PDF(Pubmed)
Abstract：
Apixaban is a direct oral Xa inhibitor and is indicated for the treatment of venous thrombo-embolism (VTE) and prevention of stroke in atrial fibrillation (AF). Recently, a generic (ZyQuis, Zydus Lifesciences Limited, India) has received Food and Drug Administration approval. While bioequivalence has been demonstrated with Eliquis (Bristol-Myers Squibb/Pfizer, UK), it is necessary to monitor its effectiveness prior to acceptance in medical practice. This prospective study independently evaluated Apixaban (ZyQuis) at two accredited laboratories. Participants were converted from Warfarin or Rivaroxaban to Apixaban 5 mg bd for a duration of one month. Peak anti-Xa levels were measured 3-4 h post the morning dose. The samples were processed on the Atellica COAG 360 (Siemens Healthineers, Marburg, Germany) analyzers with a chromogenic anti-Xa assay (Innovance, reference interval 69-321 ng/mL). There were 26 participants; 5 men, 21 women; mean ± standard deviation age of 46 ± 12 years. Indications for anticoagulation included: VTE (88.5%) and AF (11.5%). 69.2% of the participants had at least one comorbidity. 96.2% of the anti-Xa levels were within the laboratory\'s 95% reference interval. Mean anti-Xa activity was 191 ± 69 ng/mL and 186 ± 68 ng/mL measured at respective laboratories. Mean differences in anti-Xa measurements represented by Bland-Altman statistics were small (bias of -2.6%, 95% confidence interval -1.11 to -4.09) and a strong correlation was observed on Deming regression analysis (0.995). Apixaban (ZyQuis) was effective for the management of VTE and AF as evidenced by anti-Xa activity.
摘要：
阿哌沙班是一种直接口服Xa抑制剂，适用于治疗静脉血栓栓塞（VTE）和预防房颤（AF）中的中风。最近,一个泛型(ZyQuis，ZydusLifesciencesLimited,印度）已获得食品药品监督管理局的批准。尽管Eliquis（百时美施贵宝/辉瑞，英国),在医疗实践中接受之前，有必要监测其有效性。这项前瞻性研究在两个认可的实验室独立评估了阿哌沙班（ZyQuis）。参与者从华法林或利伐沙班转换为阿哌沙班5mgbd，持续一个月。在早晨剂量后3-4小时测量峰值抗Xa水平。样品在AtellicaCOAG360(西门子健康公司，马尔堡,德国)具有显色抗Xa测定的分析仪(Innovance，参考区间69-321ng/mL)。有26名参与者；5名男子，21名女性；平均±标准差年龄为46±12岁。抗凝适应症包括:VTE(88.5%)和AF(11.5%)。69.2％的参与者至少有一种合并症。96.2%的抗Xa水平在实验室的95%参考区间内。在各个实验室测量的平均抗Xa活性为191±69ng/mL和186±68ng/mL。Bland-Altman统计量表示的抗Xa测量的平均差异很小（偏差为-2.6％，95％置信区间-1.11至-4.09），并且在Deming回归分析中观察到了很强的相关性（0.995）。阿哌沙班（ZyQuis）对VTE和AF的管理有效，如抗Xa活性所证明。
