| Part I Study of literature on the TCM syndrome in the patients after coronary artery stent implantation based on correlation analysisObjectiveBy the search of the literature in the last 25 years about the TCM syndrome in the patients after coronary artery stent implantation,we obtain the distribution regulations of the main syndromes and establish the specific items database of each main syndrome,then draw a conclusion to the distribution regulations of the main syndromes and the evidence of syndrome differentiation base on theliterature study.MethodsBy using the method of computer retrieval of electronic database with manual inspection,we obtain all the papers published around 1990 to 2014 about the TCM syndrome and treatment in the patients after coronary artery stent implantation.Then summed up the main TCM syndromes in the patients after coronary stenting and set up the specific entry pool of each main syndrome by the statistic methods such as frequency analysis,data mining,association analysis etc.Results895 articles were selected,and a total of 193 literatures with an average compound impact factor of 0.658 were screened out.There were 6 major TCM syndromes with frequency over 5%in the patients after coronary stenting that namedThe research results show that the main card heartache over 5%type chest pain after in 6,respectively:Qi deficiency and Blood stasis syndrome(26.68%),deficiency of both Qi and Yin syndrome(15.62%),Phlegm and Blood stasis syndrome(13.67%),Qi stagnation and Blood stasis syndrome(13.23%),Heat toxin and Blood stasis syndrome(8.46%),Yang Deficiency and Blood Stasis syndrome(5.21%).All entries of each syndrome were analyzed by frequency which were set as 1%in minimum support and 20%in minimum confidence,and rank with frequency from high to low:1.Qi deficiency and Blood stasis syndrome with 12 items(fatigue>Sublingual varices、black/die blausucht>sluggish pulse>oppression and pain in chest>pale tongue>pale white complexion>weak voice>thready pulse>obesity>spontaneous sweating>poor appetite>white fur)2.deficiency of both Qi and Yin syndrome with 15 items(fatigue>oppression and pain in chest>thready pulse>night sweat>red tongue>fissured tongue>flushed face>pale tongue>running pulse>tachypnea>dizziness>nodus>intermittent pulse)3.Phlegm and Blood stasis syndrome with 20 items(slippery pulse>glossy coating>the tongue with teeth marks>oppression and pain in chest>white fur>obesity>poor appetite>thin phlegm/heavy phlegm>Sublingual varices、black/die blausucht>thick fur>yellow fur>pale tongue>sleepless>thready pulse>white phlegm>dizziness>fatigue>thin fur>yellow phlegm>thick sputum)4.Qi stagnation and Blood stasis syndrome with 16 items(Sublingual varices、black/die blausucht>oppression and pain in chest>sluggish pulse>wiry pulse>poor appetite>dim complexion>palpitation>thready pulse>dry and bitter mouth>insomnia>yellow fur>pale tongue>squamous and dry skin>irritability)thin fur)5.Heat toxin and Blood stasis syndrome with 23 items(Sublingual varices、black/die blausucht>red tongue>oppression and pain in chest>irritability>rapid pulse>reddish complexion>yellow fur>loud voice)fear of heat>tachypnea>yellow urine>dry stool>thick fur>halitosis)glossy coating>excess pulse>thick sputum>yellow phlegm>slippery pulse>dry and bitter mouth>thin fur>surging pulse>insomnia)6.Yang deficiency and Blood stasis syndrome with 24 items(poor appetite>pale white complexion>dim complexion>fear of cold>Sublingual varices、black/die blausucht)white phlegm>sluggish pulse>clear urine>white fur>oppression and pain in chest>deep pulse>glossy coating>slippery pulse>cold limbs>fatigue>clear stool>pale tongue>tachypnea>slow pulse>frequent urination at night>thin fur>thick sputum>nodus>intermittent pulse)ConclusionThe major TCM syndromes in the patients after coronary artery stent implantation were the following six that Qi deficiency and Blood stasis syndrome,deficiency of both Qi and Yin