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奥马珠单抗治疗过敏性鼻炎的效果:一项初步研究。

Effects of omalizumab therapy on allergic rhinitis: a pilot study.

作者信息

Masieri S, Cavaliere C, Begvarfaj E, Rosati D, Minni A

机构信息

Department of Sensory Organs, "Sapienza" University, Rome, Azienda Policlinico Umberto I, Rome, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2016 Dec;20(24):5249-5255.

Abstract

OBJECTIVE

The use of omalizumab, a humanized monoclonal antibody able to binding Ig-E, is currently authorized only for treatment of severe bronchial asthma. The use of omalizumab in other Ig-E related diseases is off-label, although some studies have provided promising results about it. The aim of this study was to evaluate if therapy with omalizumab in patients affected by asthma and allergic rhinitis has an impact also on allergic rhinitis-related symptoms.

PATIENTS AND METHODS

A longitudinal study was conducted on 11 patients affected by severe asthma and a periodic allergic rhinitis. Patients were treated with omalizumab for 24 weeks with a monthly subcutaneous administration at the dosage recommended by the current guidelines. We observed at the start and at the end of treatment: rhinitis symptoms using the Visual Analogue Scale (VAS); the state of nasal mucosa with fiberoptic nasal endoscopy; airways inflammation by measuring the Fractional Exhaled Nitric Oxide (FeNO); asthmatic symptomatology by means of the Asthma Control Test; the amount of total Ig-E in a blood sample; and the use of symptomatic drugs before and after treatment.

RESULTS

VAS scores to measure general symptomatology and symptoms including nasal obstruction, rhinorrhea, itching and sneezing were significantly reduced. Turbinate hypertrophy was resolved in six of nine patients. Furthermore, eight patients (73%) reduced or eliminated the use of symptomatic drugs.

CONCLUSIONS

Our data confirm the efficacy of omalizumab in the treatment of allergic rhinitis. Controlled studies will now have to be carried out to confirm these preliminary data and will specify indications for a very efficacious but still significantly expensive therapy.

摘要

目的

奥马珠单抗是一种能够结合Ig - E的人源化单克隆抗体,目前仅被批准用于治疗重度支气管哮喘。尽管一些研究已提供了关于奥马珠单抗在其他Ig - E相关疾病治疗中的有前景的结果,但该药在这些疾病中的使用仍属于超适应证用药。本研究旨在评估奥马珠单抗治疗哮喘和过敏性鼻炎患者时,是否也会对过敏性鼻炎相关症状产生影响。

患者与方法

对11例患有重度哮喘和周期性过敏性鼻炎的患者进行了一项纵向研究。患者接受奥马珠单抗治疗24周,按照现行指南推荐的剂量每月皮下注射一次。在治疗开始和结束时,我们观察了以下指标:使用视觉模拟量表(VAS)评估鼻炎症状;通过纤维鼻内镜观察鼻黏膜状态;通过测量呼出一氧化氮分数(FeNO)评估气道炎症;通过哮喘控制测试评估哮喘症状;检测血样中的总Ig - E含量;以及治疗前后对症药物的使用情况。

结果

用于衡量总体症状以及包括鼻塞、流涕、瘙痒和打喷嚏等症状的VAS评分显著降低。9例患者中有6例的鼻甲肥大得到缓解。此外,8例患者(73%)减少或停用了对症药物。

结论

我们的数据证实了奥马珠单抗在治疗过敏性鼻炎方面的疗效。现在必须开展对照研究以证实这些初步数据,并明确这种非常有效但仍然昂贵的治疗方法的适应证。

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