Objective:To explore the appropriate modeling method of the early warning model of ischemic stroke recurrence in TCM.Methods:This was a prospective,multi-center and registered study conducted in 7 clinical subcenters ...Objective:To explore the appropriate modeling method of the early warning model of ischemic stroke recurrence in TCM.Methods:This was a prospective,multi-center and registered study conducted in 7 clinical subcenters from 8 provinces and 10 cities in China between 3rd November 2016 and 27th April,2019.1,741 patients with first-ever ischemic stroke were recruited.Univariate analysis was carried out using distance correlation coefficient,mutual information entropy,and statistical correlation test.Multivariate analysis adopted multi-factor Cox regression model and combined with expert opinions in the field of stroke to determine modeling variables.The generalized estimating equation of longitudinal data and the Cox proportional hazard regression model of cross-sectional data were used to construct and compare in the early warning model of ischemic stroke recalls.The area under the ROC curve(AUC value)was used to evaluate the early warning capability of the model.Results:The follow-up time was 1-3 years,and the median follow-up time was 1.42 years(95%CI:1.37-1.47).Recurrence events occurred in 175 cases,and the cumulative recurrence rate was 10.05%(95%CI:8.64%-11.47%).The AUC values of the TCM syndrome and TCM constitution model were 0.71809 and 0.72668 based on the generalized estimating equation and the AUC values.Conclusion:The generalized estimating equation may be more suitable for the construction of early warning models of stroke recurrence with TCM characteristics,which provides a certain reference for the evaluation of secondary prevention of ischemic stroke.展开更多
Objective:To assess the effect and safety of Hydroxysafflor Yellow A for Injection(HSYAI)in treating patients with acute ischemic stroke(AIS)and blood stasis syndrome(BSS).Methods:A multicenter,randomized,double-blind...Objective:To assess the effect and safety of Hydroxysafflor Yellow A for Injection(HSYAI)in treating patients with acute ischemic stroke(AIS)and blood stasis syndrome(BSS).Methods:A multicenter,randomized,double-blind,multiple-dose,active-controlled phaseⅡtrial was conducted at 9 centers in China from July 2013 to September 2015.Patients with moderate or severe AIS and BSS were randomly assigned to low-,medium-,high-dose HSYAI groups(25,50 and 70 mg/d HSYAI by intravenous infusion,respectively),and a control group(Dengzhan Xixin Injection(灯盏细辛注射液,DZXXI)30 mL/d by intravenous infusion),for 14 consecutive days.The primary outcome was the Modified Rankin Scale(mRS)score 1 at days 90 after treatment.The secondary outcomes included the National Institute of Health Stroke Scale(NIHSS)score 1,Barthel Index(BI)score 95,and BSS score reduced 30%from baseline at days 14,30,60,and 90 after treatment.The safety outcomes included any adverse events during 90 days after treatment.Results:Of the 266 patients included in the effectiveness analysis,66,67,65 and 68 cases were in the low-,medium-,and high-dose HSYAI and control groups,respectively.The proportions of patients in the medium-and high-dose HSYAI groups with mRS score 1 at days 90 after treatment were significantly larger than the control group(P<0.05).The incidences of favorable outcomes of NIHSS and BI at days 90 after treatment as well as satisfactory improvement of BSS at days 30 and 60 after treatment in the medium-and high-dose HSYAI groups were all significantly higher than the control group(P<0.05).No significant difference was reported among the 4 groups in any specific adverse events(P>0.05).Conclusions:HSYAI was safe and well-tolerated at all doses for treating AIS patients with BSS.The medium(50 mg/d)or high dose(75 mg/d)might be the optimal dose for a phaseⅢtrial.展开更多
