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瑞苏伐他汀预防静脉血栓形成——一项随机试验

时间:2010-08-24 11:47:15  来源:  作者:

       Background: Controversy persists regarding the extent of shared pathways between arterial and venous thrombosis and whether treatments of known efficacy for one disease process have consistent benefits for the other. Observational studies have yielded variable estimates of the effect of statin therapy on the risk of venous thromboembolism, and evidence from randomized trials is lacking.
背景:关于对动脉及静脉血栓中一种血栓治疗有效的方法在另一种血栓治疗效果如何一直存在争议。目前关于评估他汀类在治疗静脉血栓形成风险的相关研究还没有定论,并且缺乏随机研究的证据。

    Methods: We randomly assigned 17,802 apparently healthy men and women with both low-density lipoprotein (LDL) cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter) and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to receive rosuvastatin, 20 mg per day, or placebo. We followed participants for the first occurrence of pulmonary embolism or deep-vein thrombosis and performed analyses of the data on an intention-to-treat basis.
    方法:我们纳入17802名看似健康的男性及女性患者,其低密度脂蛋白(LDL)均小于130mg/dl(3.4mmol/L)且高敏C反应蛋白大于或等于2.0mg/L,随机给予瑞苏伐他汀20mg/d或安慰剂。我们随访参与者的主要事件为肺栓塞及深静脉血栓形成,使用意向处理分析数据。

    Results: During a median follow-up period of 1.9 years (maximum, 5.0), symptomatic venous thromboembolism occurred in 94 participants: 34 in the rosuvastatin group and 60 in the placebo group. The rates of venous thromboembolism were 0.18 and 0.32 event per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio with rosuvastatin, 0.57; 95% confidence interval [CI], 0.37 to 0.86; P=0.007); the corresponding rates for unprovoked venous thromboembolism (i.e., occurring in the absence of a known malignant condition, trauma, hospitalization, or surgery) were 0.10 and 0.17 (hazard ratio, 0.61; 95% CI, 0.35 to 1.09; P=0.09) and for provoked venous thromboembolism (i.e., occurring in patients with cancer or during or shortly after trauma, hospitalization, or surgery), 0.08 and 0.16 (hazard ratio, 0.52; 95% CI, 0.28 to 0.96; P=0.03). The rates of pulmonary embolism were 0.09 in the rosuvastatin group and 0.12 in the placebo group (hazard ratio, 0.77; 95% CI, 0.41 to 1.45; P=0.42), whereas the rates of deep-vein thrombosis only were 0.09 and 0.20, respectively (hazard ratio, 0.45; 95% CI, 0.25 to 0.79; P=0.004). Consistent effects were observed in all the subgroups examined. No significant differences were seen between treatment groups in the rates of bleeding episodes.
      结果:在中位随访期1.9年中(最长5年),94名参与者发生了症状性静脉血栓:瑞苏伐他汀组34名而安慰剂组60名。在随访期间,瑞苏伐他汀组及安慰剂组静脉血栓发生率分别为0.18%及0.32%(风险比0.57;95%可信区间,0.37-0.86,P=0.007);其中自发性静脉血栓(如无已知的有害条件,创伤,住院治疗及手术等)发生率分别为0.10及0.17(风险比,0.61,95% CI,0.35-1.09;P=0.09),而继发性静脉血栓(如肿瘤患者,长期或短期创伤,住院治疗及手术等)发生率为0.08%及0.16%(风险比,0.52,95% CI,0.28-0.96;P=0.03)。瑞苏伐他汀组及安慰剂组肺栓塞发生率分别为0.09%及0.12%(风险比,0.77,95% CI,0.41-1.45;P=0.42),但深静脉血栓发生率分别为0.09%及0.20%(风险比,0.45,95% CI,0.25-0.79;P=0.004)。在所有观察的亚组中,这些效果持续存在。两组处理组的出血事件发生率无显著性差异。

    Conclusions: In this trial of apparently healthy persons, rosuvastatin significantly reduced the occurrence of symptomatic venous thromboembolism.
    结论:对本试验中看似健康的人群,瑞苏伐他汀能降低其发生症状性静脉血栓的风险。

   编译:

     瑞苏伐他汀预防静脉血栓形成——一项随机试验

    背景:关于对动脉及静脉血栓中一种血栓治疗有效的方法在另一种血栓治疗效果如何一直存在争议。目前关于评估他汀类在治疗静脉血栓形成风险的相关研究还没有定论,并且缺乏随机研究的证据。

    方法:我们纳入17802名看似健康的男性及女性患者,其低密度脂蛋白(LDL)均小于130mg/dl(3.4mmol/L)且高敏C反应蛋白大于或等于2.0mg/L,随机给予瑞苏伐他汀20mg/d或安慰剂。我们随访参与者的主要事件为肺栓塞及深静脉血栓形成,使用意向处理分析数据。

     结果:在中位随访期1.9年中(最长5年),94名参与者发生了症状性静脉血栓:瑞苏伐他汀组34名而安慰剂组60名。在随访期间,瑞苏伐他汀组及安慰剂组静脉血栓发生率分别为0.18%及0.32%(风险比0.57;95%可信区间,0.37-0.86,P=0.007);其中自发性静脉血栓(如无已知的有害条件,创伤,住院治疗及手术等)发生率分别为0.10及0.17(风险比,0.61,95% CI,0.35-1.09;P=0.09),而继发性静脉血栓(如肿瘤患者,长期或短期创伤,住院治疗及手术等)发生率为0.08%及0.16%(风险比,0.52,95% CI,0.28-0.96;P=0.03)。瑞苏伐他汀组及安慰剂组肺栓塞发生率分别为0.09%及0.12%(风险比,0.77,95% CI,0.41-1.45;P=0.42),但深静脉血栓发生率分别为0.09%及0.20%(风险比,0.45,95% CI,0.25-0.79;P=0.004)。在所有观察的亚组中,这些效果持续存在。两组处理组的出血事件发生率无显著性差异。

     结论:对本试验中看似健康的人群,瑞苏伐他汀能降低其发生症状性静脉血栓的风险。

                                                                 文章来自:丁香园

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