BACKGROUND Mild cognitive impairment(MCI)and subjective cognitive decline(SCD)are risk indicators for dementia and require ongoing management.Traditional Korean medicine(TKM)commonly employs acupuncture and herbal med...BACKGROUND Mild cognitive impairment(MCI)and subjective cognitive decline(SCD)are risk indicators for dementia and require ongoing management.Traditional Korean medicine(TKM)commonly employs acupuncture and herbal medicine for cognitive impairment;yet,clinical research on acupotomy is lacking.Although most TKM treatments occur in primary care,the research is largely hospital-based.This registry was established to systematically collect real-world data on the clinical progress,efficacy,and safety of TKM with acupotomy for patients with MCI or SCD in primary care.It is hypothesized that TKM with acupotomy improves cognitive function and is safe for these patients.AIM To establish an MCI or SCD registry of patients receiving TKM,including acupotomy,to analyze its clinical efficacy and safety.METHODS This observational registry study will be conducted across 22 medical institutions;approximately 500 participants will be recruited.Data—sociodemographic information,medication history,height,weight,vital signs,and assessment questionnaires(Montreal Cognitive Assessment-Korean,short form of Korean-Everyday Cognition,Numeric Rating Scale,Korean version of the Insomnia Severity Index)—will be collected at 3-month intervals over a year.This study will also document the TKM treatment administered and any adverse events.Routine TKM procedures will be followed,with acupuncture and acupotomy administered as per protocol;treatments including herbal medicine,Chuna therapy,and moxibustion may be administered at the practitioner’s discretion.RESULTS The registry will capture a wide range of real-world clinical data regarding demographic profiles,treatment processes,and adverse events.This detailed documentation is expected to clarify patient characteristics,evaluate the clinical course,and identify factors that may affect cognitive improvement in patients with MCI and SCD.CONCLUSION This research may provide evidence supporting acupotomy for cognitive impairment in primary care by confirming its efficacy and safety,providing preliminary evidence for TKM-based interventions aimed at improving cognitive function.展开更多
Background: Coronary artery disease (CAD) is the commonest cause of heart failure (HF), whereas pulmonary hypertension (PH) has not been established or reported in this patient population. Therefore, we assessed the p...Background: Coronary artery disease (CAD) is the commonest cause of heart failure (HF), whereas pulmonary hypertension (PH) has not been established or reported in this patient population. Therefore, we assessed the prevalence, risk factors, and survival in CAD-associated HF (CAD-HF) complicated with PH.Methods: Symptomatic CAD-HF patients were continuously enrolled in this prospective, multicenter registry study. Echocardiography, coronary arteriography, left and right heart catheterization (RHC), and other baseline clinical data were recorded. Patients were followed up and their survival was recorded.Results: One hundred and eighty-two CAD-HF patients were enrolled, including 142 with HF with a preserved ejection fraction (heart failure with preserved ejection fraction [HFpEF];left ventricular ejection fraction [LVEF] ≥50%) and 40 with a reduced ejection fraction (heart failure with reduced ejection fraction [HFrEF];LVEF < 50%). PH was diagnosed with RHC in 77.5% of patients. Patients with PH showed worse hemodynamic parameters and higher mortality. HFrEF-PH patients had worse survival than HFpEF-PH patients. CAD-HF patients with an enlarged left ventricular end-diastolic diameter and reduced hemoglobin were at higher risk of PH. Nitrate treatment reduced the risk of PH. Elevated creatinine and mean pulmonary arterial pressure (mPAP), diastolic pressure gradient (DPG) ≥7 mmHg, and previous myocardial infarction (MI) entailed a higher risk of mortality in CAD-HF patients with PH.Conclusions: PH is common in CAD-HF and worsens the hemodynamics and survival in these patients. Left ventricle enlargement and anemia increase the risk of PH in CAD-HF. Patients may benefit from nitrate medications. Renal impairment, elevated mPAP, DPG ≥7 mmHg, and previous MI are strong predictors of mortality in CAD-HF-PH patients.Trial Registration: ClinicalTrials.gov, NCT02164526.展开更多
