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safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery:A prospective,multicenter,single-arm clinical trial

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Journal of Interventional Medicine 2022年第3期5卷 143-147页

作者： Huan Liu Rufeng Jia Yanyan He Tengfei Zhou Liangfu Zhu Yonghong Ding Juha Antero Hernesniemi Tianxiao Li Yingkun He Department of Cerebrovascular Disease Zhengzhou University People's HospitalHenan University People's HospitalHenan Provincial People's HospitalHenan Provincial Neurointerventional Engineering Research CenterHenan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of CerebrovascularInterventionZhengzhou450003China Department of Radiology Mayo CliniRochesterMNUS “Juha Hernesniemi”International Center for Neurosurgery Henan Provincial People s HospitalZhengzhouChina

Objective:To evaluate the safety and efficacy of the SeparGateballoon-guiding catheter(BGC)for blocking flow and delivering devices in neurointerventional ***:This prospective multicenter single-arm trial enrolled patients who received BGC adjuvant therapy to provide temporary blood flow arrest of the supra-aortic arch arteries and their branch vessels in interventional *** primary endpoint was immediate procedural success rate in flow arrest,device delivery,and *** efficacy endpoints were intraoperative product performance,including rigidity,smoothness,fracture resistance of the catheter wall,catheter push performance,compatibility and radiopaque display,integrity,adhesion thrombus after withdrawal and balloon *** safety endpoints were adverse and serious adverse events associated with the test device and serious adverse events resulting in death or serious health ***:A total of 129 patients were included;of them,128 were analyzed in the full analysis set(FAS)and per protocol set(PPS).Immediate procedural success was achieved in 97.7%of patients with FAS and *** lower bound of the 95%confidence interval was 94.6%,higher than the preset efficacy margin of 94%.Device-related adverse events occurred in 2(1.6%)*** was mild adverse event of vasospasm,which resolved *** other was serious adverse event of dissection aggravation,which was treated with stenting *** device defects were ***:In neurointerventional surgery,the SeparGateBGC can be used to temporarily block the flow of the supra-aortic arch arteries and their branch vessels and guide the interventional device to the target vascular position.

关键词： SeparGateTM balloon guiding catheter safety and efficacy Neurointerventional surgery

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safety and efficacy of acute normovolemic hemodilution during liver surgery: a Meta-analysis

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Oncology and Translational Medicine 2019年第6期5卷 285-292页

作者： Ming Yang Jinlong Liu Department of Hepatobiliary Surgery Affiliated Hospital of Chengde Medical College

Objective The aim of this study was to evaluate the safety and efficacy of acute normovolemic hemodilution(ANH) during liver *** Structured searches of the Pub Med,Chinese Biological Medicine Database,and Cochrane Library electronic databases were performed,followed by a meta-analysis of outcomes,including intraoperative blood transfusion(s),intraoperative bleeding,postoperative hematocrit(Hct) levels,postoperative prothrombin time(PT),and number of patients who underwent transfusions during liver *** In total,14 eligible studies were included in the meta-analysis,which revealed that ANH for liver resection was associated with a reduction in intraoperative blood transfusions [weighted mean difference(WMD)-1.99;95% confidence interval(CI)-2.82 to -1.16;P<0.00001].The ANH group experienced less intraoperative bleeding(WMD -72.81;95% CI -136.12 to -9.50;P<0.00001) and exhibited a lower postoperative Hct level(WMD -3.38;95% CI -7.14 to -0.67;P<0.00001) than the control ***,meta-analysis revealed that postoperative prothrombin time was not affected by ANH(WMD -0.02;95% CI -0.18 to -0.32;P=0.65).Finally,the number of patients requiring allogeneic transfusion was significantly smaller in the ANH group than in the control group(odds ratio 0.13;95% CI 0.09 to 0.18;P=0.24).Conclusion Results of the present meta-analysis indicated that ANH can reduce intraoperative bleeding and the need for blood *** addition,ANH did not negatively affect the coagulation system after surgery;therefore,ANH appears to be safe and effective during liver surgery.

关键词： safety and efficacy acute normovolemic hemodilution(ANH) liver surgery meta-analysis

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Evaluation of safety and efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients： A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China

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Chinese Medical Journal 2016年第22期129卷 2659-2665页

