Evaluation On The Curative Effect Of Syndrome Differentiation Of Heart - Brain Healing Syndrome And The Treatment Of Cardio - Brain Disease With Phlegm And Blood Stasis

Purpose：Based on clinical epidemiological investigation, to explore thesyndrome distribution regularity of Cardiovascular and Cerebrovascular DiseaseCombined, and to evaluate the clinical efficacy of Hexuetongmai Granulestreating phlegm-stasis syndrome of Cardiovascular and Cerebrovascular DiseaseCombined.Material and method：Study Ⅰ: A cross-sectional survey study,2947caseswere collected in11tertiary hospitals, which included Cardiovascular andCerebrovascular Disease Combined (angina pectoris combined atherothromboticcerebral infarction) group in982cases, Cardiovascular Disease (angina pectoris)group in1002cases and Cerebrovascular Disease (atherothrombotic cerebralinfarction) group in963cases. We collected general information, medicalhistory, four diagnostic information in cases conforming to inclusion criteriaand established the corresponding database. Respectively, we performedstatistical analyses of TCM syndromes, deficiency or excess syndromes,syndrome elements and distribution of the four diagnostic information of3groupsand studied the syndrome distribution regularity of Cardiovascular andCerebrovascular Disease Combined contrasted with Cardiovascular Disease groupand Cerebrovascular Disease group.Study Ⅱ: Randomized, double-blind trial design, phlegm-stasis syndrome ofCardiovascular and Cerebrovascular Disease Combined in383cases wassimultaneously collected in7sub-centers of Liaoning Province, in whichincluded experimental group in191cases and control group in192cases. Patientsin experimental group were treated by Hexuetongmai Granules combined basictreatment of Western medicine, while ones in control group were the placebocombined basic treatment of Western medicine. Course of treatment in experimental group and control one were both8weeks. Through scoring TCMsyndrome integral table, the U.S. National Institutes of Health Stroke Scale(NIHSS) and Angina pectoris integral table in various time points, to evaluatethe clinical efficacy of Hexuetongmai Granules treating Phlegm-stasis syndromeof Cardiovascular and Cerebrovascular Disease Combined.Results：1. Study Ⅰ contained a total of2947cases, which included Cardiovascular andCerebrovascular Disease Combined group in982cases, Cardiovascular Disease(angina pectoris) group in1002cases and Cerebrovascular Disease(atherothrombotic cerebral infarction) group in963cases, and3groups showedno significant difference in the number of cases (P=0.679>0.05).Among the3groups, there was of a great significant difference in gender, age, hypertension,diabetes, smoking, alcohol consumption, improper diet, oldness and sickness andinvasion seasons (P<0.01), whereas there was no significant difference indyslipidemia, obesity and six exogenous pathogens (P>0.05).2. Distribution of TCM syndromes in Study Ⅰ: Constitution ratio greater than5%of TCM syndromes in Cardiovascular and Cerebrovascular Disease Combined groupwas, in order, phlegm-stasis syndrome, wind-phlegm syndrome, qi-deficiency andblood-stasis syndrome and qi-yin deficiency syndrome. In CerebrovascularDisease group was, in order, wind-phlegm syndrome, phlegm-stasis syndrome andqi-deficiency and blood-stasis syndrome, while in Cardiovascular Disease groupwas qi-deficiency and blood-stasis syndrome, qi-yin deficiency syndrome,phlegm-stasis syndrome and blood-stasis syndrome. The constitution ratio ofphlegm-stasis syndrome and qi-deficiency and blood-stasis syndrome in3groupswas greater than5%.3. Distribution of deficiency or excess syndromes in Study Ⅰ: In3groups, thenumbers of excess syndrome were more than ones of syndrome of intermingleddeficiency and excess, deficiency syndrome was least. The constitution ratioof excess syndrome: Cerebrovascular Disease group was greater than Cardiovascular and Cerebrovascular Disease Combined group, CardiovascularDisease group was least. The constitution ratio of syndrome of intermingleddeficiency and excess: Cardiovascular and Cerebrovascular Disease Combinedgroup was greater than Cardiovascular Disease group, Cerebrovascular Diseasegroup was least. The constitution ratio of deficiency syndrome: CardiovascularDisease group was greater than Cardiovascular and Cerebrovascular DiseaseCombined group,Cerebrovascular Disease group was least(P﹤0.01). Excess syndrome ofCardiovascular and Cerebrovascular Disease Combined group and CardiovascularDisease group was negatively associated with age, whereas deficiency syndromewas positively correlated with age(P﹤0.01). In