Panahi Yunes, Ghanei Mostafa, Maghsoudi Hooshyar, Saffar Soflaei Sara, Sahebkar Amirhossein
Pharmacotherapy Department, School of Pharmacy, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Chemical Injuries Research Center, Systems Biology and Poisonings Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Acta Biomed. 2018 Jun 7;89(2):186-192. doi: 10.23750/abm.v89i2.5411.
Asthma is the most chronic inflammatory disease of the airways worldwide. Combination therapy with inhaled fluticasone and salmeterol is a common practice for the long-term management of asthma. Seretide® and Fluticort plus® are two available generic and brand name products of salmeterol/fluticasone. This study aimed to compare the efficacy and safety of these two drugs.
In this randomized comparative, clinical trial, 80 asthmatic patients were allocated to Fluticort plus® (n=40) or Seretide® (n=40) for a period of 4 weeks. Patients with mild asthma were instructed to inhale one puff each 12 hours and those with moderate asthma two puffs every 12 hours. Respiratory volumes (assessed using spirometry), quality of life (assessed using St. George's Respiratory Questionnaire [SGRQ]) and control of asthmatic symptoms (assessed using asthma control test [ACT]) were evaluated at baseline and at the end of the study.
ACT score improved only in the Fluticort plus® group (p=0.012) while it was not significantly changed in the Seretide® group (p=0.178). In both treatment groups, FEV1, FEV1/FVC, and total as well as subscale SGRQ scores were significantly improved by the end of the study (p<0.05). Seretide® more efficiently improved respiratory volumes and SGRQ score in comparison with Fluticort plus® (p<0.05).
Our comparative trial indicated that generic fluticasone/salmeterol product could improve respiratory volumes, quality of life but its efficacy is lower than the brand-name product. However, Fluticort plus® improved asthma control more efficiently compared with Seretide®.
哮喘是全球最常见的气道慢性炎症性疾病。吸入氟替卡松和沙美特罗联合治疗是哮喘长期管理的常用方法。舒利迭®和辅舒酮加®是沙美特罗/氟替卡松两种可获得的通用名和品牌名产品。本研究旨在比较这两种药物的疗效和安全性。
在这项随机对照临床试验中，80例哮喘患者被分配至辅舒酮加®组（n = 40）或舒利迭®组（n = 40），为期4周。轻度哮喘患者被指示每12小时吸入1吸，中度哮喘患者每12小时吸入2吸。在基线和研究结束时评估呼吸量（使用肺量计评估）、生活质量（使用圣乔治呼吸问卷[SGRQ]评估）和哮喘症状控制情况（使用哮喘控制测试[ACT]评估）。
ACT评分仅在辅舒酮加®组有所改善（p = 0.012），而在舒利迭®组无显著变化（p = 0.178）。在两个治疗组中，到研究结束时FEV1、FEV1/FVC以及SGRQ总分和各子量表得分均显著改善（p < 0.05）。与辅舒酮加®相比，舒利迭®更有效地改善了呼吸量和SGRQ评分（p < 0.05）。
我们的对照试验表明，通用名氟替卡松/沙美特罗产品可改善呼吸量和生活质量，但其疗效低于品牌名产品。然而，与舒利迭®相比，辅舒酮加®能更有效地改善哮喘控制。
