Regis University School of Pharmacy, 3333 Regis Boulevard, Mail Code: H-28, Denver, CO 80221-1099, USA.
J Thromb Thrombolysis. 2013 Jul;36(1):91-5. doi: 10.1007/s11239-012-0810-y.
The United States Pharmacopeia recently changed the standards for unfractionated heparin (UFH) resulting in reduction in potency by about 10 %. Despite the reduction in potency, no new recommendations for UFH dosing were recommended. A retrospective review was conducted on patients receiving UFH and at least one activated partial thromboplastin time (aPTT) after start of infusion. Patients receiving UFH prior to April 2010 were collected as old UFH potency patients versus those receiving UFH after May 1st, 2010 were defined as new UFH potency patients. The primary endpoint was time to a therapeutic aPTT. Secondary endpoints included the number venous thrombotic events (VTE) and bleeding events during hospitalization through 30 days post discharge. Thrombotic events were defined as acute coronary syndrome, ischemic stroke, and VTE. Bleeding was defined in accordance with the GUSTO bleeding scale. A total of 359 patients were included for evaluation, 181 in the old UFH group and 178 in the new UFH group. The primary endpoint was similar between groups with an average time of 18.8 ± 25.4 versus 20.8 ± 22.2 h in the old and new UFH groups respectively (p = 0.092). Patients receiving old UFH and an initial bolus had higher aPTTs (96.6 ± 43.7 s) than those receiving new UFH and an initial bolus (76.7 ± 34.5 s) (p = 0.003). There was no difference found between groups in regards to bleeding or thrombotic events during hospitalization or through 30 days. In patients receiving UFH, dosed per the institutions' nomogram, no clinically significant outcomes were found between the old and new UFH potencies.
美国药典最近改变了未分级肝素 (UFH) 的标准,导致其效价降低约 10%。尽管效价降低,但没有推荐新的 UFH 剂量建议。对开始输注后至少接受一次激活部分凝血活酶时间 (aPTT) 的 UFH 患者进行回顾性审查。2010 年 4 月前接受 UFH 的患者被收集为旧 UFH 效价患者,而 2010 年 5 月 1 日后接受 UFH 的患者被定义为新 UFH 效价患者。主要终点是达到治疗性 aPTT 的时间。次要终点包括住院期间至出院后 30 天内静脉血栓栓塞事件 (VTE) 和出血事件的数量。血栓事件定义为急性冠脉综合征、缺血性中风和 VTE。出血按照 GUSTO 出血量表定义。共纳入 359 例患者进行评估,旧 UFH 组 181 例,新 UFH 组 178 例。两组主要终点相似,平均时间分别为旧 UFH 组 18.8 ± 25.4 小时和新 UFH 组 20.8 ± 22.2 小时(p = 0.092)。接受旧 UFH 初始推注的患者 aPTT 较高(96.6 ± 43.7 s),而接受新 UFH 初始推注的患者 aPTT 较低(76.7 ± 34.5 s)(p = 0.003)。两组在住院期间或出院后 30 天内的出血或血栓事件无差异。在接受 UFH 治疗的患者中,根据机构的列线图进行剂量调整,新旧 UFH 效价之间没有发现临床意义的结果。