excess syndrome: phlegm-stasissyndrome was the most common one in Cardiovascular and Cerebrovascular DiseaseCombined group, followed by wind-phlegm syndrome, both of which accounted for50.81%. Wind-phlegm syndrome was the most common one in Cerebrovascular Diseasegroup, followed by phlegm-stasis syndrome, both of which accounted for65.80%.Phlegm-stasis syndrome was the most common one in Cardiovascular Disease group,followed by blood-stasis syndrome and phlegm syndrome, all of which accountedfor79.03%. In deficiency syndrome: qi-yin deficiency syndrome was the mostcommon one in Cardiovascular and Cerebrovascular Disease Combined group,followed by syndrome of yin deficiency of liver and kidney, both of whichaccounted for69.48%. Syndrome of yin deficiency of liver and kidney was themost common one in Cerebrovascular Disease group, which accounted for52.17%.Qi-yin deficiency syndrome was the most common one in Cardiovascular Diseasegroup, which accounted for61.80%. In syndrome of intermingled deficiency andexcess: qi-deficiency and blood-stasis syndrome was the most common one inCardiovascular and Cerebrovascular Disease Combined group, which accounted for22.19%compared with other syndromes accounted for less than10%. Qi-deficiencyand blood-stasis syndrome was the most common one in Cerebrovascular Diseasegroup, followed by phlegm-stasis syndrome and yin-deficiency andyang-predominance syndrome, all of which accounted for56.49%. Qi-deficiency and blood-stasis syndrome was the most common one in Cardiovascular Disease group,which accounted for51.24%.4. Distribution of syndrome elements in Study Ⅰ: in Cardiovascular andCerebrovascular Disease Combined group, single syndrome elements whosefrequency were greater than10%were, in order, phlegm, blood stasis, yin-deficiency, qi-deficiency, wind and yang-predominance, the first four of whichwere greater than10%in the other two groups. Double syndrome elements whosefrequency were greater than10%were, in order, phlegm-stasis, wind-phlegm,qi-yin deficiency, qi-deficiency and blood-stasis and yin-deficiency andblood-stasis, while phlegm-stasis and qi-deficiency and blood-stasis weregreater than10%in the other two groups. Phlegm syndrome element in3groupswas more common in male (P<0.01), and stasis syndrome element in CardiovascularDisease group was also more common in male (P<0.01). Qi-deficiency syndromeelement in Cardiovascular and Cerebrovascular Disease Combined group andCardiovascular Disease group was more common in female (P<0.01), andyin-deficiency syndrome element in Cardiovascular and Cerebrovascular DiseaseCombined group was also more common in female (P<0.01), while the other syndromeelements within the gender composition of each group were no significantdifference (P>0.05). With age increasing, in Cardiovascular and CerebrovascularDisease Combined group phlegm and wind syndrome element significantly decreased(P<0.01), while yin-deficiency and qi-deficiency syndrome element slightlyincreased(P＞0.05),and stasis and yang-predominance syndrome element had noconsistency upward or downward trend. In Cardiovascular Disease group stasisand qi-stagnation syndrome element significantly decreased (P<0.01), whileyin-deficiency and qi-deficiency syndrome element significantly increased(P<0.01). In Cerebrovascular Disease group wind syndrome element significantlydecreased (P<0.01), while stasis syndrome element significantly increased(P<0.01). The frequency of phlegm syndrome element for all ages in Cardiovascularand Cerebrovascular Disease Combined group and Cerebrovascular Disease groupwas significantly higher than the one in Cardiovascular Disease group. Although the frequency of phlegm syndrome element in Cardiovascular and CerebrovascularDisease Combined group and Cerebrovascular Disease group decreased with ageincreasing, it decreased more significantly in Cardiovascular andCerebrovascular Disease Combined group. The frequency of yin-deficiencysyndrome element for all ages in Cardiovascular and Cerebrovascular DiseaseCombined group and Cardiovascular Disease group was significantly higher thanthe one in Cerebrovascular Disease group. Although the frequency of stasissyndrome element in Cardiovascular and Cerebrovascular Disease Combined groupand Cardiovascular Disease group increased with age increasing, it increasedmore significantly in Cardiovascular Disease group. The frequency of stasissyndrome element for all ages in Cardiovascular Disease group was higher thanthe one in Cerebrovascular Disease group, and the one in Cardiovascular andCerebrovascular Disease Combined group was least. The frequency of