| Purpose:To study the influencing factors and core indicators for efficacy evaluation of treating method from spleen on the therapeutic effects of stable angina pectoris patients with spleen deficiency and phlegm turbidity.Exploring the best indications for treating spleen.Material and method:Combined with the preliminary study of"973"group on the mechanism and regularity of therapeutic effect on"treating stable angina pectoris from spleen"caused by"spleen deficiency and phlegm generation",initially forming a pool of items of therapeutic effect indicators of coronary heart disease patients with spleen deficiency and phlegm turbidity syndrome intervened with treatment from the spleen,including four secondary indicators,namely,disease of Western medicine,syndrome of traditional Chinese medicine,quality of life and end-point event,which called the base entry pool.From May 2013 to December 2014,using the clinical trial design of multicenter,blind,randomized,selecting six hospitals in the north as sub-centers for the recruitment of subjects,we enrolled a total of 160 patients.Intervention for 12 weeks with treatment based on spleen,including invigorating qi,invigorating spleen and eliminating phlegm with blood and invigorating qi,invigorating spleen,eliminating phlegm and removing blood stasis from spleen.Seven patients were deleted and 153 patients were enrolled in the statistics.According to the effective rate of angina pectoris,patients were divided into effective group and ineffective group.All items except terminal events in the basic item pool were used as test variables.Single factor analysis was carried out for two groups of patients to screen the symptoms indicators with statistical differences and clinical guiding significance.Using the principal component of factor analysis as independent variable and the effective or ineffective treatment of spleen as dependent variable.The above items were further screened by binary logistic regression analysis to study the influencing factors and core indicators for efficacy evaluation of treating method from spleen on the therapeutic effects of stable angina pectoris patients with spleen deficiency and phlegm turbidity.Exploring the best indications for treating spleen.Results:1.Investigating the patients with spleen deficiency and phlegm turbidity syndrome of coronary heart disease treated by spleen theory.The test variables were all items.The items with statistical differences or clinical guiding significance in univariate analysis included that indicators of Western medicine:the average number of attacks of angina pectoris,the average duration of pain,the degree of pain,average nitroglycerin consumption,triglyceride,total cholesterol,high density lipoprotein,low density lipoprotein,C reactive protein,blood homocysteine,ECG;Indicators of TCM syndromes:chest tightness,chest pain,short breath,palpitation,burnout,fatigue,heaviness of limbs,heavy head,brilliant complexion,abdominal distension and impaired appetite;Indicators of quality of life:degree of physical activity limitation,stable state of angina pectoris,attack of angina pectoris,disease awareness.2.The independent variables were factors above with statistical differences in the results of single factor analysis or clinical guiding significance.The effective and ineffective treatment of spleen was taken as dependent variable.According to the results of binary logistic regression analysis,the results showed that the five factors of average number of attacks of angina pectoris,high density lipoprotein,blood homocysteine,abdominal distension and stable state of angina pectoris were significant independent variables（P<0.05）.3.It can be concluded that the discriminant formula of the therapeutic effect of treating stable angina pectoris with spleen deficiency and phlegm turbidity syndrome by spleen theory“Logit（P）=-1.625-2.039×x1-0.586×x2-0.813×x3+1.116×x4+2.065×x5”.Among them,x1 was the average attack frequency of angina pectoris:no=0,<1/week=1,1-2 times/week=2,1-2 times/week=2,3-6 times/week=3,1-3 times/day=3,3-3-6 times/week=3,1-3 times/day=4,1-3 times/day=4,<4 times/day=4,<4 times/day=5,x2 was high density lipoprotein:<35.22-70.14 mg/dL=1,35.22-70.14mg/dL=2,70.14-70.14-105.06mg/dL=3,105.06-139 139.98-174.90 mg/dL=5,<3-174.90 mg/dL=5,<174.9090mg;x3 was blood homocysteine:<8.97 um mol/L=1,8.97-17.83 um ol/L=2,17.83-26.69 um o L/L=3,26.69-35.55 umol/L=4,35.55-44.41umol/L=5,>44.41 umol/L=6;x4 was abnormal appetite:no=0,mild=1,moderate=2,severe=3;x5 was stable state of angina:1=1,2=2,3=3,4=4,5=5.The critical value of ROC curve analysis is 1.474.Conclusion:1The evaluation index set of the therapeutic effect of spleen therapy on patients with spleen deficiency and phlegm turbidity syndrome of coronary heart disease includes 3secondary indicators and 5 items,which are respectively western medicine diseases:average attack times of angina pectoris,high density lipoprotein,blood homocysteine;TCM syndromes:abdominal distension;quality of life:stable state of angina pectoris.2.The influencing factors of the therapeutic effect of spleen deficiency and phlegm turbidity syndrome of coronary heart disease from spleen theory include the average attack times of angina pectoris,high density lipoprotein level,blood homocysteine level,abdominal distension degree and stable state of angina pectoris of the patients.3.The best indications for intervention of patients with spleen deficiency and phlegm turbidity syndrome of coronary heart disease from the treatment of spleen including average attack times of angina pectoris<1 time/week,high density lipoprotein≤35.22mg/dL,blood homocysteine≤8.97μmol/L;TCM syndromes:severe abdominal distension;stable state of angina pectoris with 1 score.4.Logistic discriminant formula“Logit（P）=-1.625-2.039×x1-0.586×x2-0.813×x3+1.116×x4+2.065×x5”could be applied to predict the effective probability of treating stable angina pectoris patients with spleen deficiency and phlegm turbidity syndrome from the spleen theory according to the Logit（P）greater than 1.474 or not.Among them,X1 was the average attack frequency of angina pectoris,x2 was the high density lipoprotein level,X3 was the blood homocysteine level,X4 was the rank of pimples,and X5 was the stable state of angina pectoris. |
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