syndrome,Phlegm and Blood stasis syndrome,Qi stagnation and Blood stasis syndrome,Heat toxin and Blood stasis syndrome,Yang deficiency and Blood stasis syndrome.All of above syndromes were obtained with entry database of syndrome differentiation.Part Ⅱ The establishment of differentiation standard of the major TCM syndromes in the patients after coronary artery stent implantation by Delphi methodObjectiveBased on the results of literature research,through the questionnaire survey on the Delphy method consulting experts,summed up the consensus of the importance of evaluation about the major TCM syndromes in the patients after coronary artery stent implantation,and the formation of diagnostic model of each major syndrome.MethodBased on the results of the first part of the literature research,the research group make the expert consultation questionnaire with the combination of the relevant guidelines for the diagnosis and treatment of Chinese medicine diagnosis textbook.With the investigation of experts from 3 armour hospital of TCM in China by the Delphy method,and with the statistic means of Arithmetic mean,full marks rate,rank sum,coefficient of variation,coefficient of coordination,the research group summed up the consensus of the importance of evaluation about the major TCM syndromes in the patients after coronary artery stent implantation,and the formation of diagnostic model of each major syndrome.Finally,the weighting method is used to weight the diagnostic items,and the syndrome differentiation criteria of each main syndrome diagnosis model are formed according to the weight.Result23 experts selected and a total of 2 rounds of Delphi expert questionnaire were finished with authority coefficient greater than 0.8 and positive coefficient at 100%.The coordination coefficients of the two rounds respectively at each syndrome were:Qi deficiency and Blood stasis 0.240,0.289;Qi and Yin deficiency 0.557,0.404;Phlegm and Blood stasis syndrome0.417,0.409;Qi stagnation and Blood stasis0.721,0.211;Hheat toxin and Blood stasis0.418,0.230;Yang deficiency and Blood stasis 0.623,0.270.According to the survey results,experts believe that:1.There are also 6 major TCM syndromes in the patients after coronary artery stenting that:Qi deficiency and Blood stasis;Qi and Yin deficiency;Phlegm and Blood stasis syndrome;Qi stagnation and Blood stasis;Hheat toxin and Blood stasis;Yang deficiency and Blood stasis.2.The syndromes distribution preoperative ranked by percentage from large to small were:phlegm and blood stasis(25.47%),qi stagnation and blood stasis(20.91%),heat toxin and blood stasis(17.18),Yang deficiency and blood stasis(15.32%),Qi deficiency and blood stasis syndrome(14.49%),two of Qi and yin deficiency syndrome(6.63%);3.The syndromes distribution one weeks after operation ranked by percentage from large to small were:phlegm and blood stasis(21.85%),qi stagnation and blood stasis(18.43%),Qi deficiency and blood stasis(17.81%),heat toxin and blood stasis(16.77%),Yang deficiency and blood stasis(14.70%),two of Qi and yin deficiency syndrome(10.35%);4.The syndromes distribution three months after operation ranked by percentage from large to small were:Qi deficiency and blood stasis syndrome(24.22%),qi stagnation and blood stasis syndrome(15.73%),two of Qi and yin deficiency(15.32%),phlegm and blood stasis(15.32%),heat toxin and blood stasis(14.70%),yang deficiency and blood stasis(14.70%);5.All of this 6 main syndromes were composed by two accompanied symptoms respectively means that each diagnose of the major syndromes should contain two sub diagnoses which the diagnostic rules as follows:one of the main symptoms with three of secondary symptoms,or two of main symptoms with one of secondary symptoms,or the top one of main symptoms with one of secondary symptoms(PS:with only one symptom"Sublingual varices、black/die blausucht" can make the diagnose of Blood stasis syndrome).The main