Efficacy and safety of Shexiang Baoxin pill (MUSKARDIA) in patients with stable coronary artery disease: a multicenter, double-blind, placebo-controlled phase IV randomized clinical trial / 中华医学杂志(英文版)

BACKGROUND@#The Shexiang Baoxin Pill (MUSKARDIA) has been used for treating coronary artery disease (CAD) and angina for more than 30 years in China. Nevertheless, methodologically sound trials on the use of MUSKARDIA in CAD patients are scarce. The aim of the study is to determine the effects of MUSKARDIA as an add-on to optimal medical therapy (OMT) in patients with stable CAD.@*METHODS@#A total of 2674 participants with stable CAD from 97 hospitals in China were randomized 1:1 to a MUSKARDIA or placebo group for 24 months. Both groups received OMT according to local tertiary hospital protocols. The primary outcome was the occurrence of a major adverse cardiovascular event (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke. Secondary outcomes included all-cause mortality, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or heart failure, peripheral revascularization, angina stability and angina frequency.@*RESULTS@#In all, 99.7% of the patients were treated with aspirin and 93.0% with statin. After 2 years of treatment, the occurrence of MACEs was reduced by 26.9% in the MUSKARDIA group (MUSKARDIA: 1.9% vs. placebo: 2.6%; odds ratio = 0.80; 95% confidence interval: 0.45-1.07; P  = 0.2869). Angina frequency was significantly reduced in the MUSKARDIA group at 18 months (P = 0.0362). Other secondary endpoints were similar between the two groups. The rates of adverse events were also similar between the two groups (MUSKARDIA: 17.7% vs. placebo: 17.4%, P = 0.8785).@*CONCLUSIONS@#As an add-on to OMT, MUSKARDIA is safe and significantly reduces angina frequency in patients with stable CAD. Moreover, the use of MUSKARDIA is associated with a trend toward reduced MACEs in patients with stable CAD. The results suggest that MUSKARDIA can be used to manage patients with CAD.@*TRIAL REGISTRATION@#chictr.org.cn, No. ChiCTR-TRC-12003513.

Protective Effects of Salvianolate on Myocardial Injury or Myocardial Infarction after Elective Percutaneous Coronary Intervention in NSTE-ACS Patients: A Randomized Placebo-Controlled Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the protective effects of salvianolate on percutaneous coronary intervention (PCI) related myocardial injury or myocardial infarction after elective PCI in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients.@*METHODS@#A total of 149 patients with NSTE-ACS who underwent elective PCI were enrolled. The patients were randomly allocated in a 1:1 ratio to the salvianolate group (74 cases) or the control group (75 cases). After exclusion criteria of coronary angiography, 60 patients with PCI therapy remained in the salvianolate group and 68 in the control group. The incidence and the severity of PCI related myocardial injury or myocardial infarction, in addition to major adverse cardiac events (MACEs) during 1 year follow-up after PCI were studied between the two groups. Multivariate logistic regression analysis was used to determine the independent factors for PCI related myocardial injury or myocardial infarction after elective PCI.@*RESULTS@#Compared with the control group, salvianolate treatment reduced the incidence of PCI related severe myocardial injury or myocardial infarction (11.7% vs. 26.5%, P=0.035). The rate of MACEs or all-cause death within 1 month or 1 year after the procedure was not significantly different between the two groups.@*CONCLUSIONS@#Periprocedural treatment with salvianolate reduces the incidence of PCI related severe myocardial injury or myocardial infarction, although it does not influence clinical prognosis. [Chinese clinical trial registry: ChiCTR1800016992].

