Efficacy and safety of intratonsillar immunotherapy for allergic rhinitis: A randomized, double-blind, placebo-controlled clinical trial

作者：Junyan Zhang, Xiaobin Yang, Guangui Chen, Jintao Hu, Ying He, Jinxiang Ma, Zhaoen Ma, Huifang Chen, Yuyi Huang, Qiurong Wu, Yongping Liu, Lu Yu, Hong Zhang, He Lai, Jianguo Zhang, Jinming Zhai, Minqi Huang, Zehong Zou, Ailin Tao · 发表于：Annals of Allergy Asthma & Immunology · 年份：2023 · DOI：10.1016/j.anai.2023.10.029 · 被引用次数：21 · 研究领域：Allergic Rhinitis and Sensitization、Sinusitis and nasal conditions、Asthma and respiratory diseases

BACKGROUND: A lower adherence rate existed in patients receiving allergen-specific immunotherapy due to its lengthy period and adverse effects even though it is the only curative treatment for IgE-mediated allergies. Therefore, exploring innovative allergen-specific immunotherapy routes is necessary. OBJECTIVE: To explore the efficacy and safety of the intratonsillar injection of house dust mite (HDM) extract in patients with HDM-induced allergic rhinitis (AR). METHODS: A randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 80 patients with HDM-induced AR were randomized to receive 6 intratonsillar injections with HDM extract or placebo in 3 months. The total nasal symptom score (TNSS), visual analogue scale of nasal symptoms, combined symptom and medication score, mini rhinoconjunctivitis quality of life questionnaire, and serum allergen-specific IgG4 to Dermatophagoides pteronyssinus were all monitored at baseline and 3 months, 6 months, and 12 months after the treatment was finished. The intent-to-treat and per-protocol set (PPS) are both analyzed. RESULTS: The primary end points TNSS and ΔTNSS were improved significantly at 3 months after the patients with AR finished a 3-month 6-injection intratonsillar immunotherapy compared with those in the placebo treatment in both intent-to-treat and PPS. Results of visual analogue scale, combined symptom and medication score, and mini rhinoconjunctivitis quality of life questionnaire were also impro...