OBJECTIVE: To evaluate the risk of ischemic stroke endpoints by establishing risk assessment models that combine Traditional Chinese Medicine(TCM)and modern medicine indicators.METHODS/DESIGN: The proposed study is a ...OBJECTIVE: To evaluate the risk of ischemic stroke endpoints by establishing risk assessment models that combine Traditional Chinese Medicine(TCM)and modern medicine indicators.METHODS/DESIGN: The proposed study is a registry-based participant survey conducted in seven hospitals nationwide in China. After obtaining informed consent, 3000 patients diagnosed with ischemic stroke will be recruited. One-year follow-ups will be performed on-site in hospitals and by telephone to track endpoint events. Comparative analysis of the prevalence of endpoint events and other TCM or modern medicine features in different groups will be conducted using frequency analysis and χ2tests, and the results will be expressed as composition ratios. Comparative analysis of quantitative scores and related patterns or symptoms will be conducted using a rank-sum test. Correlation analysis of endpoint events and TCM or modern medicine factors will be performed using a multivariate Cox proportional hazard model.DISCUSSION: Previous reports have described modern medicine indicator-based risk assessment models for ischemic stroke endpoint events, but no such studies have included TCM features. Our new risk assessment model combines TCM and modern medicine indicators and thus has the potential to facilitate early warning, early intervention, and early control of ischemic stroke endpoint events.展开更多
OBJECTIVE: To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease(heat in the lung-wei) to further identify the indications....OBJECTIVE: To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease(heat in the lung-wei) to further identify the indications.METHODS: This randomized, double-blind, parallel, controlled trial will include patients with acute upper respiratory infection and wind-warmth lung-heat disease(heat in the lung-wei). Patientswith serious bacterial infection(white blood cell count > 12 × 10~9, neutrophils > 80%) will be excluded. Patients will be divided into three categories(blocks) according to their condition: fever only, a swollen and sore throat, and combined fever plus a swollen and sore throat. Patients within each of the three blocks will be further divided into a treatment group and a control group via stratified blocked randomization. The treatment group will be treated with Jinye Baidu granule, and the control group will be treated with Fufang Shuanghua granule. The primary outcome measure will be body temperature recovery time for patients with fever, throat symptom score for patients with a swollen and sore throat, and body temperature recovery time and throat symptom score for patients with combined fever plus a swollen and sore throat. Routine blood testing, urine testing, liver function, kidney function and ECG data of all patients will be collected as safety indices before and after enrollment, and adverse events will be recorded during the whole trial course.CONCLUSION: This study protocol will include stratified block analysis according to patients' symptoms, and identify the accurate clinical indications of Jinye Baidu granule. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment.展开更多
基金Supported by Special Research Project by the State Administration of Traditional Chinese Medicine:Traditional Chinese Medicine Health Management Based Risk Assessment System Development and Demonstration for Recurrence of Ischemic Stroke(No.201507003-8)
文摘OBJECTIVE: To evaluate the risk of ischemic stroke endpoints by establishing risk assessment models that combine Traditional Chinese Medicine(TCM)and modern medicine indicators.METHODS/DESIGN: The proposed study is a registry-based participant survey conducted in seven hospitals nationwide in China. After obtaining informed consent, 3000 patients diagnosed with ischemic stroke will be recruited. One-year follow-ups will be performed on-site in hospitals and by telephone to track endpoint events. Comparative analysis of the prevalence of endpoint events and other TCM or modern medicine features in different groups will be conducted using frequency analysis and χ2tests, and the results will be expressed as composition ratios. Comparative analysis of quantitative scores and related patterns or symptoms will be conducted using a rank-sum test. Correlation analysis of endpoint events and TCM or modern medicine factors will be performed using a multivariate Cox proportional hazard model.DISCUSSION: Previous reports have described modern medicine indicator-based risk assessment models for ischemic stroke endpoint events, but no such studies have included TCM features. Our new risk assessment model combines TCM and modern medicine indicators and thus has the potential to facilitate early warning, early intervention, and early control of ischemic stroke endpoint events.
基金Supported by the Ninth Scientific Research Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(No.Z0406)the Research Project of World Federation of Chinese Medicine Societies(SCEPCM12E001)the Special Research Project of Traditional Chinese Medicines by the State Administration of Traditional Chinese Medicine(No.201507003-8)
文摘OBJECTIVE: To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease(heat in the lung-wei) to further identify the indications.METHODS: This randomized, double-blind, parallel, controlled trial will include patients with acute upper respiratory infection and wind-warmth lung-heat disease(heat in the lung-wei). Patientswith serious bacterial infection(white blood cell count > 12 × 10~9, neutrophils > 80%) will be excluded. Patients will be divided into three categories(blocks) according to their condition: fever only, a swollen and sore throat, and combined fever plus a swollen and sore throat. Patients within each of the three blocks will be further divided into a treatment group and a control group via stratified blocked randomization. The treatment group will be treated with Jinye Baidu granule, and the control group will be treated with Fufang Shuanghua granule. The primary outcome measure will be body temperature recovery time for patients with fever, throat symptom score for patients with a swollen and sore throat, and body temperature recovery time and throat symptom score for patients with combined fever plus a swollen and sore throat. Routine blood testing, urine testing, liver function, kidney function and ECG data of all patients will be collected as safety indices before and after enrollment, and adverse events will be recorded during the whole trial course.CONCLUSION: This study protocol will include stratified block analysis according to patients' symptoms, and identify the accurate clinical indications of Jinye Baidu granule. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment.
