急性肺栓塞后 3 个月和 12 个月的生活质量：一项前瞻性多中心队列研究的分析。
Quality of Life 3 and 12 Months Following Acute Pulmonary Embolism: Analysis From a Prospective Multicenter Cohort Study.
机构信息
Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany; Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland.
出版信息
Chest. 2021 Jun;159(6):2428-2438. doi: 10.1016/j.chest.2021.01.071. Epub 2021 Feb 3.
BACKGROUND
Few data are available on the long-term course and predictors of quality of life (QoL) following acute pulmonary embolism (PE).
RESEARCH QUESTION
What are the kinetics and determinants of disease-specific and generic health-related QoL 3 and 12 months following an acute PE?
STUDY DESIGN AND METHODS
The Follow-up after Acute Pulmonary Embolism (FOCUS) study prospectively followed up consecutive adult patients with objectively diagnosed PE. Patients were considered for study who completed the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire at predefined visits 3 and 12 months following PE. The course of disease-specific QoL as assessed using the PEmb-QoL and the impact of baseline characteristics using multivariable mixed effects linear regression were studied; also assessed was the course of generic QoL as evaluated by using the EuroQoL Group 5-Dimension 5-Level utility index and the EuroQoL Visual Analog Scale.
RESULTS
In 620 patients (44% women; median age, 62 years), overall disease-specific QoL improved from 3 to 12 months, with a decrease in the median PEmb-QoL score from 19.4% to 13.0% and a mean individual change of -4.3% (95% CI, -3.2 to -5.5). Female sex, cardiopulmonary disease, and higher BMI were associated with worse QoL at both 3 and 12 months. Over time, the association with BMI became weaker, whereas older age and previous VTE were associated with worsening QoL. Generic QoL also improved: the mean ± SD EuroQoL Group 5-Dimension 5-Level utility index increased from 0.85 ± 0.22 to 0.87 ± 0.20 and the visual analog scale from 72.9 ± 18.8 to 74.4 ± 19.1.
INTERPRETATION
In a large cohort of survivors of acute PE, the change of QoL was quantified between months 3 and 12 following diagnosis, and factors independently associated with lower QoL and slower recovery of QoL were identified. This information may facilitate the planning and interpretation of clinical trials assessing QoL and help guide patient management.
CLINICAL TRIAL REGISTRATION
German Clinical Trials Registry (Deutsches Register Klinischer Studien: www.drks.de); No.: DRKS00005939.
背景
关于急性肺栓塞（PE）后生活质量（QoL）的长期病程和预测因素，数据很少。
研究问题
在急性 PE 后 3 个月和 12 个月时，疾病特异性和一般健康相关 QoL 的变化趋势和决定因素是什么？
研究设计和方法
急性肺栓塞后随访（FOCUS）研究前瞻性地随访了连续确诊的成人 PE 患者。完成 PE 质量生活问卷（PEmb-QoL）的患者在 PE 后 3 个月和 12 个月的预设访视中被认为符合研究条件。研究了使用 PEmb-QoL 评估的疾病特异性 QoL 的变化趋势以及使用多变量混合效应线性回归评估的基线特征的影响；还评估了使用 EuroQoL 组 5 维度 5 级效用指数和 EuroQoL 视觉模拟量表评估的一般 QoL 的变化趋势。
结果
在 620 名患者（44%为女性；中位年龄 62 岁）中，总体疾病特异性 QoL 从 3 个月到 12 个月得到改善，PEmb-QoL 评分中位数从 19.4%降至 13.0%，个体平均变化为-4.3%（95%CI，-3.2 至-5.5）。女性、心肺疾病和更高的 BMI 在 3 个月和 12 个月时与较差的 QoL 相关。随着时间的推移，BMI 的相关性变弱，而年龄较大和既往 VTE 与 QoL 恶化相关。一般 QoL 也有所改善：EuroQoL 组 5 维度 5 级效用指数的平均值±标准差从 0.85±0.22 增加到 0.87±0.20，视觉模拟量表从 72.9±18.8 增加到 74.4±19.1。
解释
在急性 PE 幸存者的大队列中，在诊断后 3 个月至 12 个月之间量化了 QoL 的变化，并确定了与较低 QoL 和较慢 QoL恢复相关的独立因素。这些信息可以帮助规划和解释评估 QoL 的临床试验，并有助于指导患者管理。
临床试验注册
德国临床试验注册处（Deutsches Register Klinischer Studien：www.drks.de）；编号：DRKS00005939。
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