2.Effectiveness and safety of Shexiang Baoxin Pill (MUSKARDIA) in patients with stable coronary artery disease and concomitant diabetes mellitus: a subgroup analysis of a randomized clinical trial.
Jingmin ZHOU ; Haiming SHI ; Fusui JI ; Yang WU ; Yulan ZHAO ; Jun QIAN ; Junbo GE
Chinese Medical Journal 2023;136(1):82-87
BACKGROUND:
Preliminary studies have indicated that Shexiang Baoxin Pill (MUSKARDIA) has a coronary artery dilation effect and increases the coronary blood flow, relieving the symptoms of angina. This study aimed to evaluate the benefit of MUSKARDIA on patients with stable coronary artery disease (CAD) and diabetes mellitus (DM).
METHODS:
This was a subgroup analysis of a multicenter, randomized, placebo-controlled phase IV trial. CAD patients with a medical history of DM or baseline fasting blood glucose (FBG) ≥7.0 mmol/L were grouped according to the treatment (standard therapy plus MUSKARDIA or placebo). The primary outcome was major adverse cardiovascular events (MACEs), which was the composite outcome of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. The secondary outcome was the composite outcome of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina or heart failure, and coronary angioplasty.
RESULTS:
MACEs occurred in 2.6% (9/340) and 4.8% (18/376) of patients in the MUSKARDIA and placebo groups, respectively ( P = 0.192). Secondary composite outcome was significantly less frequent with MUSKARDIA than with placebo (15.3% [52/340] vs . 22.6% [85/376], P = 0.017). Risk of MACEs (hazard ratio [HR] = 0.69, 95% confidence interval [CI]: 0.31-1.57) was comparable between two groups. In patients with uncontrolled DM (≥4 measurements of FBG ≥7 mmol/L in five times of follow-up), the risk of secondary outcome was significantly lower with MUSKARDIA (5/83, 6.0%) than with placebo (15/91, 16.5%) (HR = 0.35, 95%CI: 0.13-0.95).
CONCLUSION:
As an add-on to standard therapy, MUSKARDIA shows a trend of reduced MACEs in patients with stable CAD and DM. Furthermore, MUSKARDIA may reduce the frequency of all-cause death, hospitalization, and coronary angioplasty in this population, especially in those with uncontrolled DM.
TRIAL REGISTRATION
ChiCTR.org.cn, ChiCTR-TRC-12003513.
Humans
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Coronary Artery Disease/complications*
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Diabetes Mellitus, Type 2/drug therapy*
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Myocardial Infarction/complications*
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Stroke/epidemiology*
3.Review on treatment of unstable atherosclerotic plaque with traditional Chinese medicine.
Chinese Journal of Integrated Traditional and Western Medicine 2006;26(5):472-474
Rupture of unstable atherosclerotic plaque is an essential pathogenetic mechanism of acute coronary syndrome (ACS), thereby, to stabilize the vulnerable plaque is of great importance for prevention and treatment of ACS. Recent study has shown the multi-target effects of traditional Chiese medicine intervention in stabilizing unstable atherosclerotic plaque is promising. The literatures involving this topic in recent years were reviewed in this paper.
Acute Coronary Syndrome
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complications
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drug therapy
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pathology
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Animals
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Coronary Artery Disease
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complications
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drug therapy
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pathology
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Coronary Vessels
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pathology
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Drugs, Chinese Herbal
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therapeutic use
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Humans
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Phytotherapy
4.Clinical and angiographic outcome in coronary artery disease patients with type-II diabetes mellitus undergoing elective bare-metal stenting or drug-eluting stenting.
Shu-bin QIAO ; Qing HOU ; Bo XU ; Jue CHEN ; Hai-bo LIU ; Yue-jin YANG ; Yong-jian WU ; Jin-qing YUAN ; Yuan WU ; Jun DAI ; Shi-jie YOU ; Wei-hua MA ; Pei ZHANG ; Zhan GAO ; Ke-fei DOU ; Hong QIU ; Chao-wei MU ; Ji-lin CHEN ; Run-lin GAO
Chinese Journal of Cardiology 2007;35(6):523-526
OBJECTIVETo compare the clinical and angiographic outcome in patients with type-II diabetes mellitus undergoing drug-eluting stent (DES) or bare-metal stent (BMS).