Protective Effects of Salvianolate on Myocardial Injury or Myocardial Infarction after Elective Percutaneous Coronary Intervention in NSTE-ACS Patients: A Randomized Placebo-Controlled Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the protective effects of salvianolate on percutaneous coronary intervention (PCI) related myocardial injury or myocardial infarction after elective PCI in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients.@*METHODS@#A total of 149 patients with NSTE-ACS who underwent elective PCI were enrolled. The patients were randomly allocated in a 1:1 ratio to the salvianolate group (74 cases) or the control group (75 cases). After exclusion criteria of coronary angiography, 60 patients with PCI therapy remained in the salvianolate group and 68 in the control group. The incidence and the severity of PCI related myocardial injury or myocardial infarction, in addition to major adverse cardiac events (MACEs) during 1 year follow-up after PCI were studied between the two groups. Multivariate logistic regression analysis was used to determine the independent factors for PCI related myocardial injury or myocardial infarction after elective PCI.@*RESULTS@#Compared with the control group, salvianolate treatment reduced the incidence of PCI related severe myocardial injury or myocardial infarction (11.7% vs. 26.5%, P=0.035). The rate of MACEs or all-cause death within 1 month or 1 year after the procedure was not significantly different between the two groups.@*CONCLUSIONS@#Periprocedural treatment with salvianolate reduces the incidence of PCI related severe myocardial injury or myocardial infarction, although it does not influence clinical prognosis. [Chinese clinical trial registry: ChiCTR1800016992].

The anticoagulation status:a cross-sectional survey of 1 000 cases single center study of patients with atrial fibrillation / 复旦学报（医学版）

Objective To investigate the epidemiological status and the anticoagulation treatment of atrial fibrillation (AF) patients,and to provide evidence for improving anticoagulation therapeutic effect in AF patients.Methods We performed a cross-sectional epidemiological investigation of 1 000 patients and out-patients with AF in Huashan Hospital.The clinical data including clinical feature,coexistent diseases,auxiliary examination,and treatment regimen of these patients were collected.The clinical features and anticoagulation status of AF patients were analyzed based on the stroke history,stroke risk evaluation and CHA2DS2-VASc score stratification.Results The mean age of these AF patients was (72.1 ± 11.1) years old.The most common coexistent diseases were hypertension (65％),coronary heart disease (32％) and diabetes (27％).About 6％ of the AF patients were diagosed with non-valvularatrial fibrillation (NVAF),and 22％ had stroke history.Patients were divided into two groups according to their stroke history.Compared with the non-stroke group,the stroke group was found to be older,with longer course of AF and poorer hypertension control.The overall anticoagulation rate was 32 ％ and antiplatelet rate was 46 ％.The anticoagulation rate of stroke group was 44％,higher than the non-stroke group (P＜0.001) but 78％ of these patients began anticoagulation therapy after the occurrence of stroke.When CHA2 DS2-VASc scores of NVAF patients were 2 to 5,the anticoagulation proportion increased gradually.When the scores were 2 to 6,the antiplatelet ratio increased gradually.But when the scores were 7-8 points,both anticoagulation and antiplatelet rates were in decline.Conclusions The anticoagulation rate in AF patients was still low at present,while relatively higher in patients with stroke.Anticoagulation could prevent stroke,AF patients still could benefit from anticoagulation after stroke,but anticoagulation before stroke could get more benefits.

Observation of bacterial biofilms in patients with chronic rhinosinusitis / 中华耳鼻咽喉头颈外科杂志

<p><b>OBJECTIVE</b>To explore the presence of bacterial biofilms (BF) in patients with CRS and the effect of BF on clinical symptoms and postoperative outcomes.</p><p><b>METHODS</b>Seventy-two patients with chronic sinusitis were enrolled in this study. The control group included 15 patients with deviation of the nasal septum and 10 patients had a fracture of the nasal bone. Mucosa of the uncinate process or ethmoid near the ostium of the maxillary sinus was obtained during endoscopic sinus surgery. The specimens were subjected to scanning electron microscopy. Patients were followed for 1 year and observed by the Lund-Kennedy endoscopy, and the Haikou standard classification (ESS-1997). Statistical analysis was performed by t-test or chi-square test.</p><p><b>RESULTS</b>Three patients were lost to follow-up. The scanning electron microscopy analysis showed bacterial biofilms in 49 of the 69 patients with chronic sinusitis. A marked destruction of the epithelium and cilia was observed in samples positive for bacterial biofilms. No bacterial biofilms were detected in the control group, and scanning electron microscopy showed normal epithelium and cilia in those specimens. There was no significant difference in gender, classification or duration of disease between the BF(-) and BF(+) groups. At six months and one year postoperative, the Lund-Kennedy endoscopy scores for CRS patients with BF (4.78 +/- 1.67; 4.55 +/- 1.61) were significantly higher than those without BF (3.65 +/- 1.39; 3.65 +/- 1.18) (t = -2.654, P < 0.01; t = -2.264, P < 0.05). Based on the Haikou standard classification, there was a significantly difference between patients with BF and those without BF (chi2 = 18.014, 22.063, P < 0.001, respectively).</p><p><b>CONCLUSIONS</b>Different life stages of bacterial biofilms were demonstrated to be present in CRS. Gender, classification or duration of disease did not affect the presence of bacterial biofilms in patients with CRS. There is a correlation between bacterial biofilms and an unfavorable outcome in patients with CRS after ESS.</p>

