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在糖耐量受损(ACE)的中国冠心病患者中健康效用值:一项随机、双盲、安慰剂对照试验的纵向分析。

Health utilities in Chinese patients with coronary heart disease and impaired glucose tolerance (ACE): A longitudinal analysis of a randomized, double-blind, placebo-controlled trial.

机构信息

Health Economics Research Centre, University of Oxford, Oxford, UK.

Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.

出版信息

J Diabetes. 2022 Jul;14(7):455-464. doi: 10.1111/1753-0407.13294.

Abstract

BACKGROUND

We estimate health-related quality of life and the impact of four cardiovascular events (myocardial infarction [MI], stroke, congestive heart failure, angina) and gastrointestinal events in 6522 Chinese patients with coronary heart disease (CHD) and impaired glucose tolerance (IGT) participating in the Acarbose Cardiovascular Evaluation (ACE) trial.

METHODS

Health-related quality of life was captured using the EuroQol-5 Dimension-3 Level (EQ-5D-3L), with data collected at baseline and throughout the trial. Multilevel mixed-effects linear regression with random effects estimated health-related quality of life over time, capturing variation between hospital sites and individuals, and a fixed-effects linear model estimated the impact of cardiovascular and gastrointestinal events.

RESULTS

Patients were followed for a median of 5 years (interquartile range 3.4-6.0). The average baseline EQ-5D score of 0.930 (SD 0.104) remained relatively unchanged over the trial period with no evidence of statistically significant differences in EQ-5D score between randomized treatment groups. The largest decrement in the year of an event was estimated for stroke (-0.107, P < .001), followed by heart failure (-0.039, P = .022), MI (-0.021, P = .047), angina (-0.012, P = .047), and gastrointestinal events (-0.005, P = .430). MI and stroke reduced health-related quality of life beyond the year in which the event occurred (-0.031, P = .006, and -0.067, P < .001, respectively).

CONCLUSIONS

Acarbose treatment had no impact on health-related quality of life in ACE trial participants with CHD and IGT. Events such as MI, stroke, heart failure, and angina reduce health-related quality of life around the time they occurred, but only MI and stroke impacted on longer-term health-related quality of life.

摘要

背景

我们评估了 6522 例中国冠心病(CHD)合并糖耐量受损(IGT)患者的健康相关生活质量,以及 4 种心血管事件(心肌梗死[MI]、中风、充血性心力衰竭、心绞痛)和胃肠道事件的影响,他们参与了阿卡波糖心血管评估(ACE)试验。

方法

采用欧洲五维健康量表 3 级(EQ-5D-3L)评估健康相关生活质量,在基线和整个试验期间收集数据。采用多水平混合效应线性回归模型进行随机效应估计,以捕捉医院和个体之间的差异,采用固定效应线性模型估计心血管和胃肠道事件的影响。

结果

患者中位随访时间为 5 年(四分位距 3.4-6.0)。试验期间,平均基线 EQ-5D 评分为 0.930(SD 0.104),相对稳定,随机治疗组间 EQ-5D 评分无统计学差异。在发生事件的那一年,估计中风的健康相关生活质量下降最大(-0.107,P < .001),其次是心力衰竭(-0.039,P = .022)、MI(-0.021,P = .047)、心绞痛(-0.012,P = .047)和胃肠道事件(-0.005,P = .430)。MI 和中风导致健康相关生活质量在发生事件的那一年之后也有所下降(-0.031,P = .006,和-0.067,P < .001)。

结论

在 ACE 试验中,阿卡波糖治疗对 CHD 合并 IGT 患者的健康相关生活质量没有影响。MI、中风、心力衰竭和心绞痛等事件会降低发生时的健康相关生活质量,但只有 MI 和中风对长期健康相关生活质量有影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84a5/9310045/e1d39f5ea4a6/JDB-14-455-g001.jpg

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