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Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine

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Journal of Integrative Medicine 2021年第5期19卷 389-394页

作者： Rui-jin Qiu Min Li Jia-yuan Hu Jing Chen hong-cai shang Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing Dongzhimen HospitalBeijing University of Chinese MedicineBeijing 100700China The Third Affiliated Hospital Beijing University of Chinese MedicineBeijing 100029China Dermatology Department Beijing Hospital of Traditional Chinese MedicineBeijing 100010China Department of Health Care Baokang HospitalTianjin University of Traditional Chinese MedicineTianjin 300193China

Clinical trial outcome reporting differs between studies integrating traditional Chinese medicine(TCM)and Western medicine, so that some clinical trials are not eligible for inclusion in a systematic *** excluded studies are therefore less widely disseminated, and even valid studies are less likely to yield impact. This problem may be addressed by developing core outcome sets(COSs) for integrative medicine in specific healthcare areas. The first stage of development is to define the scope of the COS for integrative medicine, the second stage is to establish the need for such a COS, and the third stage is to develop a protocol and register the COS. The final stage involves three steps:(i) development of a comprehensive list of outcomes(including efficacy outcomes and safety outcomes and TCM syndromes) using systematic review, qualitative or cross-sectional research, and reviews of package inserts and medical records;(ii) merging and grouping of outcomes within domains;(iii) conducting two rounds of Delphi survey and consensus meetings with a range of stakeholders. The final COS will include a general COS and core TCM syndrome-set. Development of COSs for clinical trials of integrative medicine may help to standardize outcome reporting and reduce publication bias in the future.

关键词： Clinical trials Outcome assessment Traditional Chinese medicine Integrative medicine Methodology

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Evaluating the methodology of studies conducted during the global COVID-19 pandemic: A systematic review of randomized controlled trials

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Journal of Integrative Medicine 2021年第4期19卷 317-326页

作者： Meng-zhu Zhao Chen Zhao Shuang-shuang Tu Xu-xu Wei hong-cai shang Department of Cardiology First Teaching Hospital of Tianjin University of Traditional Chinese MedicineTianjin 300381China National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion Tianjin 300381China Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical SciencesBeijing 100700China Editorial Department of Journals Tianjin University of Traditional Chinese MedicineTianjin 301617China Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing Dongzhimen Hospital Affiliated to Beijing University of Chinese MedicineBeijing 100700China International Evidence-based Research Institute of Chinese Medicine Beijing University of Chinese MedicineBeijing 100029China

Background: The therapeutic evidence collected from well-designed studies is needed to help manage the global pandemic of the coronavirus disease 2019(COVID-19). Evaluating the quality of therapeutic data collected during this most recent pandemic is important for improving future clinical research under similar ***: To assess the methodological quality and variability in implementation of randomized controlled trials(RCTs) for treating COVID-19, and to analyze the support that should be provided to improve data collected during an urgent pandemic *** strategy: Pub Med, Excerpta Medica Database, China National Knowledge Infrastructure, Wanfang,and Chongqing VIP, and the preprint repositories including Social Science Research Network and Med Rxiv were systematically searched, up to September 30, 2020, using the keywords "coronavirus disease 2019(COVID-19)," "2019 novel coronavirus(2019-n Co V)," "severe acute respiratory syndrome-related coronavirus-2(SARS-Co V-2)," "novel coronavirus pneumonia(NCP)," "randomized controlled trial(RCT)" and "random."Inclusion criteria: RCTs studying the treatment of COVID-19 were eligible for *** extraction and analysis: Screening of published RCTs for inclusion and data extraction were each conducted by two researchers. Analysis of general information on COVID-19 RCTs was done using descriptive statistics. Methodological quality was assessed using the risk-of-bias tools in the Cochrane Handbook for Systematic Reviews of Interventions(Version 5.1.0). Variability in implementation was assessed by comparing consistency between RCT reports and registration ***: A total of 5886 COVID-19 RCTs were identified. Eighty-one RCTs were finally included, of which,45 had registration information. Methodological quality of the RTCs was not optimal due to deficiencies in five main domains: allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomp

关键词： COVID-19 Randomized controlled trial Therapeutic evidence Methodology Systematic review

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Xuebijing injection,a Chinese patent medicine,against severe pneumonia:Current research progress and future perspectives

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Journal of Integrative Medicine 2023年第5期21卷 413-422页

