Mark D B, Hlatky M A, Califf R M, Naylor C D, Lee K L, Armstrong P W, Barbash G, White H, Simoons M L, Nelson C L
Economic and Quality of Life Coordinating Center, Duke University Medical Center, Durham, N.C. 27710, USA.
N Engl J Med. 1995 May 25;332(21):1418-24. doi: 10.1056/NEJM199505253322106.
Patients with acute myocardial infarction who were treated with accelerated tissue plasminogen activator (t-PA) (given over a period of 1 1/2 hours rather than the conventional 3 hours, and with two thirds of the dose given in the first 30 minutes) had a 30-day mortality that was 15 percent lower than that of patients treated with streptokinase in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) study. This was equivalent to an absolute decrease of 1 percent in 30-day mortality. We sought to assess whether the use of t-PA, as compared with streptokinase, is cost effective.
Our primary, or base-case, analysis of cost effectiveness used data from the GUSTO study and life expectancy projected on the basis of the records of survivors of myocardial infarction in the Duke Cardiovascular Disease Database. In the primary analysis, we assumed that there were no additional treatment costs due to the use of t-PA after the first year and that the comparative survival benefit of t-PA was still evident one year after enrollment.
One year after enrollment, patients who received t-PA had both higher costs ($2,845) and a higher survival rate (an increase of 1.1 percent, or 11 per 1000 patients treated) than streptokinase-treated patients. On the basis of the projected life expectancy of each treatment group, the incremental cost-effectiveness ratio--with both future costs and benefits discounted at 5 percent per year--was $32,678 per year of life saved. The use of t-PA was least cost effective in younger patients and most cost effective in older patients. At all ages, the use of t-PA in patients with anterior infarctions yielded more favorable cost-effectiveness values. In our secondary analyses, the cost-effectiveness values were most sensitive to a lowering of the projected long-term survival benefits of t-PA and to moderate or greater increases in the projected medical costs for patients in the t-PA group after the first year. In contrast, our results were not sensitive to even very unfavorable assumptions about the additional costs associated with the higher rate of disabling stroke that was noted in patients treated with t-PA in the GUSTO study.
The cost effectiveness of treatment with accelerated t-PA rather than streptokinase compares favorably with that of other therapies whose added medical benefit for dollars spent is judged by society to be worthwhile.
在“全球应用链激酶和组织型纤溶酶原激活剂治疗冠状动脉闭塞症”(GUSTO)研究中,接受加速给药组织型纤溶酶原激活剂(t-PA)治疗的急性心肌梗死患者(给药时间为1.5小时而非传统的3小时,且三分之二的剂量在前30分钟内给予),其30天死亡率比接受链激酶治疗的患者低15%。这相当于30天死亡率绝对降低了1%。我们试图评估与链激酶相比,使用t-PA是否具有成本效益。
我们对成本效益的主要(即基础病例)分析使用了GUSTO研究的数据以及根据杜克心血管疾病数据库中心肌梗死幸存者记录预测的预期寿命。在主要分析中,我们假设第一年之后使用t-PA不会产生额外的治疗成本,并且t-PA的相对生存获益在入组一年后仍然明显。
入组一年后,接受t-PA治疗的患者比接受链激酶治疗的患者成本更高(2845美元),且生存率更高(提高了1.1%,即每治疗1000例患者增加11例存活)。根据每个治疗组预测的预期寿命,增量成本效益比(未来成本和效益均按每年5%贴现)为每挽救一年生命32678美元。使用t-PA在年轻患者中成本效益最低,在老年患者中成本效益最高。在所有年龄段,t-PA用于前壁梗死患者产生的成本效益值更有利。在我们的次要分析中,成本效益值对t-PA预测的长期生存获益降低以及t-PA组患者第一年之后预测医疗成本适度或大幅增加最为敏感。相比之下,我们的结果对关于GUSTO研究中接受t-PA治疗的患者出现致残性中风发生率较高所带来的额外成本的非常不利假设并不敏感。
与其他治疗方法相比,加速给药t-PA治疗的成本效益较好,社会认为这些治疗方法每花费一美元所带来的额外医疗效益是值得的。