Clinical Evaluation Of The Method Of Syndrome Differentiation And Treatment Of Blood Stasis Syndrome Of Academician Chen Keji

This paper includes the following two parts:pragmatic randomized controlled clinical trial (PRCT) and cross-sectional study on international Blood-stasis syndrome.Objective:1. PRCT:The aims of this research were to assess the effectiveness and safety of "Chen Ke-ji on pattern identification(PI) of blood stasis syndrome (BSS) " in treating stable angina pectoris.2. Cross-sectional study on international BBS:The aims of this research were to analysis and prove if the Chinese criteria of BBS were suitable for people in different nation and race. And we expect to formulate international criteria of BBS for all the people abroad.Method1.PRCTThis research is a pragmatic stratified randomized controlled trial. On the basis of Western conventional therapy and traditional Chinese medicine(TCM) conventional therapy,the treatment group was assigned to "Chen Ke-ji PI methods of BBS" guided treatment. While, the control group was assigned to "conventional PI methods of BBS" guided therapy. The effectiveness and safety of " Chen Ke-ji PI methods of BBS " in treating stable angina pectoris were evaluated according to the comparison within groups and between groups. The sensitivity of "Chen Ke-ji PI methods of BBS"was also examined. This analysis was interim analysis; just focusing on patients who had finished 4 weeks follow up from initiate to January 27,2016.2. Cross-sectional study on international BBSWe released 79 questionnaires of international BBS and 65 copies recovered.Then two trained researchers inquired and observed the 65 people face-to-face, comfirming the accuracy of the filled questionnaires, then they made BBS diagnosis of the 65 people. The suvey included general information (age, gender, nationality, and profession), medical history, symptoms, the signs of tongue and pause. The questionares of BBS were divided into two parts, the first part filled in by the inquired people themselves, and the seond part by the researches after checking the inquired people. At the same time, researchers need to check the first part of the questionares by asking the people some questions, in order to comfirm the accuracy.Results1.PRCTWe foucused on the 220 patients with stable angina pectoris who had finished 4 weeks follow up (110 patients in the treatment group and 110 patients in the control group). The results were as follows:(1) During the 220 patients, there were 170 patients diagnosed with BBS according to "Chen Ke-ji PI methods of BBS "and "conventional PI methods of BBS". While there were 50 patients diagnosed with BBS not according to "conventional PI methods of BBS" but "Chen Ke-ji PI methods of diagnostic criterion of BBS". The BBS scores of the 50 patients who had no statistically significant difference with that of the 170 patients at the enrollment time(Z=-1.36, P=0.17). In addition, those 50 patients had hyper-coagulation state, with one or more hemorheology indexes higher beyond the range of normal value, which prove that "Chen Ke-ji PI methods of BBS"was more sensitive than the "conventional PI methods of BBS"in early diagnosing and treating BBS.(2)We found that after 2-week treatment (conventional western therapy and TCM guided with "Chen Ke-ji PI of BBS"), paitents in experimental group had reduction in angina scores (Z=4.88,P<0.01). Furthermore, after 4-week treatment, patients in experimental group had reduction in angina scores (Z=7.47, P<0.01)、BBS scores (Z=4.42, P<0.01、and hemorheology index except red blood cell deformation rate, the blood viscosity (1.0s-1,5.0s-1,10.0s-1) (P<0.05).At the same time, there were no significant differences in antiplatelet drug at the enrollment time and after treatment.(3)On the basis of conventional therapy and TCM treated in the guidance of "Chen Ke-ji PI methods of BBS" for 2 weeks and 4 weeks, patients in experimental group had no increase in the use of nitroglycerin. After 2-week treatment,82.76% of the 110 patients stopped or reduced the use of nitroglycerin.After 4-week treatment,85.71% of the 110 patients stopped or reduced the use of nitroglycerin.