In this study we describe the fabrication of a variety of open-cellular titanium alloy（Ti-6 Al-4 V） implants,both reticular mesh and foam structures, using electron beam melting（EBM）. These structures allow for th...In this study we describe the fabrication of a variety of open-cellular titanium alloy（Ti-6 Al-4 V） implants,both reticular mesh and foam structures, using electron beam melting（EBM）. These structures allow for the elimination of stress shielding by adjusting the porosity（or density） to produce an elastic modulus（or stiffness） to match that of both soft（trabecular） and hard（cortical） bone, as well as allowing for bone cell ingrowth, increased cell density, and all-matrix interactions; the latter involving the interplay between bone morphogenetic protein（BMP-2） and osteoblast functions. The early formation and characterization of elementary vascular structures in an aqueous hydrogel matrix are illustrated.Preliminary results for both animal（sheep） and human trials for a number of EBM-fabricated, and often patient-specific Tialloy implants are also presented and summarized. The results, while preliminary, support the concept and development of successful, porous, engineered ＂living＂ implants.展开更多
The “informed consent principle” in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedi...The “informed consent principle” in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedical research. In recent years, the legal protection of the right to informed consent for research subjects has been gradually improved in China. The right to informed consent for research subjects has been improved from an ethical norm to a legal norm. The legal status of legal norms has also been gradually improved. Based on the public law regulations, private law relief has been added to the legal relief system for the infringement of the right to informed consent for research subjects. As a result, the protection of rights has been enhanced. The domestic informed consent protection system is partially in line with international norms. The protection of the right to informed consent depends on the perfection of the legal system and the social consensus to respect human rights and the right to self-determination.展开更多
The efficacy requirements of cosmetic instruments and explored their efficacy evaluation methods was investigated.The efficacy and claims of common cosmetic instruments on the market were investigated,and human clinic...The efficacy requirements of cosmetic instruments and explored their efficacy evaluation methods was investigated.The efficacy and claims of common cosmetic instruments on the market were investigated,and human clinical trials were conducted to evaluate the efficacy of household cosmetic instruments.Household cosmetic instruments mainly include technologies such as sound wave,ion conduction,LED light,EMS microcurrent,RF radio frequency,and laser.This paper took microcurrent as an example to explore its efficacy claim methods.In human test I,the water content in the stratum corneum of the forearms of 31 subjects increased significantly compared with the blank control after 8 h.In human test II,30 subjects showed significant decreases in skin texture R5,transepidermal water loss TEWL,skin firmness F4 value,skin elasticity R2 value,overall size and depth of facial wrinkles,and facial jawline angle,and a significant increase in facial gloss value.The results showed that the cosmetic instrument had effects of moisturizing,improving facial evenness,repairing barrier,improving skin elasticity and firmness,and improving facial edema.展开更多
Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE （Lepu Medical Technology Co., Ltd, Beijing, China） is a novel polyme...Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE （Lepu Medical Technology Co., Ltd, Beijing, China） is a novel polymer-free stent system with nanotechnology and elutes rapamycin （1.6 μg/mm2） and probucol （0.8 μg/mm2）. The millpores on the surface of the stents were produced by nanotechnology. Studies on in-vitro release profile and the preliminary feasibility and safety of the BICARE stent were conducted. The results of release profile study demonstrated the ability of dual-drug polymer-free loading stents to release rapamycin and probucol in a controlled and sustained manner. The preliminary feasibility and safety of BICARE dual-drug polymer-free stent are demonstrated firstly in human study. Optical coherence tomography （OCT） findings indicated excellent stent strut coverage at 4-month. Further pivotal randomized trial will confirm if this early results could translate into longer term safety and efficacy benefits.展开更多