Objective:To delineate the onset and recurrence characteristics of noncardiogenic ischemic stroke patients in China.Methods:A prospective,multicenter and registry study was carried out in 2,558 patients at 7 represent...Objective:To delineate the onset and recurrence characteristics of noncardiogenic ischemic stroke patients in China.Methods:A prospective,multicenter and registry study was carried out in 2,558 patients at 7 representative clinical sub-centers during November 3,2016 to February 17,2019.A questionnaire was used to collect information of patients regarding CM syndromes and constitutions and associated risk factors.Additionally,stroke recurrence was defined as a primary outcome indicator.Results:A total of 327(12.78%)patients endured recurrence events,1,681(65.72%)patients were men,and the average age was 63.33±9.45 years.Totally 1,741(68.06%)patients suffered first-ever ischemic stroke,1,772(69.27%)patients reported to have hypertension,and1,640(64.11%)of them reported dyslipidemia,1,595(62.35%)patients exhibited small-artery occlusion by The Trial of Org 10172 in Acute Stroke Treatment(TOAST)classification.Specifically,1,271(49.69%)patients were considered as qi-deficient constitution,and 1,227(47.97%)patients were determined as stagnant blood constitution.There were 1,303(50.94%)patients diagnosed as blood stasis syndrome,1,280(50.04%)patients exhibited phlegm and dampness syndrome and 1,012(39.56%)patients demonstrated qi deficiency syndrome.And 1,033(40.38%)patients declared intracranial artery stenosis,and 478(18.69%)patients reported carotid artery stenosis.The plaque in 1,508(41.36%)patients were of mixed.Particularly,41.09%of them demonstrated abnormal levels of glycated hemoglobin(HbA1 c)levels.Conclusions:Recurrence in minor and small-artery stroke cannot be ignored.Hypertension,dyslipidemia,abnormal HbA1 c,intracranial artery stenosis and carotid plaque were more common in stroke patients.Particularly,phlegm-dampness and blood stasis syndromes,as well as qi deficiency and blood stasis constitutions,were still the main manifestations of stroke.(Trial registration at ClinicalTrials.gov,No.NCT03174535)展开更多
基金National Key R&D Program of the Ministry of Science and TechnologyConstruction of the Technical System for"Treating the Disease"in Traditional Chinese Medicine(No.2018YFC1704705)2015 Special Research Project of the Chinese Medicine Industry of the National Administration of Traditional Chinese Medicine:R&D and Demonstration of Recurrence Risk Assessment System for Ischemic Stroke Disease with Chinese Medicine Characteristic Health Management(No.201507003-8).
文摘Objective:To explore the appropriate modeling method of the early warning model of ischemic stroke recurrence in TCM.Methods:This was a prospective,multi-center and registered study conducted in 7 clinical subcenters from 8 provinces and 10 cities in China between 3rd November 2016 and 27th April,2019.1,741 patients with first-ever ischemic stroke were recruited.Univariate analysis was carried out using distance correlation coefficient,mutual information entropy,and statistical correlation test.Multivariate analysis adopted multi-factor Cox regression model and combined with expert opinions in the field of stroke to determine modeling variables.The generalized estimating equation of longitudinal data and the Cox proportional hazard regression model of cross-sectional data were used to construct and compare in the early warning model of ischemic stroke recalls.The area under the ROC curve(AUC value)was used to evaluate the early warning capability of the model.Results:The follow-up time was 1-3 years,and the median follow-up time was 1.42 years(95%CI:1.37-1.47).Recurrence events occurred in 175 cases,and the cumulative recurrence rate was 10.05%(95%CI:8.64%-11.47%).The AUC values of the TCM syndrome and TCM constitution model were 0.71809 and 0.72668 based on the generalized estimating equation and the AUC values.Conclusion:The generalized estimating equation may be more suitable for the construction of early warning models of stroke recurrence with TCM characteristics,which provides a certain reference for the evaluation of secondary prevention of ischemic stroke.