作者： Mei-Xiang Xiang Dong-Qi Wang Jing Xu Zheng Zhang Jian-Xin Hu Dong-Mei Wang Xiang Gu He-Ping Liu Tao Guo Xiang-Jun Yang Feng Ling Jia-Feng Lin Shang-Lang Cai Guo-Bin Zhu Jian-An Wang Department of Cardiology Cardiovascular Key Laboratory of Zhejiang Province The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang 310009 China Department of Cardiology The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi 710061 China Department of Cardiology Tianjin Chest Hospital Tianjin 300051 China Department of Cardiology The First Hospital of Lanzhou University Lanzhou Gansu 730000 China Department of Cardiology The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi 330008 China Department of Cardiology Bethune International Peace Hospital of the Chinese PLA Shijiazhuang Hebei 050082 China Department of Cardiology Northern Jiangsu People's Hospital Yangzhou Jiangsu 225001 China Department of Cardiology Jilin Province People's Hospital Changchun Jilin 130021. China Department of Cardiology The First Affiliated Hospital of Kunming Medical University Kunming Yunnan 650032 China Department of Cardiology The First Affiliated Hospital of Suzhou University Suzhou Jiangsu 215006 China Department of Cardiology The First People's Hospital of Hangzhou Hangzhou Zhejiang 310006 China Department of Cardiology The Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang 325027 China Department of Cardiology The Affiliated Hospital of Qingdao University Medical College Qingdao Shandong 266003 China Department of Cardiology The Second Hospital of Shanxi Medical University Taiyuan Shanxi 030001 China

Background：High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia,and a domestically developed pacemaker will help lower the *** study aimed to evaluate the safety and efficacy ofQinming8631 DR （Qinming Medical,Baoji,China）,the first domestically developed dual-chamber pacemaker of China,compared with a commercially available pacemaker Talos DR （Biotronik,Berlin,Germany） in Chinese ***：A prospective randomized trial was conducted at 14 centers in *** were randomized into trial （Qinming8631 DR） and control （Talos DR） *** of the pacing systems were collected immediately after device implantation and during *** effective pacing rate at 6-month follow-up was recorded as the primary end *** properties,magnet response,single-and double-pole polarity conversion,rate response function,and adverse events of the pacing system were *** Cochran-Mantel-Haenszel Chi-square test,paired t-test,and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement ***：A total of 225 patients with a diagnosis ofbradyarrhythmia and eligible for this study were randomly enrolled into the trial （n =113） and control （n =112） *** underwent successful pacemaker implantation with acceptable postoperative pacing threshold and *** pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set （81.4% vs.79.5%,P =0.712 and 95.4% vs.89.5%,P =0.143,respectively）.In both data sets,noninferiority of the trial group was above the predefined noninferiority limit（-9.5%）.Conclusions：This study established the noninferiority ofQinming8631 DR to Talos *** safety and efficacy ofQinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

关键词： Bradyarrhythmia Cardiac Pacemaker Qinming8631 safety and efficacy

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Comparison of safety,efficacy,and long-term follow-up between“one-step”and“step-up”approaches for infected pancreatic necrosis

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World Journal of Gastrointestinal Surgery 2021年第11期13卷 1372-1389页

作者： Zhi Zheng Jiong-Di Lu Yi-Xuan Ding Yu-Lin Guo Wen-Tong Mei Yuan-Xu Qu Feng Cao Fei Li Department of General Surgery Xuanwu HospitalCapital Medical UniversityBeijing 100053China

BACKGROUND Although the“Step-up”strategy is the primary surgical treatment for infected pancreatic necrosis,it is not suitable for all such ***“One-step”strategy represents a novel treatment,but the safety,efficacy,and long-term follow-up have not yet been compared between these two *** To compare the safety,efficacy,and long-term follow-up of two surgical approaches to provide a reference for infected pancreatic necrosis *** This was a retrospective analysis of infectious pancreatic necrosis patients who underwent“One-step”or“Step-up”necrosectomy at Xuan Wu Hospital,Capital Medical University,from May 2014 to December *** primary outcome was the composite endpoint of severe complications or *** were followed up every 6 mo after discharge until death or June 30,*** analysis was performed using SPSS 21.0 and GraphPad Prism 8.0,and statistical significance was set at P<*** One-hundred-and-fifty-eight patients were enrolled,of whom 61 patients underwent“One-step”necrosectomy and 97 patients underwent“Step-up”*** the long-term follow-up period,40 patients in the“Onestep”group and 63 patients in the“Step-up”group *** time from disease onset to hospital admission(53.69±38.14 vs 32.20±20.75,P<0.001)and to initial surgical treatment was longer in the“Step-up”than in the“One-step”group(54.38±10.46 vs 76.58±17.03,P<0.001).Patients who underwent“Step up”necrosectomy had a longer hospitalization duration(65.41±28.14 vs 52.76±24.71,P=0.02),and more interventions(4.26±1.71 vs 3.18±1.39,P<0.001).Postoperative inflammatory indicator levels were significantly lower than preoperative levels in each *** the incisional hernia incidence was higher in the“One-step”group,no significant difference was found in the composite outcomes of severe complications or death,new-onset organ failure,postoperative complications,inflammatory indicators,long-term complications,quality of life,and

