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H1抗组胺药在变应性鼻炎中的体内抗炎作用:一项随机临床试验

In Vivo Anti-Inflammatory Effect of H1 Antihistamines in Allergic Rhinitis: A Randomized Clinical Trial.

作者信息

Bocşan Corina I, Bujor Adriana I, Miron Nicolae, Vesa Ştefan C, Deleanu Diana, Buzoianu Anca D

机构信息

Department of Clinical Pharmacology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj Napoca, Romania.

Department of Allergology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj Napoca, Romania.

出版信息

Balkan Med J. 2015 Oct;32(4):352-8. doi: 10.5152/balkanmedj.2015.15884. Epub 2015 Oct 1.

DOI:10.5152/balkanmedj.2015.15884
PMID:26740893
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4692333/
Abstract

BACKGROUND

Allergic rhinitis is characterized by a chronic inflammation of nasal mucosa and represents a risk factor for asthma occurrence. H1 antihistamines reduce the symptoms of rhinitis, but some compounds may have anti-inflammatory properties.

AIMS

We evaluated the plasma level of some cytokines in patients with persistent allergic rhinitis (PAR) and their evolution after a 4-week treatment with H1 anti-histamines, as well as the risk of asthma after 1.5 years.

STUDY DESIGN

Randomized clinical trial.

METHODS

Eighty-five patients with PAR and 30 healthy volunteers were included in the study. The patients with PAR were randomly divided into 2 groups: 41 patients treated with 5 mg/day desloratadine and 44 patients under 5 mg/day levocetirizine for 4 weeks. The clinical and biological evaluations were performed before and after treatment and included rhinitis symptoms and total symptoms score, type of sensitization, and plasmatic levels of total IgE, IL-1β, IL-6, IL-8 and TNF-α.

RESULTS

IL-8 and TNF-α were significantly increased in patients with PAR compared to healthy volunteers (5.85 vs 3.12, p<0.001 and 2.32 vs 1.06, p<0.001, respectively). Both H1 antihistamines reduce all symptoms of allergic rhinitis, including nasal congestion and the plasmatic level of IL-1β, IL-6, IL-8 and TNF-α, after 4 weeks of treatment. The reduction of cytokine levels was not influenced by patients' age, sex, duration or severity of rhinitis, or type of sensitization. Levocetirizine has a superior effect compared to desloratadine in reducing the rhinitis symptoms and cytokines' level. Twenty eight (32.9%) of the patients presented asthma symptoms after 1.5 years. The occurrence of asthma was influenced by house dust sensitization (OR-14.6; CI 95% 1.8-116.3; p=0.01), but baseline values of cytokines were not predictive factors for its appearance.

CONCLUSION

Levocetirizine and desloratadine as a prolonged therapy reduce plasmatic levels of some pro-inflammatory cytokines in patients with PAR. Levocetirizine has a better effect on decreasing the symptoms and plasmatic levels of IL-1β and IL-8. (ClinicalTrials. gov Identifier: NCT02507635).

FOUNDING

POSDRU and University of Medicine and Pharmacy, Iuliu Haţieganu, Cluj Napoca.

摘要

背景

变应性鼻炎以鼻黏膜慢性炎症为特征,是哮喘发生的危险因素。H1抗组胺药可减轻鼻炎症状,但有些化合物可能具有抗炎特性。

目的

我们评估了持续性变应性鼻炎(PAR)患者某些细胞因子的血浆水平及其在接受H1抗组胺药4周治疗后的变化,以及1.5年后发生哮喘的风险。

研究设计

随机临床试验。

方法

85例PAR患者和30名健康志愿者纳入研究。PAR患者随机分为2组:41例患者接受5mg/天地氯雷他定治疗,44例患者接受5mg/天左西替利嗪治疗,为期4周。在治疗前后进行临床和生物学评估,包括鼻炎症状和总症状评分、致敏类型以及总IgE、IL-1β、IL-6、IL-8和TNF-α的血浆水平。

结果

与健康志愿者相比,PAR患者的IL-8和TNF-α显著升高(分别为5.85对3.12,p<0.001;2.32对1.06,p<0.001)。两种H1抗组胺药在治疗4周后均能减轻变应性鼻炎的所有症状,包括鼻塞以及IL-1β、IL-6、IL-8和TNF-α的血浆水平。细胞因子水平的降低不受患者年龄、性别、鼻炎病程或严重程度以及致敏类型的影响。在减轻鼻炎症状和细胞因子水平方面,左西替利嗪比地氯雷他定效果更好。1.5年后,28例(32.9%)患者出现哮喘症状。哮喘的发生受屋尘致敏影响(比值比-14.6;95%置信区间1.8-116.3;p=0.01),但细胞因子的基线值不是其出现的预测因素。

结论

作为长期治疗,左西替利嗪和地氯雷他定可降低PAR患者某些促炎细胞因子的血浆水平。左西替利嗪在减轻症状以及降低IL-1β和IL-8的血浆水平方面效果更好。(ClinicalTrials.gov标识符:NCT02507635)。

资助

POSDRU以及克鲁日-纳波卡市尤利乌·哈蒂根努医科药科大学。

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