摘要
目的 评估尘螨舌下免疫治疗片对尘螨诱发的过敏性鼻炎患者的疗效和安全性.方法 采用随机双盲法选取2017年9月至11月南京医科大学附属儿童医院与南京医科大学第二附属医院耳鼻喉科的300例患者.随机分成安慰剂组(舌下含服糖片)和尘螨舌下免疫组(舌下含服尘螨舌下免疫治疗片剂),每组150例.治疗为期52周,最后8周的平均调整症状评分为主要评价依据.次要评价依据包括个人鼻眼症状评分、缓解药物使用情况和鼻结膜炎生活质量问卷评分.对比尘螨舌下免疫组和安慰剂组的临床效果和安全性.结果 尘螨舌下免疫组在第44～52周时的平均症状评分、平均综合评分、鼻结膜炎总症状评分和个人鼻眼症状评分(包括喷嚏、鼻溢液、鼻塞、鼻瘙痒、流泪)较安慰剂组显著改善(P<0.001);尘螨舌下免疫组较安慰剂组显著减少了药物使用(P=0.007);尘螨舌下免疫组患者生活障碍评分显著改善(P<0.001).尘螨舌下免疫组鼻眼症状评分、生活质量问卷分数较安慰剂组显著提高(P<0.05).尘螨舌下免疫组患者在日常活动、室外活动、社会功能和物理障碍四个方面较安慰剂组显著改善(P<0.05).尘螨舌下免疫组总药物不良反应的发生率比安慰剂组高(P<0.05).结论 尘螨舌下免疫治疗片对尘螨诱发的过敏性鼻炎效果显著,可明显改善鼻眼部症状,降低过敏性鼻炎缓解药物的使用率,同时具有较高安全性.
Abstract
Objective To evaluate the efficacy and safety of sublingual immunotherapy tablets for patients with dust mite-in-duced allergic rhinitis.Methods A randomized,double-blind study was conducted from September to November 2017 involving 300 patients from the Department of Otolaryngology at the Children's Hospital of Nanjing Medical University and the Second Affiliated Hospital of Nanjing Medical University.Patients were randomly assigned to a placebo group(sublingual sugar pill)and a dust mite sub-lingual immunotherapy group(sublingual dust mite immunotherapy tablets),with 150 patients in each group.The treatment period last-ed 52 weeks,with the average adjusted symptom score(AASS)over the final 8 weeks as the primary evaluation criterion.Secondary evaluation criteria included individual nasal and ocular symptom scores,relief medication usage,and Rhinoconjunctivitis Quality of Life Questionnaire scores.The clinical effects and safety of the dust mite sublingual immunotherapy group and the placebo group were compared.Results From the 44th to 52nd week,the average symptom score,overall composite score,total symptom score for rhinocojunctivitis,and individual nasal and ocular symptom scores(including sneezing,rhinorrhea,nasal congestion,nasal itching,and tearing)in the dust mite sublingual immunotherapy group were significantly improved compared to the placebo group(P<0.001).The dust mite sublingual immunotherapy group showed a significant reduction in medication use compared to the placebo group (P=0.007).The life impairment scores of the patients in the dust mite sub-lingual immunotherapy group were significantly improved(P<0.001).The nasal and ocular symptom scores and quality of life questionnaire scores in the dust mite sublingual immunotherapy group were significantly higher than those in the placebo group(P<0.05).Patients in the dust mite sublingual immunotherapy group showed significant improvements in daily activities,outdoor activities,social function-ing,and physical barriers compared to the placebo group(P<0.05).The incidence of total adverse drug reactions in the dust mite sub-lingual immunotherapy group was higher than that in the placebo group(P<0.05).Conclusion Dust mite sublingual immunothera-py tablets are effective in treating dust mite-induced allergic rhinitis,significantly improving nasal and ocular symptoms with high safe-ty,reducing the usage rate of allergy relief medications,while maintaining high safety.
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