作者： Mei Zhang Rui Zheng Wen-jing Liu Jun-ling Hou Yu-lei Yang hong-cai shang School of Chinese Materia Medica Beijing University of Chinese MedicineBeijing 102488China Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing Dongzhimen HospitalBeijing University of Chinese MedicineBeijing 100700China Department of Health Research Methods Evidenceand ImpactMcMaster UniversityHamilton L8S 4K1Canada

Severe pneumonia is one of the most common infectious diseases and the leading cause of sepsis and septic *** infection,balancing the patient’s immune status,and anti-coagulation therapy are all important elements in the treatment of severe *** multi-target agents,Xuebijing injection(XBJ)has shown unique advantages in targeting complex conditions and saving the lives of patients with severe *** review outlines progress in the understanding of XBJ’s anti-inflammatory,endotoxin antagonism,and anticoagulation *** the hundreds of publications released over the past few years,the key results from representative clinical studies of XBJ in the treatment of severe pneumonia were selected and *** was observed to effectively suppress the release of pro-inflammatory cytokines,counter the effects of endotoxin,and assert an anticoagulation effect in most clinical trials,which are consistent with experimental ***,this evidence suggests that XBJ could play an important and expanding role in clinical medicine,especially for sepsis,septic shock and severe pneumonia.

关键词： Xuebijing injection Severepneumonia Pneumonia,bacterial Pneumonia,viral Treatmentmechanism Clinical trial

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Comprehensive Comparison and Analysis of the Prevention and Treatment of Coronavirus Disease 2019 and Severe Acute Respiratory Syndrome with Traditional Chinese Medicine

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World Journal of Traditional Chinese Medicine 2020年第2期6卷 124-131页

作者： Ying Chen Jing-Jing Zhang Yan Liu hong-cai shang Key Laboratory of Chinese Internal Medicine of Ministry of Education Dongzhimen HospitalBeijing University of Chinese MedicineBeijing 100700China First Clinical Medical College Beijing University of Chinese MedicineBeijingChina

Since December 2019 the Coronavirus Disease 2019(COVID-19)has erupted in many places around the world,which is strong infectious and highly *** the outbreak of COVID-19 in China,traditional Chinese medicine(TCM)has been in the front line of the fight against the *** has shown characteristics and advantages in the prevention and treatment of *** also played an important role in the winter of 2002 and in the spring of 2003 during the outbreak of severe acute respiratory syndrome(SARS).This article compares the strategies,programs,measures,resource investments,and effects of TCM for the prevention and treatment of COVID-19 with those for *** present,the involvement of TCM has been earlier,faster,and more comprehensive in the fight against the epidemic and has shown good clinical efficacy and treatment prospects.

关键词： Coronavirus disease 2019 prevention and treatment of traditional Chinese medicine severe acute respiratory syndrome

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Traditional Chinese Medicine in the New Era——New Year Message 2019

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TMR Modern Herbal Medicine 2019年第1期2卷 1-2页

作者： hong-cai shang Editor-in-Chief Beijing University of Chinese Medicine Beijing China

The past year of 2018 is destined to be extraordinary for traditional Chinese medicine(TCM)over her profound history of forming and *** witnessed for the first time the World Heath Organization’s(WHO)move to include traditional medicine(TCM inclusive)in the list of the International Classification of Diseases(ICD-11),which is a really positive step recognizing traditional Chinese *** exciting is in the 2019 first issue,the National Geographic Magazine commented on how ancient remedies are changing modern medicine,and acknowledged China as one of the Nations possessing the oldest continuous accumulations of documented medical observations,which offers the biggest trove for scientists to sift through.

关键词：中医药事业国际疾病分类世界卫生组织中医药现代化中医药学医学体系医学观察现代医学

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Efficacy and safety of transhepatic arterial chemoembolization with drug-loaded microspheres in unresectable primary liver cancer

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World Journal of Gastrointestinal Oncology 2024年第12期16卷 4728-4737页

作者： Jun Deng Yan-hong Mi Le Xie Xiong-Xing Sun Dan-hong Liu Hua-Jun Long Li-Yong He Da-Hua Wu hong-cai shang Department of Integrated Traditional Chinese and Western Medicine Hunan University of Traditional Chinese MedicineChangsha 410208Hunan ProvinceChina Department of Neurology Hunan Provincial Hospital of Integrated Traditional Chinese and Western MedicineChangsha 410208Hunan ProvinceChina Department of Prevention Diseases Hunan Provincial Hospital of Integrated Traditional Chinese and Western MedicineChangsha 410006Hunan ProvinceChina Institute of Clinical Pharmacology of Traditional Chinese Medicine Hunan Provincial Hospital of Integrated Traditional Chinese and Western MedicineChangsha 410006Hunan ProvinceChina Department of Emergency Hunan Provincial Hospital of Integrated Traditional Chinese and Western MedicineChangsha 410006Hunan ProvinceChina Department of Hepatobiliary Surgery The First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou 510062Guangdong ProvinceChina State Key Laboratory of Internal Medicine of Traditional Chinese Medicine Beijing University of Chinese MedicineBeijing 100700China