The impact of evidence-based medicine and clinical epidemiology on clinical research has contributed to the development of Chinese medicine in modem times over the past two decades.Many concepts and methods of modem s...The impact of evidence-based medicine and clinical epidemiology on clinical research has contributed to the development of Chinese medicine in modem times over the past two decades.Many concepts and methods of modem science and technology are emerging in Chinese medicine research,resulting in constant progress.Systematic reviews,randomized controlled trials and other advanced mathematic approaches and statistical analysis methods have brought reform to Chinese medicine.In this new era,Chinese medicine researchers have many opportunities and challenges.On the one hand,Chinese medicine researchers need to dedicate themselves to providing enough evidence to the world through rigorous studies,whilst on the other hand,they also need to keep up with the speed of modem medicine research.For example,recently,real world study,comparative effectiveness research,propensity score techniques and registry study have emerged.This article aims to inspire Chinese medicine researchers to explore new areas by introducing these new ideas and new techniques.展开更多
Objective To investigate the changes of home blood pressure from weekdays to weekends and its influencingfactors.Methods This study was a national multicenter prospective registry study.Data came from the registry stu...Objective To investigate the changes of home blood pressure from weekdays to weekends and its influencingfactors.Methods This study was a national multicenter prospective registry study.Data came from the registry study on the"Action of controlling home blood pressure to target in ten thousand patients".展开更多
Background Recent studies have showed that the fine mesh stents are associated with a significant reduction in both clinical and angiographic re-stenosis of the coronary arteries. To maintain a very satisfactory radio...Background Recent studies have showed that the fine mesh stents are associated with a significant reduction in both clinical and angiographic re-stenosis of the coronary arteries. To maintain a very satisfactory radio-opacity using the stents, Guidant of the USA has designed a new type of bare metal stents （BMS）-Multi-link （ML） Vision / ML MiniVision stents. The clinical outcomes of Asian patients with coronary artery disease （CAD） after implanting the Multi-link Vision or MiniVision stent were investigated in this study. Methods An observational, prospective, multi-center, non-randomized post marketing registry was conducted to demonstrate the efficacy of the BMS- ML Vision / ML MiniVision stents. The primary end point of the registry was clinical target lesion revascularization （TLR） at a 6-month follow-up. The major secondary end points included the rate of major adverse cardiac events （MACE） and serious adverse events （SAE） in hospital and at 6 months; and the rate of clinical TLR as a function of the type of angina. A total of 429 Asian people with 449 lesions from 14 centers were selected for this study, The average reference diameter of the lesions was （3.0±0.5） mm, and the mean length was （15.7±5.0） mm. Results The successful rate of the procedure was 99.3%. Twenty-five percent of the lesions were treated by direct stenting without pre-dilation. Eighty-six percent of the lesions were implanted with ML Vision stent. After the 6-month follow-up, the rate of clinical TLR was 1.4%. The MACE, SAE and target vessel revascularization （TVR） were 6.8%, 3.5% and 1.4% respectively. Conclusion The current registry showed the excellent 6-month clinical outcomes of ML Vision/ML MiniVision stents in Asian patients with CAD.展开更多
Objective To evaluate the prevalence,potential risk factors,and correlation between coronary and peripheral microvascular dysfunction in heart failure with nonreduced ejection fraction(nHFrEF)patients.Methods This was...Objective To evaluate the prevalence,potential risk factors,and correlation between coronary and peripheral microvascular dysfunction in heart failure with nonreduced ejection fraction(nHFrEF)patients.Methods This was a prospective registry study.nHFrEF patients admitted to Zhongshan Hospital affiliated with Fudan University from December 2021 to December 2023 were enrolled.According to coronary flow reserve(CFR)or reactive congestion index(RHI),enrolled patients were divided into coronary microvascular endothelial dysfunction(CMD)group(CFR<2.5)and no CMD group(CFR≥2.5)or peripheral microvascular endothelial dysfunction(MED)group(RHI<1.67)and no MED group(RHI≥1.67).Patients'general information,laboratory and auxiliary examination data were collected.Univariate and multivariate logistic regression were used to analyze the influencing factors of CMD and MED in nHFrEF patients,and Spearman correlation analysis was used to evaluate the correlation between MED and CMD.Results A total of 142 nHFrEF patients were enrolled,aged 69.0(59.0,74.0)years,with a male proportion of 66.9%(95/142).The grouping results were as follows:(1)According to CFR,there were 73 cases in the CMD group and 69 cases in the no CMD group;(2)According to RHI,there were 57 cases in the MED group and 85 cases in the no MED group.The prevalence of CMD and MED in this study