Arteriosclerosis Obliterans Syndrome Elements Diagnostic Scale Developed

[Objective] This study is under the'Significant New Drug Creation',Project of National Science and Technology Major Project——Research of key techniques in clinical efficacy evaluation of Chinese medicine that displays the therapeutic advantages of Chinese medicine (Research Index:2009ZX09502-028). Studies on standardization of syndromes have been a hot topic in recent years, and one of the key basic work of the research, is constructing tools for Chinese medicine diagnostic and therapeutic evaluation. Under the inspiration and guidance of internal medicine related researches, this study aims to construct the syndrome key elements diagnostic scale for arteriosclerosis obliterans, form a macro-level quantitative diagnostic standard, and explore the ideas and methods of syndrome diagnosis standardization research in Chinese medicine external disease.[Methodology] Using literature research, clinical epidemiological survey, and by three times Delphi method, the syndrome key elements diagnostic scale dimensions of lower limb arteriosclerosis obliterans were formed, and categorized into nine syndrome key element dimensions:cold condensation, blood stasis, damp heat, toxic heat, phlegm dampness, qi deficiency, yang deficiency, yin deficiency, and established the corresponding four-diagnostic information entry pools for every syndrome key element. Through collection of clinical cases, combined with clinical practice, and on the basis of epidemiological surveys, syndrome key element entries and local symptom entries were selected, after index weighting, macro-level quantitative diagnostic model and standards based on local symptoms of the lower limb arteriosclerosis obliterans syndrome were constructed. The syndrome key elements diagnostic scales suitable for lower limb arteriosclerosis obliterans patients without gangrene (Fontaine stages 1-3) and patients with gangrene (Fontaine stage 4) were respectively established, and finally the standards were subjected to clinical diagnostic testing.[Results] Syndrome key elements diagnostic scales suitable for lower limb arteriosclerosis obliterans patients without ulcerous (Fontaine stages 1-3) and ulcerous patients (Fontaine stage 4) were established respectively. Using this as the basis, the syndrome key element quantitative diagnostic standards of lower limb arteriosclerosis obliterans were constructed, for non-ulcerous patients, cold condensation key element diagnosis threshold value was 47, blood stasis key element diagnosis threshold value was 13, phlegm dampness key element diagnosis threshold value was 35, qi deficiency key element diagnosis threshold value was 20, for ulcerous patients, blood stasis key element diagnosis threshold value was 13, toxic heat key element diagnosis threshold value was 31, qi deficient key element diagnosis threshold value was 5. Clinical diagnostic testing results indicated, the syndrome key element diagnostic scale possessed relatively high sensitivity (higher than 85%), all syndrome element diagnostic scale except cold condensation possessed relatively high specificity (higher than 85%), and positive likelihood ratio (Youden index) (higher than 0.85).[Conclusion] The standardized syndrome key elements diagnostic scale for lower limb arteriosclerosis obliterans constructs via literature research, clinical epidemiological survey, diagnostic scale development, statistical analysis, and clinical validation possesses good feasibility, accuracy and practical value. The results from this research will provide a standardized scale for further study and objective evaluation of clinical syndrome diagnosis and therapeutic effects on lower limb arteriosclerosis obliterans, providing reference for ideas and methods to syndrome standardization research in other external diseases.