Relationship between post-stenting coronary thrombolysis in myocardial infarction flow and plasma von Willebrand factor and ADAMTS-13 levels in patients with ST segment elevation myocardial infarction / 中华心血管病杂志

<p><b>OBJECTIVE</b>To investigate the relationship between post-stenting coronary thrombolysis in myocardial infarction (TIMI) flow and plasma von Willebrand factor (vWF) and its cleaving protease (ADAMTS-13) levels in patients with ST segment elevation myocardial infarction (STEMI).</p><p><b>METHODS</b>STEMI patients who underwent primary percutaneous coronary intervention (PCI) and stenting between September, 2007 and December, 2009 were enrolled. According to the post-stenting TIMI flow, patients were divided to TIMI ≤ 2 group (n = 43) and TIMI 3 group (n = 43). Patients with chest pain or dyspnea and normal coronary angiographic results served as control group (n = 43). The levels of vWF and ADAMTS-13 were measured by ELISA at three time points: immediately after admission, beginning of PCI and 1 week after PCI.</p><p><b>RESULTS</b>Levels of vWF in STEMI patients at all 3 time points were significantly higher than in control patients, and the level of vWF was significantly higher in TIMI ≤ 2 group than in TIMI 3 group [at admission: (6721.83 ± 1380.58) U/L vs. (4786.12 ± 2362.01) U/L, P < 0.05; at the beginning of PCI: (5744.65 ± 1240.71) U/L vs. (3011.33 ± 2270.40) U/L, P < 0.05 and at 1 week after PCI: (2001.48 ± 931.70) U/L vs. (1365.17 ± 724.12) U/L, P < 0.05]. ADAMTS-13 levels were similar among groups at admission and at beginning of PCI, however, the level of ADAMTS-13 at 1 week after PCI was significantly higher in TIMI ≤ 2 group than that in TIMI 3 group [(406.93 ± 101.44) mg/L vs. (270.34 ± 115.12) mg/L, P < 0.001]. Logistic regression analysis showed that both vWF at admission (OR = 1.917, P < 0.01) and vWF at the beginning of PCI (OR = 2.016, P < 0.01) were risk factors of TIMI ≤ 2.</p><p><b>CONCLUSION</b>Increased vWF during peri-PCI periods was associated with post-stenting coronary TIMI ≤ 2 after primary PCI in STEMI patients, and the imbalance between vWF and ADAMTS-13 may thus play an important role in the development of slow flow post PCI.</p>

Effects of shexiang baoxin pill on angiogenesis in atherosclerosis plaque and ischemic myocardium / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To investigate the effects of Shexiang Baoxin Pill (SBP) in intervening atherosclerosis and myocardial infarction (AS-MI) in experimental animals, and inspect its influences on angiogenesis.</p><p><b>METHODS</b>Twenty male New-Zealand rabbits were made into AS-MI model, and randomly divided into 2 groups equally. Group A was fed with high-fat diet for control; Group B was fed with high-fat diet but intervened with SBP. The cardiac function and the positive area of plaque were determined. The CD34 positive response intensity at infarcted marginal zone and aorta vessel wall, and the capillary density of myocardium were measured by immunohistochemical staining. In addition, the protein expressions of vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor-2 (VEGFR-2) were detected by Western blot.</p><p><b>RESULTS</b>Compared to Group A, the cardiac function was obviously improved (P<0.05) and the plaque positive area (%) was significantly decreased in Group B (45.82 +/- 3.68 vs 82.56 +/- 4.97, P<0.01). The CD34 positive response intensity and the capillary density as well as VEGF and VEGFR-2 expressions in infarcted marginal zone in Group A were higher than those in Group B (P<0.01); but these parameters at aorta vessel walls were lower in Group A than in Group B (P<0.01).</p><p><b>CONCLUSION</b>SBP could advance the angiogenesis in the marginal zone of infarction, improve heart function, and embarrass angiogenesis in atherosclerotic plaque.</p>