was 51.4%(73/142)and 40.1%(57/142),respectively.Univariate logistic regression analysis showed that increased heart rate,chronic kidney disease,atrial fibrillation,elevated N-terminal pro-B type natriuretic peptide levels,and increased urinary albumin/creatinine ratio were risk factors for CMD,while increased RHI was a protective factor for CMD;Atrial fibrillation is a risk factor for MED,while increased CFR isa protectivefactor for MED.Incorporating clinically significant variables from univariate analysis into multivariate analysis,the results showed that increased heart rate and elevated RHI remained risk and protective factors for CMD,respectively;increased CFR remains a protective factor for MED.Spearman correlation analysis showed that CFR was negatively correlated with lg urinary albumin/creatinine ratio,lg cardiac troponin T,lg N-terminal pro-B type natriuretic peptide,and heart rate;RHI is positively correlated with CFR.Conclusion The prevalence of CMD and MED in nHFrEF patients is high,and the two have a certain positive correlation.Increased heart rate and RHI are risk and protective factors for CMD,respectively,while increased CFR is a protective factor for MED.MED may be a potential therapeutic target for nHFrEF patients.展开更多
Increasing emphasis has been placed on registries for an organized system used in developing clinical research to improve health care. China has sufficient data that can be applied broadly, but the heterogeneity and i...Increasing emphasis has been placed on registries for an organized system used in developing clinical research to improve health care. China has sufficient data that can be applied broadly, but the heterogeneity and irregularity of registries limit their applicability. This article aims to describe the status of registries in China and the related challenges. Patient registries for observational studies were retrieved from the International Clinical Trials Registry to quantitatively evaluate the number of comparatively high-quality registries in China. A literature search was also performed to provide support and updates. A total of 64 patient registries were retrieved from ClinicalTrials.gov using disease, product, and health service as criteria. The sample sizes ranged from 15 to 30 400, with only 12 registries marked as completed. This article describes and compares the detailed information in many aspects. The efficient use of registries has already made considerable progress in China; however, registries still require standardization, high-quality transition, and coordinated development.展开更多
基金Supported by The Korea Health Technology Project through the Korea Health Industry Development Institute,funded by the Ministry of Health and Welfare,Republic of Korea,No.RS-2023-KH138802.
文摘BACKGROUND Mild cognitive impairment(MCI)and subjective cognitive decline(SCD)are risk indicators for dementia and require ongoing management.Traditional Korean medicine(TKM)commonly employs acupuncture and herbal medicine for cognitive impairment;yet,clinical research on acupotomy is lacking.Although most TKM treatments occur in primary care,the research is largely hospital-based.This registry was established to systematically collect real-world data on the clinical progress,efficacy,and safety of TKM with acupotomy for patients with MCI or SCD in primary care.It is hypothesized that TKM with acupotomy improves cognitive function and is safe for these patients.AIM To establish an MCI or SCD registry of patients receiving TKM,including acupotomy,to analyze its clinical efficacy and safety.METHODS This observational registry study will be conducted across 22 medical institutions;approximately 500 participants will be recruited.Data—sociodemographic information,medication history,height,weight,vital signs,and assessment questionnaires(Montreal Cognitive Assessment-Korean,short form of Korean-Everyday Cognition,Numeric Rating Scale,Korean version of the Insomnia Severity Index)—will be collected at 3-month intervals over a year.This study will also document the TKM treatment administered and any adverse events.Routine TKM procedures will be followed,with acupuncture and acupotomy administered as per protocol;treatments including herbal medicine,Chuna therapy,and moxibustion may be administered at the practitioner’s discretion.RESULTS The registry will capture a wide range of real-world clinical data regarding demographic profiles,treatment processes,and adverse events.This detailed documentation is expected to clarify patient characteristics,evaluate the clinical course,and identify factors that may affect cognitive improvement in patients with MCI and SCD.CONCLUSION This research may provide evidence supporting acupotomy for cognitive impairment in primary care by confirming its efficacy and safety,providing preliminary evidence for TKM-based interventions aimed at improving cognitive function.
