| Objective: To evaluate the efficacy of the treatment and the effect on qualityof life by the combination of TCM and west medicine for CAD stable angina pectoriswith Qi deficiency and blood stasis.Methods:1.Subjects：Randomised block, parallel control, triple blinding and multicenterstudies trial was carried out. Reinforcing Qi activating blood granules of TCMcombining with conventional western medicine were used for CAD stable anginapectoris with Qi deficiency and blood stasis.2.Grouping method：240subjects were selected and randomly divided into testand control group at a proportion of1:1, each group have120cases.3.Interventions：On the basis of conventional western medicine (aspirin0.1Qd,atorvastatin calcium10mg Qd, sublingual nitroglycerin when necessary),subjects in test group were given Qi deficiency and blood stasis granules,controlgroups were given placebo granules of traditional Chinese medicine, SAQ wasselected as the evaluation indicator. The course of treatment is8weeks andthe3-stage quality control system was carried out.4.Evaluating：Patients’ information in SAQ were collected at the beginning、2weeks、4weeks、8weeks and follow up periods.5.Outcome measures：The differences of each dimension of SAQ, the influencing factors of the dynamicchange of each dimension of SAQ for patients in class Ⅰor Ⅱ according to CCSwere respectively recorded at the treatment course of enrollment,2weeks,4weeks and8weeks. The security and subjects’compliance were also evaluated.Theusing frequency and percentage of each Chinese herbal medicine and the medicinepairs were observed.6.Statistical methods：Descriptive statistics, independent samples t-test,Mann-Whitney U-test and chi-square test were used for data statistics. Results:111subjects in test group and110subjects in control groupcompleted the trial finally.1,The difference of each dimension of SAQ: no significant differences wereobserved among SAQ dimension of physical limitation (PL), angina stability (AS),angina frequency (AF), treatment satisfaction (TS), disease perception (DP) atthe treatment course of enrollment,2weeks,4weeks and8weeks (P＞0.05).2,The difference of each dimension of SAQ for patients in class Ⅰor Ⅱaccording to CSS in each specific treatment ponit:SAQ dimension of AF, DP ofthe test group were better than control group for patients in class Ⅱat thetreatment course of8weeks, the differences were statistically significant (P＜0.05).However,no significant differences can be observed in other SAQdimensions.3,The using frequency and percentage of each kind of traditional Chinese medicine:the top5kinds were DANGSHEN (95.02%), HUANGQI (94.12%), DANGGUI (93.21%),CHISHAO (92.31%), CHUANXIONG (90.95%) respectively.Our studies conductexploratory factor analysis in using frequency of each kind of traditional Chinesemedicine and obtain3common factors. These factors can be described ascomprehensive factor, activating factor, Qi factor.,4,The evaluation of security: there was one case in test group occur adverseevent, there was no adverse reaction, no adverse event occurred in control groupand no significant differences were observed between test and control group(P＞0.05).6, The evaluation of subjects’ compliance: the compliance was reflected by theratio of taking medicine. The ratio for test group was (97.50±3.44)%, controlgroup was (97.61±3.76)%, no significant deference was observed by t-testbetween the two groups (P＞0.05).Conclusion:1.The integrated therapeutic treatment can improve patients’ quality of lifein the aspects of physical activity,angina frequency,mental status among the CHD patients in NYHA II class.2.Patients in different condition pay various attention on the factors thatinfluence quality of life.3.Disease awareness and active concern of Coronary heart disease patients hasbeen enhanced by social development, living standards improve, improve healthconditions. |
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