An open-label comparison of the efficacy and safety of certoparin versus unfractionated heparin for the prevention of thromboembolic complications in acutely ill medical patients: CERTAIN
An open-label comparison of the efficacy and safety of certoparin versus unfractionated heparin for the prevention of thromboembolic complications in acutely ill medical patients: CERTAIN
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西托肝素与普通肝素预防急症患者血栓栓塞并发症的疗效和安全性的开放标签比较：CERTAIN
DOI：
10.1517/14656566.2010.521498
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发表时间：
2010
影响因子：
3.2
通讯作者：
H. Riess
中科院分区：
文献类型：
--
作者：
S. Schellong;S. Haas;A. Greinacher;U. Schwanebeck;C. Sieder;C. Abletshauser;P. Bramlage;H. Riess
目的：指南推荐小剂量普通肝素(UFH)和低分子肝素预防内科急症患者静脉血栓栓塞症(VTE)。我们报告了一项开放标记、主动对照、多中心研究的结果，该研究对急症内科患者进行了比较：Certoparin和UFH。研究设计与方法：开放标签、主动对照、多中心研究。患者每天服用鹿角草素3000 IU或UFH 7500 IU，每日两次。主要观察指标：主要终点包括有症状或无症状的近端或远端深静脉血栓形成、症状性肺栓塞或静脉血栓栓塞症相关死亡。结果：172例患者随机接受UFH治疗，163例接受Certoparin治疗，疗程为8.5±2.1天。主要终点的发生率在接受UFH的患者中为18.0%，在使用Certoparin的患者中为10.7%[绝对差异-7.3%，95%可信区间(CI)-16.9%至2.3%；p=0.1353]。随访期间UFH的发生率为2.6%，Certoparin组为2.0%(绝对差值-0.6；95%CI-4.0至2.8；p=0.7150)。主要出血事件发生在三名UFH患者和一名使用Certoparin的患者。结论：在年龄在40岁以上的内科急症患者中，每天使用鹿角素3000IU预防血栓是有效和安全的，与每天两次7500IU的超滤相比是安全有效的。
Objective: Guidelines recommend low-dose unfractionated heparin (UFH) and low-molecular-weight heparin for the prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients. We report the findings of an open-label, active-controlled, multicenter study in acutely ill medical patients comparing certoparin and UFH. Research design and methods: Open-label, active-controlled, multicenter study. Patients received certoparin 3000 IU daily or UFH 7500 IU twice daily. Main outcome measures: The primary endpoint was a composite of symptomatic or asymptomatic proximal or distal deep vein thrombosis, symptomatic pulmonary embolism, or VTE-related death. Results: 172 patients were randomized to UFH and 163 to certoparin for 8.5 ± 2.1 days. The incidence of the primary endpoint was 18.0% in patients receiving UFH and 10.7% with certoparin [absolute difference -7.3; 95% confidence interval (CI) -16.9 to 2.3; p = 0.1353]. The incidence during follow-up was 2.6% in the UFH and 2.0% in the certoparin group (absolute difference -0.6; 95%CI -4.0 to 2.8; p = 0.7150). Major bleeding events occurred in three patients with UFH and one patient with certoparin. Conclusions: In acutely ill medical patients of at least 40 years of age, thromboprophylaxis with certoparin 3000 IU daily is effective and safe in comparison with 7500 IU twice daily UFH.