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【求助】药物临床材料英翻中 已有1人参与
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The primary endpoints of the study were to assess , the changes in severity of hemorrhage during the use of Futhan. The severity of hemorrhage after Futhan-used hemodialysis was evaluated by measuring the percentage of subjects, such that the same test as initially conducted test were conducted within 2 days after completion of the final Futhan-used hemodialysis. After the final completion of Futhan-used hemodialysis, the hemorrhage test was conducted to compare the severity of hemorrhage prior to use of Futhan. The changes in the severity of hemorrhage were objectively assessed in accordance with the following scale: I. (reduced), II. (no change), III. (slightly increased), and IV (significantly increased). The scales (III, IV) were assessed as the worsening of hemorrhage). Table 11 shows the changes in the severity of hemorrhage, calculated by the number and percentage of patients per drug. The study protocol dictated that the primary endpoints were to assess during the use of Futhan only in consideration of subjects’ safety. However, during heparin-used hemodialysis, increased severity in hemorrhage was reported by 1 patient and thus related data were presented as a reference. 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. Despite heparin-used hemodialysis in 22 patients who did not occur hemorrhage yet or recovered from hemorrhage completely, there was a slight increase in hemorrhage in 1 patient (94.5%). ITT analysis had a similar result. 谢谢 |
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jeipee(金币+70): 2010-04-09 12:28
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本实验是为了评估使用甲磺酸卡萘司他后出血程度的改变。通过受试者的比例来评价使用甲磺酸卡萘司他进行血液透析后的出血程度，与最初相同的对照试验是在完成最后一次使用甲磺酸卡萘司他血液透析后两天内进行。 最后一次使用甲磺酸卡萘司他血液透析后，进行出血试验，与使用甲磺酸卡萘司他之前的出血程度做比较。用以下等级客观地表示出血严重性的变化，I.（减少），II.（无变化），III.（略有增加），IV.（明显增加）。III, IV等级被视为出血情况恶化。 表11反映了出血严重性的变化，以病人数量和每种药物的病人的百分比计算 本实验方案的原则是在受试者安全的前提下，评估使用甲磺酸卡萘司他后出血严重性的变化。但是，在使用肝素血液透析试验中，报告了一例出血严重性增加，因此相关数据作为参考。 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（指示剂时间试验？）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。 尽管22例使用肝素血液透析患者，这些患者都没有发生出血或者出血情况已经完全没有了，但是还是有一例报告出血严重性增加（94.5%）。ITT分析结果相似。 |
2楼2010-04-09 12:28:02