qi-deficiency syndrome element for all ages in Cardiovascular Disease group washigher than the one in Cardiovascular and Cerebrovascular Disease Combined group,and the one in Cerebrovascular Disease group was least. The frequency of phlegmsyndrome element in Cardiovascular and Cerebrovascular Disease Combined groupwas negatively correlated with age, and the frequency of stasis syndrome elementin Cardiovascular Disease group and Cerebrovascular Disease group was negativelycorrelated with age. The frequency of qi-deficiency syndrome element inCardiovascular Disease group was positively correlated with age, and yin-deficiency syndrome element in Cardiovascular and Cerebrovascular DiseaseCombined group and Cardiovascular Disease group was positively correlated withage.5. Distribution of four diagnostic information in Study Ⅰ: more than80percentof patients in Cardiovascular and Cerebrovascular Disease Combined group showedhemiplegia, chest tightness, fatigue, dizziness, or body weight difficulties,while the frequencies of fatigue, dizziness, body weight difficulties, weary,lack of energy, purple sublingual collaterals, weakness of waist and knees andwhite fur tongue in3groups were more than50%. The frequencies of hemiplegia, chest tightness, body weight difficulties, fatigue，dizziness, weary, chest painand lack of energy in4high-frequency syndromes of Cardiovascular andCerebrovascular Disease Combined group were more than60%. In addition，patientssuffering from phlegm-stasis syndrome showed purple sublingual collaterals,tortuous sublingual collaterals, dizziness, smooth pulse, greasy fur tongue,numbness of the limbs and phlegm. Patients suffering from wind-phlegm syndromeshowed taut pulse, smooth pulse, greasy fur tongue, dizziness and white furtongue. Patients suffering from qi-deficiency and blood-stasis syndrome showedwhite fur tongue, purple sublingual collaterals, thin fur tongue, thready pulse,deep pulse and numbness of the limbs. Patients suffering from qi-yin deficiencysyndrome showed white fur tongue, weakness of waist and knees, thready pulse,lumbago, insomnia, deep pulse and thirst or abnormal drinking, the frequenciesof which were more than60%. There were7four diagnostic information, thefrequencies of which were more than50%, in phlegm-stasis syndrome of3groups,namely body weight difficulties, fatigue, purple sublingual collaterals,dizziness, greasy fur tongue, smooth pulse and taut pulse. There were9fourdiagnostic information, the frequencies of which were more than50%, inqi-deficiency and blood-stasis syndrome of3groups, namely fatigue, lack ofenergy, weary, dizziness, body weight difficulties, purple sublingualcollaterals, thin fur tongue, thready pulse and deep pulse.6. Study Ⅱ contained a total of383cases, which included experimental groupin191cases and control group in192cases. Before treatment, the patientsbetween2groups are were comparable, because they showed no significantdifference between gender, age, height, weight, body temperature, heart rate,systolic blood pressure, diastolic blood pressure, pulse, electrocardiogram,duration, TCM syndrome integral table, Angina pectoris integral table and NIHSS(P>0.05).7. Therapeutic evaluation in Study Ⅱ: The total effective rate of experimentalgroup was78.01%, while the one of control group was55.73%, higher than formerone. The2groups showed significant difference (P=0.000) between total effective rate.8. Score changes of TCM syndrome integral table in Study Ⅱ: TCM syndromes totalscores, TCM main symptoms scores and TCM minor symptoms scores decreased incontrol group and experimental group following extended therapy, and2groupsat various time points were statistically significant difference (P<0.01). Butthe changes in experimental group were more significant. TCM main symptoms scoresand TCM minor symptoms scores between the2groups showed statisticallydifference after the4-week treatment (P<0.05). TCM syndromes total scores, TCMmain symptoms scores and TCM minor symptoms scores between the2groups showedstatistically difference after the8-week treatment and on the sixth month(P<0.01). The above three indicators of decline in value has increased followingextended therapy, and the2groups after treatment at various time points showedstatistically significant difference (P<0.01). Experimental group decreasedvalues were greater than control group at various time points, and TCM syndromestotal scores decreased values between the2groups showed statisticallydifference after the2-week treatment, and the above three indicators showedstatistically significant difference after the4-week,8-week treatment and