Lou Hongfei, Huang Yanran, Ouyang Yuhui, Zhang Yuan, Xi Lin, Chu Xiaohan, Wang Yang, Wang Chengshuo, Zhang Luo
Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China.
Beijing Key Laboratory of Nasal Disease, Beijing Institute of Otolaryngology, Beijing, China.
Allergy. 2020 Aug;75(8):2026-2036. doi: 10.1111/all.14218. Epub 2020 Feb 23.
Artemisia annua is an important autumnal pollen allergen for seasonal allergic rhinitis (SAR) in northern China. To date, no study has investigated allergen immunotherapy with A annua. We aimed to investigate the efficacy and mechanisms underlying A annua-sublingual immunotherapy (SLIT).
This was a randomized, double-blind, placebo-controlled phase III clinical trial involving 71 SAR patients, randomized to SLIT with A annua extract (n = 47) or placebo (n = 24) for 32 weeks. Total nasal symptom score (TNSS; primary clinical end point) was evaluated at baseline (peak pollen phase (PPP) in the previous year), initiation of A annua-SLIT, 1st PPP during SLIT, end of SLIT and 2nd PPP during follow-up. Blood samples and nasal secretions were collected at beginning and after SLIT for assessment of T cells and inflammatory mediators. Safety was assessed according to adverse events (AEs) reported.
Artemisia annua-SLIT significantly reduced TNSS to a greater level from baseline (from 9.45 ± 1.68 to 6.16 ± 2.27) than placebo (from 9.29 ± 2.09 to 9.05 ± 2.40) at the 1st PPP (P < .001) and sustained the improvement in symptoms throughout to the 2nd PPP. Preseasonal A annua-SLIT for 16 weeks significantly decreased Th2 cells, increased nTreg and Tr1 cells in blood; and increased cystatin 1 (CST1) in nasal secretion after 16 and 32 weeks compared with pretreatment. Overall, 17/47 patients experienced mild local AEs and 2 patients mild systemic AEs, after A annua-SLIT.
Artemisia annua-SLIT is an efficacious and safe treatment in patients with A annua SAR.
在中国北方，黄花蒿是季节性变应性鼻炎（SAR）的一种重要秋季花粉过敏原。迄今为止，尚无研究对黄花蒿变应原免疫疗法进行调查。我们旨在研究黄花蒿舌下免疫疗法（SLIT）的疗效及潜在机制。
这是一项随机、双盲、安慰剂对照的III期临床试验，纳入71例SAR患者，随机分为接受黄花蒿提取物SLIT治疗组（n = 47）或安慰剂组（n = 24），治疗32周。在基线（上一年花粉高峰期（PPP））、黄花蒿SLIT开始时、SLIT期间第1个PPP、SLIT结束时以及随访期间第2个PPP评估总鼻症状评分（TNSS；主要临床终点）。在SLIT开始时和结束后采集血样和鼻分泌物，用于评估T细胞和炎症介质。根据报告的不良事件（AE）评估安全性。
在第1个PPP时，黄花蒿SLIT组的TNSS较基线（从9.45±1.68降至6.16±2.27）显著低于安慰剂组（从9.29±2.09降至9.05±2.40）（P <.001），且症状改善持续至第2个PPP。16周的季节性前黄花蒿SLIT显著降低了血液中的Th2细胞，增加了nTreg和Tr1细胞；与治疗前相比，16周和32周后鼻分泌物中的胱抑素1（CST1）增加。总体而言，黄花蒿SLIT治疗后，47例患者中有17例出现轻度局部AE，2例出现轻度全身AE。
黄花蒿SLIT对黄花蒿SAR患者是一种有效且安全的治疗方法。
