Cafolla Arturo, Manisco Luigia, Baldacci Erminia, Porcu Alessandro, Campanelli Melissa, Cursano Maria Concetta, Rossi Enza, Dragoni Francesco, Foà Roberto
Dipartimento di Biotecnologie Cellulari ed Ematologia, "Sapienza" Università, Via Benevento, 6 00161, Rome, Italy,
Drugs Aging. 2015 Mar;32(3):235-41. doi: 10.1007/s40266-015-0247-z.
The use of oral anticoagulant therapy (OAT) has constantly increased in the prevention of thromboembolism, particularly in patients 80 years of age or older.
The aim of this multicentre study was to evaluate the efficacy and safety of vitamin K antagonists (VKAs) in elderly patients managed with a computer dosing algorithm compared with a dosage decided by expert physicians.
Nine Italian thrombosis centres utilising the Zeus dosing algorithm were involved. The before-after study enrolled patients managed firstly by medical staff (manual system) or with the PARMA algorithm for 12 months from July 2008 to June 2009 and then with the Zeus algorithm during the analogous period from 2010 to 2011. Of 7605 patients in the OAT maintenance phase, 2281 were older than 80 years (mean age 84.2 years). Data for these 2281 patients managed with both modalities were analysed.
Of the 2281 patients 80 years of age or older, 1776 underwent OAT for atrial fibrillation (AF). Use of a dosing algorithm increased the OAT quality: time in therapeutic range (TTR) was significantly (p < 0.001) higher during the Zeus period than during the manual period (71.6 vs. 68.8 %). The TTR achieved with Zeus was similar to that obtained with the PARMA algorithm. In addition, patients managed with Zeus took a weekly drug dosage significantly (p < 0.01) lower than that both suggested by PARMA and prescribed by expert physicians, with a reduced number of adverse events.
This study confirms that the effectiveness and safety of VKA therapy in patients 80 years of age or older increases with computer dosing algorithms.
口服抗凝治疗(OAT)在预防血栓栓塞方面的应用持续增加,尤其是在80岁及以上的患者中。
本多中心研究的目的是评估与专家医生确定的剂量相比,使用计算机给药算法管理老年患者时维生素K拮抗剂(VKA)的疗效和安全性。
九个使用宙斯给药算法的意大利血栓形成中心参与了研究。前后对照研究纳入了2008年7月至2009年6月首先由医务人员管理(手动系统)或采用帕尔马算法管理12个月,然后在2010年至2011年同期采用宙斯算法管理的患者。在7605例处于OAT维持阶段的患者中,2281例年龄超过80岁(平均年龄84.2岁)。分析了这2281例采用两种管理方式的患者的数据。
在2281例80岁及以上的患者中,1776例接受了房颤(AF)的OAT治疗。给药算法的使用提高了OAT质量:宙斯算法期间的治疗范围内时间(TTR)显著高于手动管理期间(p < 0.001)(71.6%对68.8%)。宙斯算法实现的TTR与帕尔马算法获得的TTR相似。此外,采用宙斯算法管理的患者每周药物剂量显著低于帕尔马算法建议的剂量和专家医生开出的剂量(p < 0.01),不良事件数量减少。
本研究证实,对于80岁及以上的患者,计算机给药算法可提高VKA治疗的有效性和安全性。