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达肝素延长预防静脉血栓栓塞事件:大型骨科手术患者的成本效益分析

Extended dalteparin prophylaxis for venous thromboembolic events: cost-utility analysis in patients undergoing major orthopedic surgery.

作者信息

Dranitsaris George, Stumpo Carmine, Smith Reginald, Bartle William

机构信息

Augmentium Pharma Consulting, Toronto, Ontario, Canada.

出版信息

Am J Cardiovasc Drugs. 2009;9(1):45-58. doi: 10.2165/00129784-200909010-00005.

Abstract

BACKGROUND

Deep vein thrombosis (DVT) and pulmonary embolism (PE) are manifestations of venous thromboembolic events (VTEs). Patients undergoing major surgical procedures such as total hip replacement (THR), total knee replacement (TKR), and hip fracture surgery (HFS) are at an elevated risk for VTEs. The American College of Chest Physicians' (ACCP) guidelines recommend that such patients receive thromboprophylaxis for at least 10 days. In patients undergoing THR or HFS, extended prophylaxis for up to 28-35 days is the recommended approach for those at high risk of thromboembolic events. The NAFT (North American Fragmin Trial) compared the prophylactic efficacy of dalteparin with that of warfarin during the in-hospital period, and with that of placebo during the period of hospital discharge until day 35 postsurgery, in patients who underwent total hip arthroplasty. During both the in-hospital and the postdischarge time periods, dalteparin significantly reduced the occurrence of DVT. Given the clinical relevance of these results, the low specificity of the ACCP recommendations regarding optimal prophylaxis duration, and the importance of optimizing the efficiency of DVT prophylaxis in the practice setting, a cost-utility analysis was conducted comparing dalteparin 10-day and 35-day (extended) with a warfarin 10-day protocol, in patients undergoing major orthopedic surgeries such as THR, TKR, or HFS.

DESIGN AND SETTING

A three-arm decision model was developed using the prevalence of symptomatic DVT from NAFT publications, epidemiologic studies, and published meta-analyses. Healthcare resource use was abstracted from a survey of clinicians and from the economic literature. Utility estimates were obtained by interviewing a sample of 24 people from the general public using the time trade-off technique. The clinical, economic and utility data were then used to estimate the cost per quality-adjusted life-year (QALY) gained with dalteparin for 10 or 35 days relative to 10 days of warfarin.

STUDY PERSPECTIVE

Canadian provincial healthcare system.

MAIN OUTCOME MEASURES AND RESULTS

The cost per QALY gained with 10 days of dalteparin was below $Can1000 for all the surgeries evaluated (all costs are reported in 2007 Canadian dollars [$Can1 = $US1, as of December 2007]). In the case of extended prophylaxis, the incremental cost per QALY gained with 35 days of dalteparin over warfarin was $Can40 100, $Can46 500, and $Can31 200 for patients undergoing THR, TKR, and HFS, respectively. Reducing the duration of prophylaxis from 35 to 28 days generated ratios that were below $Can35 000 for all three surgeries evaluated.

CONCLUSION

Ten days of dalteparin following major orthopedic surgery is a clinically and economically attractive alternative to warfarin for DVT prophylaxis. In the case of the 35-day dalteparin protocol, the results also indicated acceptable economic value to a publicly funded healthcare system, particularly in the settings of HFS and THR. In addition, reducing the duration of prophylaxis to 28 days postsurgery would be associated with a more favorable return on public healthcare expenditures.

摘要

背景

深静脉血栓形成(DVT)和肺栓塞(PE)是静脉血栓栓塞事件(VTE)的表现形式。接受诸如全髋关节置换术(THR)、全膝关节置换术(TKR)和髋部骨折手术(HFS)等大型外科手术的患者发生VTE的风险升高。美国胸科医师学会(ACCP)指南建议此类患者接受至少10天的血栓预防。对于接受THR或HFS的患者,对于血栓栓塞事件高风险者,建议延长预防时间至28 - 35天。北美达肝素试验(NAFT)比较了达肝素与华法林在全髋关节置换术患者住院期间的预防效果,以及与安慰剂在术后直至第35天出院期间的预防效果。在住院期间和出院后时间段,达肝素均显著降低了DVT的发生率。鉴于这些结果的临床相关性、ACCP关于最佳预防持续时间建议的低特异性以及在实际临床中优化DVT预防效率的重要性,开展了一项成本效用分析,比较了达肝素10天和35天(延长)方案与华法林10天方案在接受THR、TKR或HFS等大型骨科手术患者中的效果。

设计与设置

使用NAFT出版物、流行病学研究及已发表的荟萃分析中症状性DVT的患病率,开发了一个三臂决策模型。医疗资源使用情况从对临床医生的调查及经济文献中提取。效用估计通过使用时间权衡技术对24名普通公众样本进行访谈获得。然后使用临床、经济和效用数据来估计相对于华法林10天方案,达肝素10天或35天预防方案每获得一个质量调整生命年(QALY)的成本。

研究视角

加拿大省级医疗保健系统。

主要结局指标及结果

对于所有评估的手术,达肝素10天预防方案每获得一个QALY的成本低于1000加元(所有成本均以2007年加拿大元报告,截至2007年12月,1加元 = 1美元)。在延长预防方案的情况下,接受THR、TKR和HFS的患者使用达肝素35天相对于华法林每获得一个QALY的增量成本分别为40100加元、46500加元和31200加元。对于所有三项评估手术,将预防持续时间从35天缩短至28天产生的成本效益比低于35000加元。

结论

大型骨科手术后使用达肝素10天预防DVT在临床和经济上是一种比华法林更具吸引力的选择。对于达肝素35天方案,结果也表明对公共资助的医疗保健系统具有可接受的经济价值,特别是在HFS和THR的情况下。此外,将术后预防持续时间缩短至28天会使公共医疗保健支出获得更有利的回报。

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