节性前，患者接受342,500个花粉变应原单位（PNU），在6个月内总共接受4,500,000个PNU。接受积极治疗的患者没有任何副作用。在研究期间，患者对草花粉的皮肤和鼻腔反应性没有显著变化。梯牧草特异性IgE、IgG、总IgE以及嗜碱性粒细胞组胺释放也没有任何变化。
