Evaluation of enoxaparin given before and after operation to prevent venous thromboembolism during digestive surgery: Play-the-winner designed study

Evaluation of enoxaparin given before and after operation to prevent venous thromboembolism during digestive surgery: Play-the-winner designed study
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DOI:
10.1007/s002689900277
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发表时间:
1997-07-01
影响因子:
2.6
通讯作者:
Reiertsen, O
Reiertsen, O
中科院分区:
医学3区
文献类型:
--
作者:
Bjerkeset, O;Larsen, S;Reiertsen, O

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共有316名患者被纳入一项比赛赢家者(PTW)设计的研究,比较了术前与术后开始依诺肝素预防消化道手术静脉血栓栓塞的安全性。在PTW设计的研究中,下一位患者的治疗取决于前一位患者的结果,如果成功,下一位患者接受相同的治疗,如果不成功,则给予比较方案。根据规定的标准,严重不良反应,临床检测到的深静脉血栓形成(DVT)或肺栓塞(PE)的过度出血是分类为“失败者”的标准。PTW设计将大多数患者分配到上级治疗。PTW研究中的主要变量是接受相同治疗的连续患者数量。在本研究中,163例患者被分配至术后开始依诺肝素预防治疗,153例患者被分配至术前开始依诺肝素预防治疗。术后治疗组和术前治疗组的“优胜者"频率分别为82.8%和78.4%。在改变治疗前,两组之间的“获胜者”频率或连续患者数量无显著差异。生存分布的百分位数未检测到任何组的优效性。术前使用依诺肝素预防消化道手术后静脉血栓栓塞是安全的。
A total of 316 patients were included in a play-the-winner (PTW) designed study comparing the safety of enoxaprain started preoperatively versus postoperatively as prophylaxis against venous thromboembolism for digestive surgery. In a PTW-designed study the treatment of any next patient depends on the outcome of the previous patient, If successful, the next patient receives the same treatment, if not, the comparative regimen is given. Excessive bleeding according to specified criteria, severe adverse reactions, clinically detected deep venous thrombosis (DVT), or pulmonary embolism (PE) were criteria for classification as ''loser.'' The PTW design allocates most patients to the superior treatment. The main variable in PTW studies is the number of consecutive patients receiving the same treatment. In this study 163 patients were allocated to postoperatively started and 153 to preoperatively started prophylaxis with enoxaparin. The frequency of ''winners'' was found to he 82.8% and 78.4% in the post- and preoperatively treated groups, respectively. No significant differences were found between the groups with regard to frequency of ''winners'' or the number of consecutive patients before change of treatment. The percentile of survival distribution did not detect superiority of any group. Prophylaxis against postoperative venous thromboembolism for digestive surgery using enoxaparin can safely be started preoperatively.