冠心病患者双心治疗的临床随机对照研究

A clinical randomized controlled study on the psycho-cardiological therapy for patients with coronary atherosclerosis disease

目的探讨心脏心理(双心)治疗管理对冠心病患者的预后改善效果。方法本研究为临床随机对照试验。纳入2021年8月至2024年1月于首都医科大学附属北京安贞医院心内科住院的冠心病患者。采集患者基线信息, 并采用9项患者健康问卷(PHQ-9)、7个症状条目的广泛性焦虑量表(GAD-7)、阿森斯睡眠量表(AIS)、欧洲5维度5水平健康量表(EQ-5D-5L)分别进行抑郁、焦虑、睡眠、生活健康质量的评估。患者入组后随机分为常规治疗组及双心治疗组, 双心治疗组加入微信群管理, 酌情给予抗抑郁焦虑等药物治疗。于患者出院后2、4、12、24、48、72、96周, 由专业心血管医生通过电话、微信、门诊等形式进行定期随访, 于2~48周评估上述量表, 2~96周记录心血管事件。采用Kaplan-Meier生存曲线和多因素Cox比例风险模型, 分析双心治疗与心血管事件之间的关系。结果共纳入552例冠心病患者, 年龄61.0(54.0, 67.0)岁, 男性379例(68.7%)。其中, 常规治疗组279例(50.5%), 双心治疗组273例(49.5%)。治疗后4、12、48周, 双心治疗组的PHQ-9评分低于常规治疗组, 治疗后12周, 双心治疗组的EQ-5D-5L效用值高于常规治疗组, 治疗后2、4、12、24、48周, 双心治疗组的EQ-5D-5L健康自我评分高于常规治疗组(P均<0.05)。Kaplan-Meier生存曲线显示, 双心治疗组各个随访期的总心血管事件率均低于常规治疗组(log-rankP<0.001)。多因素Cox比例风险模型分析结果显示, 校正年龄后, 双心治疗可使总心血管不良事件率降低80.3%(HR=0.197, 95%CI:0.067~0.582, P=0.003)。结论双心治疗有利于改善冠心病患者心理压力、生活质量, 并减少心血管事件发生, 改善患者预后, 有利于患者双心康复。

ObjectiveTo explore the prognosis efficacy of psycho-cardiological therapy and management on patients with coronary atherosclerosis disease(CAD).MethodsThis was a clinical randomized controlled study.This study included inpatients with CAD at the cardiology department in Beijing Anzhen Hospital,Capital Medical University from August 2021 to January 2024.The patients enrolled in this study were asked for basic information,and received measurements for depression,anxiety,sleep quality and living quality by the scales of Patient Health Questionnaire-9(PHQ-9),General Anxiety Disorder scale-7(GAD-7),Athens Insomnia Scale(AIS),EuroQol 5-dimension 5-level(EQ-5D-5L)respectively.The patients were randomly grouped into a regular treatment group and a psycho-cardiological treatment group which included WeChat management or antidepressant/antianxiety medical therapy according to the situation.After the patients discharging from hospital for 2,4,12,24,48,72,and 96 weeks,professional cardiovascular doctors would follow up by telephone,WeChat,and outpatient department,including scales(2-48 weeks),and cardiac events(2-96 weeks).Kaplan-Meier survival curve and multivariate Cox proportional hazards model were used for analyzing the association between psycho-cardiological treatment and cardiac events.ResultsThis study recruited a total of 552 patients with CAD,aged 61.0(54.0,67.0)years,and 379(68.7%)were male.There were 279(50.5%)in the regular treatment group and 273(49.5%)in the psycho-cardiological treatment group.After treatment for 4,12 and 48 weeks,the PHQ-9 score in psycho-cardiological was significantly lower than the regular treatment group;After treatment for 12 weeks,the EQ-5D-5L effective value in psycho-cardiological group was higher than the regular treatment group;After treatment for 2,4,12,24 and 48 weeks,the EQ-5D-5L VAS score in psycho-cardiological group was higher than the regular therapy group(all P<0.05).The Kaplan-Meier survival curve showed that,during the different follow-up periods,the rate of cardiac events in psycho-cardiological treatment group was lower than regular treatment group(log-rank P<0.001).The multivariate Cox proportional hazards model adjusted the factor of age,the psycho-cardiological treatment contributed to reducing the cardiac events rate by 80.3%(HR=0.197,95%CI:0.067-0.582,P=0.003).ConclusionPsycho-cardiological treatment is beneficial for improving psychological stress,living quality,and reducing cardiac events,and helps to improve prognosis and psycho-cardiological rehabilitation in CAD patients.