BACKGROUND Transhepatic arterial chemoembolization(TACE),as a local treatment,has been widely used in the treatment of unresectable liver *** introduction of drug carrier microspheres has brought new hope for the therapeutic effect of *** can realize the slow release and directional delivery of drugs,reduce systemic toxicity and improve local curative *** To compare the effectiveness of traditional transcatheter arterial chemoembolization against microsphere-assisted transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma that is *** We searched the PubMed,Embase,Cochrane Library,and CNKI databases for clinical trials of drug-luting beads TACE(DEB-TACE)vs conventional TACE(cTACE)for the treatment of unresectable liver *** screened references based on inclusion and exclusion criteria and then selected valid data for meta-analysis using RevMan 53 *** complete response(CR)rate,partial response(PR)rate,postoperative stable disease(SD)rate,and 6-month and 12-month survival rates were *** A total of 12 articles were included,including 1177 patients,519 of whom received DEB-TACE and 658 of whom received *** CR rate in the DEB-TACE group was much greater than that in the cTACE group[relative risk(RR)=1.42,95%CI:1.18-1.72,P=0.0002].The 12-month survival rate significantly increased(RR=1.09;95%CI:1.01-1.17,P=0.03);the PR rate(RR=1.13;95%CI:0.97-1.30,P=0.12);the SD rate(RR=0.82;95%CI:0.64-1.05,P=0.12);and the 6-month survival rate(RR=1.05;95%CI:1.00-1.10,P=0.07).There was no significant difference(P<0.05).CONCLUSION Compared with those of iodized oil TACE,the drug-loaded microspheres tended to have therapeutic advantages.

关键词： Transhepatic arterial chemoembolization Drug-loaded microspheres Unresectable primary liver cancer Metaanalysis

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Clinical evaluation of Xiaoyao Jieyu prescription in the treatment of persistent postural-perceptual dizziness

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TMR Modern Herbal Medicine 2018年第2期1卷 18-27页

作者： shang-Yi Yang hong-cai shang Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine of Hebei University of Chinese Medicine Hebei China Beijing University of Chinese Medicine Beijing China

Objective： The objective of this study is to evaluate the clinical efficacy of Xiaoyao Jieyu prescription （XJP） in the treatment of persistent postural-perceptual dizziness （PPPD）. Methods： A total of 33 PPPD patients were randomly divided into test group and control group. Two groups of patients were given psychological treatment. The test group was given XJP and the control group was given escitalopram. The course of treatment was 12 weeks. Before and after 4 weeks and 8 weeks and 12 weeks, the dizziness handicap inventory （DHI）, Hamilton anxiety scale （HAMA） and Hamilton Depression scale （HAMD） were used to evaluate the treatment effect. Results： The total scores of HAMA, HAMD, DHI and the respective factor scores of DHI significantly decreased in both groups after 4 weeks of treatment compared with those before the treatment （P 〈 0.01）. The DHI scores and the score of function, physiology at 8-week, 12-week, as well as the HAMA and HAMD scores at 4-week, 8-week, 12-week in the test group were significantly lower than those in the control group （P 〈 0.05）. The incidence of adverse reactions in the test group was significantly lower than the control group （P 〈 0.05）. Conclusion： XJP can improve the clinical symptoms of patients with PPPD. It can both improve the physical and functional symptoms of PPPD and reduce anxiety and depression. In the course of treatment, the adverse reaction of the prescription is less and mild. It has the advantages of high efficiency, safety, low price and easy access to materials.