METHODSA total of 139 consecutive diabetic patients (114 males) with coronary disease who underwent successful elective percutaneous coronary intervention with DES (n = 83 with 151 lesions) or BMS (n = 56 with 70 lesions) on native coronary arteries from April 2004 to August 2005 at our institution were included in this study. All patients were treated according to guidelines and coronary angiography was repeated at 6 months post procedure in all patients. Aspirin (300 mg/d) and clopidogrel (75 mg/d) were administered till 6 months after the procedure.
RESULTSThere were 42.5% C type by ACC/AHA and 19.0% total occlusion lesions. The average stent length of each lesion was 26.53 +/- 14.72 mm, and mean reference diameter was 2.80 +/- 0.43 mm. Baseline characteristics were similar between DES and BMS groups except lower mean reference vessel diameter in DES than that of BMS group (2.71 +/- 0.41 mm vs. 2.98 +/- 0.53 mm, P < 0.001). The in stent restenosis rate at 6 months (10.6% vs. 38.6%, P < 0.001) and in-segment late loss (0.24 +/- 0.56 mm vs. 0.91 +/- 0.77 mm, P < 0.001) were significantly lower in DES group than those of BMS group. The target lesion revascularization (TLR) incidence was also significantly lower in DES group compared to BMS group (8.6% vs. 30.0%, P < 0.001). However, 4 late in-stent thrombosis were seen in DES group and none in BMS group of DES (P = 0.148).
CONCLUSIONDES implantation in patients with diabetes mellitus is associated with lower in-stent restenosis and TLR rates compared to BMS implantation 6 months after procedure and attention should be paid on late in-stent thrombosis after DES implantation.
Aged ; Angioplasty, Balloon, Coronary ; Coronary Artery Disease ; complications ; therapy ; Diabetes Mellitus, Type 2 ; complications ; therapy ; Drug-Eluting Stents ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Treatment Outcome
6.Influence of insulin resistance on long-term outcomes in patients.
Liang-ping ZHAO ; An-kang LÜ ; Wei-feng SHEN ; Hai-feng LIU ; Xiao-ye MA ; Xiao-ming FAN ; Qi ZHANG
Chinese Medical Journal 2010;123(6):651-657
BACKGROUNDInsulin resistance (IR) is significantly associated with coronary artery disease and cardiovascular events in patients with or without type 2 diabetes mellitus. This study aimed to evaluate the influence of IR on long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) with sirolimus-eluting stent (SES) implantation.
METHODSA total of 467 consecutive patients undergoing SES-based PCI were divided into IR group (n = 104) and non-IR group (n = 363). The patients were followed up for one year. The rate of major adverse cardiac events (MACEs) including death, non-fatal myocardial infarction and recurrent angina pectoris was compared by the log-rank test, and the independent risk factors were identified by the Cox regression analysis.
RESULTSMACEs occurred more frequently, and cumulative survival rate was lower in the IR group than in the non-IR group during the follow-up (all P < 0.05). IR was an independent risk factor for the occurrence of cardiac death and non-fatal myocardial infarction (OR = 2.76, 95%CI = 1.35 - 5.47, P = 0.034). Old age, diabetes, and multi-vessel disease were determinants for recurrent angina pectoris after PCI (P < 0.05). Subgroup analysis revealed that IR (OR = 3.35, 95%CI = 1.07 - 13.59, P = 0.013) and multi-vessel disease (OR = 2.19, 95%CI = 1.01 - 5.14, P = 0.044) were independent risk predictors for recurrent angina pectoris in patients with diabetes after PCI.
CONCLUSIONSIR is associated with reduced MACE-free survival and remains an independent predictor for recurrent angina pectoris after PCI with SES implantation.
