Lower Limb Arteriosclerosis Occlusion Disorder Syndrome Elements Of Traditional Chinese Medicine (tcm) Diagnosis Scale Validation And Curative Effect Evaluation Of Modern Literature Research

[Objective] Research on Traditional Chinese Medicine (TCM) syndrome standardization is one of the groundwork for assessment of TCM clinical therapeutic efficacy. A scientific approach to both syndrome diagnosis and clinical therapeutic efficacy evaluation methods are important contents to standardization research. Currently, work on many TCM syndrome diagnoses and clinical therapeutic efficacy evaluations have been carried out, with some results that have been obtained. The results of "Lower limb arteriosclerosis obliterans syndrome key elements diagnostic scales", a previous study on lower limb arteriosclerosis obliterans (ASO) syndrome diagnosis that was completed under the support of a major project in the Ministry of Science and Technology of the People’s Republic of China——Major new drug creation:"Research on key techniques in clinical therapeutic efficacy evaluation of TCM that displays the therapeutic advantages of TCM", was validated prospectively in this study. Credibility of the scales in clinical application was also looked into during the study. These provided a basis for further scale optimization. In the aspect of therapeutic efficacy evaluation, this study has served to define lower limb ASO therapeutic efficacy evaluation indexes commonly seen in recent years, helping to pave the way for future therapeutic efficacy evaluation research.[Methodology] Clinical ASO patients were collected. Trained investigators conducted questionnaire surveys on patients and filled up the scales. Experts were invited to carry out syndrome diagnoses. Analysis using statistics software was carried out after results from the scales were quantified. Sensitivity, specificity and Youden’s index of the respective syndrome key elements diagnoses were calculated. Literature in the last10years related to clinical observations on lower limb ASO was researched. Frequency analyses were then carried out for symptom entries, sign entries and auxiliary examination entries used in therapeutic efficacy evaluation.[Results] Lower limb ASO syndrome key elements diagnostic scale.-Non-ulcerous group cold condensation key element47points:diagnosis sensitivity was0.96, specificity0.23, Youden’s index0.19. Non-ulcerous group cold condensation key element52points:sensitivity0.94, specificity0.35, Youden’s index0.29. Non-ulcerous group blood stasis key element: sensitivity0.90, specificity0.38, Youden’s index0.28. Non-ulcerous group phlegm dampness key element:sensitivity0.87, specificity0.84, Youden’s index0.71. Non-ulcerous group qi deficiency key element:sensitivity0.75, specificity0.44, Youden’s index0.19. Ulcerous group blood stasis key element:sensitivity0.83, specificity1.00, Youden’s index0.83. Ulcerous group heat toxic key element:sensitivity0.25, specificity1.00, Youden’s index0.25. Ulcerous group qi deficiency key element:sensitivity1.00, specificity0.33, Youden’s index0.33. Main symptom entries used in recent literature for therapeutic efficacy evaluation were numbness of affected limb, pain in affected limb, intermittent claudication and affected limb rest pain. Main sign entries were skin temperature, skin color, ulcers and changes in state of arterial pulse. Main auxiliary examinations were blood lipids, blood clotting functions, hemorheology, ankle-brachial index and changes in state of arterial blood flow.[Conclusion] Through this study, we have found that lower limb ASO syndrome key elements diagnostic scales possess very good operability. Non-ulcerous group’s syndrome key elements were comparatively more comprehensive in incorporating ASO patients’ syndrome diagnosis status. Non-ulcerous phlegm dampness key element’s Youden’s index was the highest amongst the respective syndrome key elements, while the diagnosis of other syndrome key elements in non-ulcerous group still requires further improvement. As the number of enrolled medical cases in ulcerous group was lesser, the scales could not be evaluated comprehensively. However, judging from the validation results, the Youden’s index for ulcerous group’s blood stasis key element was higher than0.8, indicating that it possesses relatively good diagnostic value. The high prevalence of expert diagnoses with cold condensation key element within the ulcerous group was also a point worth consideration. Research on modern literature in lower limb ASO therapeutic efficacy evaluation index had revealed that the indexes used in ASO therapeutic efficacy evaluation were relatively concentrated, with strong operability in all of the indexes. A difference was however observed when compared with diagnostic entries; suggesting the entry selection for therapeutic evaluation tools was different from diagnostic tools’ entry selection.