Mahatme Mohini Sachin, Dakhale Ganesh Natthuji, Tadke Kanchan, Hiware Sachin Keshaorao, Dudhgaonkar S D, Wankhede Sumit
Department of Pharmacology, Indira Gandhi Government Medical College, Nagpur, Maharashtra, India.
Department of ENT, Indira Gandhi Government Medical College, Nagpur, Maharashtra, India.
Indian J Pharmacol. 2016 Nov-Dec;48(6):649-653. doi: 10.4103/0253-7613.194854.
Allergic rhinitis (AR) is a global health problem. Almost 10%-25% of population worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor antagonists, and intranasal corticosteroids are the pillars in the management of AR. The combination therapy of montelukast with antihistaminic provides enhancing and complimentary effects, thereby reducing the symptoms effectively, but there are scanty data regarding the comparisons of combinations. Therefore, we aimed to compare the efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine combination in patients of AR.
Seventy patients with AR participated in a prospective, randomized, double-blind, parallel, active-controlled, comparative 4-week trial. The patients between the age group of 18-65 years of either gender having moderate-severe intermittent or mild persistent AR were included in the study. The study inclusion criteria required the patients with total nasal symptom score (TNSS) of 5 or higher. The patients were randomly divided into two treatment groups with montelukast-levocetirizine (10 mg and 5 mg) in one group and montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main effectiveness parameter.
Evaluation of TNSS revealed significant difference ( < 0.05) when compared from baseline to 4 week in both groups. The mean change of TNSS, i.e., 9.46 was significant ( < 0.05) in montelukast-fexofenadine group. The cost-effectiveness ratio was less in montelukast-levocetirizine group than in montelukast-fexofenadine group.
The decrease in TNSS was more in montelukast-fexofenadine group, but the cost-effectiveness is more with montelukast-levocetirizine combination.
变应性鼻炎（AR）是一个全球性的健康问题。全球近10%-25%的人口受AR影响。口服/鼻内用H1抗组胺药、减充血剂、白三烯受体拮抗剂和鼻内用糖皮质激素是AR治疗的支柱。孟鲁司特与抗组胺药的联合治疗具有增强和互补作用，从而有效减轻症状，但关于联合用药比较的数据较少。因此，我们旨在比较孟鲁司特-左西替利嗪和孟鲁司特-非索非那定联合用药在AR患者中的疗效、安全性和成本效益。
70例AR患者参与了一项前瞻性、随机、双盲、平行、活性对照、比较性4周试验。纳入研究的患者年龄在18-65岁之间，性别不限，患有中重度间歇性或轻度持续性AR。研究纳入标准要求患者的总鼻症状评分（TNSS）为5分或更高。患者被随机分为两个治疗组，一组服用孟鲁司特-左西替利嗪（10mg和5mg），另一组服用孟鲁司特-非索非那定（10mg和120mg）。TNSS参数是主要疗效参数。
两组从基线到4周时TNSS评估显示有显著差异（<0.05）。孟鲁司特-非索非那定组TNSS的平均变化，即9.46有显著意义（<0.05）。孟鲁司特-左西替利嗪组的成本效益比低于孟鲁司特-非索非那定组。
孟鲁司特-非索非那定组TNSS的降低幅度更大，但孟鲁司特-左西替利嗪联合用药的成本效益更高。