Effects of rhodiola on expression of vascular endothelial cell growth factor and angiogenesis in aortic atherosclerotic plaque of rabbits / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To investigate the effects of rhodiola on expression of vascular endothelial cell growth factor (VEGF) and angiogenesis in aortic atherosclerotic plaque of rabbits.</p><p><b>METHODS</b>Thirty male New Zealand rabbits were randomly divided into 3 groups equally, i. e. the control group (A) fed with common diet and treated with distilled water, the high fat diet group (B) and the rhodiola group (C) fed with diet containing 1.5% cholesterol and treated respectively with distilled water and rhodiola (1 mL/kg per day), all the treatments were administered via gastrogavage once a day for 9 successive weeks. Level of blood lipids in various groups was determined and compared at the end of the experiment. Meanwhile, the tissue sample of aorta was taken for observation through HE and Sudan red staining, for detecting the CD34 positive response intensity by immunohistochemical staining and the VEGF expression by Real-time fluorescent quantitative PCR and Western blot.</p><p><b>RESULTS</b>Determination of blood lipids showed that in Group C, TC was 42.01 +/- 1.99 mmol/L, TG 4.83 +/- 0.75 mmol/L and LDL-C 38.40 +/- 0.74 mmol/L, all lower than those in Group B (70.74 +/- 2.66 mmol/L, 8.75 +/- 0.78 mmol/L and 51.05 +/- 0.34 mmol/L, respectively), showing statistical difference between groups (P < 0.05). The intima/media tunica thickness ratio and the CD34 positive area of plaque in Group C were all lower than those in Group B (0.35 +/- 0.03 vs 0.43 +/- 0.03 and 29.12 +/- 2.56% vs 39.28 +/- 3.48%, P <0.05). Besides, the VEGF expression in atherosclerotic plaque was also lower in Group C than that in Group B.</p><p><b>CONCLUSION</b>Rhodiola has the effects of inhibiting atherosclerosis formation, decreasing the VEGF expression and suppressing the angiogenesis in the plaque.</p>

Glycated Hemoglobin and Blood Pressure Related to Carotid Artery Atherosclerosis in Continuum in Non-diabetic Persons / 中华高血压杂志

Objective To analyze the relationship between glyeated hemoglobin,blood pressure and carotid ar- tery atheroselerosis (AS) in non-diabetic patients.Methods To recruite 300 non-diabetic patients and retrospec tively study the relationship between glycated hemoglobin HbAlc,blood pressure and carotid artery AS.Carotid AS was determined by carotid uhrasound.Carotid AS was defined as intima-media thickness (IMT) of common ca- rotid artery≥0.9 mm,or occurrence of carotid plaque.Results Compared with the carotid AS negative subjects, the carotid AS positive patients had significant higher fasting glucose,2 h glucose,HbAlc and systolic blood pres- sure (SBP) level,without difference in DBP.Higher HbAlc or SBP levels were associated with increased incidence of carotid AS.For patients with similar SBP levels,higher HbAlc was associated with more prevalence of carotid AS.Logistic regression analysis shows HbAlc (OR=4.1,P=0.009) was an independent predictor of carotid AS,after adjusting for sex,BMI,SBP,DBP,LDL-C,HDL-C,hypersensitive C-reactive protein (hsCRP),and fasting and 2 h glucose.Conclusion These results suggests that even a slight increase of HbAlc may be independ- ently associated with carotid AS in non-diabetic subjects;and the coexistence of elevated systolic blood pressure syn- ergetically enhance the carotid atherosclerosis.