symptoms and secondary symptoms ofeach major syndromes were list as follows with weights:① The Qi deficiency and Blood stasis syndrome:main symptoms of Qi deficiency(fatigue9,pale tongue8,weak voice8),secondary symptoms of Qi deficiency(pale white complexion8,sluggish pulse8;spontaneous sweating8,obesity7,the tongue with teeth marks7,white fur7,poor appetite7),main symptoms of Blood stasis(Sublingual varices、black/die blausucht8,thready pulse7),secondary symptoms of Blood stasis(oppression and pain in chest7);② deficiency of both Qi and Yin syndrome:main symptoms of Qi deficiency(fatigue10,thready pulse9),secondary symptoms of Qi deficiency(pale tongue9,dizziness9,oppression and pain in chest8),main symptoms of Yin deficiency(flushed facell,red tongue10),secondary symptoms of Yin deficiency(scanty fur10,night sweat10,fissured tongue9);③ Phlegm and Blood stasis syndrome:main symptoms of Phlegm stasis(slippery pulse7,the tongue with teeth marks7,thick fur,6,glossy coating6),secondary symptoms of Phlegm stasis(yellow fur 6,dizziness 6,obesity 6,yellow phlegm 6,somnolence6,poor appetite5,fatigue5,white phlegm5,white furs,thick sputum5,thin phlegm/heavy phlegm5),main symptoms of Blood stasis(Sublingual varices、black/die blausucht7),secondary symptoms of Blood stasis(oppression and pain in chest6);④ Qi stagnation and Blood stasis syndrome:main symptoms of Qi stagnation(sighing and belching frequently13,wiry pulsel5),secondary symptoms of Qi stagnation(dim complexion14,irritabilityl2),main symptoms of Blood stasis(Sublingual varices、black/die blausuchtl6,oppression and pain in chest15),secondary symptoms of Blood stasis(sluggish pulsel5,squamous and dry skin13);⑤ Heat toxin and Blood stasis syndrome:main symptoms of Heat t oxin(red tongue6,irritability5,dry and bitter mouth5,reddish comp lexion5,yellow urine5),secondary symptoms of(dry stool5,fear of heat5,yellow phlegm5,thick sputum5,rapid pulse5,yellow fur5,thi ck fur5,surging pulse5,excess pulse5,loud voice5,halitosis4,insom nia4,slippery pulse4),main symptoms of Blood stasis(Sublingual var ices、black/die blausucht5),secondary symptoms of Blood stasis(oppre ssion and pain in chest5)⑥ Yang deficiency and Blood stasis syndrome:main symptoms of Yang deficiency(thready pulse6,fear of cold6,cold limbs6),secondary symptoms of Yang deficiency(slow pulse6,pale white complexion6,clear urine6,deep pulse5,white fur5,frequent urination at night5,clear stool5,white phlegm5,thin fur5,fatigue5,pale tongue5),main symptoms of Blood stasis(Sublingual varices、black/die blausucht6),secondary symptoms of Blood stasis(oppression and pain in chest6,sluggish pulse 5,dim complexions).Conclusion1.There were 6 major TCM syndrome in the patients after coronary stenting summed up by expert questionnaire based on Delphi method,which list from hight frequency to low at the period of pre-operation were:Phlegm and Blood stasis syndrome>Qi stagnation and Blood stasis syndrome>Heat toxin and Blood stasis syndrome>Yang deficiency and Blood stasis syndrome>Qi deficiency and Blood stasis syndrome>deficiency of both Qi and Yin syndrome;At the period of one week after operation were:Phlegm and Blood stasis syndrome>Qi stagnation and Blood stasis syndrome>Qi deficiency and Blood stasis syndrome>Heat toxin and Blood stasis syndrome>Yang deficiency and Blood stasis syndrome>deficiency of both Qi and Yin syndrome;At the period of three months after operation were:Qi deficiency and Blood stasis syndrome>Qi stagnation and Blood stasis syndrome>Phlegm and Blood stasis syndrome>deficiency of both Qi and Yin syndrome;>Heat toxin and Blood stasis syndrome>Yang deficiency and Blood stasis syndrome.2.Establish the diagnostic model of each major syndrome of TCM in the patients after coronary artery stenting preliminarily.Part Ⅲ The clinical study of Diagnosis standard of major TCM syndromes in the patients after coronary stentingObjectiveThrough clinical diagnostic tests,we were