| Objective1. Retrospective study:To investigate the Traditional Chinese Medicine (TCM) syndrome characteristics of patients with pre-clinical heart failure (stage B) induced by CHD, and grasp the TCM syndrome distribution and the basic pathogenesis characteristics of patients with pre-clinical heart failure (stage B) for the early prevention of heart failure induced by CHD and providing reference and basis for diagnosis and treatment.2. Prospective study:On the basis of the retrospective study, applying Yiqi Huoxue Decoction to treat the patients with pre-clinical heart failure (stage B), and observe the influence of Yiqi Huoxue Decoction for neuroendocrine factors and inflammatory cytokines, to research the effects of Yiqi Huoxue Decoction on patients’clinical symptoms and the quality of life, in order to provide certain clinical evidence for pre-clinical heart failure (stage B) induced by CHD.Methods1. Retrospective study:Based on the principles of epidemiological cross-sectional survey, the structured questionnaire was designed, including two survey ways for inpatients and outpatients. The questionnaire was completed by Chinese physicians after examination and investigation, the physical and chemical inspection part was filled in according to the results of the physical examination and auxiliary examinations. The acquisition includes the patient’s general condition, medical history, four diagnosis information of TCM, and so on. By the way to investigate different factors such as gender, age, degree of coronary artery disease in patients with pre-clinical heart failure (stage B), to analysis the correlation of TCM syndrome distribution and the factors above, preliminarily grasp the TCM syndromes rules of pre-clinical heart failure (stage B), summarize the basic pathogenesis characteristics of pre-clinical heart failure (stage B).2. Prospective study:On the basis of retrospective analysis, the clinical safety and efficacy, randomized, controlled clinical trial was carried out in patients with pre-clinical heart failure (stage B). They were randomly divided into control medicine group and treatment group.In the control group, the western medicine guidelines for the treatment of heart failure stage B was fully implemented. In the treatment group, on the basis of heart failure guidelines, Yiqi Huoxue decoction was added to apply. The changes of the two group patients with the clinical indicators were observed, from the aspects of blocking the excessive activation of neuroendocrine factors and inflammatory cytokines, preventing and delaying the influence on the development of the myocardial remodeling mechanism, the effects of Yiqi Huoxue decoction were reviewed and analyzed.Results1. Retrospective study:(1)Different age group of patients with coronary artery lesion distribution had significant difference (P=0.001), with the increase of age, the proportion of patients with coronary artery three lesions showed a trend of increase, further by the Spearman rank correlation test,P= 0.001,showed the significant correlation.(2) Heart failure in patients with stage B manifested 6 types of TCM syndromes, the deficiency syndrome included qi deficiency, Yin deficiency and Yang deficiency, the empirical syndrome included blood stasis, phlegm turbidity, and qi stagnation. Qi deficiency syndrome was the most commonly type, the highest occurrence frequency, consist of 124 cases (90.51%).(3)Qi deficiency+blood stasis syndrome was the basic combination form, a total of 109 cases (79.6%), mainly has the following four types: ①Qi deficiency+blood stasis②qi deficiency+blood stasis+phlegm turbidity③qi deficiency+blood stasis+Yin deficiency④qi deficiency+blood stasis+Yin deficiency+phlegm turbidity.(4)There were differences of syndromes distribution in gender, qi deficiency and blood stasis syndrome was common in women, Yin deficiency and phlegm turbidity syndrome based on qi deficiency and blood stasis was common in men, by the chi-square test the difference was significant (P=0.031).(5)The constituent ratio of qi deficiency and blood stasis syndrome increased significantly with the increase of age. The constituent ratio of qi deficiency+blood stasis+Yin deficiency, and the constituent ratio of Qi deficiency+blood stasis+Yin deficiency+phlegm turbidity decreased with the increase of age. By the CMH test, P=0.012,the results showed the age distribution between different TCM syndrome types had significant differences, further by the Spearman rank correlation test, P=0.01, indicated that the TCM syndrome types had significant correlation with age distribution. (6)The constituent ratio of E/A between different TCM syndrome types had significant difference (P=0.002).Further by SNK-q test, there were significant differences in these syndromes distribution (P<0.05, such as qi deficiency+blood stasis and qi deficiency+blood stasis+phlegm turbidity, qi deficiency+blood stasis+phlegm turbidity and qi deficiency+blood stasis+Yin deficiency,qi deficiency+blood stasis+Yin deficiency and qi deficiency+blood stasis+Yin deficiency+phlegm turbidity.