基金National Key Technology R&D Program of China(No. 2011BAI11B15)National Key Research and Development Program of China(No. 2016YFC1304400)。
文摘Background: Coronary artery disease (CAD) is the commonest cause of heart failure (HF), whereas pulmonary hypertension (PH) has not been established or reported in this patient population. Therefore, we assessed the prevalence, risk factors, and survival in CAD-associated HF (CAD-HF) complicated with PH.Methods: Symptomatic CAD-HF patients were continuously enrolled in this prospective, multicenter registry study. Echocardiography, coronary arteriography, left and right heart catheterization (RHC), and other baseline clinical data were recorded. Patients were followed up and their survival was recorded.Results: One hundred and eighty-two CAD-HF patients were enrolled, including 142 with HF with a preserved ejection fraction (heart failure with preserved ejection fraction [HFpEF];left ventricular ejection fraction [LVEF] ≥50%) and 40 with a reduced ejection fraction (heart failure with reduced ejection fraction [HFrEF];LVEF < 50%). PH was diagnosed with RHC in 77.5% of patients. Patients with PH showed worse hemodynamic parameters and higher mortality. HFrEF-PH patients had worse survival than HFpEF-PH patients. CAD-HF patients with an enlarged left ventricular end-diastolic diameter and reduced hemoglobin were at higher risk of PH. Nitrate treatment reduced the risk of PH. Elevated creatinine and mean pulmonary arterial pressure (mPAP), diastolic pressure gradient (DPG) ≥7 mmHg, and previous myocardial infarction (MI) entailed a higher risk of mortality in CAD-HF patients with PH.Conclusions: PH is common in CAD-HF and worsens the hemodynamics and survival in these patients. Left ventricle enlargement and anemia increase the risk of PH in CAD-HF. Patients may benefit from nitrate medications. Renal impairment, elevated mPAP, DPG ≥7 mmHg, and previous MI are strong predictors of mortality in CAD-HF-PH patients.Trial Registration: ClinicalTrials.gov, NCT02164526.
基金Supported by National Natural Science Foundation of China(No.81202776)the Seventh-Science Foundation of China Academy of Chinese Medical Sciences(No.ZZ070817)the Sixth-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(No.Z0215)
文摘The impact of evidence-based medicine and clinical epidemiology on clinical research has contributed to the development of Chinese medicine in modem times over the past two decades.Many concepts and methods of modem science and technology are emerging in Chinese medicine research,resulting in constant progress.Systematic reviews,randomized controlled trials and other advanced mathematic approaches and statistical analysis methods have brought reform to Chinese medicine.In this new era,Chinese medicine researchers have many opportunities and challenges.On the one hand,Chinese medicine researchers need to dedicate themselves to providing enough evidence to the world through rigorous studies,whilst on the other hand,they also need to keep up with the speed of modem medicine research.For example,recently,real world study,comparative effectiveness research,propensity score techniques and registry study have emerged.This article aims to inspire Chinese medicine researchers to explore new areas by introducing these new ideas and new techniques.
文摘Objective To investigate the changes of home blood pressure from weekdays to weekends and its influencingfactors.Methods This study was a national multicenter prospective registry study.Data came from the registry study on the"Action of controlling home blood pressure to target in ten thousand patients".