关键词： Chronic subjective dizziness Persistent postural-perceptual dizziness Xiaoyao Jieyu prescription Anxiety Depression

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Standardizing Individualized Efficacy Evaluation to Optimize Evidence-Using Pattern in Traditional Chinese Medicine-Preliminarily Establishing Traditional Chinese Medicine Evidence-based Case Reporting System

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World Journal of Traditional Chinese Medicine 2016年第4期2卷 49-54页

作者： Chen Zhao Zhi Liu Jia Lin Yan-Ping Wang Yong-Yan Wang hong-cai shang Tianjin University of Traditional Chinese Medicine Tianjin 300193 China Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Beijing 100700 China Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing Dongzhimen Hospital Beijing University of Chinese MedicineBeijing 100700 China

Individualized treatment is a basic feature of Traditional Chinese Medicine(TCM), and individualized efficacy evaluation is also emphasized in TCM clinical practice. Individualized evaluation is in favor of improving intervention continuously, and optimizing the TCM evidenceusing pattern gradually. Traditional case reports can better demonstrate the efficacy of individual, but lack of standardized design, making such evidence show a lower quality. Meanings, objectives and design elements of TCM individualized evaluation were discussed in this *** based on the original work, design ideas and framework of TCM evidence-based case reporting system were established *** work will improve the methodology of TCM individualized evaluation to realize the goal of optimizing TCM clinical evidence-using pattern.

关键词： Individualized evaluation Transformation and using of evidence TCM evidence-based case report system Standardization

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Blood stasis syndrome:clinical multi-omics research and related problems

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TMR Modern Herbal Medicine 2022年第1期5卷 60-70页

作者： Min Li Rui-Jin Qiu hong-cai shang Department of Cardiology Beijing University of Chinese Medicine Third Affiliated HospitalBeijing100029China Key laboratory of Chinese Internal Medicine of Ministry of Education and Beijing Dongzhimen HospitalBeijing University of Chinese MedicineBeijingChina

Multi-omics is a biological analysis approach in which the data sets are multiple"omics",such as genomics,transcriptomics,proteomics,*** can be used in the detection,diagnosis,treatment,and prognosis of diseases as a kind of potential *** stasis syndrome(BSS)is a common syndrome in traditional Chinese medicine(TCM).Multi-omics can reflect the change of BSS as a ***,the purpose of this manuscript was to fully review the clinical multi-omics research and related problems of *** found that the multi-omics of BSS reflected many pathophysiological processes through regulating vascular endothelial cells,vasodilation and contraction,oxidative stress,thrombosis,angiogenesis,platelet aggregation,lipid metabolism,inflammatory response,immune and coagulation function,energy balance,amino acid metabolism,and so *** potential biomarkers of BSS were found in multi-omics and some promoting blood circulation Chinese medicines(PBCCMs)could well regulate the abnormal biomarkers and make them return to the normal level.

关键词： Blood stasis syndrome Multi-omics Genomics Transcriptomics Proteomics Metabolomics

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Effect of rosuvastatin on expression of angiotensin Ⅱ receptors in rat aortic endothelium after balloon injury

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South China Journal of Cardiology 2011年第1期12卷 49-55页

作者： LIU Ping LI Yong-hong cai shang-lang Affiliated Hospital of Qingdao University Medical College ofCardiology Qingdao 266003 China

Background It＇s established that Angiotensin Ⅱ and its receptors are involved in intimal hyperplasia after balloon injury and stent restenosis. Recent evidence also suggests that statins have some anti-intimal hyperplasia effects. In this study, the effect of Rosuvastatin on expression of angiotensin Ⅱ receptors in rat aortic endothelium after balloon injury is therefore investigated. Methods All 52 Wistar Kyoto rats were established to aorta injury models by 2F balloon catheter, then were randomly divided into sham operation group, aorta injury group and Rosuvastatin-treatment group. After 14 days, the aortic specimens of the animals were harvested and performed immunohistochemistry and determination of molecular biology. Results The results showed that （i） The 14 days-balloon injury induced obvious intima thickening （P 〈 0.01）, however, the phenomenon was reduced by 14 daystreatment with Rosuvastatin （P 〈 0.01）. （ii） The expressions of angiotention Ⅱ type Ⅰ （AT1） and type Ⅱ （AT2） receptor mRNA and protein were markedly up-regulated by the balloon injury （P 〈 0.01）, after 14 days-treatment with Rosuvastatin, the expression of AT1 receptor mRNA and its protein was decreased （P 〈 0.01）, but the expression of AT2 receptor mRNA and its protein was further increased （P 〈 0.05）. Conclusion In this study, we observed that the balloon injury induced-intima thickening was reduced by Rosuvastatin in rats, which might be linked with the regulation of expression of angiotensin Ⅱ receptors.

关键词： rosuvastatin balloon injury angiotention Ⅱ receptor

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