Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.
Laboratory of Immunopharmacology, Faculty of Pharmaceutical Sciences, Setsunan University, Osaka, Japan.
Rhinology. 2020 Jun 1;58(3):241-247. doi: 10.4193/Rhin19.301.
Intralymphatic immunotherapy (ILIT) for allergic patients requires only a few intralymphatic injections of the allergen. However, the effectiveness and safety for Japanese cedar pollinosis are unclear. The objectives of this study were to clarify whether and how long ILIT is effective for pollinosis, and its safety.
In an open pilot investigation followed by a double-blind, placebo-controlled study, patients with Japanese cedar pollinosis received 3 intralymphatic inguinal injections of the pollen extracts before the first pollen season. The symptom medication score (SMS), nasal provocation testing and scoring visual analogue scale (VAS) were assessed after the first-third seasons.
(1) Although mild adverse events were induced at the injected site, severe adverse events were not noted. (2) During the latter part of the first season, ILIT-treated patients (n=12) tended to show improved SMS compared to placebo-treated (n=6) without statistical significance. When assessed by nasal provocation testing and VAS scoring after the first season, the effectiveness of ILIT was significant. (3) The effects of ILIT continued until the second or third season. (4) Neither allergen-specific antibodies nor Treg/Breg cells changed in the peripheral blood.
ILIT was safe and effective for Japanese cedar pollinosis. The clinical effects remained for 1-2 years.
针对过敏患者的淋巴内免疫疗法 (ILIT) 仅需对过敏原进行几次淋巴内注射。然而，其对日本扁柏花粉症的有效性和安全性尚不清楚。本研究旨在明确 ILIT 对花粉症的有效性及其安全性。
在一项开放性初步研究之后，进行了一项双盲、安慰剂对照研究，18 例日本扁柏花粉症患者在首个花粉季节前接受 3 次腹股沟淋巴内注射花粉提取物。在第一个至第三个季节后，评估症状药物评分 (SMS)、鼻激发测试和评分视觉模拟量表 (VAS)。
(1) 尽管注射部位出现轻微不良反应，但未观察到严重不良反应。(2) 在第一个季节的后半段，与安慰剂治疗组（n=6）相比，ILIT 治疗组（n=12）的 SMS 有改善趋势，但无统计学意义。在第一个季节后进行鼻激发测试和 VAS 评分评估时，ILIT 的有效性显著。(3) ILIT 的作用持续到第二个或第三个季节。(4) 外周血中的过敏原特异性抗体和 Treg/Breg 细胞均未发生变化。
ILIT 对日本扁柏花粉症安全且有效。临床效果可持续 1-2 年。
