制造商：
Lundbeck公司，公司
药理分类：
抗凝血酶
活性成分（补）：
抗凝血酶（重组）; 1750国际单位/瓶（约），而静脉输注后重建密码，不含防腐剂。
指示（补）：
抗凝血酶预防遗传性缺陷患者围手术及围产后血栓栓塞事件。
药理作用：
抗凝血酶中起着关键作用的止血调节。这是主要的凝血酶和Xa因子抑制剂。抗凝血酶中和通过形成一个从复杂的流通的凝血酶和Xa因子活性。
遗传性抗凝血酶缺乏症患者面临的静脉血栓栓塞（VTE）的风险增加。在如手术或外伤或怀孕妇女在围产后期，高风险的情况下，他们对静脉血栓栓塞的风险是10-50倍，在正常人群的风险较高。
ATryn是人类抗凝血酶重组形式，是在利用基因工程重组DNA技术，山羊生产。它具有与人血浆来源的抗凝血酶相同的氨基酸序列，但其糖基化剖面不同的是，在增加亲和力肝素导致。相较于血源性抗凝血酶，ATryn具有较短的半衰期。在怀孕的患者，清除，分布容积比非妊娠患者高，因此，不同的给药方案是怀孕主场迎战手术病人使用。
临床试验：
对在职业教育ATryn遗传性抗凝血酶缺乏病人的预防效果进行了评估比较了在31 ATryn治疗的患者和35人血浆来源的抗凝血酶治疗的患者，如血栓性事件的发生率。两个前瞻性，单臂，开放标签研究提供ATryn治疗的患者数据。对血源性抗凝血酶治疗的患者，收集数据从一个同时，进行前瞻性设计的回溯性病历审查。这两项研究的患者中抗凝血酶活性≤60％的正常，证实遗传AT缺陷，以及血栓性事件的个人历史。 ATryn被认为是不逊色于血浆中的围手术期或城郊产后血栓栓塞事件的预防抗凝血酶。
法律分类：
接收
成人：
相应剂量预处理功能抗凝血酶活性和体重。启动前交货（围产后使用）或约24术前（手术病人）小时。如果孕妇和接受手术比剖腹产等，使用围产后剂量的治疗方案。给装货静脉输注15分钟，然后通过不断的维持剂量静脉注射剂量。抗凝血酶活性监测每天一次或两次，调整，维持在80％和120％的正常抗凝血酶活性。另一个可能会大剂量抗凝血酶活性，如果是“80％立即后程序（使用最新的抗凝血酶活性的数据来计算剂量）。此后，重新启动在输液和以前同样的速度丸维持剂量。见文献。
儿童：
不推荐。
禁忌（补）：
羊或羊奶牛奶蛋白过敏。
警告/注意事项：
密切监视其他抗凝血剂（例如，APTT的，抗Xa因子活性），尤其是当启动或停止治疗。出血或血栓形成监测病人。老人。妊娠（Cat.C）。哺乳的母亲。
互动（补）：
Potentiates肝素，低分子量肝素。也许是受到其他抗凝血剂。
不良反应（补）：
过敏反应，注射部位反应，出血。
如何提供：
单剂量小瓶- 1
最后更新：
2009/8/20
ATRYN
Manufacturer:
Lundbeck, Inc.
Pharmacological Class:
Antithrombin
Active Ingredient(s):
Antithrombin (recombinant); 1750 IU/vial (approx); pwd for IV infusion after reconstitution; preservative-free.
Indication(s):
Prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
Pharmacology:
Antithrombin plays a pivotal role in the regulation of hemostasis. It is the principal inhibitor of thrombin and Factor Xa. Antithrombin neutralizes the activity of thrombin and Factor Xa by forming a complex that is removed from the circulation.
Patients with hereditary antithrombin deficiency face an increased risk of venous thromboembolism (VTE). During high-risk situations such as surgery or trauma or, for pregnant women, during the peri-partum period, their risk of VTE is 10–50 times higher than the risk in the normal population.
ATryn is a recombinant form of human antithrombin that is produced in genetically engineered goats using recombinant DNA technology. It has the same amino acid sequence as human plasma-derived antithrombin, but its glycosylation profile is different, resulting in an increased heparin affinity. Compared to plasma-derived antithrombin, ATryn has a shorter half-life. In pregnant patients, the clearance and volume of distribution are higher than non-pregnant patients; therefore, different dosing schemes are used for pregnant vs. surgical patients.
Clinical Trials:
The efficacy of ATryn in the prevention of VTE in hereditary antithrombin deficient patients was assessed by comparing the incidence of the occurrence of such thrombotic events in 31 ATryn-treated patients and 35 human plasma-derived antithrombin-treated patients. Two prospective, single-arm, open label studies provided data on ATryn-treated patients. Data for plasma-derived antithrombin treated patients were collected from a prospectively-designed concurrently-conducted retrospective chart review. Patients in both studies had antithrombin activity ≤60% of normal, confirmed hereditary AT deficiency, and a personal history of thrombotic events. ATryn was found to be non-inferior to plasma antithrombin in the prevention of peri-operative or peri-partum thromboembolic events.
Legal Classification:
Rx
Adults:
Base dose on pretreatment functional antithrombin activity and body weight. Initiate before delivery (peri-partum use) or about 24 hrs before surgery (surgical patients). If pregnant and undergoing surgery other than C-section, use peri-partum dose regimen. Give loading dose as 15 mins IV infusion, then maintenance dose by continuous IV infusion. Monitor antithrombin activity once or twice daily and adjust to maintain antithrombin activity between 80% and 120% of normal. May give another bolus dose if antithrombin activity is <80% immediately post-procedure (use most recent antithrombin activity data to calculate dose). Thereafter, restart maintenance dose at the same rate of infusion as before the bolus. See literature.
Children:
Not recommended.
Contraindication(s):
Goat or goat milk protein allergy.
Warnings/Precautions:
Monitor other anticoagulants closely (eg, aPTT, anti-Factor Xa activity), especially when starting or stopping therapy. Monitor patients for bleeding or thrombosis. Elderly. Pregnancy (Cat.C). Nursing mothers.
Interaction(s):
Potentiates heparin, low molecular weight heparins. May be affected by other anticoagulants.
Adverse Reaction(s):
Hypersensitivity reactions, infusion site reactions, hemorrhage.
How Supplied:
Single-dose vial—1