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与使用重组组织型纤溶酶原激活剂治疗急性缺血性脑卒中相关的质量调整生命年获益:1998-2011 年。

Quality adjusted life year gains associated with administration of recombinant tissue-type plasminogen activator for treatment of acute ischemic stroke: 1998-2011.

机构信息

Outcomes Insights, Inc., Westlake Village, CA, USA

Outcomes Insights, Inc., Westlake Village, CA, USA.

出版信息

Int J Stroke. 2016 Feb;11(2):198-205. doi: 10.1177/1747493015609776.

Abstract

BACKGROUND

Intravenous recombinant tissue-type plasminogen activator (r-tPA) is an approved treatment for select patients with acute ischemic stroke (AIS). Data indicate r-tPA improves functional outcome three months after AIS compared with placebo. This study models the increase in quality adjusted life years (QALYs) associated with r-tPA compared with similar patients not treated with r-tPA.

METHODS

Hospital discharge data for AIS and r-tPA were obtained from the Nationwide Inpatient Sample from 1998 to 2011. Discharge location (home, rehabilitation, long-term care, death) was mapped to modified Rankin Scale (mRS) scores based on National Institute of Neurological Disorders and Stroke (NINDS) Study Group Part 1 and 2 clinical studies. The mRS scores were mapped to relative risk of death and QALYs obtained from the literature. The model estimated expected survival and QALYs by age, gender and mRS for patients receiving r-tPA. Life expectancy and QALYs for patients not receiving r-tPA were estimated based on discharge location and mRS for placebo patients in the NINDS study.

RESULTS

AIS discharges declined from over 635,000 in 1998 to over 593,000 in 2011. A total of 183,235 patients received r-tPA. Utilization of r-tPA increased from 1% of AIS patients in 1998 to over 4% in 2011. Estimated projections for QALYs gained from utilization of r-tPA to QALYS without r-tPA were just under 240,000 for the 13 years and with no discounting, and just over 165,000 assuming 3% annual discounting. In the most conservative scenario, assuming no difference in proportional discharge status (i.e. patients not treated with r-tPA are discharged in the same manner as r-tPA patients), the estimated life years gained are approximately 35,000 and QALYS gained are approximately 90,000.

CONCLUSIONS

r-tPA for AIS has resulted in estimated gains in quality-adjusted life years due to reduction in disability and improvement in functioning since its introduction in 1998.

摘要

背景

静脉注射重组组织型纤溶酶原激活物(r-tPA)是治疗急性缺血性脑卒中(AIS)的一种已批准的疗法。数据表明,与安慰剂相比,r-tPA 可改善 AIS 后三个月的功能预后。本研究模拟了与未接受 r-tPA 治疗的类似患者相比,r-tPA 治疗所带来的质量调整生命年(QALY)的增加。

方法

从 1998 年至 2011 年,从全国住院患者样本中获取了 AIS 和 r-tPA 的住院数据。根据国立神经病学与卒中研究所(NINDS)研究组第 1 部分和第 2 部分临床试验,将出院地点(家庭、康复、长期护理、死亡)映射到改良 Rankin 量表(mRS)评分。根据文献中的 NINDS 研究组安慰剂患者的 mRS 评分,将 mRS 评分映射到死亡的相对风险和 QALY。根据 r-tPA 患者的年龄、性别和 mRS 评估了接受 r-tPA 治疗的患者的预期生存和 QALY。根据 NINDS 研究中安慰剂患者的出院地点和 mRS 评估了未接受 r-tPA 治疗的患者的预期寿命和 QALY。

结果

1998 年,AIS 出院人数超过 635000 人,到 2011 年降至超过 593000 人。共有 183235 名患者接受了 r-tPA 治疗。r-tPA 的使用率从 1998 年 AIS 患者的 1%增加到 2011 年的 4%以上。不进行贴现的情况下,13 年期间,r-tPA 使用率增加带来的 QALY 获益估计接近 24 万,而假设每年贴现 3%,则获益超过 16.5 万。在最保守的情况下,假设出院比例没有差异(即未接受 r-tPA 治疗的患者以与 r-tPA 患者相同的方式出院),估计获得的生命年约为 35000 年,获得的 QALY 约为 90000 年。

结论

自 1998 年 r-tPA 上市以来,由于残疾减少和功能改善,r-tPA 治疗 AIS 导致了质量调整生命年的估计获益。

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