Shenzhu Guanxin Recipe Granules () for Improving Exercise Tolerance in Patients with Stable Angina (SERIES Trial): A Protocol of Multicenter, Randomized, Double-Blind, Placebo Parallel Controlled Clinical Trial / 中国结合医学杂志

BACKGROUND@#Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules (, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES (ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic (ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events (MACE) in stable anginal patients.@*METHODS@#A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR (10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up.@*DISCUSSION@#This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events. (Trial registration No. ChiCTR-TRC-14004504).

Effect of Shenzhu Guanxin Recipe () on patients with angina pectoris after percutaneous coronary intervention: A prospective, randomized controlled trial / 中国结合医学杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of a combination therapy using Chinese medicine (CM) Shenzhu Guanxin Recipe (, SGR) and standard Western medicine treatment (SWMT) in patients with angina pectoris after percutaneous coronary intervention (PCI).</p><p><b>METHODS</b>Double-blind randomized controlled trial was used in this experimental procedure. One hundred and eighty-seven patients with coronary heart disease receiving SWMT after PCI were randomly assigned to the treatment (SGR) and control (placebo) groups. Outcome measures including angina pectoris score (APS), CM symptom score, and Seattle Angina Questionnaire (SAQ) score were evaluated in 1, 2, 3 and 12 months, and the death rate, restenosis and other emergency treatments were observed. The mixed-effects models were employed for the data analysis.</p><p><b>RESULTS</b>In the treatment group, a larger within-treatment effect size (d=1.74) was found, with a 76.7% reduction in APS from pretreatment to 12-month follow-up assessment compared with the control group (d=0.83, 53.8% symptom reduction); betweentreatment (BT) effect size was d=0.66. CM symptom scores included an 18.3% reduction in the treatment group (d=0.46), and a 16.1% decrease in the control group (d=0.31); d=0.62 for BT effect size. In regard to scores of SAQ, the BT effect size of cognition level of disease was larger in the treatment group (d=0.63), followed by the level of body limitation of activity (d=0.62), condition of angina pectoris attacks (d=0.55), satisfaction level of treatments (d=0.31), and steady state of angina pectoris (d=0.30). Two cardiovascular related deaths and one incidental death were recorded in the control and treatment groups, respectively. No significant difference in any cardiovascular event (including death toll, frequency of cardiovascular hospitalization or emergency room visits) was found between the two groups.</p><p><b>CONCLUSION</b>The combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.</p>

Effect of Huxin Formula on reverse cholesterol transport in ApoE-gene knockout mice / 中国结合医学杂志

<p><b>OBJECTIVE</b>To observe the effect of Huxin Formula on expressions of the chief reverse cholesterol transport (RCT) associated genes, caveolin-1 and scavenger receptor-BI (SR-BI) in ApoE-gene knockout [ApoE (-/-)] mice.</p><p><b>METHODS</b>Thirty ApoE (-/-) mice of 4-6 weeks old were randomly divided into three groups (A-C). After being fed with high-fat diet for 16 weeks, they were treated with HXF (1 mL/100 g), pravachol (0.3 mg/100 g), and saline in equal volume respectively for 16 weeks successively; in addition, a blank group was set up with 10 C57BL/6J mice of 6-week old received 16-week high-fat feeding and saline treatment. Animals were sacrificed at the termination of the experiment, their paraffin sections of aortic tissue were used to measure the size of plaque, expressions of cavolin-1 and SR-BI were detected by immunological histochemical method.</p><p><b>RESULTS</b>As compared with the blank group, levels of caveolin-1 and SR-BI were increased in Groups A and B (P<0.01); but the increase in Group A was more significant than that in Group B (P<0.05). The plaque/aorta area ratio decreased significantly in Groups A and B, but showed insignificant difference between the two groups.</p><p><b>CONCLUSION</b>HXF could obviously increase the expressions of RCT associated genes, caveolin-1 and SR-BI, promote the RCT process, so as to reduce the formation of aorta atherosclerotic plaque in ApoE (-/-) mice.</p>

Literature study on the syndrome diagnosis and classification of coronary artery disease / 中国中西医结合杂志

To investigate the application of diagnosis methods for coronary artery disease (CAD) and the status quo of its syndrome typing. The literature content analysis was used in this study. The frequency statistics was performed by comprehensively collecting CAD (thoracic obstruction) syndrome typing correlated literatures, designing content analysis tables, extracting information such as typing methods, typing elements, and syndrome typing, and so on. Results showed that blood stasis, yin deficiency, qi deficiency, yang deficiency, phlegm turbidity, and other syndrome elements extensively exist in literatures concerning CAD syndrome typing. Modem doctors prefer to use syndrome typing of qi, blood, jinye, and eight principles in syndrome typing of CAD more frequently. The asthenia in origin and asthenia in superficiality has been widely recognized as the basic syndrome of CAD.