关键词： Acute pancreatitis Follow-up Infectious pancreatic necrosis safety and efficacy Surgical approach

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Complementary and Alternative Medicine Therapies for Chronic Pain

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Chinese Journal of Integrative Medicine 2016年第6期22卷 403-411页

作者： Brent A.Bauer Jon C.Tilburt Amit Sood 李光熙王师菡 Division of Complementary and Integrative Medicine Mayo Clinic Division of Pulmonary and Critical Care Medicine Mayo Clinic Guang'anmen Hospital China Academy of Chinese Medical Sciences Division of Cardiovascular Diseases Mayo Clinic

ABSTRACT Pain afflicts over 50 million people in the US, with 30.7% US adults suffering with chronic pain. Despite advances in therapies, many patients will continue to deal with ongoing symptoms that are not fully addressed by the best conventional medicine has to offer them. The patients frequently turn to therapies outside the usual purview of conventional medicine （herbs, acupuncture, meditation, etc.） called complementary and alternative medicine （CAM）. Academic and governmental groups are also starting to incorporate CAM recommendations into chronic pain management strategies. Thus, for any physician who care for patients with chronic pain, having some familiarity with these therapies--including risks and benefits--will be key to helping guide patients in making evidence-based, well informed decisions about whether or not to use such therapies. On the other hand, if a CAM therapy has evidence of both safety and efficacy then not making it available to a patient who is suffering does not meet the need of the patient. We summarize the current evidence of a wide variety of CAM modalities that have potential for helping patients with chronic pain in this article. The triad of chronic pain symptoms, ready access to information on the internet, and growing patient empowerment suggest that CAM therapies will remain a consistent part of the healthcare of patients dealing with chronic pain.

关键词： complementary and alternative medicine therapy chronic pain safety and efficacy

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Intelligent tunable CAR-T cell therapy leads the new trend

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Synthetic and Systems Biotechnology 2023年第4期8卷 606-609页

作者： Jiayi Cheng Mingyao Liu Jiqin Zhang Shanghai Frontiers Science Center of Genome Editing and Cell Therapy Shanghai Key Laboratory of Regulatory BiologyInstitute of Biomedical Sciences and School of Life SciencesEast China Normal UniversityShanghaiChina

Adoptive transfer of T cells engineered with chimeric antigen receptor(CAR)has been proved to have robust anti-tumor effects against hematological ***,problems about safety and efficacy,such as cytokine release syndrome(CRS),T cell exhaustion and antigen escape are still raised when patients are treated with CAR-T ***,CAR-T therapy has limited applications in treating solid tumors,owing to inefficient infiltration and poor functional persistence of CAR-T cells and diverse immunosuppression in tumor *** order to overcome these limitations and broad its applications,multiple controllable CAR-T technologies were *** this article,we review the designs of intelligent controlled CAR-T technologies and the innovations that they bring about in recent years.

关键词： Chimeric antigen receptor T Tumor safety and efficacy On and off systems Autologous universal system Synthetic notch system

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No evidence demonstrating hepatotoxicity associated with hydroxycitric acid

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World Journal of Gastroenterology 2009年第32期15卷 4087-4089页

作者： Sidney J Stohs Harry G Preuss Sunny E Ohia Gilbert R Kaats Carl L Keen Lonnie D Williams George A Burdock School of Pharmacy and Health Professions Creighton University Medical Center4967 Stillwater TrailFriscoTX 75034United States

Although a number of cases of hepatotoxicity are associated with the use of Hydroxycut weight management products, it has been alleged that their effects are primarily due to the presence of hydroxycitric acid (HCA, as Super CitriMax) in the formulations. However, while these products contain up to 20 different ingredients, some do not contain HCA. Case studies reported to date have not considered in depth the literature on the numerous animal and human studies that have been conducted on the safety and effi cacy of HCA. No HCA-associated hepatotoxicity or treatment-related adverse effects have been reported in these studies, and thus it is premature to make the assumptions presented in the recent case studies regarding Hydroxycut. If it is established in well controlled studies that the use of these formulations with and/or without HCA can result in the occurrence or progression of hepatotoxicity, additional studies should be conducted to characterize the causative factor(s).