Selenium(Se)is an essential trace mineral crucial for human health.Nearly a dozen human clinical trials with seleno-methionine(SeMet)and selenized-yeast(contains mostly SeMet)for the prevention of non-cutaneous solid ...Selenium(Se)is an essential trace mineral crucial for human health.Nearly a dozen human clinical trials with seleno-methionine(SeMet)and selenized-yeast(contains mostly SeMet)for the prevention of non-cutaneous solid organ cancers in North America and European countries conclusively refuted their utility.We have articulated two lessons from these trials:(1)the anti-oxidant hypothesis was tested in inappropriate Se-adequate populations,and(2)the selection of these Se forms was not supported by cell culture and animal efficacy data.Nevertheless,preclinical studies of proximal methylselenol precursors(“methyl Se”)have shown many desirable attributes,involving crucial molecules and pathways in cancer epithelial cells,vascular endothelial,immune and inflammatory cells in the tumor microenvironment,for potential use as chemopreventive and therapy agents.Methylseleninic acid and Se-methylselenocysteine are prototypicalmethyl-Se,yet not equal in their targets.Selenate,selenite and selenious acid had been recently studied in human clinical trials,providing novel safety data,but,missing critical genotoxicity assessments.Given the popularity of Se-enriched foods in China and a continued presence of nutritional Se deficiency in many localities,we discuss recommendations for clinical studies of Se forms for cancer therapy or chemoprevention in China and other countries with similar Se nutrition predicament.展开更多
Hypercholesterolemia is a risk factor of cardiovascular diseases,which have been managed using statin drugs.Red yeast rice(RYR)as a traditional food in the Eastern Asia countries has anti-hyperlipidemia activity.Recen...Hypercholesterolemia is a risk factor of cardiovascular diseases,which have been managed using statin drugs.Red yeast rice(RYR)as a traditional food in the Eastern Asia countries has anti-hyperlipidemia activity.Recently,a variety of food supplement products containing RYR have been developed to lower blood cholesterol,which is attributed to the presence of monacolins,especially monacolin K(lovastatin,a statin drug).This review was aimed to summarize the clinical trials using RYR products to investigate their effects on lipid profiles in humans.Relevant articles of human clinical trials were retrieved from PubMed and discussed here.Results showed that RYR and its extracts have been included in commercially available products alone and in combinations with various other materials,which include bioactive compounds such as coenzyme Q10 and berberine,vitamins,extracts from other plants such as phytosterols,polyunsaturated fatty acids or even probiotics.The durations of the trials ranged from 4 weeks to 60 months.The content of monacolin K ranged from 0.32 mg/pack to 10 mg/pack.The data of these human clinical trials demonstrated that these RYR supplement products were sufficient to reduce blood cholesterol in different populations.However,the inclusions of certain materials might not have additive effect.Additionally,studies including a lovastatin only positive control group with the equivalent dose as that of monacolin K in the RYR products remain to be done.Furthermore,variations of monacolin K contents and presence of toxic citrinin are still concerns.Last,bioactivities of other components in RYR should be investigated as well.More future studies will certainly help to fully explore the potentials of this traditional food in the combat against cardiovascular and other metabolic diseases.展开更多
基金supported in part by the Ministry of Science and Technology Project(2017YFC1104900 and 2016YFC1102601)the National Natural Science Foundation of China(51271182 and 51631007)+2 种基金Chinese Academy of Sciences Project(QYZDJ-SSW-JSC031)the Department of Metallurgical,Materials and Biomedical Engineering(Nune KC and Misra RDK)the Office of Research and Sponsored Projects(Correa-Rodriguez VL and Murr LE)at the University of Texas at El Paso
文摘In this study we describe the fabrication of a variety of open-cellular titanium alloy（Ti-6 Al-4 V） implants,both reticular mesh and foam structures, using electron beam melting（EBM）. These structures allow for the elimination of stress shielding by adjusting the porosity（or density） to produce an elastic modulus（or stiffness） to match that of both soft（trabecular） and hard（cortical） bone, as well as allowing for bone cell ingrowth, increased cell density, and all-matrix interactions; the latter involving the interplay between bone morphogenetic protein（BMP-2） and osteoblast functions. The early formation and characterization of elementary vascular structures in an aqueous hydrogel matrix are illustrated.Preliminary results for both animal（sheep） and human trials for a number of EBM-fabricated, and often patient-specific Tialloy implants are also presented and summarized. The results, while preliminary, support the concept and development of successful, porous, engineered ＂living＂ implants.
文摘The “informed consent principle” in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedical research. In recent years, the legal protection of the right to informed consent for research subjects has been gradually improved in China. The right to informed consent for research subjects has been improved from an ethical norm to a legal norm. The legal status of legal norms has also been gradually improved. Based on the public law regulations, private law relief has been added to the legal relief system for the infringement of the right to informed consent for research subjects. As a result, the protection of rights has been enhanced. The domestic informed consent protection system is partially in line with international norms. The protection of the right to informed consent depends on the perfection of the legal system and the social consensus to respect human rights and the right to self-determination.