(7)There was a significant difference between different TCM syndrome types and HDL-C (P=0.002), by the Pearson correlation test, there was no significant correlation between TCM syndrome type and HDL-C (P=0.277).2. Prospective study:(1)Before and after the treatment, the difference of TCM syndrome score in control group was statistically significant (P<0.05), from 54.13±17.83 down to 48.87±19.48. The difference of TCM syndrome score in treatment group was statistically significant (P<0.05), from 55.48±17.23 down to 39.33±16.06. The difference of TCM syndrome score was statistically significant between the control group and treatment group after treatment (P=0.037).(2)The overall curative comparison about the clinical efficacy of TCM:The treatment group had 9 cases marked obviously effective,19 cases marked effective,5 cases marked failed,0 cases marked aggravating, the total effective rate was 84.85%.The control group had 2 cases marked improved effective,18 cases marked effective,10 cases marked invalid,0 cases marked aggravating, the total effective rate was 66.67%.By chi-square test, X2=6.401, P=0.041, the difference was statistically significant.(3)The single curative comparison about the clinical efficacy of TCM:The treatment group in the aspect of chest tightness, fatigue, shortness of breath had obviously improved than the control group, and the difference was statistically significant (P<0.05). On the contrary, there was no statistically significant difference in the aspect of palpitation, insomnia, oral/gingiva color dark symptoms compared with control group (P>0.05).(4)Before and after the treatment, the changes in the level of interleukin 6 in control group was statistically significant (P<0.05), from 24.60±22.01pg/mL down to 11.61±8.03pg/mL.The change in the level of interleukin 6 in treatment group was statistically significant (P<0.05), from 22.79±9.15pg/mL down to 9.80±7.51pg/mL.The changes in the level of interleukin 6 was statistically significant between the control group and treatment group after treatment (P<0.05).(5)Before and after the treatment, the change in the level of tumor necrosis factor-a in control group was statistically significant (P<0.05), from 24.50±14.43 pg/mL down to 8.58±5.91pg/mL.The changes in the level of interleukin 6 in treatment group was statistically significant (P<0.05), from 22.92±14.55pg/mL down to 5.26±3.42pg/mL.The changes in the level of tumor necrosis factor-a was statistically significant between the control group and treatment group after treatment (P<0.05).(6)In the control group and treatment group before and after treatment, the changes in the levels of RA, Angll, ALD had no statistical significances (P>0.05).After treatment between the two group, the changes in the levels of them had no statistical significances (P>0.05), but there was a downward trend from the average level of Angll (P=0.122).(7)Before and after the treatment, the change in the level of NT-proBNP in control group was statistically significant (P<0.05), from 22.45±14.49pg/mL down to 17.55±10.20pg/mL L.The change in the level of NT-proBNP in treatment group was statistically significant (P<0.05), from 21.91±15.85pg/mL down to 12.18±5.54pg/mL.The change in the level of NT-proBNP was statistically significant between the control group and treatment group after treatment (P<0.05).(8)Before and after the treatment, the changes of left ventricular ejection fraction in control group was statistically significant (P<0.05), from 63.92±9.88% up to 168.52±8.21%.The changes of left ventricular ejection fraction in treatment group was statistically significant (P<0.05), from 63.05±9.32% up to 72.55±4.65%.The changes of left ventricular ejection fraction was statistically significant between the control group and treatment group after treatment (P<0.05).(9)The comparison of SF-36 every index in two groups:The changes in the scores of PF, RP, and GH were statistically significant (P<0.05), so did the treatment group. Between the control group and treatment group after treatment, the changes in the scores of PF, RP, and GH were statistically significant (P<0.05).Conclusion1-The main syndrome of TCM is qi deficiency and blood stasis type in the patients with pre-clinical heart failure (stage B) induced by CHD, for the sake of Chinese medicine syndrome reflecting the pathogenesis of TCM, qi deficiency and blood stasis may be regarded as the basic pathogenesis of the patients with pre-clinical heart failure (stage B) induced by CHD.2.There is the correlation between age and three coronary artery lesions, with the increase of age, the proportion of patients with coronary artery three lesions showed a trend of increase.3.There is the significant correlation between age and TCM syndrome type, with the increase of age, the proportion of qi deficiency and blood stasis shows a trend of increase, the proportion of qi deficiency+blood stasis+Yin deficiency, Qi deficiency+blood stasis+Yin deficiency+phlegm turbidity shows a trend of decrease.4.Yiqi Huoxue decoction may effectively improve the clinical symptoms of TCM in the patients with pre-clinical heart failure (stage B) induced by CHD, adjust the neuroendocrine hormones (reduce the concentration of plasma NT-proBNP), and inhibit the inflammatory cytokine levels (lower IL-6, concentration of TNF-α). On the other hand, Yiqi Huoxue decoction may improve the left ventricular ejection fraction and improve the patients’quality of life. In the process of treatment, there were no adverse reactions occurred, so it has a safety clinical application. |
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