Dipartimento di Biotecnologie Cellulari ed Ematologia, Sapienza Università Roma, Italy.
Thromb Res. 2011 Oct;128(4):325-30. doi: 10.1016/j.thromres.2011.04.012. Epub 2011 May 19.
The demand for oral anticoagulant therapy (OAT) has constantly increased during the last ten years with an extended use of computer assistance. Many mathematical algorithms have been projected to suggest doses and time to next visit for patients on OAT. We designed a new algorithm: "Zeus". A "before-after" study was planned to compare the efficacy and safety of this algorithm dosing OAT with manual dosage decided by the same expert physicians according to the target of International Normalized Ratio (INR). The study analysed data of 1876 patients managed with each of the two modalities for eight months, with an interval of two years between them. The aim was to verify the increased quality of therapy by time spent in INR target and efficiency and safety of Zeus algorithm. Time in therapeutic range (TTR) was significantly (p < 0.0001) higher during the algorithm dosing period in comparison with the TTR during manual management period (62.3% vs 50.3%). The number of PT/INR tests above 5 was significantly (p < 0.001) reduced by algorithm suggested prescriptions in comparison with manual those (254 vs 537 times). The anticoagulant drug amount prescribed according to the algorithm suggestions was significantly (p < 0.0001) lower than that of the manual method. The number of clinical events observed in patients during the algorithm management time was significantly (p < 0.05) lower than that in those managed with the manual dosage. This study confirms the clinical utility of the computer-assisted OAT and shows the efficacy and safety of the Zeus algorithm.
在过去十年中,随着计算机辅助的广泛应用,口服抗凝治疗 (OAT) 的需求不断增加。许多数学算法被设计用于为接受 OAT 的患者建议剂量和下次就诊时间。我们设计了一种新的算法:“Zeus”。计划进行一项“前后”研究,比较 Zeus 算法和同一专家医生根据国际标准化比值 (INR) 目标手动调整剂量的 OAT 治疗的疗效和安全性。该研究分析了 1876 名患者在两种方式下管理的 8 个月数据,两次管理之间间隔两年。目的是验证通过 INR 目标时间和 Zeus 算法的效率和安全性来提高治疗质量。与手动管理期间相比,算法剂量期间的治疗范围内时间 (TTR) 显著更高 (p < 0.0001) (62.3% 对 50.3%)。与手动管理期间相比,根据算法建议处方的 PT/INR 测试次数显著减少 (p < 0.001) (254 次对 537 次)。根据算法建议的抗凝药物剂量显著低于手动方法 (p < 0.0001)。在算法管理期间观察到的患者临床事件数量显著低于手动剂量管理的患者 (p < 0.05)。这项研究证实了计算机辅助 OAT 的临床实用性,并显示了 Zeus 算法的疗效和安全性。