文摘Objective:To assess the effect and safety of Hydroxysafflor Yellow A for Injection(HSYAI)in treating patients with acute ischemic stroke(AIS)and blood stasis syndrome(BSS).Methods:A multicenter,randomized,double-blind,multiple-dose,active-controlled phaseⅡtrial was conducted at 9 centers in China from July 2013 to September 2015.Patients with moderate or severe AIS and BSS were randomly assigned to low-,medium-,high-dose HSYAI groups(25,50 and 70 mg/d HSYAI by intravenous infusion,respectively),and a control group(Dengzhan Xixin Injection(灯盏细辛注射液,DZXXI)30 mL/d by intravenous infusion),for 14 consecutive days.The primary outcome was the Modified Rankin Scale(mRS)score 1 at days 90 after treatment.The secondary outcomes included the National Institute of Health Stroke Scale(NIHSS)score 1,Barthel Index(BI)score 95,and BSS score reduced 30%from baseline at days 14,30,60,and 90 after treatment.The safety outcomes included any adverse events during 90 days after treatment.Results:Of the 266 patients included in the effectiveness analysis,66,67,65 and 68 cases were in the low-,medium-,and high-dose HSYAI and control groups,respectively.The proportions of patients in the medium-and high-dose HSYAI groups with mRS score 1 at days 90 after treatment were significantly larger than the control group(P<0.05).The incidences of favorable outcomes of NIHSS and BI at days 90 after treatment as well as satisfactory improvement of BSS at days 30 and 60 after treatment in the medium-and high-dose HSYAI groups were all significantly higher than the control group(P<0.05).No significant difference was reported among the 4 groups in any specific adverse events(P>0.05).Conclusions:HSYAI was safe and well-tolerated at all doses for treating AIS patients with BSS.The medium(50 mg/d)or high dose(75 mg/d)might be the optimal dose for a phaseⅢtrial.
基金Supported by Traditional Chinese Medicine Research Special Project(No.201507003-8)Construction of a Service System for Traditional Chinese Medicine Preventive Treatment of Disease(No.2018YFC1704705)。
文摘Objective:To delineate the onset and recurrence characteristics of noncardiogenic ischemic stroke patients in China.Methods:A prospective,multicenter and registry study was carried out in 2,558 patients at 7 representative clinical sub-centers during November 3,2016 to February 17,2019.A questionnaire was used to collect information of patients regarding CM syndromes and constitutions and associated risk factors.Additionally,stroke recurrence was defined as a primary outcome indicator.Results:A total of 327(12.78%)patients endured recurrence events,1,681(65.72%)patients were men,and the average age was 63.33±9.45 years.Totally 1,741(68.06%)patients suffered first-ever ischemic stroke,1,772(69.27%)patients reported to have hypertension,and1,640(64.11%)of them reported dyslipidemia,1,595(62.35%)patients exhibited small-artery occlusion by The Trial of Org 10172 in Acute Stroke Treatment(TOAST)classification.Specifically,1,271(49.69%)patients were considered as qi-deficient constitution,and 1,227(47.97%)patients were determined as stagnant blood constitution.There were 1,303(50.94%)patients diagnosed as blood stasis syndrome,1,280(50.04%)patients exhibited phlegm and dampness syndrome and 1,012(39.56%)patients demonstrated qi deficiency syndrome.And 1,033(40.38%)patients declared intracranial artery stenosis,and 478(18.69%)patients reported carotid artery stenosis.The plaque in 1,508(41.36%)patients were of mixed.Particularly,41.09%of them demonstrated abnormal levels of glycated hemoglobin(HbA1 c)levels.Conclusions:Recurrence in minor and small-artery stroke cannot be ignored.Hypertension,dyslipidemia,abnormal HbA1 c,intracranial artery stenosis and carotid plaque were more common in stroke patients.Particularly,phlegm-dampness and blood stasis syndromes,as well as qi deficiency and blood stasis constitutions,were still the main manifestations of stroke.(Trial registration at ClinicalTrials.gov,No.NCT03174535)
