经皮冠状动脉介入术后动脉粥样硬化性心血管疾病患者中医证候分布及其与血脂和心血管预后的相关性:一项前瞻性队列研究

Association of traditional Chinese medicine syndromes with blood lipid profiles and cardiovascular prognosis in post-percutaneous coronary intervention atherosclerotic cardiovascular disease patients: a prospective cohort study

  • 摘要:
    目的 接受经皮冠状动脉介入治疗 (PCI)的动脉粥样硬化性心血管疾病 (ASCVD)患者被归类为心血管疾病 (CVD)风险分层中的极高风险个体。该患者群体中医证候的分布模式及其与血脂谱和临床预后的关联尚不清楚,通过开展前瞻性队列研究旨在探讨这些相关性,为丰富研究领域提供见解。
    方法 纳入2020年9月1日至2022年12月31日期间在中日友好医院综合心脏病科接受PCI的ASCVD患者。在基线和随访或发生主要不良心血管事件 (MACEs)时,收集人口统计数据和临床特征、体征和症状及对应中医证型,以及空腹静脉血样。我们分析了中医证型、血脂谱与MACEs之间的相关性,并使用逻辑回归开发了一个新的联合预后模型,该模型同时纳入了中医证型和血脂谱。以上分析基于详细的基线数据和一年随访数据。
    结果 对纳入的586名数据完整的患者进行了符合方案集分析。在为期一年的随访期间,174名患者 (29.69%)发生了MACEs。我们对不同中医辨证分型组患者的合并症、用药情况和生化指标进行了统计分析。在比较不同中医证型分组时,未发现年龄、体重指数 (BMI)、血运重建史、合并症、心血管疾病家族史、吸烟或饮酒情况或他汀类药物强度存在显著差异(P > 0.05)。与其他中医证型患者相比,痰瘀互结证型患者的总胆固醇 (TC,5.27 ± 1.18 mmol/L,P < 0.001)、甘油三酯 (TG,1.96 ± 1.33 mmol/L,P = 0.008)、低密度脂蛋白胆固醇 (LDL-C,3.35 ± 0.79 mmol/L,P < 0.001)以及高密度脂蛋白胆固醇 (HDL-C,1.24 ± 0.81 mmol/L,P < 0.001)水平显著升高。我们构建了一个多变量逻辑回归模型来预测主要不良心脏事件,该模型包括中医证型痰瘀互结作为预测因子,调整后的比值比 (OR)= 1.413,95%置信区间 (CI):0.517 – 3.864,P = 0.501、年龄 (调整后OR = 0.97,95% CI:0.955 – 1.001,P = 0.057)、男性 (调整后OR = 0.698,95% CI:0.416 – 1.170,P = 0.173)、TC (调整后OR = 1.004,95% CI:0.513 – 1.965,P = 0.990)和LDL-C (调整后OR = 5.825,95% CI:2.214 – 15.326,P < 0.001)。该模型对PCI术后ASCVD患者的MACEs具有良好的判别能力受试者工作特征(ROC)曲线下面积 (AUC) = 0.865,95% CI:0.816 – 0.914。
    结论 中医痰瘀互结证与致动脉粥样硬化脂质谱相关,其特征为TC和LDL-C水平升高。将该中医证型与常规脂质参数 (TC和LDL-C)相结合的预后模型,在预测PCI术后ASCVD患者的MACEs方面具有良好的判别能力,这凸显了将中医辨证纳入心血管疾病风险评估的潜在临床价值。

     

    Abstract:
    Objective Patients with atherosclerotic cardiovascular disease (ASCVD) following percutaneous coronary intervention (PCI) are classified as very-high-risk individuals in cardiovascular disease (CVD) risk stratification. The distribution pattern of traditional Chinese medicine (TCM) syndromes in this patient population, as well as its association with blood lipid profiles and clinical prognosis, remains unclear. The present prospective cohort study aims to investigate these correlations, thereby providing insights to enrich the research fields.
    Methods We enrolled consecutive patients with ASCVD who underwent PCI at the Integrated Cardiology Unit of China-Japan Friendship Hospital between September 1, 2020 and December 31, 2022. Demographics and clinical characteristics, signs and symptoms defining each TCM syndrome, and fasting venous blood samples were collected at baseline and follow up or upon major adverse cardiovascular events (MACEs). We analyzed the correlation between TCM syndromes, blood lipid profiles, and MACEs, and developed a new joint prognostic model incorporating both TCM syndromes and blood lipids using logistic regression. The analyses were based on detailed baseline and one-year follow-up data.
    Results A per-protocol analysis was performed on 586 patients with complete data ultimately. During the one-year follow-up, 174 patients (29.69%) experienced a MACE. We performed statistical analyses on comorbidities, medication, and biochemical indicators across groups defined by TCM syndrome differentiation. When comparing different TCM syndromes, no significant differences were found in age, body mass index (BMI), history of revascularization, comorbidities, family history of CVD, smoking or drinking, or statin intensity (P > 0.05). Patients with intertwined phlegm and blood stasis syndrome exhibited significantly higher levels of total cholesterol (TC, 5.27 ± 1.18 mmol/L, P < 0.001), triglyceride (TG, 1.96 ± 1.33 mmol/L, P = 0.008), low-density lipoprotein cholesterol (LDL-C, 3.35 ± 0.79 mmol/L, P < 0.001), and high-density lipoprotein cholesterol (HDL-C, 1.24 ± 0.81 mmol/L, P < 0.001) compared with those with other TCM syndromes combined. A multivariable logistic regression model was constructed to predict MACEs. The model included TCM syndrome type with intertwined phlegm and blood stasis as a predictor, adjusted odds ratio (OR) = 1.413, 95% confidence interval (CI): 0.517 – 3.864, P = 0.501, age (adjusted OR = 0.97, 95% CI: 0.955 – 1.001, P = 0.057), male gender (adjusted OR = 0.698, 95% CI: 0.416 – 1.170, P = 0.173), TC (adjusted OR = 1.004, 95% CI: 0.513 – 1.965, P = 0.990), and LDL-C (adjusted OR = 5.825, 95% CI: 2.214 – 15.326, P < 0.001). This model demonstrated good discriminatory ability for MACEs in post-PCI ASCVD patients the area under the receiver operating characteristic (ROC) curve (AUC) = 0.865, 95% CI: 0.816 – 0.914.
    Conclusion The intertwined phlegm and blood stasis TCM syndrome is associated with a distinct atherogenic lipid profile characterized by elevated levels of TC and LDL-C. The prognostic model that incorporates this TCM syndrome type along with conventional lipid parameters (TC and LDL-C) shows good discriminatory ability for predicting MACEs in ASCVD patients after PCI, underscoring the potential clinical utility of integrating TCM syndrome differentiation into CVD risk assessment.

     

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