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前瞻性验证国际华法林药物基因组学联合会算法在高危老年人中的应用(VIALE 研究)。

Prospective validation of the International Warfarin Pharmacogenetics Consortium algorithm in high-risk elderly people (VIALE study).

机构信息

Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Via S. Allende, 84081, Baronissi, SA, Italy.

Clinical Pharmacology Unit, San Giovanni di Dio e Ruggi d'Aragona University Hospital, Via San Leonardo 1, 84131, Salerno, Italy.

出版信息

Pharmacogenomics J. 2020 Jun;20(3):451-461. doi: 10.1038/s41397-019-0129-6. Epub 2019 Dec 5.

Abstract

We assessed the predictive accuracy of the Warfarin Pharmacogenetics Consortium (IWPC) algorithm in a prospective cohort of 376 high-risk elderly patients (≥65 years) who required new treatment with warfarin for either medical (non valvular atrial fibrillation) or surgical conditions (heart valve replacement), had ≥1 comorbid conditions, and regularly used ≥2 other drugs. Follow-up visits were performed according to clinical practice and lasted for a maximum of 1 year. Two hundred and eighty-three (75%) patients achieved a stable maintenance dose. Warfarin maintenance doses were low on average (median 20.3 mg/week, interquartile range, 14.1-27.7 mg/week) and were substantially overestimated by the IWPC algorithm. Overall the percentage of patients whose predicted dose of warfarin was within 20% of the actual stable dose was equal to 37.5%, (95% CI 32.0-43.3%). IWPC algorithm explained only 31% of the actual warfarin dose variability. Modifications of the IWPC algorithm are needed in high-risk elderly people.

摘要

我们在一个前瞻性队列中评估了华法林药物基因组学联合会(IWPC)算法的预测准确性,该队列包括 376 名高危老年患者(≥65 岁),他们因医疗(非瓣膜性心房颤动)或手术原因(心脏瓣膜置换)需要新的华法林治疗,有≥1 种合并症,并且经常使用≥2 种其他药物。根据临床实践进行随访,最长随访时间为 1 年。283 名(75%)患者达到稳定的维持剂量。华法林维持剂量平均较低(中位数 20.3mg/周,四分位间距 14.1-27.7mg/周),且被 IWPC 算法大大高估。总体而言,预测剂量与实际稳定剂量相差 20%的患者比例等于 37.5%(95%CI 32.0-43.3%)。IWPC 算法仅解释了实际华法林剂量变异性的 31%。在高危老年人中需要对 IWPC 算法进行修改。

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