Real World Study

wushx@sina.com

*CER :(comparative effectiveness research CER)RCTRWS CERGRACE RCT: PSS : PSSPost-market Safty Study

*PER : PERPharmacoeconomic Research-: : 1CER 2RCT3-

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( pragmatic trials)

( adaptive designs)

( clinical registries)

( clinical data registries) CER, The Real World Study

GRACEGlobal Registry of Acute Coronary Events(

GRACEGlobal Registry of Acute Coronary Events

GRACEGlobal Registry of Acute Coronary EventsST

GRACEGlobal Registry of Acute Coronary Events19994

14

Cluster Sites185

GRACEGlobal Registry of Acute Coronary Events47

GRACEGlobal Registry of Acute Coronary EventsPopulation-based ClusterUSAMassachusettsBostonResidents of Falmouth and Hyannis (n=108,800)Cape Cod Hospital, Falmouth Hospital

GRACEGlobal Registry of Acute Coronary Events10,0001861

GRACEGlobal Registry of Acute Coronary Events600

GRACEGlobal Registry of Acute Coronary Events6

6

GRACEGlobal Registry of Acute Coronary Events

Premier Research, Philadelphia, PA, USAGRACECenter for Outcomes Research, University of Massachusetts Medical School, Worcester, MA, USA

GRACEGlobal Registry of Acute Coronary EventsA comparison between B-type natriuretic peptide, global registry of acute coronary events (GRACE) score and their combination in ACS risk stratification.

Prehospital Delay in Patients With Acute Coronary Syndromes (from the Global Registry of Acute Coronary Events [GRACE]).

N-terminal pro B type natriuretic peptide complements the GRACE risk score in predicting early and late mortality following acute coronary syndrome

Thrombocytopenia in patients with an acute coronary syndrome (from the Global Registry of Acute Coronary Events [GRACE]).

GRACEGlobal Registry of Acute Coronary EventsMagnitude and prognosis associated with ventricular arrhythmias in patients hospitalized with acute coronary syndromes (from the GRACE Registry).

Time course of events in acute coronary syndromes: implications for clinical practice from the GRACE registry.

Predictive factors of recurrent angina after acute coronary syndrome: the global registry acute coronary events from China (Sino-GRACE).

GRACEGlobal Registry of Acute Coronary EventsTreatment of the acute coronary syndrome in Germany: experiences in a German cluster of the GRACE registry

Predicting outcome in patients with acute coronary syndrome: evaluation of B-type natriuretic peptide and the global registry of acute coronary events (GRACE) risk score.

Interactions between heparins, glycoprotein IIb/IIIa antagonists, and coronary intervention. The Global Registry of Acute Coronary Events (GRACE).

Bleeding events with antithrombotic therapy in patients with unstable angina or non-ST-segment elevation myocardial infarction; insights from a large clinical practice registry (GRACE).

Global Registry of Acute Coronary Events (GRACE) hospital discharge risk score accurately predicts long-term mortality post acute coronary syndrome.

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GRACEGlobal Registry of Acute Coronary Events

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CERRWS5000

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1000 100016316.3%37837.8%20920.9%22322.3%23023%13.2235035.0% 1000

1000 100034834.8%12212.2%555.5%353.5%44044% 1000

1000 2468P0.05 122344658

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1000

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1000 100041141%57257%172%

1000 13413.4%86686.6%86286.2%13813.8%

1000 28828.8%55455.4%14714.7%20.2%20.2%

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CERECRFCER

Chinese Pharmacopoeia1994199820002010National essential drugs listNational essential drugs listClass AMarkedNational essential drugs listClass A2009Songlingxuemaikang Capsule(SLXMK)

Fresh pine needlesMain componentsKudzu rootPearl

Treatment of hypertensionHeadacheVertigoInsomnia

Object of study2009/92010/3Stroke patients after discharge, 48 caseshypertension patients Class 2-3Dosing regimensTreatment GroupAmlodipine2.5mg/d + Valsartan 80mg/d + SLXMK 3#TidControl GroupAmlodipine 2.5mg/d + Valsartan 80mg/dcourse of treatment : 8 weeksEvaluation indexAmbulatory blood pressureclinical trial of SLXMK on hypertension

Effect of Hypetensionclinical trial of SLXMK on hypertension

CTP24 hour average systolic blood pressure29.677.8636.885.500.0124 hour average diastolic blood pressure14.008.6518.507.970.067Daytime average systolic blood pressure29.837.4937.135.280.01Daytime average diastolic blood pressure14.508.1918.508.930.05Nocturnal mean systolic blood pressure28.048.7837.135.020.01Nocturnal mean diastolic blood pressure13.338.6021.137.760.01

trough/peak ratioclinical trial of SLXMK on hypertension

Smoothness indexclinical trial of SLXMK on hypertension

Research topics A practical hospital registration clinical research of Songling Xuemaikang Capsule in treatment of essential hypertension Study objectiveSafety, effectiveness and satisfaction evaluationOverall designDrug epidemiology (The Real Word Study )Sample size5000 CasesTreatment programs SLXMK 3#Tid, course of treatment : 8 weeksResearch progress This test is under study, has selected 980 casesThe Real Word Study of SLXMK on hypertension

Research topicsEffects of Songling Xuemaikang Capsule on blood pressure variability(BPV) , A randomized, double blind, multicenter parallel controlled studyStudy objective:Evaluation of Songling Xuemaikang Capsule on blood pressure variability Overall designA randomized, double blind, multicenter parallel controlled studyTreatment programs Treatment GroupAmlodipine2.5mg/d + SLXMK 3#TidControl GroupAmlodipine 2.5mg/d + Placebo 3#Tidcourse of treatment : 12 weeksEvaluation index Variability of blood pressure Heart rate variabilitysystolic pressure diastolic pressurePlanned clinical trial

China's pharmaceutical enterprises, traditional Chinese medicine, urgent need:Evidence based DataInternational Journals (For example: Hypertension)Look forward to cooperation Research designQuality controlLook forward to cooperation

Thanks for Attention

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