背景:雪松季节性过敏性鼻炎的传统治疗方法包括第二代抗组胺药,鼻皮质类固醇,和舌下免疫疗法(SLIT)。奥马珠单抗(Xolair®),抗免疫球蛋白E(IgE)单克隆抗体,是对现有疗法无反应的严重病例的另一种选择。许多研究已经证明了奥马珠单抗对雪松季节性过敏性鼻炎的治疗效果;然而,大多数报告的结果仅在随访4周后.因此,这项研究评估了奥马珠单抗在整个雪松花粉季节的临床疗效。受试者和方法:本研究包括2021年至2023年来自我们部门和南上大阪医院耳鼻咽喉科的患者,这些患者年龄≥12岁,血清总IgE水平为30-1,500IU/mL,30-150公斤的基准体重,和持续严重的鼻部症状,尽管常规治疗。在招募时服用口服类固醇或服用少于两个奥马珠单抗剂量的患者被排除在外。46名患者(26名男性,20名女性;平均年龄,19.1±11.2年)符合这些标准,并根据其IgE水平和体重每2或4周接受皮下奥马珠单抗。使用总鼻部症状评分(TNSS)和日本标准生活质量问卷(JRQLQNo.1)用于过敏性鼻炎。结果:36例患者随访8周,13例12周。TNSS在4周时从6.6显著提高到4.5,4.2在8周时,在12周时为4.1(p<0.05)。鼻腔分泌物,打喷嚏,鼻塞,眼睛发痒,泪液和泪液显着改善(p<0.05)。生活质量评分在日常活动中得到改善,睡眠,从第4周到第12周的身体健康。讨论:与以前的发现一致,奥马珠单抗可显著改善严重雪松季节性变应性鼻炎患者的鼻和眼部症状及生活质量。尽管许多患者由于高昂的费用在八周后停用该药,该药物在预防症状复发方面的有效性表明潜在的长期益处。联合奥马珠单抗与SLIT在结果上没有显着差异;然而,需要进一步的药物经济学研究来评估成本-效果.结论:奥马珠单抗是治疗严重雪松季节性变应性鼻炎的有效方法,提供显著的症状缓解和生活质量改善。进一步的研究应该调查其长期疗效和安全性,包括潜在的不良反应和抗奥马珠单抗抗体的开发。
BACKGROUND: Traditional treatments for cedar seasonal allergic rhinitis include second-generation antihistamines, nasal corticosteroids, and sublingual immunotherapy (SLIT).
Omalizumab (Xolair®), an anti-immunoglobulin E (IgE) monoclonal antibody, is an additional option for severe cases unresponsive to existing therapies. Numerous studies have demonstrated the therapeutic effectiveness of
omalizumab for cedar seasonal allergic rhinitis; however, most reported results after only up to four weeks of follow-up. Therefore, this study evaluates the clinical efficacy of
omalizumab throughout one whole cedar pollen season. Subjects and methods: This study included patients from our department and the Otorhinolaryngology Department of Minami Osaka Hospital between 2021 and 2023 who were ≥ 12 years old and had serum total IgE levels of 30-1,500 IU/mL, a baseline weight of 30-150 kg, and persistent severe nasal symptoms despite conventional treatments. Patients taking oral steroids at the time of enrollment or had fewer than two
omalizumab doses were excluded. Forty-six patients (26 males, 20 females; mean age, 19.1 ± 11.2 years) met these criteria and received subcutaneous omalizumab every 2 or 4 weeks based on their IgE levels and weight. Symptoms were assessed at baseline and 4, 8, and 12 weeks post-administration using the Total Nasal Symptom Score (TNSS) and the Japanese Standard Quality of Life Questionnaire (JRQLQ No. 1) for allergic rhinitis. Results: Thirty-six patients were followed up for 8 weeks and 13 for 12 weeks. TNSS significantly improved from 6.6 to 4.5 at 4 weeks, 4.2 at 8 weeks, and 4.1 at 12 weeks (p<0.05). Nasal discharge, sneezing, nasal obstruction, itchy eyes, and tearfulness showed significant improvements (p<0.05). Quality of life scores improved in daily activities, sleep, and physical health from week 4 to week 12. Discussion: Consistent with previous findings, omalizumab significantly improved nasal and ocular symptoms and quality of life in patients with severe cedar seasonal allergic rhinitis. Despite many patients discontinuing the drug after eight weeks due to high costs, the drug\'s effectiveness in preventing symptom recurrence suggests potential long-term benefits. Combining omalizumab with SLIT showed no significant differences in outcomes; however, further pharmacoeconomic studies are warranted to evaluate cost-effectiveness. Conclusion:
Omalizumab proved to be an effective treatment for severe cedar seasonal allergic rhinitis, providing significant symptom relief and quality of life improvements. Further studies should investigate its long-term efficacy and safety, including potential adverse effects and the development of anti-omalizumab antibodies.