屋尘螨集群免疫治疗过敏性鼻炎和哮喘的疗效和安全性:一项多中心前瞻性单臂干预研究

Efficacy and safety of house dust mite cluster immunotherapy in the treatment of allergic rhinitis and asthma:a multicenter prospective single-arm interventional study

目的探讨屋尘螨注射制剂4周集群免疫治疗尘螨过敏患者的疗效和安全性。方法于2022年8月至2024年5月从北京协和医院等多中心招募屋尘螨过敏的过敏性鼻炎伴或不伴哮喘的患者80例,进行屋尘螨4周剂量递增方案皮下集群免疫治疗,在第0、1、6、12月统计患者的症状和药物、生活质量、哮喘控制测试结果以及局部和全身不良反应。结果不同时间点集群免疫治疗的每日症状总评分(P<0.001)、日均鼻部评分(P<0.001)、日均眼部评分(P=0.009)、症状和药物总评分(P=0.003)差异均具有统计学意义,活动鼻结膜炎生活质量问卷(RQLQ)(P<0.001)、睡眠RQLQ(P=0.002)、非眼鼻症状RQLQ(P=0.032)、实际问题RQLQ(P<0.001)、鼻部症状RQLQ(P<0.001)、情感RQLQ(P=0.011)、总RQLQ(P<0.001)以及儿童哮喘控制测试评分(P<0.001)的差异亦有统计学意义,且时间越长,评分越低。剂量递增期间,共22例(27.5%)患者出现局部不良反应,5例(6.3%)患者出现了全身不良反应,35剂次(3.6%)出现不良反应,包括27剂次(2.8%)的局部不良反应和8剂次(0.8%)的全身不良反应。结论屋尘螨4周集群免疫治疗对尘螨过敏的患者有显著的疗效。

Objective To investigate the efficacy and safety of 4-week cluster immunotherapy with house dust mite extracts in patients allergic to house dust mites.Methods From August 2022 to May 2024,80 patients with house dust miteinduced allergic rhinitis,complicated with or without asthma,were recruited from multiple centers(including Peking Union Medical College,et al)to undergo 4-week dose-escalation subcutaneous cluster immunotherapy with house dust mites.Patient symptoms,medication use,quality of life,asthma control test(ACT)results,as well as local and systemic adverse reactions were recorded at 0,1,6,and 12 months,respectively.Results Significant differences were observed in the daily total symptom scores(P<0.001),daily nasal scores(P<0.001),daily ocular scores(P=0.009),and total symptom and medication scores(P=0.003)across different time points during cluster immunotherapy,respectively.Significant differences were also found in the activity RQLQ(P<0.001),sleep RQLQ(P=0.002),non-eye/nose symptom RQLQ(P=0.032),practical problems RQLQ(P<0.001),nasal symptom RQLQ(P<0.001),emotional RQLQ(P=0.011),total RQLQ(P<0.001),and children’s ACT scores(P<0.001),respectively.The longer the time,the lower the score.During the dose-escalation period,22 patients(27.5%)experienced local adverse reactions,and 5 patients(6.3%)experienced systemic adverse reactions.A total of 35(3.6%)injections resulted in adverse reactions,including 27(2.8%)injections with local reactions and 8(0.8%)injections with systemic reactions.Conclusion Four-week cluster immunotherapy with house dust mites shows significant efficacy in patients allergic to house dust mites.