Kim Chang-Keun, Hwang Yoonha, Song Dae Jin, Yu Jinho, Sohn Myung Hyun, Park Yong Mean, Lim Dae Hyun, Ahn Kangmo, Rha Yeong-Ho
Asthma and Allergy Center, Department of Pediatrics, Inje University Sanggye Paik Hospital, Seoul, Korea.
Department of Pediatrics, Busan St. Mary's Hospital, Busan, Korea.
Allergy Asthma Immunol Res. 2024 Nov;16(6):652-667. doi: 10.4168/aair.2024.16.6.652.
The combination therapy of leukotriene receptor antagonists and antihistamines may alleviate allergic rhinitis (AR) symptoms better than monotherapy. This study aimed to investigate the safety and efficacy of Monterizine, a fixed-dose combination of montelukast and levocetirizine, compared to montelukast monotherapy in pediatric patients with AR.
One hundred seventy-six children aged 6 to 14 years with perennial AR symptoms were recruited. One hundred forty-seven subjects were randomized into 1 of 2 groups: the mont+levo group (fixed-dose combination of montelukast [5 mg] + levocetirizine [5 mg]) or the mont group (montelukast single agent [5 mg]). Study subjects took the treatment every evening for 4 weeks and recorded their daytime nasal symptom score (DNSS) and nighttime nasal symptom score (NNSS) in a diary every day. Adverse events (AEs) were also recorded, and patients were surveyed as to their overall satisfaction with the therapeutic product they received.
When DNSS and NNSS were assessed individually, daytime nasal congestion symptom scores decreased more in the mont+levo group during the 4-week treatment period than in the mont group ( = 0.0341). The daytime rhinorrhea symptom scores also decreased more in the mont+levo group ( = 0.0469). The nighttime nasal congestion score (severity when awake) decreased more in the mont+levo group than in the mont group ( = 0.0381). Study subjects in the mont+levo group experienced a greater improvement in quality of life than subjects in the mont group ( < 0.0001).
The combination therapy of montelukast and levocetirizine was more effective in reducing both daytime nasal symptoms (nasal congestion and rhinorrhea) and nighttime nasal symptoms (severity of nasal congestion when awake). With fewer AEs and higher overall satisfaction, combination therapy is recommended for pediatric patients with perennial AR.
白三烯受体拮抗剂与抗组胺药联合治疗可能比单一疗法能更好地缓解过敏性鼻炎（AR）症状。本研究旨在探讨孟鲁司特和左西替利嗪的固定剂量复方制剂蒙特利嗪与孟鲁司特单一疗法相比，在儿童AR患者中的安全性和有效性。
招募了176名6至14岁有常年性AR症状的儿童。147名受试者被随机分为2组中的1组：孟鲁司特+左西替利嗪组（孟鲁司特[5毫克]+左西替利嗪[5毫克]的固定剂量复方制剂）或孟鲁司特组（孟鲁司特单药[5毫克]）。研究对象每晚服用治疗药物，持续4周，并每天在日记中记录他们的日间鼻部症状评分（DNSS）和夜间鼻部症状评分（NNSS）。还记录了不良事件（AE），并就患者对所接受治疗产品的总体满意度进行了调查。
当分别评估DNSS和NNSS时，孟鲁司特+左西替利嗪组在4周治疗期内日间鼻塞症状评分的下降幅度比孟鲁司特组更大（P = 0.0341）。孟鲁司特+左西替利嗪组的日间流涕症状评分下降幅度也更大（P = 0.0469）。孟鲁司特+左西替利嗪组的夜间鼻塞评分（清醒时的严重程度）下降幅度比孟鲁司特组更大（P = 0.0381）。孟鲁司特+左西替利嗪组的研究对象在生活质量方面的改善比孟鲁司特组的受试者更大（P < 0.0001）。
孟鲁司特和左西替利嗪联合治疗在减轻日间鼻部症状（鼻塞和流涕）和夜间鼻部症状（清醒时鼻塞的严重程度）方面更有效。由于不良事件较少且总体满意度较高，建议对常年性AR的儿科患者采用联合治疗。