going to validate the diagnostic models of the major TCM syndromes in the patients after coronary stenting and evaluate the clinical value.We would figure out the diagnostic threshold of the diagnosis model and try to establish the dialectical classification of the severity of the disease.MethodsA prospective epidemiological survey was conducted to collect data from the patients after coronary stenting of multi centers and to establish the database using Epidata3.1.The collected data of clinical diagnostic tests were analyzed by using statistical methods of combination by sensitivity,specificity,positive and negative likelihood ratio,accuracy and ROC curve,to verify diagnosis accuracy of the model,to evaluate the clinical value.At the same time the threshold classification would be work out based on the theory of the Youden index calculation model.And we try to establish the dialectical classification of the severity of the disease by the method of percentiles.Result1.The clinical diagnostic test results of each diagnostic model:① Qi deficiency and Blood stasis syndrome:The sensitivity(71.15%),specificity(97.12%),positive likelihood ratio(24.74),negative likelihood ratio(0.30),accuracy(92.27%);② deficiency of both Qi and Yin syndrome:Sensitivity and specif icity(62.75%),specificity(97.62%),positive likelihood ratio(26.41),negative likelihood ratio(0.38),accuracy(94.42%)③ Phlegm and Blood stasis syndrome:The sensitivity(76.27%),specificity(92.47%),positive likelihood ratio(10.12),negative likelihood ratio(0.26),accuracy(89.03%);④ Qi stagnation and Blood stasis syndrome:The sensitivity(67.29%),specificity(95.10%),positive likelihood ratio(13.72),negativ e likelihood ratio(0.34),accuracy(89.75%);⑤ The heat toxin and blood stasis:sensitivity(80%)and specificity(95.01%),positive likelihood ratio(16.03),negative likelihood ratio(0.21)and accuracy(92.45%);⑥ The Yang deficiency and blood stasis:sensitivity(72.09%)and specificity(95.32%),positive likelihood ratio(15.41),negative likelihood ratio(0.29)and accuracy(93.53%).2.The results of research based on the statistical analysis of symptom score ROC curve diagnosis threshold were:the ROC curve area of phlegm and blood stasis,qi stagnation and blood stasis,Qi deficiency and blood stasis,heat toxin and blood stasis,yin deficiency,Yang deficiency and blood stasis were 0.873,0.822,0.904,0.837,0.835,0.888;the optimal cutoff value respectively:53.50,50.50,32.50,43.50,37.50,42.50,with the sensitivity of 77.1%,67.3%,80.8%,80.9%,66.7%and 69.8%respectively,and the specificity of 86.5%,83.5%,86.9%,74%,86.3%,90.4%respectively.3.Determine the level of differentiation of each syndromes and the severity of the disease base on the items’ scores according to the percentile method respectively:① The Qi deficiency and Blood stasis syndrome:mild(23～34),moderate(34～48),severe(more than 48);② The Qi and Yin deficiency syndrome:mild(18～30),moderate(30～54),severe(more than 54);③ The Phlegm and Blood stasis syndrome:mild(35～55),moderate(55～69),severe(more than 69);④ The Qi stagnation and Blood stasis syndrome:mild(29～58),moderate(58～69),severe(more than 69);⑤ The Toxic heat and Blood stasis syndrome:mild(25～45),moderate(45～67),severe(more than 67);⑥ The Yang deficiency and Blood stasis syndrome:mild(27～39),moderate(39～60),severe(more than 60).Conclusion1.The clinical diagnostic tests of different syndrome types were evaluated:① Qi deficiency and Blood stasis syndrome:it is good to figure out the Qi deficiency and blood stasis syndrome and eliminate the non one means a good evaluation;② The deficiency of Qi and Yin:it is good to eliminate the non Qi and yin deficiency syndrome,but mediocre on figuring out the deficiency of Qi and Yin syndrome means that it may course misdiagnosis,the evaluation is above the average;③ The Phlegm turbidity and Blood stasis syndrome:it is good to figure out phlegm turbidity and blood stasis syndrome and eliminate the non one