关键词： Hydroxycitric acid Super CitriMax Hydroxycitric acid-SX Garcinia cambogia Hydroxycut Liver failure Hepatotoxicity safety and efficacy

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Regulatory perspectives of combination products

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Bioactive Materials 2022年第4期7卷 492-503页

作者： Jiaxin Tian Xu Song Yongqing Wang Maobo Cheng Shuang Lu Wei Xu Guobiao Gao Lei Sun Zhonglan Tang Minghui Wang Xingdong Zhang Center for Medical Device Evaluation National Medical Products AdministrationBeijingChina NMPA Key Laboratory for Quality Research and Control of Tissue Regenerative Biomaterial&Institute of Regulatory Science for Medical Devices&NMPA Research Base of Regulatory Science for Medical Devices Sichuan UniversityChengduChina National Engineering Research Center for Biomaterials&College of Biomedical Engineering Sichuan UniversityChengduChina Center for Drug Evaluation National Medical Products AdministrationBeijingChina

Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological *** product research and development,clinical translation as well as regulatory evaluation of combination products are complex and *** review firstly introduced the origin,definition and designation of combination *** areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then *** and clinical evaluation of combination products was ***,the research prospect of regulatory science for combination products was *** tools of computational modeling and simulation,novel technologies such as artificial intelligence,needs of developing new standards,evidence-based research methods,new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety,efficacy,quality and performance of combination *** together,the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

关键词： Combination products Definition Designation safety and efficacy Regulatory science

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The biological effect of recombinant humanized collagen on damaged skin induced by UV-photoaging:An in vivo study

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Bioactive Materials 2022年第5期7卷 154-165页

作者： Jing Wang He Qiu Yang Xu Yongli Gao Peijie Tan Rui Zhao Zhanhong Liu Yajun Tang Xiangdong Zhu Chongyun Bao Hang Wang Hai Lin Xingdong Zhang National Engineering Research Center for Biomaterials Sichuan UniversityChengduSichuan 610064China College of Biomedical Engineering Sichuan UniversityChengduSichuan 610064China West China School/Hospital of Stomatology Sichuan UniversityChengduSichuan 610064China

The application of medical devices to repair skin damage is clinically accepted and natural polymer enjoys an important role in this field,such as collagen or hyaluronic acid,***,the biosafety and efficacy of these implants are still *** this study,a skin damage animal model was prepared by UV-photoaging and recombinant humanized type Ⅲ collagen(rhCol Ⅲ)was applied as a bioactive material to implant in vivo to study its biological effect,comparing with saline and uncrosslinked hyaluronic acid(HA).Animal skin conditions were non-invasively and dynamically monitored during the 8 weeks *** observation,specific gene expression and other molecular biological methods were applied by the end of the animal *** results indicated that rhCol Ⅲ could alleviate the skin photoaging caused by UV radiation,including reduce the thickening of epidermis and dermis,increase the secretion of Collagen Ⅰ(Col Ⅰ)and Collagen Ⅲ(Col Ⅲ)and remodel of extracellular matrix(ECM).Although the cell-material interaction and mechanism need more investigation,the effect of rhCol Ⅲ on damaged skin was discussed from influence on cells,reconstruction of ECM,and stimulus of small biological molecules based on current *** conclusion,our findings provided rigorous biosafety information of rhCol Ⅲ and approved its potential in skin repair and *** enormous efforts still need to be made to achieve successful translation from bench to clinic,the recombinant humanized collagen showed superiorities from both safety and efficacy aspects.

关键词： Recombinant collagen TypeⅢcollagen Skin regeneration safety and efficacy Biological effect

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Translation of a spinal bone cement product from bench to bedside

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Bioactive Materials 2022年第4期7卷 345-354页

作者： Fei Feng Mengmeng Chen Xuan Wang Hongwei Zhang Hongtao Nie Hai Tang Department of Orthopedics Beijing Friendship HospitalCapital Medical UniversityNo.95Yong An RdXi Cheng DistrictBeijing100050China Beijing Bonsci Technology Co Ltd No.1006th Kechuang StreetBeijing Economic and Technological Development AreaBeijing100176China

Spinal acrylic bone cements(ABCs)are used clinically for percutaneous vertebroplasty(PVP)and kyphoplasty(PKP)to treat osteoporotic vertebral compression *** translation of spinal ABC products followed the design control processes including design verification and *** bench to bedside translation of the first Chinese spinal ABC product(Alliment®,namely Alliment Cement)approved by National Medical Products Administration of China was investigated and another commercial product served as the control(Osteopal®V,namely Osteopal V Cement).Results of non-clinical bench performance verification tests of compression,bending and monomer release showed that the newly marketed Alliment Cement is similar to the Osteopal V Cement with properties of both meeting the criteria specified by *** Alliment Cement demonstrated good biocompatibility during the 26 weeks’bone implantation *** cadaver validation tests further revealed that the Alliment Cement satisfied the needs for both PVP and PKP procedures.A post-approval,retrospective clinical investigation further demonstrated the safety and efficacy of the Alliment Cement,with a significant reduction of pain and the improved stability of the fractured vertebral bodies.A successful translation of biomaterial medical products needs close collaborations among academia,industry,healthcare professionals and regulatory agencies.

关键词： Bone cement Spine Translational research Vertebroplasty Kyphoplasty safety and efficacy

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