文摘Background Recent studies have showed that the fine mesh stents are associated with a significant reduction in both clinical and angiographic re-stenosis of the coronary arteries. To maintain a very satisfactory radio-opacity using the stents, Guidant of the USA has designed a new type of bare metal stents （BMS）-Multi-link （ML） Vision / ML MiniVision stents. The clinical outcomes of Asian patients with coronary artery disease （CAD） after implanting the Multi-link Vision or MiniVision stent were investigated in this study. Methods An observational, prospective, multi-center, non-randomized post marketing registry was conducted to demonstrate the efficacy of the BMS- ML Vision / ML MiniVision stents. The primary end point of the registry was clinical target lesion revascularization （TLR） at a 6-month follow-up. The major secondary end points included the rate of major adverse cardiac events （MACE） and serious adverse events （SAE） in hospital and at 6 months; and the rate of clinical TLR as a function of the type of angina. A total of 429 Asian people with 449 lesions from 14 centers were selected for this study, The average reference diameter of the lesions was （3.0±0.5） mm, and the mean length was （15.7±5.0） mm. Results The successful rate of the procedure was 99.3%. Twenty-five percent of the lesions were treated by direct stenting without pre-dilation. Eighty-six percent of the lesions were implanted with ML Vision stent. After the 6-month follow-up, the rate of clinical TLR was 1.4%. The MACE, SAE and target vessel revascularization （TVR） were 6.8%, 3.5% and 1.4% respectively. Conclusion The current registry showed the excellent 6-month clinical outcomes of ML Vision/ML MiniVision stents in Asian patients with CAD.
文摘Objective To evaluate the prevalence,potential risk factors,and correlation between coronary and peripheral microvascular dysfunction in heart failure with nonreduced ejection fraction(nHFrEF)patients.Methods This was a prospective registry study.nHFrEF patients admitted to Zhongshan Hospital affiliated with Fudan University from December 2021 to December 2023 were enrolled.According to coronary flow reserve(CFR)or reactive congestion index(RHI),enrolled patients were divided into coronary microvascular endothelial dysfunction(CMD)group(CFR<2.5)and no CMD group(CFR≥2.5)or peripheral microvascular endothelial dysfunction(MED)group(RHI<1.67)and no MED group(RHI≥1.67).Patients'general information,laboratory and auxiliary examination data were collected.Univariate and multivariate logistic regression were used to analyze the influencing factors of CMD and MED in nHFrEF patients,and Spearman correlation analysis was used to evaluate the correlation between MED and CMD.Results A total of 142 nHFrEF patients were enrolled,aged 69.0(59.0,74.0)years,with a male proportion of 66.9%(95/142).The grouping results were as follows:(1)According to CFR,there were 73 cases in the CMD group and 69 cases in the no CMD group;(2)According to RHI,there were 57 cases in the MED group and 85 cases in the no MED group.The prevalence of CMD and MED in this study was 51.4%(73/142)and 40.1%(57/142),respectively.Univariate logistic regression analysis showed that increased heart rate,chronic kidney disease,atrial fibrillation,elevated N-terminal pro-B type natriuretic peptide levels,and increased urinary albumin/creatinine ratio were risk factors for CMD,while increased RHI was a protective factor for CMD;Atrial fibrillation is a risk factor for MED,while increased CFR isa protectivefactor for MED.Incorporating clinically significant variables from univariate analysis into multivariate analysis,the results showed that increased heart rate and elevated RHI remained risk and protective factors for CMD,respectively;increased CFR remains a protective factor for MED.Spearman correlation analysis showed that CFR was negatively correlated with lg urinary albumin/creatinine ratio,lg cardiac troponin T,lg N-terminal pro-B type natriuretic peptide,and heart rate;RHI is positively correlated with CFR.Conclusion The prevalence of CMD and MED in nHFrEF patients is high,and the two have a certain positive correlation.Increased heart rate and RHI are risk and protective factors for CMD,respectively,while increased CFR is a protective factor for MED.MED may be a potential therapeutic target for nHFrEF patients.
文摘Increasing emphasis has been placed on registries for an organized system used in developing clinical research to improve health care. China has sufficient data that can be applied broadly, but the heterogeneity and irregularity of registries limit their applicability. This article aims to describe the status of registries in China and the related challenges. Patient registries for observational studies were retrieved from the International Clinical Trials Registry to quantitatively evaluate the number of comparatively high-quality registries in China. A literature search was also performed to provide support and updates. A total of 64 patient registries were retrieved from ClinicalTrials.gov using disease, product, and health service as criteria. The sample sizes ranged from 15 to 30 400, with only 12 registries marked as completed. This article describes and compares the detailed information in many aspects. The efficient use of registries has already made considerable progress in China; however, registries still require standardization, high-quality transition, and coordinated development.
