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
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
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
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.
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.
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.