文摘The efficacy requirements of cosmetic instruments and explored their efficacy evaluation methods was investigated.The efficacy and claims of common cosmetic instruments on the market were investigated,and human clinical trials were conducted to evaluate the efficacy of household cosmetic instruments.Household cosmetic instruments mainly include technologies such as sound wave,ion conduction,LED light,EMS microcurrent,RF radio frequency,and laser.This paper took microcurrent as an example to explore its efficacy claim methods.In human test I,the water content in the stratum corneum of the forearms of 31 subjects increased significantly compared with the blank control after 8 h.In human test II,30 subjects showed significant decreases in skin texture R5,transepidermal water loss TEWL,skin firmness F4 value,skin elasticity R2 value,overall size and depth of facial wrinkles,and facial jawline angle,and a significant increase in facial gloss value.The results showed that the cosmetic instrument had effects of moisturizing,improving facial evenness,repairing barrier,improving skin elasticity and firmness,and improving facial edema.
文摘Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE （Lepu Medical Technology Co., Ltd, Beijing, China） is a novel polymer-free stent system with nanotechnology and elutes rapamycin （1.6 μg/mm2） and probucol （0.8 μg/mm2）. The millpores on the surface of the stents were produced by nanotechnology. Studies on in-vitro release profile and the preliminary feasibility and safety of the BICARE stent were conducted. The results of release profile study demonstrated the ability of dual-drug polymer-free loading stents to release rapamycin and probucol in a controlled and sustained manner. The preliminary feasibility and safety of BICARE dual-drug polymer-free stent are demonstrated firstly in human study. Optical coherence tomography （OCT） findings indicated excellent stent strut coverage at 4-month. Further pivotal randomized trial will confirm if this early results could translate into longer term safety and efficacy benefits.
基金supported by US National Institutes of Health National Cancer Institute grant R01 CA172169 and others.
文摘Selenium(Se)is an essential trace mineral crucial for human health.Nearly a dozen human clinical trials with seleno-methionine(SeMet)and selenized-yeast(contains mostly SeMet)for the prevention of non-cutaneous solid organ cancers in North America and European countries conclusively refuted their utility.We have articulated two lessons from these trials:(1)the anti-oxidant hypothesis was tested in inappropriate Se-adequate populations,and(2)the selection of these Se forms was not supported by cell culture and animal efficacy data.Nevertheless,preclinical studies of proximal methylselenol precursors(“methyl Se”)have shown many desirable attributes,involving crucial molecules and pathways in cancer epithelial cells,vascular endothelial,immune and inflammatory cells in the tumor microenvironment,for potential use as chemopreventive and therapy agents.Methylseleninic acid and Se-methylselenocysteine are prototypicalmethyl-Se,yet not equal in their targets.Selenate,selenite and selenious acid had been recently studied in human clinical trials,providing novel safety data,but,missing critical genotoxicity assessments.Given the popularity of Se-enriched foods in China and a continued presence of nutritional Se deficiency in many localities,we discuss recommendations for clinical studies of Se forms for cancer therapy or chemoprevention in China and other countries with similar Se nutrition predicament.
基金the Diabetes Action Research and Education Foundation for the research grant(#466)to G.Chen.
文摘Hypercholesterolemia is a risk factor of cardiovascular diseases,which have been managed using statin drugs.Red yeast rice(RYR)as a traditional food in the Eastern Asia countries has anti-hyperlipidemia activity.Recently,a variety of food supplement products containing RYR have been developed to lower blood cholesterol,which is attributed to the presence of monacolins,especially monacolin K(lovastatin,a statin drug).This review was aimed to summarize the clinical trials using RYR products to investigate their effects on lipid profiles in humans.Relevant articles of human clinical trials were retrieved from PubMed and discussed here.Results showed that RYR and its extracts have been included in commercially available products alone and in combinations with various other materials,which include bioactive compounds such as coenzyme Q10 and berberine,vitamins,extracts from other plants such as phytosterols,polyunsaturated fatty acids or even probiotics.The durations of the trials ranged from 4 weeks to 60 months.The content of monacolin K ranged from 0.32 mg/pack to 10 mg/pack.The data of these human clinical trials demonstrated that these RYR supplement products were sufficient to reduce blood cholesterol in different populations.However,the inclusions of certain materials might not have additive effect.Additionally,studies including a lovastatin only positive control group with the equivalent dose as that of monacolin K in the RYR products remain to be done.Furthermore,variations of monacolin K contents and presence of toxic citrinin are still concerns.Last,bioactivities of other components in RYR should be investigated as well.More future studies will certainly help to fully explore the potentials of this traditional food in the combat against cardiovascular and other metabolic diseases.
