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首页> 外文期刊>Platelets >Comparison of the antiplatelet effect of two clopidogrel bisulfate formulations: Plavix and generic-Egitromb
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Comparison of the antiplatelet effect of two clopidogrel bisulfate formulations: Plavix and generic-Egitromb

机译：两种氯吡格雷硫酸氢盐制剂（Plavix和通用Egitromb）的抗血小板作用比较

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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).
机译：由于药品市场的扩大，似乎有必要证明仿制药的功效。这项研究的目的是比较两种氯吡格雷制剂的效果：品牌名称-Plavix和非专利药物-Egitromb。这是一项前瞻性，随机研究，比较了两组使用两种氯吡格雷治疗的患者：商标名Plavix和非专利药Egitromb。该研究纳入了连续53例符合冠状动脉造影和PCI要求的稳定冠状动脉疾病患者。他们被随机分为两组。在A组（n = 28）中，患者入院时接受300 mg Egitromb，随后每天8天服用75 mg Egitromb。在B组（n = 25）中，患者在入院时接受300mg的Plavix，然后进行8天的75mg Plavix维持治疗。服用负荷剂量后的基线，5小时和8天抽取用于多电极凝集测试的血样。在基线时，Plavix和Egitromb组之间的血小板凝集抑制中值无差异：239AU / min（IQR：329）与209（IQR：406; p = 0.894），加载后5小时：183 AU / min （IQR：107）与165（IQR：171; p = 0.831）或第8天：174 AU / min（IQR：133）与211（IQR：133; p = 0.332）。研究表明，两种氯吡格雷制剂（Egitromb和Plavix）的治疗效果。

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