| Unstable angina pectoris (UAP), as the important type of coronary heart disease (CHD), is a serious condition which threats people's health and life. Nowadays, percutaneous coronary intervention (PCI) has become one of the most important therapeutical method and been widely used in the treatment of UAP. However, as a invasive treatment, it can not only open the lesion coronary arteries, but also bring about much influence on the TCM syndromes which determines the choosing of the TCM treatment methods in patients after PCI. Therefore, how to grasp the syndrome characteristics and evolution laws during PCI and carry out TCM treatment based on "combination of disease and syndrome and formula corresponding to syndrome" are the very important approaches for the normalization of diagnosis and treatment models, and improvement of clinical effects. Based on the previous literature and epidemiological studies, our study was performed to investigate the distributive characteristics of TCM main symptoms, syndromes, and generalize the syndrome evolution laws in UAP patients before and after PCI (Pre-PCI,1-,4-,12-week after PCI). Meanwhile, basing on these results, a clinical trial evaluating clinical effects of Huoxue Huayu formula (Xuefu Zhuyu capsule) in the treatment of post-PCI UAP patients was also carried out. Both studies were aimed to provide some scientific evidence for the establishment of normal and comprehensive treatment for the patients with UAP.1.Literature studies of CHDThe study systematically generalized the TCM etiopathogenisis from ancient literatures and analyzed the research status of the TCM syndrome in patients with angina pectoris of CHD. The study also analyzed the complexity of syndrome dynamic evolution law and its research thoughts. Additionally, many basic and clinical studies of Chinese medicine application in the treatment of post-PCI patients were also comprehensively generalized. It is pointed out that some deficiencies are now existed in the research of TCM syndromes in angina pectoris of CHD and it is important for our investigators to carry out the studies which could provide the scientific and effective therapeutical methods and normalize the diagnosis-treatment standard in the treatment of CHD under the principles of clinical epidemiology and evidence based medicine (EBM), and the advanced statistical analysis.2.Study on TCM sydrome evolution laws in UAP patients during PCIFour time points (Pre-PCI,1-day after PCI,4-weeks after PCI,12-weeks after PCI) were setted as the observational points and TCM syndrome characteristics and evolutiona laws were prospectively studied in UAP patients during PCI.(1) Analysis of the TCM main symptom (signs) evolution laws in UAP patients during PCIThe deficiency and excess main TCM symptoms (signs) are usually coexisted in UAP patients during PCI and they are different in proportion and severity at different time points. One week after PCI, the frequency of excess main symptoms (signs) were quickly decreased and the scores were gradually reduced, while the frequency of deficiency main symptoms (signs) were quickly increased and the scores were gradually elevated. As the time going on, there are some specific evolution laws in deficiency and excess main symptoms (signs) in patients with UAP during PCI.(2) Analysis of TCM syndromes in patients with UAP during PCIThe methods of cluster analysis, principal component analysis and factor analysis are applied to analysis the TCM four-diagnosis information of 112 UAP patients during PCI. It is found that there are six basic TCM syndrmes existed in UAP patients during PCI, which are yang deficiency-cold stagnation-blood stasis, qi deficiency and blood stasis, qi-yin-deficiency, phlegm-blood stasis blocking, qi stagnation and blood stasis, heart and kidney yin deficiency. And among these, qi deficiency and blood stasis syndrome is the commonest one indicating that qi deficiency and blood stasis syndrome is the most important syndrome type in patients with UAP during PCI.(3) Analysis of the TCM syndrome evolution laws in patients with UAP during PCIAfter analysing of the syndrome characteristics at four different time points, we can find that the pathological characteristics of the UAP patients is deficiency-excess blocking. As the time going on, there are some specific evolution laws in deficiency and excess syndromes in patients with UAP. Of these, the qi deficiency and blood stasis syndrome is always in a high level before and after PCI. The syndromes of phlegm-blood stasis blocking, and yang deficiency-cold stagnation-blood stasis gradually decreased shortly after PCI and again incresed to a high level 12 weeks after PCI. The qi stagnation and blood stasis syndrome is always decreased during the whole process. The syndromes of qi-yin-deficiency, heart and kidney yin deficiency gradually increased 4 weeks after PCI again decreased to a low level 12 weeks after PCI. From the whole syndrome evolution law, the deficiency syndrome is gradually increased before and after PCI while the excess syndrome is gradually decreased. There is a tendency that the pure deficiency and excess syndromes will change into the deficiency-excess blocking syndrome before and after PCI.(4) Study of correlations between TCM sydrome types and blood lipids and angiography results in patients with UAPAfter analysing of the correlations between TCM sydrome types and blood lipids levels and angiography results, we can find that qi stagnation and blood stasis is common in patients of single-branch lesion; qi deficiency and blood stasis, and qi-yin-deficiency syndromes are commom in patients of double-branch lesion; while yang deficiency and cold plus blood stagnation syndrome is commom in patients of triple-branch lesion. As the coronary artery Gensini scores increasing, the TCM syndromes is in a evolution process which is from qi stagnation and blood stasis→qi deficiency and blood stasis→phlegm-blood stasis blocking→yang deficiency-cold stagnation-blood stasis. The levels of TG and LDL-C were significantly higher in patients of phlegm-blood stasis blocking and qi-yin-deficiency syndrome than those of other TCM syndromes indicating the great significance of activating blood and clearing phlegm, and supplementary of qi and yin in the treatment of UAP who were in concomitant with hyperlipidemia.3.Study of formula corresponding to syndrome in patients with UAP after PCI:A randomized, double-blinded, controlled trialWith a prospective, randomized, double-blinded, double-dummy,'placebo controlled design, the study was performed to evaluate the clinical effects of Xuefu Zhuyu capsules in the treatment of patients with UAP after PCI. Chinese medical symptoms, electrocardiography performances, blood-stasis syndrome scores, biochemical indexes, quality of life and the main adverse cardiovascular events (MACE) were applied to evaluated the clinical effects. The results indicated that Xuefu Zhuyu capsules (treatment based on "formula corresponding to syndrome") can not only improve the clinical symptoms and decrease the blood-stasis syndrome scores, but also improve the biochemical indexes, quality of life and MACE, which were better than those of Shengmai capsules (treatment not based on "formula corresponding to syndrome"). The results not only confirmed the beneficial effects of Huoxue Huayu formula (Xuefu Zhuyu capsule) on patients with post-PCI UAP patients, but also indicated the great significance of the TCM principle of "combination of disease and syndrome and formula corresponding to syndrome" in acquiring the best clinical effects of Chinese herbal formulas in TCM clinical practice.The specific features and innovative points of this study are as follows:(1)The study comprehensively applied the methods of literature researches, clinical epidemiological survey, and randomized controlld design, which makes our results more scientific and reliable. (2)The study also applied the multivariate statistical analysis in determining TCM syndrome distributive characteristics and evolution laws in UAP patients during PCI. (3)Randomized controlled study design was also applied to evaluate the effects of Huoxue Huayu formula in the treatment of post-PCI patients, which provided much scientific evidence for the establishment of normal and comprehensive TCM treatment for the patients with UAP after PCI.
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