House dust mite sublingual tablet is effective and safe in patients with allergic rhinitis.
House dust mite sublingual tablet is effective and safe in patients with allergic rhinitis.
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DOI：
10.1111/all.12996
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发表时间：
2017-03
期刊：
影响因子：
12.4
通讯作者：
Masuyama K
中科院分区：
文献类型：
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作者：
Okamoto Y;Fujieda S;Okano M;Yoshida Y;Kakudo S;Masuyama K
屋尘螨（HDM）是过敏性鼻炎（AR）和哮喘等过敏性疾病的主要室内过敏原。尽管舌下免疫治疗是HDM诱导的AR的根治性治疗，但大规模研究的数据有限。我们评估了HDM片对伴有或不伴有间断性哮喘的HDM诱导AR的青少年和成人患者（12-64岁）的疗效和安全性。在日本的一项双盲试验中，968名受试者被随机分为1:1:1至300反应指数（IR）组、500 IR组或安慰剂组。主要终点是52周治疗最后8周的平均调整症状评分（AASS）。次要终点包括个体鼻和眼症状评分、抢救药物使用和日本鼻结膜炎生活质量问卷（JRQLQ）评分。与安慰剂组相比，300 IR组和500 IR组在治疗后8周的AASS显著改善（P < 0.001）。300ir组在第8-10周开始起效。两组患者四种鼻部症状均显著改善；300ir组抢救用药和JRQLQ结果均有改善。大多数不良事件（ae）为轻度，严重ae (SAEs) 16例；然而，没有一例与药物相关。用300 IR和500 IR HDM片治疗一年是有效的，没有主要的安全问题。AR的推荐治疗剂量为300ir。
House dust mite (HDM) is the major indoor allergen for allergic diseases such as allergic rhinitis (AR) and asthma. Although sublingual immunotherapy is a curative treatment for HDM‐induced AR, data from large‐scale studies are limited. We evaluated the efficacy and safety of HDM tablets in adolescent and adult patients (aged 12–64 years) with HDM‐induced AR with or without intermittent asthma. In a double‐blind trial in Japan, 968 subjects were randomized 1 : 1 : 1 to 300 index of reactivity (IR), 500 IR, or placebo groups. The primary endpoint was the Average Adjusted Symptom Score (AASS) in the last eight weeks of the 52‐week treatment. Secondary endpoints included individual nasal and ocular symptom scores, rescue medication use, and the Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) scores. The AASS in the last eight weeks of treatment significantly improved in both the 300 IR and the 500 IR groups compared to that in the placebo group (P < 0.001). In the 300 IR group, the onset of action occurred at week 8–10. All four nasal symptoms significantly improved in both active treatment groups; rescue medication use and JRQLQ outcome improved in the 300 IR group. Most adverse events (AEs) were mild, and 16 serious AEs (SAEs) were reported; however, none of them were drug‐related. One‐year treatment with 300 IR and 500 IR HDM tablets was effective without major safety concerns. The recommended therapeutic dose for AR is 300 IR.