Designing Reliable Care Through Clinical Pathways: A Human Factors Framework.

Metabolic Syndrome (MetS) represents a significant global public health challenge in the 21st century (). It is characterized by a cluster of core components including central obesity, hyperglycemia, hypertension, and dyslipidemia (elevated triglycerides/reduced high-density lipoprotein cholesterol) (). Its pathophysiological essence involves the superimposition of insulin resistance (IR)-mediated metabolic disorders and a state of chronic low-grade inflammation (–). Since its first formal definition by the World Health Organization (WHO) in 1998 (), the prevalence of MetS has experienced exponential growth, paralleling the global rise in obesity rates and population aging. The latest Chinese epidemiological data (2023 Report on Chronic Diseases and Risk Factors Surveillance in China) indicates that the prevalence of MetS among adults has reached 31.2%, with a notable trend towards younger age groups—the prevalence among individuals under 40 has increased by 47% compared to a decade ago. This population faces not only a high risk of metabolic diseases such as diabetes and non-alcoholic fatty liver disease but also (–), due to vascular endothelial injury and accelerated atherosclerosis induced by metabolic disturbances, constitutes a “high-risk group” for cardiovascular and cerebrovascular events (, –) (e.g., myocardial infarction, stroke). Studies have shown that the risk of cardiovascular events in patients with MetS is 2.3-3.1 times that of healthy individuals, with all-cause mortality increased by 1.8-2.5 times; among these, MetS patients with comorbid diabetes have a 10-year risk of cardiovascular and cerebrovascular events exceeding 40% (–). However, current clinical management of MetS predominantly focuses on intervening in individual risk factors (e.g., glucose-lowering, blood pressure control, lipid regulation), lacking multi-target intervention strategies aimed at the “metabolic-vascular injury” network (). Furthermore, some pharmacological agents (e.g., long-term use of statins, insulin) are associated with side effects such as hepatic and renal impairment and hypoglycemia, making it difficult to meet patients’ needs for “safe, efficient, and holistic regulation” therapeutic approaches. Recent large cardiovascular outcome trials (, ) have shown that in high-risk populations with obesity and cardiovascular disease, the annual MACE rate remains substantial despite contemporary standard care. Traditional Chinese medicine (TCM) compounds, by virtue of their “multi-component, multi-target, multi-pathway” intervention characteristics, offer novel insights for the comprehensive management of MetS. Meta-analyses have shown that TCM or the combination of TCM and Western medicine can effectively improve metabolic syndrome and reduce cardiovascular and cerebrovascular risk (–). Tongmai Jiangtang Capsule (TJC) is an innovative proprietary Chinese medicine developed independently, derived from the classical empirical formula “Method for Boosting Qi, Activating Blood, and Dredging Collaterals.” Its main components include Astragalus membranaceus (Huangqi), Salvia miltiorrhiza (Danshen), Ligusticum chuanxiong (Chuanxiong), Hirudo (Shuizhi), and Pheretima (Dilong), among others. Modern pharmacological studies have confirmed that its core active ingredients (e.g., astragaloside IV, tanshinone IIA, ligustrazine) can ameliorate metabolic disorders through multiple mechanisms (–): On one hand, astragaloside IV can activate the AMPK pathway—a key energy sensor that not only enhances insulin sensitivity and inhibits hepatic gluconeogenesis but also exerts anti-inflammatory effects by suppressing NF-B signaling—thereby ameliorating metabolic disorders; tanshinone IIA can downregulate the expression of inflammatory cytokines (TNF-α, IL-6) in adipose tissue, alleviating IR. On the other hand, ligustrazine and hirudin can inhibit platelet overactivation, reduce hypercoagulability, and simultaneously improve vascular endothelial function and delay the formation of atherosclerotic plaques by modulating the endothelin-1 (ET-1)/nitric oxide (NO) balance. Preliminary studies have indicated that TJC has beneficial effects on both macro- and micro-vascular complications of diabetes, with a good safety profile (–); however, its impact on hard cardiovascular and cerebrovascular endpoints (e.g., myocardial infarction, stroke, cardiovascular death) remains unclear. Currently, clinical research on interventions for cardiovascular and cerebrovascular risk in MetS predominantly focuses on Western drugs (e.g., GLP-1 receptor agonists, SGLT2 inhibitors) or single TCM components (e.g., Salvia miltiorrhiza injection). Large-scale, multi-center, long-term follow-up randomized controlled trials (RCTs) investigating TCM compounds, particularly Tongmai Jiangtang Capsule, are still lacking. The complexity and heterogeneity of MetS components, coupled with its insidious progression, necessitate multi-center collaboration to enroll populations fro