JMIR Publications

ABSTRACT

Background:

Peripheral arterial disease (PAD) is a prevalent vascular disorder predominantly affecting the lower extremities. Its pathophysiology is characterized by atherosclerotic thickening of the intimal layer in limb-supplying arteries, leading to luminal narrowing or occlusion and consequent reduction in distal blood flow. Clinically, PAD manifests as intermittent claudication and rest pain; in advanced stages, it may progress to chronic limb-threatening ischemia (CLTI), with an associated risk of amputation [1]. Revascularization constitutes the only definitive strategy for limb salvage [2]. Although timely restoration of blood flow is essential for recovering ischemic tissue function, it may paradoxically induce further tissue injury—a phenomenon termed ischemia–reperfusion injury [3]. This injury can evolve from localized damage to systemic involvement, frequently accompanied by systemic inflammatory response syndrome, and may impair multiple organs, thereby posing a serious threat to patient health and survival [4]. In recent years, ongoing advances in clinical diagnostics and standardized TCM syndrome research have increased academic attention to the clinical diagnosis and TCM syndrome patterns of reperfusion injury following revascularization in PAD. At present, clinical diagnosis and traditional Chinese medicine (TCM) syndrome classification for reperfusion injury following revascularization in peripheral artery disease remain entirely unexplored domains in China. Both diagnostic and syndrome differentiation approaches continue to rely predominantly on physicians' clinical experience and subjective judgment, which, to a certain extent, constrains diagnostic accuracy and objectivity [5]. With the rapid advancement of modern medical technology, substantial progress has been achieved in elucidating the correlation between post-revascularization reperfusion injury and biochemical indicators [6]. Evidence indicates that affected patients frequently exhibit abnormalities in specific parameters, including inflammatory storms [7] and oxidative stress [8], thereby offering novel perspectives and methodological approaches for clinical diagnosis and TCM syndrome differentiation in this condition.

Objective:

To apply the Delphi method in screening clinical diagnostic criteria and traditional Chinese medicine (TCM) syndrome patterns for reperfusion injury after peripheral arterial revascularization, thereby providing an evidence-based foundation for the development of a diagnostic scoring scale.

Methods:

Employing the Delphi approach and integrating preliminary literature findings from the working group, we conducted three rounds of consultation with Western medical experts and two rounds with TCM experts. Expert opinions were evaluated using mean scores, coefficients of variation, and consensus coefficients. Items were revised iteratively based on clinical experience, culminating in a consensus on clinical diagnosis and TCM syndrome criteria for post-revascularization reperfusion injury.

Results:

In the clinical diagnosis section, 54 domestic experts participated, with response rates of 100%, 94%, and 97% across the three rounds and authority coefficients of 0.96, 0.89, and 0.89, respectively. Following item reduction guided by mean scores, coefficient of variation, and clinical rationale, 13 core diagnostic items were finalized: onset within 72 hours post-surgery, local swelling, limb pain, increased skin temperature, skin color changes, localized tenderness, white blood cell count, C‑reactive protein, interleukin‑6, lactate, creatine kinase, ultrasound, and magnetic resonance imaging. For the TCM syndrome section, 44 domestic experts participated, with response rates of 100% and 97% over two rounds and authority coefficients of 0.92 and 0.94. Similar analyses refined the criteria into seven core syndrome patterns: blood heat invading the collaterals; toxic pathogen attacking the heart; toxic pathogen impairing the spleen; toxic pathogen injuring the liver; toxic pathogen damaging the kidneys; toxic pathogen affecting the lungs; and qi deficiency with dampness and stasis in the limbs.

Conclusions:

The 13 Western diagnostic items and 7 TCM syndrome patterns identified in this study integrate modern precision diagnostics with traditional TCM syndrome differentiation and treatment. This framework offers evidence-based support for standardized clinical management and complication prevention, serving as a reference standard for future development of integrated TCM‑Western medicine scales, mechanistic research, and clinical guideline updates.