Panahi Yunes, Ghanei Mostafa, Behzadi Mohammad, Salehi Maryam, Soflaei Sara Saffar, Sahebkar Amirhossein
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Neurogenic Inflammation Research Center, Department of Modern Sciences and Technologies, Mashhad University of Medical Sciences, Mashhad, Iran.
Saudi Pharm J. 2016 Mar;24(2):147-52. doi: 10.1016/j.jsps.2015.01.005. Epub 2015 Jan 12.
The beneficial effects of tiotropium bromide, a long acting anticholinergic bronchodilator, in the management of chronic obstructive pulmonary disease have been shown in previous studies. The present study aimed to compare the efficacy and safety of generic (Tiova®) and brand-name (Spiriva®) tiotropium preparations in patients with COPD.
In this randomized double-blind parallel-group trial, 79 patients with documented COPD were assigned to Tiova® or Spiriva® for a period of 4 weeks. Assessment of pulmonary function (using spirometry), quality-of-life (using St. George respiratory Questionnaire [SGRQ]) and severity of respiratory symptoms (using breathlessness, cough and sputum scale [BCSS]) was performed at baseline and at the end of treatment period.
There were significant increases in FEV1 and reductions in FVC by the end of study in both Tiova® and Spiriva® groups. FEV1/FVC ratio did not change significantly neither in the Tiova® nor in Spiriva® group. Overall SGRQ score as well as subscale scores of symptoms, activity and impacts were improved by both drugs. In the BCSS scale, the frequency and severity of three main symptoms (dyspnea, cough and sputum) was decreased by both drugs. Baseline as well as post-treatment values of spirometric parameters, SGRQ and BCSS scores was comparable between the groups, apart from a lower post-treatment frequency of cough and sputum in the Spiriva® versus Tiova® group. There was no report of adverse events in either of the study groups.
The findings of this comparative trial showed equivalent efficacy and safety of Spiriva® and Tiova® in lessening the symptoms as well as improving the quality of life in patients with COPD. This finding has an important translational value given the significantly lower costs of generic versus brand-name products.
先前的研究已表明，长效抗胆碱能支气管扩张剂噻托溴铵在慢性阻塞性肺疾病管理中的有益作用。本研究旨在比较通用型（Tiova®）和品牌型（Spiriva®）噻托溴铵制剂对慢性阻塞性肺疾病患者的疗效和安全性。
在这项随机双盲平行组试验中，79例确诊为慢性阻塞性肺疾病的患者被分配使用Tiova®或Spiriva®，为期4周。在基线和治疗期结束时进行肺功能评估（使用肺量计）、生活质量评估（使用圣乔治呼吸问卷[SGRQ]）以及呼吸症状严重程度评估（使用呼吸困难、咳嗽和痰液量表[BCSS]）。
在研究结束时，Tiova®组和Spiriva®组的第一秒用力呼气容积（FEV1）均显著增加，用力肺活量（FVC）均降低。Tiova®组和Spiriva®组的FEV1/FVC比值均未发生显著变化。两种药物均改善了总体SGRQ评分以及症状、活动和影响的子量表评分。在BCSS量表中，两种药物均降低了三种主要症状（呼吸困难、咳嗽和痰液）的频率和严重程度。除了Spiriva®组治疗后咳嗽和痰液的频率低于Tiova®组外，两组之间肺量计参数、SGRQ和BCSS评分的基线值以及治疗后值具有可比性。两个研究组均未报告不良事件。
这项比较试验的结果表明，Spiriva®和Tiova®在减轻慢性阻塞性肺疾病患者症状以及改善生活质量方面具有等效的疗效和安全性。鉴于通用型产品相对于品牌型产品成本显著降低，这一发现具有重要的转化价值。
