Lv Chunxiao, Cheng Zuozhang, Yu Hao, Du Huiqing, Zhao Yingqiang, Liu Yujie, Zhang Junhua, Gao Sheng, Liu Ruifeng, Huang Yuhong
Department of Clinical Pharmacology, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Department of Geriatrics, Changle People's Hospital, Weifang, China.
Front Cardiovasc Med. 2021 Nov 17;8:743262. doi: 10.3389/fcvm.2021.743262. eCollection 2021.
To investigate the compliance and the outcome of Traditional Chinese Medicine (TCM) in patients with coronary heart disease (CHD) after treatment of revascularization. In this prospective cohort study, the non-exposure group (NEG), low-exposure group (LEG), and high-exposure group (HEG) were divided after 2 years follow-up. The primary outcome was a composite of death from cardiovascular causes, non-lethal myocardial infarction, heart transplantation, or stroke. Time-to-event data were evaluated by using the Cox regression analysis with hazard ratios (HRs) and 95% CIs. Then, the two-sided -values were calculated by using the Cox models. In order to indicate the therapeutic effects of TCM on the CHD after revascularization, the survival analysis and the nested case-control study were conducted separately. There were 1,003 patients with CHD enrolled, 356 patients (35.49%) did not choose the TCM, 379 patients (37.79%) used the TCM seldom, and only 268 patients (26.72%) used TCM regularly. A total of 653 patients with revascularization participated in the prospective cohort study. Over the duration of the trial, the primary endpoints occurred in 12 (4.35%), 11 (4.80%), and 2 (1.35%) patients in the NEG, LEG, and HEG, while the secondary endpoints occurred in 84 (30.43%), 57 (24.89%), and 15 (10.14%) patients in the NEG, LEG, and HEG, respectively. The occurrence time of secondary endpoint events in HEG was significantly postponed ( < 0.001) compared with the other cohorts. The Cox regression analysis indicated that the HRs in the primary endpoints, the secondary endpoint events, the major adverse cardiac and cerebrovascular events (MACCE), and the composite endpoint events for HEG were all around 0.3 ( < 0.05) and HRs for LEG were all around 0.8. The results of the nested case-control study showed that the TCM exposure was significantly different between the cases and controls in the secondary endpoints ( < 0.05), while no significant difference in the primary endpoints ( > 0.05), but the percentage of HEG in the cases was extremely lower than the controls. The HEG-TCM may improve the outcomes of the patients with CHD after treatment of revascularization. http://www.chictr.org.cn. Unique identifier: ChiCTR-OOC-17012995.
探讨冠心病（CHD）患者血管重建术后接受中医药治疗的依从性及治疗效果。在这项前瞻性队列研究中，经过2年随访后分为非暴露组（NEG）、低暴露组（LEG）和高暴露组（HEG）。主要结局为心血管原因死亡、非致死性心肌梗死、心脏移植或中风的复合终点。采用Cox回归分析评估事件发生时间数据，计算风险比（HRs）和95%可信区间（CIs）。然后，通过Cox模型计算双侧P值。为了表明中医药对血管重建术后冠心病的治疗效果，分别进行了生存分析和巢式病例对照研究。共纳入1003例冠心病患者，356例（35.49%）未选择中医药治疗，379例（37.79%）很少使用中医药治疗，仅268例（26.72%）经常使用中医药治疗。共有653例接受血管重建的患者参与了前瞻性队列研究。在试验期间，NEG、LEG和HEG组的主要终点事件分别发生在12例（4.35%）、11例（4.80%）和2例（1.35%）患者中，次要终点事件分别发生在84例（30.43%）、57例（24.89%）和15例（10.14%）患者中。与其他队列相比，HEG组次要终点事件的发生时间显著推迟（P<0.001）。Cox回归分析表明，HEG组主要终点、次要终点事件、主要不良心脑血管事件（MACCE）和复合终点事件的HRs均约为0.3（P<0.05），LEG组的HRs均约为0.8。巢式病例对照研究结果显示，次要终点中病例组和对照组的中医药暴露存在显著差异（P<0.05），而主要终点无显著差异（P>0.05），但病例组中HEG的比例极低于对照组。高暴露组中医药治疗可能改善血管重建术后冠心病患者的治疗效果。http://www.chictr.org.cn。唯一标识符：ChiCTR - OOC - 17012995。