Analysis on TCM syndrome distribution laws in 319 patients with coronary heart disease / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To study TCM syndrome distribution laws in patients with coronary heart diseases (CHD) by epidemiological investigation.</p><p><b>METHODS</b>A clinical survey was carried out in 319 inpatients with CHD, whose diagnosis was confirmed by coronary arteriography, in the authors' hospital from January 2004 to December 2004. The TCM syndrome distribution laws were analyzed, and the relationship of coronary arteriographic picture with TCM syndrome elements, common symptoms, pulse and tongue figures, as well as the correlation between syndrome typing and blood-lipid levels were analyzed, too.</p><p><b>RESULTS</b>Qi deficiency was the most popular syndrome in patients with CHD (87.1%), blood stasis syndrome and phlegm retention syndrome took the second place, accounting for 79.9% and 78.7% respectively. No significant difference was shown in comparison of tongue and pulse figures with the affected branches of coronary artery, the dark-pale tongue with white greasy fur and taut-slippery pulse being the dominance in patients. The blood-lipid levels in patients with various TCM syndrome types were similar, showing insignificant difference.</p><p><b>CONCLUSION</b>The TCM pathogenesis of CHD takes qi deficiency as the core, blood stasis and phlegm retention as the important pathologic products.</p>

Cluster analysis on TCM syndromes in 319 coronary artery disease patients for establishment of syndrome diagnostic figure / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To explore the diagnostic figures for TCM syndrome typing in coronary heart disease (CHD) patients.</p><p><b>METHODS</b>A retrospective investigation was carried out in 319 CHD patients hospitalized from Jan. 2004 to Dec. 2004 in authors' hospital. Through cluster analysis, descriptive statistics and frequency normalization in combination of clinical observation, the diagnostic figures of TCM syndromes were obtained.</p><p><b>RESULTS</b>The figures for qi deficiency syndrome were: primary symptoms: chest pain and stuffiness, secondary symptoms: tiredness, short breath, poor appetite, light colored tongue, deep and thready pulse; for qi deficiency with phlegm and blood stasis syndrome: primary symptoms: chest stuffiness and pain, secondary symptoms: tiredness, insomnia, palpitation, obesity, dark red tongue, string and slippery pulse; for turbid-phlegm blocking collateral syndrome: primary symptoms: chest stuffiness, secondary symptoms: cough, expectoration with much white sputum, tiredness, short breath and poor appetite, light colored tongue with white greasy coating, slippery pulse.</p><p><b>CONCLUSION</b>Research on diagnostic criteria for TCM syndrome typing could be established upon clinical epidemiologic survey and statistic analysis in combining with specialists' suggestions to primarily set the referrence figures.</p>

Study on TCM syndrome differentiation rules in coronary artery bypass grafting patients during peri-operation period / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To study the TCM syndrome differentiation rules in coronary artery bypass grafting (CABG) patients during peri-operation period.</p><p><b>METHODS</b>According to the Guideline for Clinical Trail of Traditional Chinese New Drugs and experience of Professor DENG Tie-tao, the standard of TCM syndrome differentiation for CABG patients was established, with which 161 CABG patients were classified before and two weeks after CABG operation.</p><p><b>RESULTS</b>Before CABG, the qi stagnation and blood stasis syndrome type was the type most commonly seen (46.0%), the next in turn was the phlegm stagnation type (24.8%), the yang-qi deficiency type (15.5%), and the yin-blood deficiency type (13.7%). While after CABG, the phlegm stagnation syndrome type was the most frequently occurred one (35.9%), then in turn was the yang-qi deficiency type (30.8%), the yin-blood deficiency type (21.2%) and the qi stagnation with blood stasis type (12.2%).</p><p><b>CONCLUSION</b>For patients before CABG, the pathological characteristic is mostly the deficiency in root with excess in superficiality, and the commonest syndrome is the qi stagnation with blood stasis type. For patients after CABG, both deficiency and excess is the pathological characteristic, the Xin-qi and Xin-yang deficiency syndrome the commonest type, and with phlegm as the main pathologic factor.</p>

Trial study on DENG Tie-tao's coronary heart disease capsules in improving patients' quality of life / 中国结合医学杂志

<p><b>OBJECTIVE</b>To assess the efficacy of the Coronary Heart Disease (CHD) Capsules worked out by Prof. Deng --in improving quality of life of CHD patients of qi deficiency with phlegm and blood stasis syndrome.</p><p><b>METHOD</b>According to the WHO's diagnosis criteria of CHD, a total of 93 stable angina patients were divided into 3 groups using the single blinded method. The groups were evenly distributed into CHD Capsule treated group (CHDC), isosorbide dinitrate control group (ID), and Compound Prescription Danshen Droplet Pills control group (CPDDP). Two courses of treatment lasting for 6 months were given. During the courses of treatment, the following parameters were observed: clinical symptoms of angina pectoris, ECG change, treadmill exercise test, 36 items in short form of health survey (SF-36) and Seattle Angina Questionnaire (SAQ) scale.</p><p><b>RESULTS</b>After 6 months of treatment, all the three groups showed good curative effect in angina pectoris, ECG and treadmill exercise test, differences between them had no statistical significance. The CHDC group showed a better result in nitro-glycerine stopping or alleviation rate and in improving symptoms than the other groups (P < 0.05). The general health, vitality, role-emotional, mental health and reported health transition in the CHDC group were significantly better than those in the control groups (P < 0.05). The scores in physiological functioning role, physiological function and pain alleviation were not different among the three groups.</p><p><b>CONCLUSION</b>Prof. DENG Tie-tao's CHDC is effective in treating CHD with qi deficiency, phlegm and blood stasis and also in improving the quality of life. CHDC is more suitable to be used in long-term treatment than isosorbide dinitrate. The SF-36 and SAQ can be used to appraise the curative effect of traditional Chinese medicine agents for CHD angina pectoris.</p>