Zou Y-X, Zhang J, Ma C, Li J, Zai J, Guo Y-S
Department of Respiratory Diseases, the Second Hospital of Jilin University, Changchun, China.
Eur Rev Med Pharmacol Sci. 2014;18(6):775-80.
The efficacy and safety of a single-dose of Montelukast sodium for treating virus-related infantile wheezing are investigated in this study.
A prospective, open, randomized, controlled study was carried out on 595 cases of infants who exhibited wheezing after a respiratory syncytial virus infection. Treatment with Montelukast sodium was provided over the course of 12 weeks. The clinical efficacy of Montelukast sodium was determined based on the clinical symptom score, tidal breathing lung function, and short-acting bronchodilator usage, as well as infantile asthma diagnosis rate change at the 4th and 12th week after the administration of the treatment. The adverse reactions were also observed, and a control group was set. The mean age of the 595 patients with infantile wheezing was 10.82 months ± 4.22 months. Among these patients, 45.9% (273 out of 595) had a family history of asthma, 30.6% (182 out of 595) had allergic rhinitis, 23.9% (142 out of 595) increased peripheral blood eosinophilia, 6.1% (36 out of 595) exhibited total IgE increase, 40.0% (238 out of 595) had a recurrent history of wheezing, and 64.0% (381 out of 595) had a family history of eczema.
After 12 weeks of treatment, the clinical symptom scores significantly improved. Significant differences in the cough, wheezing, and motility scores were observed before and after the treatment (p < 0.05). TPTEF/TE and VPEF/VE significantly improved (p < 0.05) after the treatment. The asthma diagnosis rate was 9.6% (57 out of 595). At four weeks after treatment, various indicators correspondingly improved. Twenty-nine (4.9%) patients exhibited adverse reactions, 55.2% exhibited excitation, 20.7% suffered from insomnia, 10.3% had headaches, 3.4% had erythra, 3.4% suffered from abdominal pain, and 3.4% exhibited an increased glutamic-pyruvate transaminase level. The symptoms of eczema were relieved to some extent, and the symptoms of rhinitis became less serious. Significant differences were observed in the number of wheezing attacks, annual number of days hospitalized, annual number of days when β2AG was utilized, and lung function improvement (p < 0.05).
Montelukast sodium is clinically effective in treating virus-related wheezing, and clinical application for 4 weeks to 12 weeks can effectively relieve the symptoms of wheezing, improve lung function, and reduce the incidence rate of infantile asthma. Montelukast sodium also causes few adverse reactions.
本研究旨在探讨单剂量孟鲁司特钠治疗病毒相关性婴儿喘息的疗效和安全性。
对595例呼吸道合胞病毒感染后出现喘息的婴儿进行了一项前瞻性、开放性、随机对照研究。孟鲁司特钠治疗疗程为12周。基于临床症状评分、潮气呼吸肺功能、短效支气管扩张剂使用情况以及治疗给药后第4周和第12周婴儿哮喘诊断率的变化来确定孟鲁司特钠的临床疗效。同时观察不良反应，并设立对照组。595例婴儿喘息患者的平均年龄为10.82个月±4.22个月。在这些患者中，45.9%（595例中的273例）有哮喘家族史，30.6%（595例中的182例）有过敏性鼻炎，23.9%（595例中的142例）外周血嗜酸性粒细胞增多，6.1%（595例中的36例）总IgE升高，40.0%（595例中的238例）有喘息复发史，64.0%（595例中的381例）有湿疹家族史。
治疗12周后，临床症状评分显著改善。治疗前后咳嗽、喘息和活动度评分有显著差异（p<0.05）。治疗后TPTEF/TE和VPEF/VE显著改善（p<0.05）。哮喘诊断率为9.6%（595例中的57例）。治疗4周后，各项指标相应改善。29例（4.9%）患者出现不良反应，55.2%表现为兴奋，20.7%失眠，10.3%头痛，3.4%皮疹，3.4%腹痛，3.4%谷丙转氨酶水平升高。湿疹症状有一定程度缓解，鼻炎症状减轻。喘息发作次数、年度住院天数、年度使用β2激动剂天数以及肺功能改善情况有显著差异（p<0.05）。
孟鲁司特钠治疗病毒相关性喘息临床有效，临床应用4至12周可有效缓解喘息症状、改善肺功能并降低婴儿哮喘发病率。孟鲁司特钠不良反应也较少。
