Objective To evaluate the efficacy and safety of sublingual drops of Artemisia annua pollen allergen in the treatment of seasonal allergic rhinitis(SAR)sensitized by Artemisia annua pollen,and to provide a clinical basis for allergen-specific immunotherapy(AIT)in patients with SAR.Methods One hundred and forty-eight patients diagnosed with Artemisia pollen AR were enrolled in this randomized,placebo-controlled,double-blind parallel-group study.The SLIT group(n=74)was given sublingual drops of Artemisia annua,supplemented with symptomatic treatment(ST)as needed;while the placebo group(n=74)was given sublingual placebo,supplemented with antihistamines and topical hormone therapy as needed.The total nasal symptom score(TNSS),visual analogue scale(VAS),allergic rhinoconjunctivitis quality of life scale(RQLQ)and Th17/Treg immune balance were used as efficacy evaluation indexes,and the occurrence of adverse events was used as safety evaluation index.Results After 9 months of treatment,compared with placebo group,SLIT group showed better improvement in TNSS,VAS and RQLQ scores,with statistically significant differences(P<0.05).The percentage of Th17 cells and the expression of serum IL-17 in the SLIT group were lower than those in the placebo group,while the percentage of Treg cells and the expression of transforming grouth factor-β1(TGF-β1)were higher than those in the placebo group,with statistically significant differences(P<0.05).A total of 39 adverse events were observed in the two groups,most of which were mild and transient adverse reactions,and few were moderate adverse reactions,no serious adverse reactions,and no adverse outcomes.Conclusions Specific immunotherapy with sublingual Artemisia annua pollen allergen can control the progression of the disease and improve the quality of life of patients with Artemisia pollen induced AR,without increasing adverse reactions.The effect may be achieved by regulating the immune balance of Th17/Treg.
关键词
变应性鼻炎/花粉症/黄花蒿花粉变应原舌下滴剂/有效性/安全性
Key words
Allergic rhinitis/Pollinosis/Sublingual drops of Artemisia annua pollen allergen/Effectiveness/Security