Artemisia Annua sublingual immunotherapy for seasonal allergic rhinitis: A multicenter, randomized trial
Artemisia Annua sublingual immunotherapy for seasonal allergic rhinitis: A multicenter, randomized trial
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DOI：
10.1016/j.waojou.2020.100458
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发表时间：
2020-09-01
影响因子：
5.1
通讯作者：
Zhang, Luo
中科院分区：
文献类型：
--
作者：
Lou, Hongfei;Wang, Xueyan;Zhang, Luo
背景资料：黄花蒿是中国北方最常见的户外空气过敏原;然而，没有多中心研究将舌下免疫疗法（SLIT）作为黄花蒿诱导的过敏性鼻炎（AR）的治疗选择。本研究的目的是评估创新SLIT治疗青蒿相关AR的疗效和安全性。方法：这是一项在中国进行的随机、双盲、安慰剂对照、多中心、III期临床试验（NCT XXX）。共有702名青蒿素致敏的合格患者以2：1的比例随机接受青蒿素SLIT或安慰剂。治疗持续32周;包括5周的剂量递增期和27周的维持期。主要终点为每日药物和鼻结膜炎症状的联合评分（CSMRS），次要终点为花粉高峰期每日鼻部症状总评分（dTNSS）和每日补救药物评分（dRMS）。结果：与安慰剂组相比，SLIT组在花粉高峰期的平均每日CSMRS明显改善（全分析集[FAS]为1.46 ± 0.47 vs 1.88 ± 0.42，P < 0.0001;符合方案集[PPS]为1.49 ± 0.52 vs 1.95 ± 0.46，P < 0.0001）;相对于安慰剂分别降低22.3%和23.6%。在青蒿单致敏患者中，当比较活性药物治疗与安慰剂治疗时，FAS和PPS人群的平均每日CSMRS降低分别为24.1%和27.0%。同样，与安慰剂相比，SLIT使FAS和PPS中花粉高峰期的dTNSS分别降低19.0%和22.3%。巧合的是，花粉高峰期的dRMS在FAS中减少了22.0%，在PPS中减少了26.0%。SLIT组65.8%的患者发生治疗相关AE，无严重不良事件。结论：SLIT联合青蒿滴剂治疗青蒿诱导的AR是一种安全有效的治疗方法。
Background: Artemisia annua is the most common outdoor aeroallergen throughout Northern China; however, no multicenter study has investigated sublingual immunotherapy (SLIT) as a treatment option for Artemisia annua-induced allergic rhinitis (AR). The aim of this study was to evaluate the efficacy and safety of an innovative SLIT for Artemisia annua-related AR.Methods: This was a randomized, double-blind, placebo-controlled, multicenter, phase 3 clinical trial conducted in China (NCT XXX). A total of 702 Artemisia annua-sensitized eligible patients were randomized in a ratio of 2:1 to receive Artemisia annua-SLIT or placebo. The treatment lasted 32 weeks; including 5-weeks up-dosing phase and 27-weeks maintenance phase. The primary endpoint was the daily combined score of medication and rhinoconjunctivitis symptom (CSMRS), and secondary endpoints were daily total nasal symptom score (dTNSS) and daily rescue medication score (dRMS) during peak pollen period. Safety of treatment was evaluated according to adverse events (AEs) experienced.Results: Mean daily CSMRS was significantly improved during the peak pollen period in the SLIT group compared with the placebo group (1.46 +/- 0.47 vs 1.88 +/- 0.42, P < 0.0001 in full analysis set [FAS]; 1.49 +/- 0.52 vs 1.95 +/- 0.46, P < 0.0001 in per protocol set [PPS]); representing a 22.3% and 23.6% reduction, respectively, relative to placebo. In specifically Artemisia annua monosensitized patients, mean daily CSMRS reductions were demonstrated as 24.1% and 27.0% in the FAS and PPS populations, respectively, when comparing the active treatment to placebo treatment. Similarly, SLIT decreased dTNSS in peak pollen period by 19.0% in FAS and 22.3% in PPS, respectively, relative to placebo. In coincidence, dRMS in peak pollen period was reduced by 22.0% in FAS and 26.0% in PPS. 65.8% patients in SLIT group experienced treatment-related AEs, none of which was serious.Conclusion: This study indicates that SLIT with Artemisia annua drops is an effective and safe treatment option in Chinese patients with Artemisia Annua-induced AR.