SAFETY AND EFFICACY OF RAGWEED EXTRACTS DIFFERING IN POTENCY AND COMPOSITION

一个高效价（HP）和两个低效价（LP）商业完整短型 用抗原E测定豚草提取物的相对效价 （AgE-Amb α 1）、RAST抑制和平行线生物测定（PLBA）。 的RP HP提取物（300 mg AgE）的含量与参考WSR相同，但LP 提取物的RP仅为参比品的约0.01。 每种浸提液 给予对WSR皮肤敏感的秋季花粉热患者， 最大耐受剂量，或0.5 cc的浓缩物，由9-或40- 给药方案。 HP治疗患者的症状评分显著降低 比未处理的对照组。 总的来说， HP和LP浸提液治疗患者之间的症状评分。 尽管 HP与LP浸提液的RP差异约为100倍， 产生了相似频率的严重全身性和严重晚期局部 反应. 当用PLBA估计HP和LP提取物的RP时， 达到相似的峰值剂量，IgG WSR抗体应答的相似剂量， 和相当的IgG WSR抗体水平，表明WSR剂量 基于RP的估计是生物等效的。 9剂HP方案产生 每例患者的晚期局部和全身反应少于40剂 HP方案。 大多数发生严重全身反应的患者 对WSR最敏感的皮肤。 全身反应数量 在较高的WSR剂量下，每次注射的平均剂量显著较高。 一份LP浸提液 在最初的三年中， 注射剂 相对于HP，其RP变化约10倍 取决于患者皮肤对热稳定豚草的敏感性 过敏原，这表明它是组成不同。 然而 当基于皮肤通过RP估计该提取物的剂量时， 每个患者的敏感性，提取物的峰值剂量以及 发现与晚期和全身反应相关的剂量 与HP剂量相似。 这表明免疫剂量估计 基于PLBA RP的不同组成的WSR提取物也被 生物等效性

One high potency (HP) and two low potency (LP) commercial whole short ragweed (WSR) extracts were assayed for relative potency (RP) by antigen E (AgE-Amb a 1), RAST inhibition, and parallel line bioassay (PLBA). The RP of the HP extract (300 mg AgE) was equal to the reference WSR, but the LP extracts were only about 0.01 of the RP of the reference. Each extract was administered to fall hay fever patients with skin sensitivity to WSR to the maximum tolerated dose, or 0.5 cc of the concentrate, by either a 9- or 40- dose regimen. HP-treated patients had significantly lower symptom scores than untreated controls. No significant difference was noted in the total symptom scores between HP and LP extract-treated patients. Despite approximately 100-fold differences in the RP of HP versus LP extracts, both produced similar frequencies of severe systemic and severe late phase local reactions. When RP of HP and LP extracts were estimated by PLBA, both reached similar peak dosages, similar dosage for IgG WSR antibody response, and comparable IgG WSR antibody levels, indicating that the WSR dose estimates based on RP were bioequivalent. The 9-dose HP regimen produced fewer late phase local and systemic reactions per patient than the 40-dose HP regimen. Most patients experiencing severe systemic reactions were among those most skin sensitive to WSR. The number of systemic reactions per injection was significantly higher at higher WSR doses. One LP extract produced a high incidence of systemic reactions in the initial three injections. With respect to HP, its RP varied approximately 10-fold depending on the skin sensitivity of the patient to heat-stable ragweed allergens, demonstrating that it was compositionally different. However when the dose of this extract was estimated by RP based on the skin sensitivity of each patient, the peak dose of the extract as well as the doses associated with late phase and systemic reactions were found to be similar to the HP doses. This indicated that the immunizing dose estimates of compositionally different WSR extracts based on RP by PLBA were also bioequivalent.