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首页> 外文期刊>Clinical and experimental allergy : >Omalizumab is more effective than suplatast tosilate in the treatment of Japanese cedar pollen-induced seasonal allergic rhinitis.
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Omalizumab is more effective than suplatast tosilate in the treatment of Japanese cedar pollen-induced seasonal allergic rhinitis.

机译：在日本雪松花粉诱导的季节性变应性鼻炎的治疗中，奥马珠单抗比舒普拉司特多硅酸盐更有效。

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BACKGROUND: Seasonal allergic rhinitis (SAR) induced by Japanese cedar pollens is a major problem in Japan. Omalizumab, a humanized monoclonal anti-IgE antibody, improves symptoms associated with SAR, but a comparative study with an anti-allergy drug has not yet been conducted. OBJECTIVE: To compare the efficacy and safety of omalizumab with suplatast tosilate, a selective T-helper type 2 (Th2) cytokine inhibitor, in patients with Japanese cedar pollen-induced SAR. METHODS: A randomized, double-blind, double-dummy study was conducted in 308 Japanese patients with a history of moderate-to-severe SAR who showed a CAP-RAST value (> or =2+) specifically to Japanese cedar pollens. Patients were treated for 12 weeks with omalizumab plus placebo of suplatast tosilate or suplatast tosilate plus placebo of omalizumab. RESULTS: The mean daily nasal symptom medication scores (sum of the daily nasal symptom severity score and daily nasal rescue medication score) were significantly lower in the omalizumab group than in the suplatast tosilate group during three evaluation periods (P<0.001). The omalizumab group also had significantly lower mean daily nasal severity scores, each of the mean daily nasal and ocular symptom severity scores (sneezing, runny nose, stuffy nose, itchy nose, itchy eyes, watery eyes, and red eyes). Omalizumab reduced rescue medication requirements, and the proportion of days with any rescue medication use in the omalizumab group was significantly lower. Serum-free IgE levels markedly decreased in the omalizumab group and it was associated with clinical efficacy. The adverse reaction profiles were similar between the two groups. The overall incidence of injection site reactions was higher in the omalizumab group than in the suplatast tosilate group, but all these events were of mild degree. No anti-omalizumab antibodies were detected. CONCLUSION: Omalizumab showed significantly greater improvements than suplatast tosilate in the treatment of SAR induced by Japanese cedar pollens.
机译：背景：日本雪松花粉诱发的季节性过敏性鼻炎（SAR）是日本的主要问题。人源化单克隆抗IgE抗体Omalizumab可改善与SAR相关的症状，但尚未进行抗过敏药物的比较研究。目的：比较奥马珠单抗与选择性二型T辅助（Th2）细胞因子抑制剂suplateast tosilate在日本雪松花粉诱导的SAR患者中的疗效和安全性。方法：对308名具有中度至重度SAR病史的日本患者进行了一项随机，双盲，双模拟研究，这些患者的CAP-RAST值（>或= 2 +）专门针对日本雪松花粉。用奥马珠单抗加托拉司特托来酸盐的安慰剂或托拉普司聚磺酸盐加奥来珠单抗的安慰剂治疗患者12周。结果：在三个评估期内，奥马珠单抗组的平均每日鼻症状药物得分（每日鼻症状严重程度得分和每日鼻腔抢救药物得分之和）显着低于仰卧位甲苯磺酸​​盐组（P <0.001）。奥马珠单抗组的平均每日鼻腔严重程度评分（鼻，眼症状）的平均得分（打喷嚏，流鼻涕，鼻塞，鼻痒，眼睛发痒，水汪汪的眼睛和红眼）的平均得分也明显较低。 Omalizumab减少了急救药物的需求，并且在omalizumab组中使用任何急救药物的天数比例显着降低。 omalizumab组的无血清IgE水平明显降低，并且与临床疗效相关。两组之间的不良反应情况相似。 omalizumab组的注射部位反应的总发生率高于suplateast甲苯磺酸盐组，但所有这些事件均为轻度。未检测到抗奥马珠单抗抗体。结论：奥马珠单抗在治疗日本雪松花粉引起的SAR方面显示出明显优于舒普拉司特硅酸盐。

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