Komosa A, Siller-Matula J M, Kowal J, Lesiak M, Siniawski A, Mączyński M, Michalak M, Mularek-Kubzdela T, Grajek S
1st Department of Cardiology, Poznan University of Medical Sciences , Poznan , Poland .
Platelets. 2015;26(1):43-7. doi: 10.3109/09537104.2013.877581. Epub 2014 Feb 5.
Due to expansion of the pharmaceutical market it seems necessary to prove the efficacy of the generic drugs. The aim of this study is to compare the effects of two clopidogrel formulations: brand-name-Plavix and generic drug - Egitromb. This is a prospective, randomized study comparing two groups of patients treated with two clopidogrel: brand-name Plavix and generic drug- Egitromb. The 53 consecutive patients with stable coronary artery disease qualifying for coronary angiography and PCI were enrolled in this trial. They were randomized into two groups. In the group A (n = 28) patients received Egitromb 300 mg at admission followed by 8 days of 75 mg Egitromb daily. In the group B (n = 25) patients received Plavix 300 mg on the admission followed by 8 days of 75 mg Plavix maintenance therapy. Blood samples for multiple electrode aggregometry testing were drawn at baseline, 5 hours and 8 days after taking the loading dose. Median values of platelet aggregation inhibition did not differ between the Plavix and Egitromb groups when assessed at baseline: 239AU/min (IQR:329) vs. 209 (IQR:406; p = 0.894), 5 hours after loading: 183 AU/min (IQR:107) vs. 165 (IQR:171; p = 0.831) or at day 8: 174 AU/min (IQR:133) vs. 211 (IQR:133; p = 0.332. The study showed no difference in the therapeutic effect of two clopidogrel formulations (Egitromb and Plavix).
由于制药市场的扩张，证明仿制药的疗效似乎很有必要。本研究的目的是比较两种氯吡格雷制剂的效果：品牌药波立维（Plavix）和仿制药埃吉托姆（Egitromb）。这是一项前瞻性随机研究，比较两组接受两种氯吡格雷治疗的患者：品牌药波立维（Plavix）和仿制药埃吉托姆（Egitromb）。53例符合冠状动脉造影和经皮冠状动脉介入治疗（PCI）条件的稳定型冠状动脉疾病患者连续纳入本试验。他们被随机分为两组。A组（n = 28）患者入院时服用300 mg埃吉托姆，随后8天每天服用75 mg埃吉托姆。B组（n = 25）患者入院时服用300 mg波立维，随后8天进行75 mg波立维维持治疗。在服用负荷剂量后的基线、5小时和8天采集用于多电极聚集测定测试的血样。在基线评估时，波立维组和埃吉托姆组之间的血小板聚集抑制中值无差异：分别为239 AU/min（四分位间距：329）和209（四分位间距：406；p = 0.894），负荷后5小时：183 AU/min（四分位间距：107）和165（四分位间距：171；p = 0.831），或在第8天：174 AU/min（四分位间距：133）和211（四分位间距：133；p = 0.332）。该研究表明两种氯吡格雷制剂（埃吉托姆和波立维）的治疗效果无差异。
