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ObjectiveTo observe the efficacy and safety of Tongguan Capsule（通冠胶囊）on ventricular remodeling in patients after acute myocardial infarction （AMI）， and to explore the possible mechanism. MethodsA total of 53 ST-segment elevation myocardial infarction （STEMI） patients were collected and randomly divided into 26 cases in the treatment group and 27 cases in the control group. The control group was given conventional therapy after percutaneous coronary intervention （PCI） for AMI， and the treatment group was given Tongguan Capsules （4.5 g each time， 3 times a day） on the basis of the control group. The course of treatment was 12 weeks. Echocardiographic data and stool samples were collected from subjects before and after the intervention， and left ventricular ejection fraction （LVEF）， left ventricular end-diastolic volume index （LVEDVi）， left ventricular end-systolic volume index （LVESVi）， left ventricular mass index （LVMi） were measured and calculated， so as to compare the number of cases of left ventricular remodeling in the two groups. At the same time， 16S rDNA sequencing was performed on the stool samples to analyze the diversity of gut microbiota （GM）， the composition of the GM， the GM difference between the groups； recording the incidence of major adverse cardiovascular events （MACEs） and adverse reactions of patients in the two groups during the study period； and performing Spearman's correlation analyses of the post-treatment flora data with LVEF， LVEDVi， LVESVi， LVM， and LVMi in the two groups. ResultsOne case fail to follow up in the treatment group and 2 cases fail to follow up in the control group， and 25 cases in each of the two groups were finally included in the analysis. LVEDVi， LVESVi， and LVMi of the control group after treatment were higher than those before treatment （P＜0.05）； after treatment， LVEDVi， LVESVi and LVMi in the treatment group were lower than those in the control group （P＜0.05）. Left ventricular remodeling occurred in 5 cases （20.00%） in the treatment group and 13 cases （52.00%） in the control group， and the incidence of left ventricular remodeling in the treatment group was lower than that in the control group （P=0.03）. After treatment， the ACE estimation and Chao estimation of bacterial abundance in the treatment group were higher than that before treatment and that in the control group （P＜0.05）. The treatment group showed an increase in Mycobacterium anisopliae phylum and a decrease in Mycobacterium thickum， Mycobacterium anisopliae phylum， and Mycobacterium patella phylum after treatment （P＜0.05）. When comparing between groups after treatment， the relative abundance of Prevotella， Agathobacter， Dialister， Eubacterium coprostanoligenes group was up-reuglated and the relative abundance of Enterococcus was down-regulated in the treatment group（P＜0.05 or P＜0.01）. There was no statistically significant difference in the incidence of MACEs and the occurrence of adverse reactions between groups during treatment （P＞0.05）. The results of correlation analysis showed that Prevotella were positively correlated with LVEF and negatively correlated with LVEDVi， LVESVi， LVM， and LVMi （P＜0.01）. Agathobacter group were negatively correlated with LVEDVi， LVESVi （P＜0.01）； Enterococcus group were positively correlated with LVESVi （P＜0.05）. ConclusionTongguan Capsules can improve ventricular remodeling in patients with acute ST-segment elevation myocardial infarction with better safety； its mechanism may be related to adjusting the enrichment of related bacteria such as Prevotella， Dialister and Enterococcus and other related bacterial genera， increasing the colonization and diversity of beneficial bacteria， and adjusting the structure of GM.
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BACKGROUND@#Although percutaneous coronary intervention (PCI) had become widely employed therapeutic procedure for coronary artery disease, stent restenosis limited the benefits of this revascularization and the question how to prevent such events remained unresolved. While numerous empirical observations suggested Tongguan Capsules (), a patented Chinese Medicine, could decrease frequency and duration of angina pectoris attacks, evidence supporting its efficacy on restenosis remained inadequate.@*OBJECTIVE@#This trial was designed to determine whether Tongguan Capsules would reduce restenosis rate in patients after successful stent implantation.@*METHODS@#Approximately 400 patients undergoing percutaneous coronary stent deployment were enrolled and randomized to control group or Tongguan Capsules (4.5 g/d) for 3 months. All patients received standard anti-platelet, anti-coagulation and lipid-decreasing treatments, concurrently. The primary clinical endpoint was the 12-month incidence of the major adverse cardiovascular events (defined as cardiac death, myocardial infarction, and recurrence of symptoms requiring additional revascularization). The angiographic end point was restenosis rate at 6 months.@*CONCLUSION@#This study would provide important evidence for the use of Tongguan Capsules in patients after stent implantation in combination with routine therapies, which may significantly reduce incidence of the restenosis so as to potentially improve the clinical outcomes. (registration number: ChiCTR-TRC- ChiCTR-IIR-17011407).
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OBJECTIVE： To develop an method for determining the contents of dehydrocorydine and salvianolic acid B in Shuangshen tongguan capsules simultaneously. METHODS： The HPLC-dual wavelength switching method was used. The determination was performed on Waters symmetry C18 column with mobile phase consisted of acetonitrile-0.05％ phosphoric acid solution （gradient elution） at the flow rate of 1.0 mL/min， the detection wavelength was 286 nm （salvianolic acid B） and 336 nm （dehydrocorydine）. The column temperature was maintained at 25 ℃， and sample size was 10 μL. RESULTS： Under this condition， dehydrocorydaline and salvianolic acid B could be separated in baseline. The linear range of them were 0.157-1.259 μg and 0.391-3.131 μg （r＝0.999 9）. RSDs of precision， reproducibility and stability tests （within 24 h） were all lower than 2.00％ （n＝6-10）. The average recovery rates were 101.61％ and 102.85％ （RSD＝3.59％ and 2.85％， n＝6）. CONCLUSIONS： Established HPLC-dual wavelength switching method can be used for simultaneous determination of dehydrocorydine and salvianolic acid B in Shuangshen tongguan capsules. The method is simple and rapid， and can be used for the quality control of Shuangshen tongguan capsule.
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Objective To establish a quality standard forZishen Tongguan Capsules.Methods Anemarrhneae Rhizoma and Phellodendri Chinensis Cortex were qualitatively identified by TLC method. The contents of neomangferin, phellodendrine hydrochloride, mangiferin and berberine hydrochloride inZishen Tongguan Capsules were quantitatively determined by HPLC method.Results The spots of qualitative identification method were clear without interference. Neomangferin in Anemarrhneae Rhizoma and phellodendrinehy drochloride in Phellodendri Chinensis Cortex were identified. Neomangferin, phellodendrinehy drochloride, mangiferin and berberine hydrochloride showed good linearity in the range of 0.025 25–2.02 μg (r=0.999 7), 0.025 5–2.04 μg (r=0.999 7), 0.026–2.08 μg (r=0.999 7), and 0.025 5–2.04 μg (r=0.999 6) respectively. The average recoveries of neomangferin, phellodendrinehy drochloride, mangiferin and berberine hydrochloride were 99.99%, 101.06%, 103.05%, and 100.55%, respectively. The RSD were 2.69%, 5.62%, 2.49%, and 2.06%, respectively.Conclusion The method is accurate and rapid, with good stability, reliability and reproducibility, which can be used for the quality control and evaluation of the preparation of Zishen Tongguan Capsules.