Tongxinluo capsule for acute myocardial infarction: a systematic review and meta-analysis.

Objective: To evaluate the clinical and preclinical effects of Tongxinluo Capsule (TXL) on acute myocardial infarction (AMI) and to summarize reported mechanisms of action, thereby informing clinical decision-making and future research. Methods: A comprehensive computerized search of eight databases and four clinical trial registries was performed from their inception until 1 April 2025. Data extraction, quality assessment and analysis were conducted in strict accordance with predefined protocols. The methodological quality of included studies was evaluated using the RoB-2 and SYRCLE tools. Statistical analyses were carried out using RevMan 5.4 software, employing fixed-effect or random-effects models as appropriate. Results: This review included 54 clinical studies (4,353 patients in trail group; 4,296 patients in control group) and 11 animal studies (95 animals in trail group; 94 animals in control group). Meta-analysis of clinical studies indicated that, compared with control groups, TXL was associated with lower all-cause mortality, cardiovascular mortality, and incidence of myocardial reinfarction (P < 0.05). Compared with control groups, TXL was associated with lower incidence of repeated revascularization, heart failure, angina pectoris, and arrhythmias (P < 0.05). Furthermore, TXL demonstrated greater improvement in cardiac function indicators and vascular endothelial function (P < 0.001), alongside significant reductions in blood lipids levels (TC, TG, HDL-C, LDL-C; P < 0.05) and inflammation markers. TXL was associated with fewer adverse reactions (P = 0.01), primarily gastrointestinal in nature. In animal studies, TXL was correlated with lower myocardial infarction area and the no-reflow area (P < 0.001), higher cardiac function indicators (LVEF and LVFS; P < 0.05) and better vascular endothelial function (P < 0.05) compared to control group. Reported biological mechanisms of TXL include inhibition of apoptosis, suppression of inflammation, protection of cardiomyocytes and endothelial cells, promotion of angiogenesis, and synergistic lipid-lowering and plaque-stabilization effects. Conclusion: This study is the first meta-analysis to integrate both clinical and animal research on TXL for AMI. The finding suggests that TXL may be associated with alterations in left ventricular systolic function and clinical prognosis, potentially mediated through mechanisms such as inhibition of apoptosis, protecting endothelial function, reducing of inflammation, preservation of cardiomyocytes, and promotion of angiogenesis. Limitations of the included studies constrain the strength of these conclusions, and further validation through larger, high-quality randomized controlled trials is warranted.