means a good evaluation;④ The Qi stagnation and blood stasis syndrome:it is easy to exclude the non stagnation syndrome of Qi and blood stasis,but mediocre on figuring out the Qi stagnation and Blood stasis syndrome means that it may course misdiagnosis,the evaluation is above the average;⑤ The Heat toxin and blood stasis syndrome:it is good to figure out the Heat toxin and blood stasis syndrome and eliminate the non one means a good evaluation;⑥ The Yang deficiency and Blood stasis syndrome:it is good to figure out the Yang deficiency and Blood stasis syndrome and eliminate the non one means a good evaluation;2.The ROC curve analysis showed that the diagnosis model has good diagnostic significance,and the best diagnostic threshold of each syndrome was determined by the Youden index on the rank scores of symptom items.3.The severity of each type of syndrome were evaluated according to the percentile method based on the symptom scores.Part IV the study of regularities of distribution of major TCM syndromes in the patients after Coronary artery stentingObjectiveA large amount of clinical cases from multicenter were investigated base on the validated diagnostic model.A conclusion would be drawn on the constituent ratio and the transfer matrix of the major syndromesin the patients after coronary artery stenting among the periods of pre-operation,one week after operation and three months after operation including the subgroups of ACS and the non-TCM-intervention.And the regularities of distribution and transition of major TCM syndromes in the patients after Coronary artery stenting would be figured out.MethodThe first step,a database would be build to record the massage of patients after coronary stenting from multicenter among the periods of pre-operation,one week after operation and three months after operation;the second step,all cases would be differentiated in syndromes base on the the validated diagnostic model;the third step,analyze the regularities of distribution and transition of major TCM syndromes in the patients;the forth step,describe the regularities among the three periods base on the results above;the fifth step,figure out the transfer ratio between the syndromes and form the transfer matrix and draw out the illustration about the regularities.Result1.The distribution of syndrome types in the 3 time nodes is as follows:① the Phlegm and Blood stasis syndrome:all samples(24.48%、21.20%、16.51%);ACS-subgroup(21.64%、21.60%、17.95%);non-TCM-intervention-subgroup(27.11%、23.53%、18.18%);② the Qi stagnation and Blood stasis syndrome:all samples(21.90%、19.20%、19.77%);ACS-subgroup(20.90%、24.80%、21.37%);non-TCM-intervention-subgroup(18.64%、21.57%、20.45%);③ the Heat toxin and Blood stasis syndrome:all samples(19.83%、17.10%、7.68%);ACS-subgroup(34.33%、32.00%、17.09%);non-TCM-intervention-subgroup(23.73%、17.65%、11.36%);④ the Qi deficiency and Blood stasis syndrome:all samples(14.83%、18.70%、27.06%);ACS-subgroup(8.96%、8.80%、22.22%);non-TCM-intervention-subgroup(11.86%、17.65%、20.45%);⑤ the Qi and Yin deficiency syndrome:all samples(7.41%、9.71%、14.78%);ACS-subgroup(4.48%、4.80%、7.69%);non-TCM-intervention-subgroup(8.47%、5.88%、11.36%);⑥ the Yang deficiency and Blood stasis syndrome:all samples(5.34%、7.73%、12.09%);ACS-subgroup(2.99%、4.00%、8.55%);non-TCM-intervention-subgroup(6.78%、7.84%、11.36%);⑦ the Others syndrome:all samples(6.21%、6.83%、2.11%);ACS-subgroup(6.72%、4.00%、3.42%);non-TCM-intervention-subgroup(3.39%、5.88%、6.82%);⑧ The clinical survey results of literature research and expert survey showed that:in the preoperative distribution,lower probability of Yang deficiency and Blood stasis syndrome,and higher probability of Heat toxin and Blood stasis syndrome;in the distribution one week after surgery the Yang deficiency and Blood stasis syndrome got a lower probability;the distribution 3 months postoperative show that the Qi deficiency and Blood stasis syndrome,the Qi stagnation and