Assessment of Intermingled Phlegm and Blood Stasis Syndrome in Coronary Heart Disease: Development of a Diagnostic Scale

الملخص EN

Background.

Intermingled Phlegm and Blood Stasis Syndrome (IPBSS) is a common feature in patients with coronary heart disease (CHD).

In clinical practice, the diagnostic agreement of clinical doctor of Chinese Medicine (CM) is poor.

We previously developed a IPBSS diagnostic scale for use by general practitioner.

Objectives.

To assess a IPBSS diagnostic scale that we previously developed for use by non-experts.

Methods.

This is a multicenter, prospective study involving eight study sites across China.

Eligible patients were adults (≥18 years) with CHD as demonstrated by a history of myocardial infarction, stenosis, or past coronary revascularization.

IPBSS was assessed using a scale that consisted of 14 items in two domains (e.g., phlegm and blood stasis).

The score range for each item was 0 to 3 points.

Maximum total score was 72 points.

Diagnostic accuracy was verified using consensus opinion by two independent experts as reference.

Results.

A total of 1,142 CHD patients were included.

IPBSS was established in 729 subjects using the IPBSS diagnostic scale.

In ROC curve analyses, at the optimal cut-off of 25.5, the sensitivity and specificity of the IPBSS scale were 67.6% and 72.4%, respectively.

The area under the ROC curve was 0.741 (95%CI: 0.711-0.772).

Conclusions.

The newly developed IPBSS scoring system showed moderate performance in diagnosing IPBSS in CHD patients.

Data from further large-scale diagnostic test accuracy studies are warranted.

This trial is registered with ChiCTR-OOC-15006599.