Adult ; Aged ; Angioplasty, Balloon, Coronary ; Coronary Artery Disease ; mortality ; therapy ; Diabetes Mellitus, Type 2 ; complications ; Drug-Eluting Stents ; Female ; Humans ; Insulin Resistance ; Male ; Middle Aged ; Proportional Hazards Models
7.Kawasaki Disease: Laboratory Findings and an Immunopathogenesis on the Premise of a "Protein Homeostasis System".
Kyung Yil LEE ; Jung Woo RHIM ; Jin Han KANG
Yonsei Medical Journal 2012;53(2):262-275
Kawasaki disease (KD) is a self-limited systemic inflammatory illness, and coronary artery lesions (CALs) are a major complication determining the prognosis of the disease. Epidemiologic studies in Asian children suggest that the etiologic agent(s) of KD may be associated with environmental changes. Laboratory findings are useful for the diagnosis of incomplete KD, and they can guide the next-step in treatment of initial intravenous immunoglobulin non-responders. CALs seem to develop in the early stages of the disease before a peak in inflammation. Therefore early treatment, before the peak in inflammation, is mandatory to reduce the risk of CAL progression and severity of CALs. The immunopathogenesis of KD is more likely that of acute rheumatic fever than scarlet fever. A hypothetical pathogenesis of KD is proposed under the premise of a "protein homeostasis system"; where innate and adaptive immune cells control pathogenic proteins that are toxic to host cells at a molecular level. After an infection of unknown KD pathogen(s), the pathogenic proteins produced from an unknown focus, spread and bind to endothelial cells of coronary arteries as main target cells. To control the action of pathogenic proteins and/or substances from the injured cells, immune cells are activated. Initially, non-specific T cells and non-specific antibodies are involved in this reaction, while hyperactivated immune cells produce various cytokines, leading to a cytokine imbalance associated with further endothelial cell injury. After the emergence of specific T cells and specific antibodies against the pathogenic proteins, tissue injury ceases and a repair reaction begins with the immune cells.
Animals
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Coronary Artery Disease/drug therapy/etiology/metabolism
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Humans
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Immunoglobulins, Intravenous/therapeutic use
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Mucocutaneous Lymph Node Syndrome/complications/*diagnosis/drug therapy/metabolism
8.Clinical and angiographic predictors of restenosis after bare metal stent deployment in coronary artery disease patients complicated with diabetes.
Ze-Ning JIN ; Yun-Dai CHEN ; Shu-Zheng LÜ ; Xian-Tao SONG ; Hua-Gang ZHU ; Hong LI
Chinese Journal of Cardiology 2006;34(12):1093-1096
OBJECTIVETo identify the potential predictors of restenosis after bare mental stent (BMS) deployment in diabetic patients in Chinese diabetic patients.
METHODSWe retrospectively analyzed all patients implanted with BMS (n = 1126 with 2376 lesions) in our department from 2002 to 2004. The multivariate logistic regression analysis was made to compare the clinical and angiographic characteristics between diabetic patients with and without restenosis. Restenosis was defined as > or = 50% diameter stenosis within the stent and 5 mm in adjacent.
RESULTSThe 6-month follow-up angiograms were available in 889 out of 1126 patients (78.9%) and 151 out of 889 patients (17%) were diabetic patients. Restenosis rate in nondiabetic patients group was 21.2% and 35.9% in diabetic patients (P < 0.001). The predictors of restenosis in diabetics were reference vessel diameter (< or = 3.0 mm), length of lesion (> 15 mm) and insulin use (P < 0.05). The restenosis predicting model showed that reference vessel caliber was the paramount predictor for restenosis in diabetic patients.
CONCLUSIONSRestenosis rate post BMS implantation is significantly higher in diabetic patients compared to non-diabetic patients. Vessel caliber, lesion length and insulin use are predictors of restenosis in diabetic patients. Diabetic patients with reference vessel diameter of > 3.0 mm combined with lesion length < 15 mm and non-diabetic patients with lesion length < 15 mm regardless of the vessel caliber could be treated with BMS since the predicted restenosis rate is lower than 15% in these patients, otherwise DES would be a better choice.
