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基于一项纵向多中心研究的数据评估中国缺血性中风患者的健康结局。

Measuring the health outcomes of Chinese ischemic stroke patients based on the data from a longitudinal multi-center study.

作者信息

Wang Luying, Guan Xin, Zhou Jiting, Hu Hongfei, Liu Wei, Wei Qiran, Huang Yining, Sun Weiping, Jin Xuejing, Li Hongchao

机构信息

School of International Pharmaceutical Business, China Pharmaceutical University, #639 Longmian Dadao, Jiangning, Nanjing, 211198, China.

Center for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing, China.

出版信息

Qual Life Res. 2025 Mar 27. doi: 10.1007/s11136-025-03957-4.

DOI:10.1007/s11136-025-03957-4
PMID:40146503
Abstract

PURPOSE

Faced with scarcity of large-scale health measurement study in China, the study aims to provide health outcomes evidence from ischemic stroke patients.

METHODS

Data were collected from a prospective multi-center real-world study held from March 2015 to December 2018. Health-related quality of life (HRQoL) was assessed at admission, hospital discharge, 90 ± 14 days after medication treatment, and 360 ± 28 days after medication treatment. Baseline characteristics of patients were summarized. Mean values and standard deviation (SD) of EQ-5D utility index scores, VAS values, and NIHSS scores were reported. Rank-sum test was applied to analyze the differences of HRQoL among patient groups. Mix-effects regression was used to investigate the impact factors.

RESULTS

At the baseline visit, a total of 9978 patients with a mean age of 64.0 years were included. The mean utility index scores recorded at admission, discharge, 90 ± 14 days after therapy initiated, and 360 ± 28 days after therapy initiated were 0.546 (SD = 0.327), 0.709 (SD = 0.306), 0.801 (SD = 0.259), and 0.846 (SD = 0.237), respectively. Differences among sex and TOAST classification subgroups were observed. The mean utility index scores stratified by mRS levels ranged from 0.983 (SD = 0.076) to 0.058 (SD = 0.167) for level 0 to level 5. The mean NIHSS scores were 5.3 (SD = 4.98) and 3.6 (SD = 4.24) at admission and discharge.

CONCLUSION

The impact of ischemic stroke on patient's HRQoL is significant, particularly during the acute phase. Results from the study are well representative and can be utilized in health policy making, economic evaluations and other comparison studies. The study was registered with ClinicalTrials.gov (NCT02470624) in October 2015.

摘要

目的

鉴于中国大规模健康测量研究稀缺,本研究旨在提供缺血性中风患者的健康结局证据。

方法

数据收集自2015年3月至2018年12月开展的一项前瞻性多中心真实世界研究。在入院时、出院时、药物治疗后90±14天以及药物治疗后360±28天评估健康相关生活质量(HRQoL)。总结患者的基线特征。报告EQ-5D效用指数得分、视觉模拟量表(VAS)值和美国国立卫生研究院卒中量表(NIHSS)得分的均值和标准差(SD)。应用秩和检验分析患者组间HRQoL的差异。采用混合效应回归研究影响因素。

结果

在基线访视时,共纳入9978例平均年龄为64.0岁的患者。入院时、出院时、治疗开始后90±14天以及治疗开始后360±28天记录的平均效用指数得分分别为0.546(SD = 0.327)、0.709(SD = 0.306)、0.801(SD = 0.259)和0.846(SD = 0.237)。观察到性别和TOAST分类亚组之间存在差异。按改良Rankin量表(mRS)水平分层的平均效用指数得分在0级至5级范围为0.983(SD = 0.076)至0.058(SD = 0.167)。入院时和出院时的平均NIHSS得分分别为5.3(SD = 4.98)和3.6(SD = 4.24)。

结论

缺血性中风对患者HRQoL的影响显著,尤其是在急性期。本研究结果具有良好的代表性,可用于卫生政策制定、经济评估和其他比较研究。本研究于2015年10月在ClinicalTrials.gov注册(NCT02470624)。

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