Clinical efficacy and gene chip expression analysis of Shenzhu Guanxin recipe granules(参术冠心方颗粒) in patients with intermediate coronary lesions

OBJECTIVE: To evaluate the clinical efficacy and safety of Shenzhu Guanxin recipe granules(参术冠心颗粒, SGR) in treating patients with intermediate coronary lesions(ICL), and to investigate the potential mechanism though a transcriptome sequencing approach. METHODS: ICL patients with Qi deficiency and phlegm stasis were adopted and randomly assigned to a case group or a control by random number generator in a 1∶1 randomization ratio to evaluate the clinical efficacy. RESULTS: There was no significant difference between the two groups in coronary computed tomography angiography related indexes in the two groups before and after intervention. Through the gene chip expression analysis, it is finally concluded that there are 355 differential mRNAs(190 up-regulated genes and 165 down regulated genes) when compared the SGR group and placebo group. Through protein-protein interaction network analysis of differentially expressed genes, 10 hub genes were finally obtained: CACNA2D2, CACNA2D3, DNAJC6, FGF12, SGSM2, CACNA1G, LRP6, KIF25, OXTR, UPB1. CONCLUSIONS: SGR combined with Western Medicine can be safely used to treat ICL patients with Qi deficiency and phlegm stasis. The possible mechanism of action and relevant gene loci and pathway were proposed.

Effect of Shenzhu Guanxin Recipe (参术冠心方)on Patients with Angina Pectoris after Percutaneous Coronary Intervention:A Prospective, Randomized Controlled Trial

Objective： To evaluate the efficacy and safety of a combination therapy using Chinese medicine （CM） Shenzhu Guanxin Recipe （参术冠心方, SGR） and standard Western medicine treatment （SWMT） in patients with angina pectoris after percutaneous coronary intervention （PCI）. Methods： 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. Results： 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）; between- treatment （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. Conclusion： The combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.