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阿昔单抗(Reo Pro)单次推注治疗高危患者经皮腔内冠状动脉成形术后预防再狭窄的有效性及成本效益

Effectiveness and cost effectiveness of single bolus treatment with abciximab (Reo Pro) in preventing restenosis following percutaneous transluminal coronary angioplasty in high risk patients.

作者信息

Aristides M, Gliksman M, Rajan N, Davey P

机构信息

Medical Technology Assessment Group, Sydney, Australia.

出版信息

Heart. 1998 Jan;79(1):12-7. doi: 10.1136/hrt.79.1.12.

Abstract

OBJECTIVE

To assess the clinical effectiveness and cost effectiveness of abciximab in preventing restenosis after percutaneous transluminal coronary angioplasty (PTCA).

DESIGN

Data from a previous study, the EPIC trial, were used because only this trial was able to provide event data capable of constructing a cost effectiveness analysis over six months. All other study data reviewed supported the findings of the EPIC trial. To provide indicative results on long term health outcomes, survival and event-free survival were extrapolated using US epidemiological data in a Markov modelling process.

SETTING AND PATIENTS

Patients who were at high risk for ischaemic complications after PTCA, treated in the standard manner.

INTERVENTIONS

Abciximab was added to the regimen of intravenous heparin and aspirin.

RESULTS

The EPIC study (n = 2099) indicated an 8.1% absolute reduction in serious cardiovascular events (95% confidence interval 3.1% to 12.7%) and a 23% relative risk reduction (p = 0.001). Based on the six month trial period, the additional cost per patient free from a serious event (Australian dollars) is $13,012 and for a special risk/benefit measure of outcome, the additional cost is $14,243. Epidemiological data support extended survival and ischaemic event-free survival with clinically successful PTCA. The results of the modelled analysis indicate a cost per additional life-year gained of $5547 and a cost per additional year event-free of $4285.

CONCLUSIONS

At up to six months abciximab offers improvements in clinically important outcomes. A modelling exercise explores and highlights the likelihood of significant long term health benefits. The analysis provides information for decision makers and funders to consider the value for money of abciximab.

摘要

目的

评估阿昔单抗在预防经皮腔内冠状动脉成形术(PTCA)后再狭窄方面的临床疗效和成本效益。

设计

使用先前一项研究(EPIC试验)的数据,因为只有该试验能够提供可用于构建六个月成本效益分析的事件数据。审查的所有其他研究数据均支持EPIC试验的结果。为了提供关于长期健康结局的指示性结果,在马尔可夫建模过程中使用美国流行病学数据对生存率和无事件生存率进行了外推。

地点和患者

以标准方式治疗的PTCA后有缺血性并发症高风险的患者。

干预措施

在静脉注射肝素和阿司匹林的治疗方案中添加阿昔单抗。

结果

EPIC研究(n = 2099)表明严重心血管事件的绝对降低率为8.1%(95%置信区间为3.1%至12.7%),相对风险降低23%(p = 0.001)。基于六个月的试验期,每位无严重事件患者的额外成本(澳元)为13,012美元,对于一种特殊的风险/效益结局衡量指标,额外成本为14,243美元。流行病学数据支持临床成功的PTCA可延长生存期和无缺血事件生存期。建模分析结果表明,每增加一个生命年的成本为5547美元,每增加一个无事件年的成本为4285美元。

结论

在长达六个月的时间里,阿昔单抗可改善具有临床重要意义的结局。一项建模研究探索并突出了显著长期健康益处的可能性。该分析为决策者和资助者提供信息,以便他们考虑阿昔单抗的性价比。

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本文引用的文献

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