(4)Compared with the control group, patients in the experimental group had more reduction in the erythrocyte aggregation rate, and there was statistic difference in the two groups. While maximum agglutination of platelet, the blood viscosity (10.0 s-1)、the blood viscosity (35.0 s-1) and the blood viscosity (120.0 s-1),but there were no statistic difference in the two groups, which may related to the limited sample size in thes interim analysis.(5) TCM added to Western conventional therapy in 220 patients with stable angina pectoris for 4 weeks showed no additional risk of bleeding.2. Cross-sectional study on international Blood-stasis syndrome:we conducted a questionnaire survey of 65 foreigners from Asia, which including white, yellow, black and brown race. Then, two trained researchers, including a master and a doctor), interviewed the 65 foreigners to confirm the accuracy of the filled questionnaires and diagnose the 65 foreigners by the criteria one and two. The contents of the convey included the general information of the patients (age, gender, nationality), medical history, medical history, symptoms and tongue blood stasis. The questionnaire is divided into two parts, the first part filled in by patients themselves, the second part by researchers interview respondents fill in, at the same time, researchers need to in the first part of the problem again asked respondents to confirm the correctness of the form. A cross-sectional survey results are as follows:(1) This investigation is mainly based on two diagnostic criteria, criteria 1 and 2. According to the criteria 1, respondents diagnosis for blood stasis syndrome a total of 46 people (accounting for 70.77%); according to the standard 2, is investigated in the diagnosis of blood stasis syndrome has 8 ((12.30%). Criteria 1 and 2 diagnosis of blood stasis of the respondents have 8 ((12.30%), and 2 standard personnel coincide.(2)The judgement of criteria of Blood stasis syndrome:the results of the judgement of each criterion of the 65 foreigners shown as follows1) Criteria 1:In line with the item 1 of 18 people (occupied 27.69%), in line with the item 2 of 5 (7.69%), in line with the item 3 of 43 people (accounting for 66.15%), in accordance with Clause 4 of 1 (1.54%), in line with the item 5 of 2 people (3.08%), with Item 6 of 1 (1.54%), in line with the entries 8,9 of 2 people (3.08%), with 10 items 6 (accounting for 9.23%), in line with the item 113 (4.62%), in line with the 12 item 8 (12.31%), in line with the item 141 (1.54%), in line with the 16th and 17th of the 2 (3.08%). (Shown in Table 1)2) Criteria 2:all conform to the criteria 2 as follows. With Item 1 in 43 cases (accounting for 66.15%), in line with the item 2 of 3 people (4.62%), in line with Item 31 (1.54%), conforms to Item 6,7%(10.77%), with 7 items of five people (7.69%), to meet the 1 (1.54%) of item 9, with 10 of item 2 (3.08%). with 1 of item 12 (1.54%), with 1 of item 14. (Shown in table 2).Conclusion1.PRCT:(1) "Chen Ke-ji PI methods of BBS "was more sensitive than "conventional PI methods of BBS ". Thus, " Chen Ke-ji PI methods of BBS " was good for the diagnosis and treatment of BBS in the early stage. (2) Treatment in the guidance of "Chen Ke-ji PI methods of BSS" added toconventional therapy in patients with stable angina pectoris could improve BSS and symptom of angina, reduce the use of nitroglycerin, decrease the maximum agglutination of platelet, the adhesion rate of platelet and the blood viscosity, with no additional risk of bleeding.(3) After 4-week treatment, compared with treatment in the guidance of "conventional PI methods of BSS", patients treated in the guidance of "Chen Ke-ji PI methods of BSS" had more decrease in the maximum agglutination of platelet, the blood viscosity (1.0 s-1)、 the blood viscosity (5.0 s-1) and the blood viscosity (120.0s-1)Experimental group showed better effects on the improvement of BBS and angina pectoris.2. Cross-sectional study on international Blood-stasis syndromeThe most frequent item in two criterias was purple dark tongue and sublingual vein varicose. And we have this in domestic clinical practice identification criterias of blood stasis syndrome, that dark purple tongue, sublingual vein can be as one of the main criteria for international identification criteria of blood stasis syndrome. But the face, lips, gums and eye purple black by race can not be as part of the criteria of international blood stasis syndrome.