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希美加群用于慢性心房颤动患者卒中预防的成本与效果

Costs and effectiveness of ximelagatran for stroke prophylaxis in chronic atrial fibrillation.

作者信息

O'Brien Cara L, Gage Brian F

机构信息

Washington University School of Medicine, St Louis, Mo 63110, USA.

出版信息

JAMA. 2005 Feb 9;293(6):699-706. doi: 10.1001/jama.293.6.699.

DOI:10.1001/jama.293.6.699
PMID:15701911
Abstract

CONTEXT

Recent trials have found that ximelagatran and warfarin are equally effective in stroke prevention for patients with atrial fibrillation. Because ximelagatran can be taken in a fixed, oral dose without international normalized ratio monitoring and may have a lower risk of hemorrhage, it might improve quality-adjusted survival compared with dose-adjusted warfarin.

OBJECTIVE

To compare quality-adjusted survival and cost among 3 alternative therapies for patients with chronic atrial fibrillation: ximelagatran, warfarin, and aspirin.

DESIGN

Semi-Markov decision model.

PATIENTS

Hypothetical cohort of 70-year-old patients with chronic atrial fibrillation, varying risk of stroke, and no contraindications to anticoagulation therapy.

MAIN OUTCOME MEASURES

Quality-adjusted life-years (QALYs) and costs in US dollars.

RESULTS

For patients with atrial fibrillation but no additional risk factors for stroke, both ximelagatran and warfarin cost more than 50,000 dollars per QALY compared with aspirin. For patients with additional stroke risk factors and low hemorrhage risk, ximelagatran modestly increased quality-adjusted survival (0.12 QALY) at a substantial cost (116,000 dollars per QALY) compared with warfarin. For ximelagatran to cost less than 50,000 dollars per QALY it would have to cost less than 1100 dollars per year or be prescribed to patients who have an elevated risk of intracranial hemorrhage (>1.0% per year of warfarin) or a low quality of life with warfarin therapy.

CONCLUSION

Assuming equal effectiveness in stroke prevention and decreased hemorrhage risk, ximelagatran is not likely to be cost-effective in patients with atrial fibrillation unless they have a high risk of intracranial hemorrhage or a low quality of life with warfarin.

摘要

背景

近期试验发现,希美加群和华法林在预防心房颤动患者中风方面效果相当。由于希美加群可以采用固定口服剂量,无需监测国际标准化比值,且出血风险可能较低,与剂量调整的华法林相比,它可能会改善质量调整后的生存率。

目的

比较慢性心房颤动患者的3种替代疗法(希美加群、华法林和阿司匹林)的质量调整生存率和成本。

设计

半马尔可夫决策模型。

患者

假设为70岁慢性心房颤动患者队列,中风风险各异,且无抗凝治疗禁忌证。

主要观察指标

质量调整生命年(QALY)和以美元计的成本。

结果

对于无额外中风风险因素的心房颤动患者,与阿司匹林相比,希美加群和华法林每获得一个QALY的成本均超过50,000美元。对于有额外中风风险因素且出血风险较低的患者,与华法林相比,希美加群大幅增加了质量调整生存率(0.12个QALY),但成本很高(每QALY为116,000美元)。要使希美加群每QALY成本低于50,000美元,其每年成本必须低于1100美元,或者必须开给颅内出血风险较高(华法林治疗每年>1.0%)或华法林治疗生活质量较低的患者。

结论

假设在预防中风方面效果相同且出血风险降低,希美加群在心房颤动患者中不太可能具有成本效益,除非他们有高颅内出血风险或华法林治疗生活质量较低。

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