Blood stasis syndrome and the Phlegm and Blood stasis syndrome got higher probability as well as the Yang deficiency and Blood stasis syndrome and the Heat toxin and Blood stasis syndrome got a lower probability.2.The transfer probability of each type of syndromes as follows:① All samples:from pre-operation to one week post-operation,the transfer ratio which was higher than 15%named the Yang deficiency and blood stasis syndrome to the Qi deficiency and blood stasis syndrome(22.58%),and most of the rest were kept the original diagnosis;from one week post-operation to three months post-operation the transfer ratio which were higher than 15%list as:the Phlegm and Blood stasis syndrome to the Qi deficiency and Blood stasis syndrome(21.10%),the Qi stagnation and Blood stasis syndrome to the Qi deficiency and Blood stasis syndrome(19.80%),the Heat toxin and Blood stasis syndrome to the Qi deficiency and Blood stasis syndrome(18.18%),the Heat toxin and Blood stasis syndrome to Qi stagnation and Blood stasis syndrome(26.14%),most of the rest were maintain the original diagnosis(the lowest was the Heat toxin and Blood stasis syndrome which was 21.59%).② The ACS subgroup:the highest transfer ratio from pre-operation to one week post-operation were the Yang deficiency and blood stasis syndrome to the Qi and Yin deficiency syndrome and the Qi stagnation and Blood stasis syndrome;the highest transfer ratio from one week post-operation to three months post-operation was the Qi and Yin deficiency syndrome to the Yang deficiency and blood stasis syndrome.③ The non-TCM-intervention-subgroup:the highest transfer ratio from pre-operation to one week post-operation was the Yang deficiency and blood stasis syndrome to the Qi deficiency and Blood stasis syndrome;the highest transfer ratio from one week post-operation to three months post-operation was the Qi and Yin deficiency syndrome to the Yang deficiency and blood stasis syndrome.Conclusion:1.The distribution of syndrome type in clinical investigation is consistent with the literature research and expert questionnaire survey,yet there are some differences which means that the deduction on the regulation of TCM syndromes in the patients after coronary stenting base on the research of TCM syndrome in coronary heart disease was significative,and the regulation of TCM syndromes in the patients after coronary stenting got its own characteristics.2.The comparison between the clinical experience and paper research with expert questionnaire survey show that:more patients more likely to get the Heat toxin and Blood stasis syndrome but the Yang deficiency and blood stasis syndrome pre-operation;the Yang deficiency and blood stasis syndrome appear to be lower ratio one week post-operation;the Qi deficiency and Blood stasis syndrome,the Qi stagnation and Blood stasis syndrome and the Phlegm and Blood stasis syndrome got higher ratio but the Yang deficiency and blood stasis syndrome and the Heat toxin and Blood stasis syndrome got lower ratio three months post-operation;3.Most of the syndromes in the patients after coronary stenting stayed and the others would like to transfer from sthenia syndromes to syndrome of intermingled deficiency and excess or deficiency syndrome;4,The regulations of syndromes from the patients in ACS subgroup gottwo characteristics compare to the all samples which were:①they had similar transfer tendency;②the Heat toxin and Blood stasis syndrome got a great higher ratio in ACS subgroup;5.The regulation of syndrome distribution of the non-TCM-intervention-subgroup was stayed the same with all samples around pre-operation,but kept more syndromes post-operation with some transferation from sthenia syndromes to deficiency syndrome.But the strength of evidence on the ACS subgroup and the non-TCM-intervention-subgroup were third-class since the amount of cases was not that enough. |
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