多剂量药物配药对使用维生素K拮抗剂患者治疗范围内时间的影响：一项随机对照试验。
Effect of multidose drug dispensing on the time in therapeutic range in patients using vitamin-K antagonists: A randomized controlled trial.
作者信息
Mertens Bram J, Kwint Henk-Frans, Belitser Svetlana V, van der Meer Felix J M, van Marum Rob J, Bouvy Marcel L
机构信息
SIR Institute for Pharmacy Practice and Policy, Leiden, the Netherlands.
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, University Utrecht, Utrecht, the Netherlands.
出版信息
J Thromb Haemost. 2020 Jan;18(1):70-78. doi: 10.1111/jth.14625. Epub 2019 Sep 19.
BACKGROUND
A high number of vitamin K antagonist (VKA) users have a low proportion of time in therapeutic range (TTR) resulting in a high number of bleeding and thromboembolism events.
OBJECTIVE
Can the quality of anticoagulation be improved by dispensing VKAs via multidose drug dispensing (MDD).
METHOD
A randomized controlled trial in the Netherlands. Patients who used VKAs, ≥65 years of age with a TTR <65% were eligible for inclusion. All oral drugs were dispensed via MDD. In MDD systems, all oral chronic medication intended for one dosing moment is packed in plastic disposable pouches. Controls received VKAs by manual dispensing. The difference in TTR between the 6 months after- and 6 months before the index date. A mixed-effects model with the intervention, TTR before the index date, MDD system at baseline as covariates, and pharmacy as random effect. A per-protocol analysis was performed with all patients who completed the study as intended.
RESULTS
One hundred and seventy-nine patients were included. Mean age was 80.0 (SD 6.9) years. Mean TTR during the study was 79.2 ± 18.0% in the intervention group and 72.5 ± 20.1% in the control group. The intervention resulted in a 5.6% (95% CI: 0.1-11.1) increase in TTR compared to the control group. Per-protocol analysis resulted in an 8.3% (95% CI: 0.99-15.61) increase in TTR compared to the control group. No differences in reduction were observed between the intervention and control group.
CONCLUSION
The quality of anticoagulation can be improved with the use of MDD systems.
背景
大量维生素K拮抗剂（VKA）使用者处于治疗范围内（TTR）的时间比例较低，导致大量出血和血栓栓塞事件。
目的
通过多剂量药物配药（MDD）方式分发VKA能否改善抗凝质量。
方法
在荷兰进行的一项随机对照试验。年龄≥65岁且TTR<65%的VKA使用者符合纳入条件。所有口服药物均通过MDD分发。在MDD系统中，所有预定在一个给药时刻服用的口服慢性药物都包装在一次性塑料药袋中。对照组通过手工配药方式接受VKA。比较索引日期后6个月与索引日期前6个月的TTR差异。采用混合效应模型，将干预措施、索引日期前的TTR、基线时的MDD系统作为协变量，药房作为随机效应。对所有按计划完成研究的患者进行符合方案分析。
结果
纳入179例患者。平均年龄为80.0（标准差6.9）岁。研究期间，干预组的平均TTR为79.2±18.0%，对照组为72.5±20.1%。与对照组相比，干预使TTR提高了5.6%（95%置信区间：0.1-11.1）。符合方案分析显示，与对照组相比，TTR提高了8.3%（95%置信区间：0.99-15.61）。干预组和对照组在减量方面未观察到差异。
结论
使用MDD系统可改善抗凝质量。
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