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1、China Coronary Secondary Prevention Study(CCSPS),Shui-Ping ZhaoCentral South UniversityChangsha,China,Background,since 1994,large-scale clinical trials such as 4S,CARE and LIPID have shown that lipid-lowering therapy for patients with coronary heart disease Decreases cardiovascular eventsimproves qu
2、ality of lifereduces medical expenses,Background,All these trials used statins All conducted in Western countries No study conducted in Chinese,Significance of CCSPS(1),Oriental population(CCSPS),Westen populations(4S、CARE、LIPID),Difference,Serum lipids,Morbidity&Mortality of CHD,Diet,Genetic,Life s
3、tyle,Questions to Answer by CCSPS,Xuezhikang therapy Can reduce the incidence of the re-occurrence of AMI and mortality from CHD?Can lower the incidence and mortality from cerebrovascular diseases?Can lower total mortality?Can decrease coronary events?Efficiency and safety of long term use of Xuezhi
4、kang,Research Design,Double Blind,Randomized and Placebo-controlled TrialNumber of subjects:4,870Subjects:1875 years old Chinese men and women who survived from MISerum TC Level:4.40 6.47 mmol/L(170-250 mg/dl)Serum TG Level:4.52 mmol/L(400 mg/dl)Drug using:Xuezhikng or placebo 0.6 BidFollow-up perio
5、d:average 4 years,Primary End Point,Non-fatal AMI Fatal MI CHD sudden death Some other CHD deaths,Secondary End Points,Other cardiocerebrovascular eventsNon-cardiovascular events(cancer,incidental death,suicide,etc)Need for PCI or CABGTotal death,Treatment Schedule,Xuezhikang or placebo 0.6g twice a
6、 dayFollow up in 6 to 8 weeks and every 6 months there afterserum lipid level and safety indexcompliance and events,Demographic Data,Medical History and Medications,Serum lipids,(mg/dl),Study time:November,1996 to December 31,2003Subjects:4870 follow up:average 4 years maximum 7 years,Dropout,47 1.9
7、3%46 1.89%p=0.9357,Serum lipids,Tested after 3.5yr,Clinical Events,Comparison of CHD Events,Following time(year),CHD events risk lowered by 45.1%P0.0001,Treatment group,Control group,CHD events include:non-fatal AMI fatal AMI sudden death other CHD deaths,Cumul-ative survival rate without CHD events
8、,Follow-up time(year),Risk lowered by 31%P=0.0048,treatment group,control group,CHD death includes:fatal AMI sudden deathother CHD deaths,Cumulativesurvival rate,Cardiac Death,AMI events,Follow-up time(year),Risk lowered by 56.0%P0.0001,treatment group,Control group,AMI events includes:fatal AMI non
9、-fatal AMI,Cumulatesurvival rate without AMI events,Total Death,Following time(year),Risk lowered by 33.0%P=0.0003,control group,Treatment group,Cumulative survival rate,Secondary events,Secondary events include:stroke cancer PCI/CABG,Risk 31.1%p0.0004,Secondary Events,Safety,Adverse Reactions,Labor
10、atory Data,CCSPS Hypertension Subgroup,Number of subjects:2740 hypertensives in 4870 CHD population Drug using:ACEI,calcium-channel blocker(CCB),-blocker,Change of blood pressure level,Compared with the level before treat:#p0.01,calculate the control rate with the standard of SBP140mmHg&DBP90mmHg.,C
11、omparison of event risks between hypertensives and non-hypertensives,Rate(%),Non-hypertensives,hypertensives,P=0.0005,P=0.0020,P0.0001,P=0.0004,41.5,49.2,51.9,179.6,Comparison of events reduced between hypertensives and non-hypertensives,hypertensives,Non-hypertensives,44.0,47.4,31.0,31.9,35.8,28.6,
12、32.0,3.23,Riskreduced(%),CCSPS Diabetes Subgroup,There are 591 diabetes cases in the 4870 subjects.control Group:285Treat Group:306Average 3.7 years,maximum 7 years,Comparison of diabetes group and non diabetes group,Rate(%),Non diabetes,Diabetes,13.71,7.29,9.48,3.97,12.18,5.68,*,*,*,*P0.0001,Compar
13、ison of risk deceased,Risk decrease(%),Non diabetes,Diabetes,43.9,50.8,60.3,63.8,27.2,44.1,30.2,44.1,Long-term XuezhiKang therapy lowers risk of cardiovascular mobidity and mortality events in the Chinese CHD patients.XuezhiKang does not have obviously adverse effects.Xuezhikang contains statins and
14、 other active compounds that may contribute to its overall beneficial effects,Discussion,Discussion,The risks of CHD and stroke events in CHD with hypertension had obviously increased.The total death was also obviously increasing.CHD with hypertension belongs to very high risk group,need more aggres
15、sive treatment on lowering blood pressure and lipids.After treatment with Xuezhikang,CHD with hypertension gained greater benefits in decreasing stroke and total death events.,Discussion,Among CHD with diabetes,the risk of CHD events are obviously higher than the subjects without diabetes.Xuezhikang
16、 is suitable to treat diabetes.It can effectively decrease the complication of the cardiovascular,lower CHD events by 50.8%and CHD death by 44.1%.,Natural statins 6mg Unsaturated fatty acids 24mg18 types of aminophenol 25.7mgErgosterin 0.3%alkaloid 0.41%Flavonoids 0.045%Trace elements 2.25%,Palmitic
17、 acid 18.61%Linoleic acid48.13%Oleic acid 28.78%Stearic acid 4.49%,Effective component of Xuezhikang,Each capsule(0.3g)contains:,Natural statins:12 types of statins,one of them is:Lovastatin 2.5mg,Xuezhikang,An extract of Cholestin approved by the Food and Drug Administration as a Chinese red-yeast
18、rice for dietary supplement.(Heber D,Yip I,Ashley JM,et al.Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement.Am J Clin Nutr.1999;69:231236.)It contains a family of naturally occurring statins and has a marked modulating effect on lipids and C-reactive protein(CR
19、P)concentrations.Zhao SP,Liu L,Cheng YC,Li YL.Effect of xuezhikang,a Cholestin extract,on reflecting postprandial triglyceridemia after a high-fat meal in patients with coronary heart disease.Atherosclerosis.2003;168:375380.Liu L,Zhao SP,Cheng YC,Li YL.Xuezhikang decreases serum lipoprotein(a)and C-
20、reactive protein concentrations in patients with coronary heart disease.Clin Chem.2003;49:13471352.,Summary,Xuezhikang,an Extract of Cholestin,Protects Endothelial Function Through Antiinflammatory and Lipid-LoweringXuezhikang can effectively reduce cardiovascular events in patients with CHD,Thank you!,
