通心络联合治疗下ST段抬高型心肌梗死12个月心血管结局：一项真实世界多中心前瞻性队列研究

YUAN Guo-qiang; CHANG Cheng-cheng; YANG Li-min; YANG Li-bo; XIAO Mu-tian; WEI Xiao-xia; KANG Xin-xin; SUN Yong-hui

doi:10.1007/s11655-025-4028-1

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通心络联合治疗下ST段抬高型心肌梗死12个月心血管结局：一项真实世界多中心前瞻性队列研究

Original Article | Updated：2026-08-04

- 通心络联合治疗下ST段抬高型心肌梗死12个月心血管结局：一项真实世界多中心前瞻性队列研究
- Tongxinluo Adjunctive Therapy and 12-Month Cardiovascular Outcomes after ST-Segment Elevation Myocardial Infarction: A Real-World Multicenter Prospective Cohort Study
- Chinese Journal of Integrative Medicine 2026年32卷第1期页码：3-11
- Affiliations：
  
  1.Department of Cardiovascular Medicine, Hebei Yiling Hospital; Key Laboratory of Collateral Disease Theory of the State Administration of Traditional Chinese Medicine, Shijiazhuang (050091), China
  2.Clinical Medical Research Center for Traditional Chinese Medicine Cardiovascular Diseases of Hebei Province, Shijiazhuang (050091), China
  3.State Key Laboratory for Innovation and Transformation of Luobing Theory, Shijiazhuang (050035), China
- Author bio：
  
  Prof. YUAN Guo-qiang, E-mail: m13223401927@163.com
- Funds：
  
  Traditional Chinese Medicine Innovation Project of Hebei Province(223777120D)
- DOI：10.1007/s11655-025-4028-1
  中图分类号：
- 录用：2025-08-08，
  
  网络首发：2025-11-10，
  
  纸质出版：2026-01
- Accepted：
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YUAN Guo-qiang, CHANG Cheng-cheng, YANG Li-min, 等. 通心络联合治疗下ST段抬高型心肌梗死12个月心血管结局：一项真实世界多中心前瞻性队列研究[J]. Chinese Journal of Integrative Medicine, 2026,32(1):3-11.

YUAN Guo-qiang, CHANG Cheng-cheng, YANG Li-min, et al. Tongxinluo Adjunctive Therapy and 12-Month Cardiovascular Outcomes after ST-Segment Elevation Myocardial Infarction: A Real-World Multicenter Prospective Cohort Study[J]. Chinese Journal of Integrative Medicine, 2026, 32(1): 3-11.
YUAN Guo-qiang, CHANG Cheng-cheng, YANG Li-min, 等. 通心络联合治疗下ST段抬高型心肌梗死12个月心血管结局：一项真实世界多中心前瞻性队列研究[J]. Chinese Journal of Integrative Medicine, 2026,32(1):3-11. DOI： 10.1007/s11655-025-4028-1.

YUAN Guo-qiang, CHANG Cheng-cheng, YANG Li-min, et al. Tongxinluo Adjunctive Therapy and 12-Month Cardiovascular Outcomes after ST-Segment Elevation Myocardial Infarction: A Real-World Multicenter Prospective Cohort Study[J]. Chinese Journal of Integrative Medicine, 2026, 32(1): 3-11. DOI： 10.1007/s11655-025-4028-1.

摘要

目的:

评价通心络胶囊在真实世界中对ST段抬高型心肌梗死 (STEMI) 患者中、远期预后的疗效与安全性.

方法:

本研究采用多中心、前瞻性队列研究方法

在中国122家拥有胸痛中心的临床医院开展. 参与者依据接受再灌注术前或术后第1天是否使用通心络被自然分为暴露组 (

598) 和非暴露组 (

600) . 两组均接受基于指南指导的经皮冠状动脉介入治疗 (PCI) 或溶栓治疗. 主要终点是12个月时主要不良心脑血管事件 (MACCEs) 发生率. 次要终点包括30天时STEMI严重并发症发生率; 30天与6月时MACCEs发生率; 6月与12月时复合终点事件发生率; 30天、6月与12月时全因死亡率.

结果:

共有3198例患者被纳入主要分析. 主要终点即12个月时的MACCEs发生率在暴露组中显著降低[40(2.5%)

.106(6.6%)

]

主要原因归结于心源性死亡与脑卒中的减少. 次要终点分析中

较非暴露组

暴露组在30天[MACCEs: 19(1.2%)

.64(4.0%)

]

和6月[MACCEs: 33(2.1%)

.90(5.6%)

]

时的风险明显降低; 暴露组在30天STEMI严重并发症方面降低了92%[16(1.0%)

.210(13.1%)

]

包括心源性休克、急性心力衰竭、机械并发症和恶性心律失常的减少; 暴露组在6个月时[36(2.3%)

.104(6.5%)

]

和12个月时[43(2.7%)

.127(7.9%)

]

的复合终点事件分别降低了65%和66%

其中心力衰竭再入院显著减少

严重出血风险降低了89%. 令人惊喜的是

暴露组在30天、6个月和1年时的全因死亡风险分别降低了71%、61%和59%.

结论:

联合通心络治疗在12个月的STEMI患+G2

Abstract

Objective:

To evaluate the efficacy and safety of Tongxinluo in improving medium- and long-term prognosis of patients with ST-segment elevation myocardial infarction (STEMI) in a real-world setting.

Methods:

This multicenter prospective cohort study enrolled STEMI patients from 122 certified chest pain centers in China. Participants were stratified into exposure (

598) and non-exposure (

600) groups based on Tongxinluo administration initia

tion before or within 24 h post-reperfusion. Both groups received percutaneous coronary intervention (PCI) or thrombolysis with guideline-based therapy. The primary endpoint was incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) at 12 months. Secondary endpoints included the incidence of severe STEMI complications at 30 days; MACCEs at 30 days and 6 months; composite endpoint events at 6 and 12 months; and all-cause mortality at 30 days

6 months

and 12 months.

Results:

A total of 3

198 patients were included in the primary analysis. The primary endpoint

MACCEs incidence at 12 months

was significantly lower in the exposure group [40 (2.5%)

. 106 (6.6%)

]

driven by reductions in cardiac death and stroke. In the secondary endpoint analysis

early risk reduction was pronounced at 30 days [MACCEs: 19 (1.2%)

. 64 (4.0%)

]

and 6 months [MACCEs: 33 (2.1%)

. 90 (5.6%)

]

. The exposure group exhibited 92% lower 30-day STEMI complications [16 (1.0%)

. 210 (13.1%)

]

including reductions in cardiogenic shock

acute heart failure

mechanical complications

and malignant arrhythmias. Composite endpoint risks decreased by 65% at 6 months [36 (2.3%)

. 104 (6.5%)

]

and 66% at 12 months [43 (2.7%)

. 127 (7.9%)

]

with significant heart failure readmission reductions and 89% lower severe bleeding risk. More surprisingly

the risk of all-cause death at 30 days

6 months

and 1 year was reduced by 71%

61% and 59% in the exposure group.

Conclusions:

Adjunctive Tongxinluo therapy demonstrated significant improvement in 12-month cardiovascular outcomes with favorable safety profile

suggesting potential benefits of integrating traditional Chinese medicine with evidence-based STEMI management. (Registration No. ChiCTR100054466)

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