Drexel University College of Medicine, Allegheny General Hospital, Pittsburgh, Pa 15212, USA.
J Allergy Clin Immunol. 2010 Mar;125(3):660-6, 666.e1-666.e4. doi: 10.1016/j.jaci.2009.12.931. Epub 2010 Feb 11.
Specific allergen immunotherapy is most often delivered subcutaneously, but sublingual immunotherapy may confer greater benefit in terms of tolerability and safety, accessibility, and improved antigen delivery.
This randomized, double-blind, placebo-controlled trial was conducted to identify a safe and effective maintenance dose range of sublingual standardized glycerinated short ragweed pollen extract in adults with ragweed-induced rhinoconjunctivitis.
In May 2006, a total of 115 patients with ragweed-induced rhinoconjunctivitis were randomly allocated to placebo (n = 40), medium-dose extract (4.8 microg Amb a 1/d; n = 39), or high-dose extract (48 microg Amb a 1/d; n = 36). In a 1-day (rush) dose-escalation regimen, ragweed pollen extract was administered sublingually in incremental doses until maximum tolerable or scheduled dose was reached and then maintained during the ragweed pollen season. Patient diaries were used to monitor nasal and ocular symptoms and medication. The primary endpoint was symptom score.
Both active treatment groups achieved a 15% reduction in total rhinoconjunctivitis symptom scores compared with placebo during the entire ragweed pollen season, but the difference was not statistically significant (P > .10) However, in an analysis of covariance correcting for preseasonal symptoms, both mean daily symptom scores (0.19 +/- 1.16 vs 1.00 +/- 2.30) and medication scores (0.0003 +/- 1.64 vs 0.63 +/- 1.06) for the entire pollen season were significantly reduced in the high-dose versus placebo groups, respectively (P <or= .05). Ragweed-specific IgG, IgG(4), and IgA antibodies were increased after treatment in the medium- and high-dose groups and not the placebo group. Frequency of adverse events was similar between the placebo and treatment groups, but oral-mucosal adverse events occurred more often with treatment.
Standardized glycerinated short ragweed pollen extract administered sublingually at maintenance doses of 4.8 to 48 microg Amb a 1/d was safe and can induce favorable clinical and immunologic changes in ragweed-sensitive subjects. However, additional trials are needed to establish efficacy.
特异性变应原免疫疗法通常通过皮下途径给予，但舌下免疫疗法在耐受性和安全性、可及性以及改善抗原递送上可能具有更大的益处。
本随机、双盲、安慰剂对照试验旨在确定舌下标准化甘油化短豚草花粉提取物在花粉诱发的鼻结膜炎成人患者中的安全和有效维持剂量范围。
2006 年 5 月，共 115 例花粉诱发的鼻结膜炎患者被随机分配至安慰剂组（n=40）、中剂量提取物组（4.8 μg Amb a 1/d；n=39）或高剂量提取物组（48 μg Amb a 1/d；n=36）。在 1 天（冲击）剂量递增方案中，舌下给予豚草花粉提取物递增剂量，直至达到最大耐受或预定剂量，然后在豚草花粉季节维持。患者日记用于监测鼻和眼部症状和用药情况。主要终点是症状评分。
在整个豚草花粉季节，与安慰剂组相比，两组活性治疗组的总鼻结膜炎症状评分均降低了 15%，但差异无统计学意义（P>.10）。然而，在对 preseasonal 症状进行协方差分析后，高剂量组的平均每日症状评分（0.19 ± 1.16 比 1.00 ± 2.30）和整个花粉季节的用药评分（0.0003 ± 1.64 比 0.63 ± 1.06）均显著低于安慰剂组（均 P<.05）。中剂量和高剂量组治疗后豚草特异性 IgG、IgG（4）和 IgA 抗体增加，而安慰剂组则没有。安慰剂组和治疗组的不良反应发生率相似，但治疗组更常发生口腔黏膜不良反应。
舌下给予 4.8 至 48 μg Amb a 1/d 的标准化甘油化短豚草花粉提取物维持剂量安全，并可诱导花粉敏感受试者产生有利的临床和免疫变化。然而，还需要进一步的试验来确定疗效。
