杭州浙大迪迅生物基因工程有限公司Allergy：黄花蒿舌下免疫疗法治疗季节性过敏性鼻炎
发布日期：2020-09-04
原标题：黄花蒿舌下免疫疗法治疗季节性过敏性鼻炎：一项随机对照试验
方法：这是一项随机、双盲、安慰剂对照的III期临床试验，共有71名SAR患者，随机分为两组，分别用黄花蒿提取物（n=47）或安慰剂（n=24）舌下免疫治疗32周。在基线（上一年的峰值花粉期（PPP）），SLIT开始，SLIT期间的第1个PPP，SLIT结束和随访期间第2个PPP这几个时段评估鼻总症状评分（TNSS；主要临床终点）。在SLIT开始和之后收集血液样本和鼻分泌物，以评估T细胞和炎性介质。根据报告的不良事件（AEs）评估安全性。
结果：在第一个PPP（P <.001）时，黄花蒿SLIT显着降低TNSS至基线水平（从9.45±1.68降低至6.16±2.27），高于安慰剂（从9.29±2.09降低至9.05±2.40），并且上述改善一直持续到第二个 PPP。另外，季前性黄花蒿SLIT治疗16周能够显著降低血液中的Th2细胞和增加nTreg和Tr1细胞；与预处理相比，治疗后第16周和32周鼻分泌物中的半胱氨酸蛋白酶抑制剂1（CST1）升高。总的来说，黄花蒿SLIT治疗后，17/47名患者出现了轻度局部AEs，2名患者出现了轻度全身性AEs。
结论：黄花蒿SLIT是一种安全有效的黄花蒿SAR治疗方法。
延伸阅读
Allergy
A randomized controlled trial
DOI: 10.1111/all.14218
Abstract:
Background: 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).
Methods: 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.
Results: 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.
Conclusion: Artemisia annua-SLIT is an efficacious and safe treatment in patients with A annua SAR.
First Author:
Hongfei Lou, Chengshuo Wang
Correspondence:
Chengshuo Wang, Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, No.1, Dongjiaominxiang, DongCheng District, Beijing 100730, China.
All Authors:
Hongfei Lou, Yanran Huang,Yuhui Ouyang,Yuan Zhang, Lin Xi, Xiaohan Chu, Yang Wang, Chengshuo Wang, Luo Zhang
2020-08-19 Article
创建过敏性疾病的科研、科普知识交流平台，为过敏患者提供专业诊断、治疗、预防的共享平台。
——浙大迪迅 译
背景：黄花蒿是中国北方季节过敏性鼻炎（SAR）的一种重要秋季花粉过敏原。到目前为止，还没有一项研究调查过黄花蒿过敏原免疫治疗的情况。本研究旨在探讨黄花蒿舌下免疫疗法（SLIT）的疗效和机制。方法：这是一项随机、双盲、安慰剂对照的III期临床试验，共有71名SAR患者，随机分为两组，分别用黄花蒿提取物（n=47）或安慰剂（n=24）舌下免疫治疗32周。在基线（上一年的峰值花粉期（PPP）），SLIT开始，SLIT期间的第1个PPP，SLIT结束和随访期间第2个PPP这几个时段评估鼻总症状评分（TNSS；主要临床终点）。在SLIT开始和之后收集血液样本和鼻分泌物，以评估T细胞和炎性介质。根据报告的不良事件（AEs）评估安全性。
结果：在第一个PPP（P <.001）时，黄花蒿SLIT显着降低TNSS至基线水平（从9.45±1.68降低至6.16±2.27），高于安慰剂（从9.29±2.09降低至9.05±2.40），并且上述改善一直持续到第二个 PPP。另外，季前性黄花蒿SLIT治疗16周能够显著降低血液中的Th2细胞和增加nTreg和Tr1细胞；与预处理相比，治疗后第16周和32周鼻分泌物中的半胱氨酸蛋白酶抑制剂1（CST1）升高。总的来说，黄花蒿SLIT治疗后，17/47名患者出现了轻度局部AEs，2名患者出现了轻度全身性AEs。
结论：黄花蒿SLIT是一种安全有效的黄花蒿SAR治疗方法。
延伸阅读
Allergy
[IF:6.771]
Artemisia annua-sublingual immunotherapy for seasonal allergic rhinitis: A randomized controlled trial
DOI: 10.1111/all.14218
Abstract:
Background: 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).
Methods: 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.
Results: 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.
Conclusion: Artemisia annua-SLIT is an efficacious and safe treatment in patients with A annua SAR.
First Author:
Hongfei Lou, Chengshuo Wang
Correspondence:
Chengshuo Wang, Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, No.1, Dongjiaominxiang, DongCheng District, Beijing 100730, China.
All Authors:
Hongfei Lou, Yanran Huang,Yuhui Ouyang,Yuan Zhang, Lin Xi, Xiaohan Chu, Yang Wang, Chengshuo Wang, Luo Zhang
2020-08-19 Article
创建过敏性疾病的科研、科普知识交流平台，为过敏患者提供专业诊断、治疗、预防的共享平台。