onthe sixth month (P<0.01).9. Syndrome changes of TCM syndrome integral table in Study Ⅱ: Scores of6mainsyndromes and15minor syndromes had a decreasing tendency following extendedtherapy in control group and experimental group. The2groups showed nodifference after2-week treatment, while significant difference at othertreatment points (P<0.01). Stiff tongue and sluggish speech in main syndromesshowed difference after4-week treatment, and stiff tongue and sluggish speechand numbness of the limbs showed significant difference after8-week treatmentand on the sixth month (P<0.01). Gloomy complexion and numbness of the limbs inminor syndromes showed difference after8-week treatment (P<0.05), whileexcessive phlegm, gloomy complexion and cyanotic lips showed significantdifference on the sixth month (P<0.01), and anorexia, body weight difficultiesand fatigue showed significant difference after8-week treatment and on the sixth month (P<0.01). With extended treatment time, the patients of2groups with21syndromes declining scores had a increasing tendency, but the changes inexperimental group were more significant. Sticky and greasy in mouth, abdominaldistension, numbness of the limbs, excessive phlegm, anorexia, choking sensationin chest, hemiplegia, deviation of the eye and mouth, body weight difficulties,fatigue, headache and gloomy complexion showed significant difference after8-week treatment and on the sixth month (P<0.01), and the former5had differenceafter4-week treatment and the former2had difference after2-week treatment(P<0.01). In addition, stiff tongue and sluggish speech had significantdifference after8-week treatment, and cyanotic lips had significant differenceon the sixth month (P<0.01).10. Score changes of angina pectoris integral table in Study Ⅱ: Scores of anginapectoris integral table decreased in control group and experimental groupfollowing extended therapy, but declining scores increased. Scores of anginapectoris integral table and declining scores showed significant difference after2-week,4-week and8-week treatment (P<0.01). Scores of angina pectoris integraltable of experimental group decreased more significantly than ones of controlgroup and showed significant difference after8-week treatment (P<0.01).Declining scores of experimental group were more than ones of control group andshowed significant difference after2-week,4-week and8-week treatment(P<0.01).11. Sub-table changes of angina pectoris integral table in Study Ⅱ: Attackfrequency, duration, pain degree of angina pectoris and scores of pain relievedby nitroglycerin had a decreasing tendency following extended therapy in2groupsand showed significant difference after4-week and8-week treatment (P<0.01).Pain degree of angina pectoris and scores of pain relieved by nitroglycerinshowed difference after8-week treatment (P<0.05).12. Score changes of NIHSS in Study Ⅱ: Scores of NIHSS decreased followingextended therapy in2groups, but declining scores increased. Scores of NIHSSand declining scores showed significant difference at any time (P<0.01). Scores of NIHSS of experimental group decreased more significantly than ones of controlgroup, and showed significant difference after4-week and8-week treatment andon the sixth month (P<0.01). Declining scores of experimental group were morethan ones of control group after2-week,4-week and8-week treatment and on thesixth month, and showed significant difference at any time (P<0.01).Conclusion：1.Excess syndrome and syndrome of intermingled deficiency were more commonin Cardiovascular and Cerebrovascular Disease Combined and phlegm-stasis syndrome, wind-phlegm syndrome, qi-deficiency and blood-stasis syndrome and qi-yin deficiency syndrome were common syndromes.2.Phlegm, stasis, deficiency syndrome elements occupied important positionsand were connected with gender and age.3.Hemiplegia, chest tightness, body weight difficulties, fatigue，dizziness, weary, chest pain and lack of energy were main symptoms of Cardiovascular and Cerebrovascular Disease Combined.4.Cardiovascular and Cerebrovascular Disease Combined can be treated basedon phlegm, stasis, deficiency (qi-deficiency and yin-deficiency).5.Hexuetongmai Granules treating phlegm-stasis syndrome of Cardiovascular and Cerebrovascular Disease Combined was effective.6. Especially in improving TCM syndromes, relieving the symptoms of anginapectoris and improving nerve functional defect.7.Hexuetongmai Granules and Western medicine combined therapy on phlegm-stasis syndrome of Cardiovascular and Cerebrovascular Disease Combined at6months still have some continuity, that is worthy of clinical application.