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【求助】临床结果 翻译 已有2人参与
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As the primary endpoint of the study, data on the changes in the severity of hemorrhage after Futhan-used hemodialysis showed that of 49 subjects, reduced and no-change hemorrhages was reported by 35 and 14, respectively, thus representing 100% efficacy (PP analysis). In the ITT analysis, the increased severity of hemorrhage in 54 subjects was not observed and thus the same outcome the per-protocol analysis was obtained. After hemodialysis using Futhan and heparin, CCT values did not increase during Futhan-used hemodialysis but with a slight increase during heparin-used hemodialysis. PP analysis showed that there were statistically significant lower residual blood clotting during the first and the second Futhan-used hemodiaylsis, when compared with heparin-used hemodialysis. There was no significant difference of blood clotting in arterial dip-chamber after hemodialysis using Futhan and heparin. In the case of blood clotting in venous drip-chamber that is deemed more important in the efficacy assessments of an anticoagulant, PP analysis showed that there was a statistically lower blood clotting during the third Futhan-used hemodialysis, when compared with heparin-used hemodialysis. The blood clotting during the first and the second Futhan-used hemodialysis were also statistically insignificantly lower than heparin-used hemodialysis. Hemostatic time at puncture site was evaluated for 26 subjects due to the fact that a number of subjects could be evaluated. PP analysis showed that there was no significant difference in hemostatic time between the two drugs. The results of the study demonstrate that Furthan is a safe anticoagulant in patients with hemorrhage during hemodialysis, compared to patients treated with heparin, as Futhan has a comparable or superior anticoagulation effect to heparin without affecting hemorrhage. |
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jeipee(金币+100): 2010-04-11 14:15
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正如本试验目的一样，使用甲磺酸卡萘司他后出血严重性的变化数据表明，49例受试者中，出血减少和无变化分别为35例和14例，因此使用甲磺酸卡萘司他血液透析100%有效（PP分析）。在ITT分析中，54例中没有观察到出血严重性增加，因此与符合方案分析结果一致。 在使用甲磺酸卡萘司他透析和肝素透析后，前者透析过程中CCT值没有上升，而后者CCT值略有上升，符合方案分析显示，与肝素透析相比，在第一、第二次使用甲磺酸卡萘司他透析时，血凝残余显著下降。 甲磺酸卡萘司他透析和肝素透析，动脉滴注器中血凝无明显差异。然而评价抗凝剂效用更注重静脉滴注器中的血凝，符合方案分析显示，与肝素透析比较，在第三次使用甲磺酸卡萘司他透析时，血凝明显下降。而第一、第二次使用甲磺酸卡萘司他透析时与肝素透析相比血凝也无明显下降。 由于需要评估许多受试者的针孔处凝血时间，本实验评估了26位受试者针孔处凝血时间。PP分析显示，两种药物的凝血时间无明显差异。 本试验表明，由于甲磺酸卡萘司他没有出血副作用，与肝素具有相同或更好的抗凝血作用，因此相对于使用肝素透析的患者，甲磺酸卡萘司他对于血液透析伴有出血的患者是一种安全的抗凝血剂。 翻得不对的地方请指教啊 |
2楼2010-04-11 13:59:15
3楼2010-04-11 14:16:18
