Coronary Heart Disease Stable Angina Pectoris (qi Deficiency Blood Stasis Syndrome) Clinical Research

Purpose: Aiming at observing the efficacy of Chixiangshen granule on thepatients with stable angina pectoris syndrome (Qi deficiency and blood stasissyndrome) and conducting a standardized clinical study on the treatment of stableangina pectoris by means of supplementing Qi and activating blood circulationmethod, this thesis intends to propose a practical and valuable treatment methodfor clinical study through demonstrating the TCM therapy of coronary heartdisease with stable angina pectoris (Qi deficiency and blood stasis syndrome).Meanwhile, statistical method is used to test relevant indices in an effort toassess efficacy and TCM symptom improvement of TCM on stable angina pectorisand to confirm the effectiveness and safety of the assessment indices of theefficacies as well as to provide a objective basis for studying the assessmentindices of TCM clinical pharmacodynamics．Material and method: Totally, there are60cases used in this thesis, ofwhich24cases were acquired from1stAffiliated Hospital to Tianjin Universityof Chinese Traditional Medicine,24cases were acquired from the AffiliatedHospital to Changchun University of Chinese Traditional Medicine and12caseswere acquired from Dalian Integrated Hospital of Chinese Traditional and WesternMedicine from May,2011to July,2011.According to the random number table, the random number is classified intotreatment group and control group based on the ratio of1/1with30cases foreach group. Randomized controlled trial is applied to the qualified subjectsto conduct the prospective randomized controlled clinical study. Standardizedtreatment of western medicine is applied to the control group. On the basis ofstandardized treatment of western medicine, the herbal decoction, Chixiangshengranule, is additionally is used for the treatment group, including red peonyroot (10g), eaglewood (1g), angelica sinensis (10g), orange peel (10g), rhizomacorydalis (6g), rhizomaligusticichuanxiong (6g), lanceolata (10g), astragalus (6g), peach kernel (10g) and safflower (10g), of which at least6kinds ofmedicine shall be orally used twice per day with100ml. This thesis conduct atwo-month observation to observe the classification of the severity of anginapectoris, cardiac function classification, discontinue rate of nitroglycerin,TCM symptom, electrocardiogram and blood lipid change before and after treatmentof the two groups and to assess the efficacy as well as to monitor the indicesof adverse reaction on a regular basis.Results:1Before treatment, cases of the two groups have no significant differences(P>0.05) in terms of such lab efficacy indices as age, gender, course, anginapectoris grade, cardiac function classification, angina pectoris score, TCMsyndrome score and electrocardiogram, which shows the two groups are ofcomparability before treatment.2With respect to the efficacy of angina pectoris symptom of the two groups,the total effective rate of the treatment group and the control group is70%and50%, respectively. The treatment group is better than the controlgroup (P<0.05), which is of statistical significance.3With respect to the efficacy of improvement of cardiac function of the twogroups, the effective rate of the treatment group and the control group is13.3%and13.3%, respectively. There is no significant differences betweenthe two groups (P>0.05), which is of no statistical significance.4With respect to the efficacy of improvement of discontinue rate ofnitroglycerin of the two groups, the discontinue rate of the treatment groupand the control group is50%and23.3%, respectively. The treatment groupis better than the control group (P<0.05), which is of statisticalsignificance.5The differences between the patients of the two groups before and after havingthe medicine in terms of TCM syndrome are all of no statistical significance(P>0.05). The differences between the patients of the two groups after treatment are all of no significant differences and of no statisticalsignificance (P>0.05).6With respect to the overall efficacy of TCM syndrome of the two groups, thetotal effective rate of the treatment group and the control group is53.3%and40.0%, respectively. There is no significant differences between the twogroups (P>0.05), which is of no statistical significance.7With respect to the efficacy of electrocardiogram of the two groups, the totaleffective rate of the treatment group and the control group is65.2%and50.0%,respectively. There is no significant differences between the two groups(P>0.05), which is of no statistical significance.8With respect to the blood-lipid change of the two groups, the differenceswithin the group and between the two groups before and after having themedicine are all of no significant differences in terms of indices of TC,TG, LDL-C (P>0.05), which is of no statistical significance.9There is no obvious or severe toxic side effects occurred to the patientsof two groups. Safety and tolerance of the patients of the two groups appearedquite well.Conclusion:1TCM supplementing Qi and activating blood circulation can effectively improvethe severity of the angina pectoris of the patients of coronary heart diseasewith stable angina pectoris (Qi deficiency and blood stasis syndrome).2TCM supplementing Qi and activating blood circulation combining with theregular treatment of western medicine can effectively shorten the durationof the angina pectoris of the patients of coronary heart disease with stableangina pectoris (Qi deficiency and blood stasis syndrome).3TCM supplementing Qi and activating blood circulation can effectively reducethe amount of nitroglycerin used by the patients of coronary heart diseasewith stable angina pectoris (Qi deficiency and blood stasis syndrome).4TCM supplementing Qi and activating blood circulation is of better safety in terms of the treatment of coronary heart disease with stable anginapectoris.