Angioplasty, Balloon, Coronary ; Coronary Angiography ; Coronary Artery Disease ; complications ; diagnostic imaging ; therapy ; Coronary Restenosis ; diagnostic imaging ; etiology ; Diabetic Angiopathies ; complications ; Drug Delivery Systems ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Stents
9.Expression of sICAM-1 in children with intravenous immunoglobulin-resistant Kawasaki disease.
Chinese Journal of Contemporary Pediatrics 2013;15(12):1109-1112
OBJECTIVETo investigate the expression of soluble intercellular adhesion molecule-1 (sICAM-1) and itd significance in children with intravenous immunoglobulin (IVIG)-resistant Kawasaki disease (KD).
METHODSA total of 271 children with KD who received IVIG treatment (including 252 IVIG-sensitive cases and 19 IVIG-resistant cases) were selected in the study; 78 of the 271 children had coronary artery dilation. Thirty-six age-matched healthy children were selected as the control group. Plasma sICAM-1 levels were measured using enzyme-linked immunosorbent assay. White blood cell count (WBC), neutrophil count, C-relative protein (CRP), aspartate aminotransferase(AST), serum sodium, and serum potassium were measured by laboratory tests.
RESULTSBefore IVIG treatment, the IVIG-sensitive cases and IVIG-resistant cases had significantly higher sICAM-1 levels than the control group (P<0.05), and the IVIG-resistant cases had significantly higher sICAM-1 levels than the IVIG-sensitive cases (P<0.05). After 24-48 hours of IVIG treatment, the IVIG-resistant cases had significantly higher sICAM-1 levels than the IVIG-sensitive cases (P<0.05). Before IVIG treatment, among the IVIG-sensitive cases, the sICAM-1 level was significantly higher in those with coronary artery dilation than in those without coronary artery dilation (P<0.05); among the IVIG-resistant cases, the sICAM-1 level was significantly higher in those with coronary artery dilation than in those without coronary artery dilation (P<0.05). In the IVIG-resistant cases, sICAM-1 level was positively correlated with WBC (before and after treatment) (r=0.7562, P<0.01; r=0.8435, P<0.01) and CRP (after treatment) (r=0.8936, P<0.01).
CONCLUSIONSHigh sICAM-1 level may be used as a risk factor for resistance to IVIG and coronary artery dilation in children with KD.
Child ; Child, Preschool ; Coronary Artery Disease ; blood ; Female ; Humans ; Immunoglobulins, Intravenous ; therapeutic use ; Infant ; Intercellular Adhesion Molecule-1 ; blood ; Male ; Mucocutaneous Lymph Node Syndrome ; blood ; complications ; drug therapy
10.Clinical features of recurrent Kawasaki disease in 20 children.
Chinese Journal of Contemporary Pediatrics 2008;10(5):617-619
OBJECTIVETo investigate the clinical features of recurrent Kawasaki disease (KD) and the relationship of recurrent KD with coronary artery lesions.
METHODSThe medical data of 20 children with recurrent KD who were admitted to the Children's Hospital from January 1998 to May 2007 were retrospectively studied. Their clinical features were compared with those of children with initial KD.
RESULTSThe incidence of recurrent KD was 1.34% (20/1489). KD relapsed 2 months to 4.6 years (average: 1.2 years) after the first episode in the 20 children. Compared with the initial KD group, the clinical symptoms in the recurrent KD group were incomplete, complicated and less severe. The period of fever, platelet count, C-reactive protein and ESR were remarkably reduced in the recurrent KD group, but the incidence of coronary artery lesions increased significantly compared with the initial KD group (40% vs 25%; P<0.05).
CONCLUSIONSThe clinical symptoms of recurrent KD were incomplete in children. Recurrent KD was associated with an increased incidence of coronary artery lesions.
Child ; Child, Preschool ; Coronary Artery Disease ; etiology ; Female ; Humans ; Immunoglobulins, Intravenous ; therapeutic use ; Infant ; Male ; Mucocutaneous Lymph Node Syndrome ; complications ; drug therapy ; Recurrence ; Retrospective Studies