| The blood stasis syndrome (BSS) of coronary heart disease (CHD) was diagnosed according to diagnostic criterion of CHD in1979and diagnostic criterion of BSS in1986respectively. The diagnostic criterion of BSS played an important role in the study of BSS. But the working criterion had been almost30years up to now, and was difficult to meet the needs of clinical work and scientific research. Furthermore, the clinical feature of BSS was different in different disease. Therefore, to establish diagnostic criterion of BSS of CHD was an urgent requirement.Fu Changgeng established "Diagnostic criterion of BSS of CHD (Draft)" through systematic review, expert consultation, cross-sectional study, case-control study in2012, published on Chinese Journal of Integrative Medicine. The criterion was proved to be reliable and feasible through primary clinical testing. Based on this, we optimized the diagnostic criterion through Delphi expert consultation, evaluated diagnostic efficiency through cross-sectional diagnostic test and double-blind randomized clinical trial (RCT), and established optimized diagnostic criterion of BSS of CHD finally. Part1Optimizing diagnostic criterion of BSS of CHD through Delphi expert consultation Objective:To optimize the location, content and score of diagnostic indicators in criterion of BSS of CHD (Draft). Methods:We selected110experts from70hospitals or scientific research institution in24provinces. Through Delphi method, two round expert consultations were carried out. Diagnostic indicators were descriptively analyzed through mean, proportion of full store and coefficient of variation (CV). According to the suggestion of experts, we regulated the location, content and score of indicators in diagnostic criterion. Results:According to the two round expert consultations, the positive coefficient of experts was99.1%and97.2%respectively, and the degree of expert authority was0.92. Diagnostic indicators with high CV were deleted in the two round consultations, including rising of D-dimer level (CV=0.50), scaly dry skin (CV=0.51), rising of blood viscosity level (CV=0.69) and cyanosis on edge of limbs (CV=0.34). The Kendall’s W of the two round consultations was0.664(P=0.000) and0.849(P=0.000) respectively.Conclusion:The location, content and score of diagnostic indicators were optimized, with results in Table1.Part2Optimizing and evaluating diagnostic criterion of BSS of CHD through cross-sectional diagnostic testObjective:To optimize the diagnostic condition in diagnostic criterion of BSS of CHD (Draft), and evaluate the diagnostic efficiency of optimized criterion.Methods:A total of3081cases of patients from10hospitals with CHD proved by coronary arteriography (CAD) were analyzed. Score of BSS of CHD was calculated according to the optimized calculating method, and the ROC curve of BSS score was analyzed. The diagnostic boundary point of BSS score was acquired according to Youden index, and diagnostic criterion of BSS of CHD was optimized. The diagnostic efficiency of optimized criterion was evaluated, and compared with diagnostic criterion of BSS in1986and diagnostic criterion of BSS of CHD (Draft).Results:The diagnostic boundary point of BSS score was19. Analyze the diagnostic efficiency of optimized criterion. The sensitivity of optimized criterion was93.3%, the specificity was91.0%, the accuracy was92.6%, the positive predictive value was95.8%, the diagnostic odd ratio (DOR) was141.18and the positive likelihood ratio (+LR) was10.33. The Kappa value of the optimized criterion was0.970(P=0.000), and the area under the ROC curve was0.949(P=0.000). The sensitivity (94.1%vs.92.1%), specificity (89.5%vs.87.1%), DOR (136.08vs.79.05) and+LR (8.97vs.7.15) of diagnostic criterion of BSS of CHD (Draft) were higher than diagnostic criterion of BSS in1986.The specificity, DOR and+LR of optimized diagnostic criterion were higher than diagnostic criterion of BSS of CHD (Draft).Conclusion:The optimized criterion of BSS of CHD was reliable and feasible, and the diagnostic efficiency of optimized criterion was higher than diagnostic criterion of BSS in1986and the diagnostic criterion of BSS of CHD (Draft).Part3The study of clinical evaluation on double-blind RCT with treatment of activating blood and dissolving stasisObjective:Based on the investigate thinking of "survey syndrome according to medicine", made treatment of activating blood and dissolving stasis on patients of BSS in CHD. Through curative effects, verified the optimized diagnostic criterion. Methods:Totally220patients of BSS in CHD were recruited from four centers, and were assigned to two groups according to the random digit table. The two groups were named the treatment group and the control group,110patients in each group. All patients took western medicine. Patients in treatment group were given Guanxindanshen Pills (GXDSP),10pills each time, triple daily, and patients in control group took GXDSP placebo. The treatment course was30days for all. The score of BSS, the score of angina, the efficacy of angina and the efficacy of electrocardiogram were observed and analyzed.Results:The total score of BSS (P<0.01), the BSS score of major indicators (P<0.05) and the BSS score of minor indicators (P<0.05) in treatment group were lower than in control group. The score of angina in treatment group was lower than in control group (P<0.01). The efficacy of angina (P<0.05) and the efficacy of electrocardiogram (P<0.05) in treatment group were better than in control group. The lowing degree of score of BSS in optimized diagnostic criterion was higher than in diagnostic criterion of BSS in1986(P<0.05). There were no significant difference in the diagnostic criterion of BSS of CHD (Draft) and diagnostic criterion of BSS in1986(P=0.057).Conclusion:The optimized criterion of BSS of CHD was reliable and feasible in clinical practices. |
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