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多中心前瞻性观察研究评价孟鲁司特钠联合左西替利嗪治疗变应性鼻炎合并哮喘患者的疗效和安全性。

Multicenter Prospective Observational Study to Evaluate the Therapeutic Effect and Safety of a Combination of Montelukast and Levocetirizine for Allergic Rhinitis when Administered to Patients with Allergic Rhinitis and Asthma.

机构信息

Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Republic of Korea.

Division of Pulmonology, and Allergy, Department of Internal Medicine, Kyung Hee Medical Center, Seoul, Republic of Korea.

出版信息

Int Arch Allergy Immunol. 2022;183(12):1251-1258. doi: 10.1159/000526094. Epub 2022 Oct 7.

DOI:10.1159/000526094
PMID:36209731
Abstract

INTRODUCTION

Allergic rhinitis and asthma share a common inflammatory mechanism and are closely related, recognized as "one airway disease." Thus, the guidelines recommend allergic rhinitis and asthma be treated together, and leukotriene antagonists and antihistamines have been administered simultaneously; however, there are few reports of the use of combination drugs so far.

METHODS

The aim of the study was to evaluate the treatment effects and adverse events of Monterizine® (a combination of montelukast and levocetirizine); a total of 2,254 patients with perennial allergic rhinitis and asthma were prospectively enrolled from 60 hospitals nationwide in Korea. They were followed up for 3 (Period 1) or 6 months (Period 2). Total nasal symptom score (TNSS), satisfaction, and safety data were collected and compared to baseline.

RESULTS

TNSS scores were analyzed for 2,254 subjects. At Period 1 (n = 2,024) and 2 (n = 1,861), the scores decreased significantly from baseline (-1.20 ± 2.49 and -1.63 ± 2.78, p < 0.001). The mean quality of life (QoL) was significantly improved at Period 1 and 2 relative to baseline (-3.75 ± 6.58, -4.83 ± 7.11, both p < 0.0001). There were no serious adverse drug reactions, but there were some minor reactions including nasopharyngitis (2.92%), rhinitis (0.37%), and somnolence (0.34%).

CONCLUSIONS

TNSS score and QoL were significantly improved by 3-6 months' treatment with Monterizine without significant adverse reactions. These results indicate that Monterizine, as a combination drug, is effective and safe for improving nasal symptoms and quality of life in patients with allergic rhinitis who also have asthma.

摘要

简介

变应性鼻炎和哮喘具有共同的炎症机制,密切相关,被认为是“一个气道疾病”。因此,指南建议同时治疗变应性鼻炎和哮喘,并同时给予白三烯拮抗剂和抗组胺药;然而,到目前为止,很少有关于联合用药的报道。

方法

本研究旨在评估孟鲁司特/左西替利嗪(Monterizine)的治疗效果和不良事件;共有 2254 名来自韩国全国 60 家医院的常年性变应性鼻炎和哮喘患者前瞻性入组,分别随访 3 个月(第 1 期)和 6 个月(第 2 期)。收集并比较了总鼻症状评分(TNSS)、满意度和安全性数据。

结果

对 2254 例患者进行了 TNSS 评分分析。在第 1 期(n=2024)和第 2 期(n=1861),与基线相比,评分显著下降(-1.20±2.49 和-1.63±2.78,p<0.001)。与基线相比,第 1 期和第 2 期的平均生活质量(QoL)均显著改善(-3.75±6.58,-4.83±7.11,均 p<0.0001)。无严重药物不良反应,但有一些轻微反应,包括鼻咽炎(2.92%)、鼻炎(0.37%)和嗜睡(0.34%)。

结论

Monterizine 治疗 3-6 个月可显著改善 TNSS 评分和 QoL,且无明显不良反应。这些结果表明,作为一种联合药物,Monterizine 可有效改善伴哮喘的变应性鼻炎患者的鼻部症状和生活质量,且安全。

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