深静脉血栓疗效PK：选择性Xa抑制剂Idraparinux与标准方案

Idraparinux versus Standard Therapy for Venous Thromboembolic Disease
静脉血栓栓塞性疾病的标准治疗与Idraparinux 的PK
Background
背景
Venous thromboembolism is treated with unfractionated heparin or low-molecular-weight heparin, followed by a vitamin K antagonist. We investigated the potential use of idraparinux, a long-acting inhibitor of activated factor X, as a substitute for standard therapy.
静脉血栓栓塞通过维生素k拮抗剂途径给予普通肝素或低分子量肝素进行治疗，我们调查了idraparinux 使用的潜在可能性，它作为标准疗法的一种替代，是一种长效的激活因子Ⅹ抑制剂。
Methods
方法
We conducted two randomized, open-label noninferiority trials involving 2904 patients with deep-vein thrombosis and 2215 patients with pulmonary embolism to compare the efficacy and safety of idraparinux versus standard therapy. Patients received either subcutaneous idraparinux (2.5 mg once weekly) or a heparin followed by an adjusted-dose vitamin K antagonist for either 3 or 6 months. The primary efficacy outcome was the 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal).
我们进行了两个随机化，公开标签的非劣性试验，它包括2904名患有深静脉血栓病人和2215名患有肺栓塞的病人，目的是比较idraparinux和标准疗法的安全性和有效性。病人接受皮下注射idraparinux（每周一次，2.5mg）或接受为期3月或6月伴随调整剂量维生素K拮抗剂的肝素，初期有效性结果为3个月复发静脉血栓栓塞症状的发病率（非致命性或致命性）
Results
结果
In the study of patients with deep venous thrombosis, the incidence of recurrence at day 92 was 2.9% in the idraparinux group as compared with 3.0% in the standard-therapy group (odds ratio, 0.98; 95% confidence interval [CI], 0.63 to 1.50), a result that satisfied the prespecified noninferiority requirement. At 6 months, the hazard ratio for idraparinux was 1.01. The rates of clinically relevant bleeding at day 92 were 4.5% in the idraparinux group and 7.0% in the standard-therapy group (P=0.004). At 6 months, bleeding rates were similar. In the study of patients with pulmonary embolism, the incidence of recurrence at day 92 was 3.4% in the idraparinux group and 1.6% in the standard-therapy group (odds ratio, 2.14; 95% CI, 1.21 to 3.78), a finding that did not meet the noninferiority requirement.
在患有深静脉血栓病人的研究中，92天时idraparinux组的复发发病率为2.9％，而标准疗法组为3.0％（OR：0.98;95％可信区间CI：0.63-1.50），这个结果满足给定非劣性需求；在6个月时，idraparinux的危害比为1.01；在92天时idraparinux组的临床相关出血率为4.5%，而标准治疗组为7.0％（P=0.004），而在6个月时两者的出血率相似。在患有肺栓塞的病人研究中，92天时idraparinux组的复发发病率为3.4%，而标准治疗组为1.6％（OR：2.14;95％可信区间CI：1.21-3.78），这一发现不能满足非劣性需求。
Conclusions
结论
In patients with deep venous thrombosis, once-weekly subcutaneous idraparinux for 3 or 6 months had an efficacy similar to that of heparin plus a vitamin K antagonist. However, in patients with pulmonary embolism, idraparinux was less efficacious than standard therapy
患有深静脉血栓的病人每周一次经皮下给予idraparinux持续3个月或6个月，这与肝素与维生素K拮抗剂合用的效果相似，然而，在患有肺栓塞的病人中，idraparinux与标准治疗比较而言，有效性更低。
编译：
静脉血栓栓塞性疾病的标准治疗与Idraparinux相比较
(N Engl J Med. 2007 Sep;357(11):1094-104)
静脉血栓栓塞通过维生素k拮抗剂途径给予普通肝素或低分子量肝素进行治疗，本研究调查了idraparinux 使用的潜在可能性，它是一种长效的激活因子Ⅹ抑制剂。
本研究进行了包括2904名患有深静脉血栓病人和2215名患有肺栓塞的病人在内的两个随机化，公开的非劣性试验，目的是比较idraparinux和标准疗法的安全性和有效性。
结果发现：在患有深静脉血栓病人的研究中，92天时idraparinux组的复发发病率为2.9％，而标准疗法组为3.0％，这个结果满足设定的非劣性需求；在6个月时，idraparinux的危害比为1.01；在92天时idraparinux组的临床相关出血率为4.5%，而标准治疗组为7.0％，而在6个月时两者的出血率相似。在患有肺栓塞的病人研究中，92天时idraparinux组的复发发病率为3.4%，而标准治疗组为1.6％，这一发现不能满足非劣性需求。
结论为：患有深静脉血栓的病人每周一次经皮下给予idraparinux持续3个月或6个月，这与肝素与维生素K拮抗剂合用的效果相似，然而，在患有肺栓塞的病人中，idraparinux与标准治疗比较而言，有效性更低。