黄花蒿花粉变应原舌下滴剂治疗蒿属花粉过敏的有效性及安全性评价

Efficacy and safety of artemisia annua pollen allergen sublingual drops in the treatment of Artemisia pollen allergy

目的评价黄花蒿花粉变应原舌下滴剂治疗蒿属花粉致敏季节性变应性鼻炎(SAR)的有效性及安全性,为SAR患者变应原特异性免疫治疗(AIT)提供临床依据。方法选取确诊为蒿属花粉AR患者148例,纳入随机、安慰剂、双盲平行对照研究。所有患者经皮肤点刺试验(SPT)证实均适合接受SLIT,其中舌下免疫治疗(SLIT)组(n=74)予以黄花蒿花粉变应原舌下滴剂含服治疗,按需辅以对症治疗(ST);安慰剂组(n=74)舌下含服安慰剂,按需辅以抗组胺药物及局部激素疗法。以鼻症状总积分(TNSS)、视觉模拟量表(VAS)评分、变应性鼻-结膜炎生活质量量表(RQLQ)评分及Th17/Treg免疫平衡状况作为有效性评价指标,以不良事件发生状况作为安全性评价指标。结果治疗9个月后,同安慰剂组比较,SLIT组在TNSS、VAS及RQLQ的评分改善方面效果更优,差异均有统计学意义(P值均<0.05);SLIT组Th17细胞百分比和血清IL-17的表达均较安慰剂组降低,Treg细胞百分比和转化生长因子β1(TGF-β1)的表达均较安慰剂组升高,差异均有统计学意义(P值均<0.05)。2组在试验周期内共观察到39例次不良事件,绝大多数为轻度、一过性的不良反应,极少有中度不良反应,均未出现严重不良反应,无不良转归。结论黄花蒿花粉变应原舌下滴剂特异性免疫治疗蒿属花粉致敏AR患者,对控制疾病进展、改善生活质量有较好效果,且未增加不良反应。作用可能是通过调节Th17/Treg免疫平衡实现的。

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,placebocontrolled,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.