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首页> 外文期刊>Indian medical journal >An Open Label Randomized Controlled Study to Compare the Efficacy and Safety of Ozagrel Versus Montelukast as Add-On Therapy to Long Acting Beta Agonist- Inhaled Glucocorticoids in Moderate to Severe Asthma
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An Open Label Randomized Controlled Study to Compare the Efficacy and Safety of Ozagrel Versus Montelukast as Add-On Therapy to Long Acting Beta Agonist- Inhaled Glucocorticoids in Moderate to Severe Asthma

机译:一个开放标签随机对照研究,比较Ozagrel与蒙特利斯特的疗效和安全性作为中度至严重哮喘的长效β激动剂吸入糖皮质激素的加入治疗

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Background & Objectives : Asthma is a chronic illness which affects all age groups. It is characterized by airway hyperresponsiveness with recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning. The objective of this study was to study the efficacy and safety of Ozagrel and Montelukast as add-on therapy to long-acting beta agonist-inhaled corticosteroids in the treatment of moderate to severe asthma and to compare the improvement in quality of life. Methods : This was a randomized, open label, comparative study. Subjects were randomized into two groups of 50 each. They received Ozagrel 200 mg, twice daily or Montelukast 10 mg once daily orally for 8 weeks. Assessment was done by calculating Pulmonary Function Parameters and Quality of Life at 4 weeks and 8 weeks. Safety was assessed based on adverse events. Results : There was a statistically significant improvement in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) in the Montelukast group, and FEV1/ FVC in the Ozagrel group, with improvement in the Mini-Asthma Quality of Life Questionnaire (M-AQLQ) in both groups. Between group differences in efficacy in terms of Pulmonary Function Test parameters was not demonstrable. There was a decrease in agonist use and nocturnal symptoms in the Montelukast group as compared to Ozagrel. Incidence of side effects was similar and there were no serious adverse effects in both the groups. Conclusion : Treatment of asthma with drugs like Montelukast and Ozagrel which target the inflammatory pathway, are novel therapeutic options and will play a major role in management of asthma in the future.
机译:背景和目标:哮喘是一种影响所有年龄段的慢性疾病。它的特点是气道高反应性,经常发作的喘息,呼吸,胸闷,咳嗽,特别是在夜晚或清晨。本研究的目的是研究Ozagrel和Montelukast的疗效和安全性作为治疗中度至严重哮喘的长效β激动剂吸入皮质类固醇的加入治疗,并比较生活质量的改善。方法:这是一个随机的开放标签,比较研究。受试者随机分为两组,每组。他们收到ozagrel 200 mg,每日两次或蒙特洛士岛10毫克每日一次口服8周。通过计算4周和8周的肺功能参数和生活质量来完成评估。根据不良事件评估安全性。结果:在蒙特洛斯特集团的1秒(FEV1)中,强制性的重要能力(FVC)和强制呼气量,在Ozagrel组中的FEV1 / FVC中,患有迷你哮喘质量问卷的致统计学意义(FEV1)有统计学上显着改善。 (M-AQLQ)在两个组中。在肺功能试验参数方面,疗效的疗效之间的差异不明显。与Ozagrel相比,蒙特洛斯特集团的激动剂使用和夜间症状有降低。副作用的发生率类似,两组中没有严重的不利影响。结论:患有蒙特洛斯特和甲状腺素等药物的哮喘的治疗,靶向炎症途径,是新的治疗选择,并将在未来对哮喘的管理发挥重要作用。

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