Aiming to meet the demand of the country＇ s nuclear demonstration project on the CAP1400 nuclear power plant, Baosteel uses the roll-bonding technology and develops the SA-533 Type B CL. 1 ＋ SA-240 Type 304L high-st...Aiming to meet the demand of the country＇ s nuclear demonstration project on the CAP1400 nuclear power plant, Baosteel uses the roll-bonding technology and develops the SA-533 Type B CL. 1 ＋ SA-240 Type 304L high-strength and high-toughness clad steel plate with a shear strength of over 310 MPa for the nuclear power plant＇ s safety injection tank. The properties of the quenched and tempered and the simulated post-weld heat treatment states are systematically studied herein through a comprehensive inspection and evaluation of the composition,microstructure,and properties of the clad steel plate. The results show that the bonding interface has high shear strength and that the base metal has high strength and good toughness at low temperatures. Hence, the performance fully meets the technical requirements of the CAP1400 nuclear power plant＇ s safety injection tank in the country＇ s nuclear demonstration project. The roll-bonded clad steel plate can be used to manufacture the safety injection tank of the CAP1400 nuclear power plant.展开更多
Objective:To review the current literature on the practice of intramuscular injections(IMIs),focusing on immunizations.Methods:The present study comprises 2 reviews,characterized by high-quality evidence,per taining t...Objective:To review the current literature on the practice of intramuscular injections(IMIs),focusing on immunizations.Methods:The present study comprises 2 reviews,characterized by high-quality evidence,per taining to the deployment of the slow injection technique without aspiration(referred to in this paper as the without-aspiration slow injection technique[WASi T])and combined with the Zeta-track technique(ZTT).The literature review is oriented toward the analysis of 2 features associated with IMIs techniques:safety and pain,integrating new evidence on vaccinee positioning for each muscle site and general relaxation techniques in the multi-parametric analysis.Results:The rigorous and in-depth reviews in the current study reveal the usefulness of including,among the international guidelines for via intramuscular immunizations,the adoption of WASi T only for compliant vaccinees,and in combination with all validated techniques for IMIs,and the use of ZTT limitedly if specific well-developed muscles are indicated.All the technique's limitations are exposed.Conclusions:Future research directions are presented by including the author's study designs to provide indirect evidence for the validity of the rationale of the slow injection technique using scientific methods,and for the conduction of future randomized controlled trials(RCTs)focused on revisiting the adoption of ZTT in a dynamic and integrated immunizations protocol in anterolateral thigh(ALT),ventrogluteal(VG),and also in the deltoid muscle,in the specific cases analyzed.展开更多
Globally, over 300 million people are living with viral he-patitis with approximately 1.3 million deaths per year. In 2016, World Health Assembly adopted the Global Health Sector Strategy on viral hepatitis to elimina...Globally, over 300 million people are living with viral he-patitis with approximately 1.3 million deaths per year. In 2016, World Health Assembly adopted the Global Health Sector Strategy on viral hepatitis to eliminate hepatitis by 2030. Different World Health Organization member countries are working on hepatitis control strategies to achieve hepatitis elimination. So far, only 12 countries are on track to achieve hepatitis elimination targets. The aim of the study was to give an update about the progress and challenges to achieving hepatitis elimination by 2030. According to the latest data, 87% of infants had received the three doses of hepatitis B virus （HBV） vaccination in the frst year of their life and 46% of infants had received a timely birth dose of HBV vaccination.There is a strong need to improve blood and injection safety. Rates of hepatitis B and C diagnosis are very low and only 11% of hepatitis B and C cases are diagnosed. There is a dire need to speed up hepatitis diagnosis and find the missing millions of people living with viral hepatitis. Up to 2016, only 3 million hepatitis C cases have been treated. Pricing of hepatitis C virus drugs is also reduced in many countries. The major hurdle to ach-ieve hepatitis elimination is lack of finances to support hepatitis programs. None of the major global donors are committed to invest in the fght against hepatitis. It will be very diffcult for the low and middle-income countries to fund their hepatitis control program. Hepatitis elimination needs strong fnancial and political commitment, support from civil societies, and support from pharmaceutical and medical companies around the globe.展开更多
OBJECTIVE:Toidentify the potential risk factors associated with Shenqifuzheng injection(SFI), a solution made of Dangshen(Radix Codonopsis) and Huangqi(Radix Astragali Mongolici), for the timely provision of informati...OBJECTIVE:Toidentify the potential risk factors associated with Shenqifuzheng injection(SFI), a solution made of Dangshen(Radix Codonopsis) and Huangqi(Radix Astragali Mongolici), for the timely provision of information to regulatory authorities.METHODS: A comprehensive analysis of the production process, quality standards, pharmacology,post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions(ADR), case analyses, and systematic reviews,intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital in-formationsystem(HIS).RESULTS: Sub-acute toxicity tests suggesting that a dose of 15 mL/kg(concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85‰. From March to November 2013,of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI ata dosageanda treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash,chills,feeling cold,palpitation,dyspnea,edemaofa lower extremity, palpebral edema, and superficial vein in flammation,among others.CONCLUSION: This study introduces "get full access" to the flow of information on medicines regarding their ADR incidence rate and characteristics and factors.It supports the safety of SFI for clinical, research, and production uses based on objec-tive, reliable, and scientific information to provide safe medication.展开更多
The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in China’s mainland recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order ...The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in China’s mainland recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for efficacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this field both in China and abroad are urgently needed.展开更多
文摘Aiming to meet the demand of the country＇ s nuclear demonstration project on the CAP1400 nuclear power plant, Baosteel uses the roll-bonding technology and develops the SA-533 Type B CL. 1 ＋ SA-240 Type 304L high-strength and high-toughness clad steel plate with a shear strength of over 310 MPa for the nuclear power plant＇ s safety injection tank. The properties of the quenched and tempered and the simulated post-weld heat treatment states are systematically studied herein through a comprehensive inspection and evaluation of the composition,microstructure,and properties of the clad steel plate. The results show that the bonding interface has high shear strength and that the base metal has high strength and good toughness at low temperatures. Hence, the performance fully meets the technical requirements of the CAP1400 nuclear power plant＇ s safety injection tank in the country＇ s nuclear demonstration project. The roll-bonded clad steel plate can be used to manufacture the safety injection tank of the CAP1400 nuclear power plant.
文摘Objective:To review the current literature on the practice of intramuscular injections(IMIs),focusing on immunizations.Methods:The present study comprises 2 reviews,characterized by high-quality evidence,per taining to the deployment of the slow injection technique without aspiration(referred to in this paper as the without-aspiration slow injection technique[WASi T])and combined with the Zeta-track technique(ZTT).The literature review is oriented toward the analysis of 2 features associated with IMIs techniques:safety and pain,integrating new evidence on vaccinee positioning for each muscle site and general relaxation techniques in the multi-parametric analysis.Results:The rigorous and in-depth reviews in the current study reveal the usefulness of including,among the international guidelines for via intramuscular immunizations,the adoption of WASi T only for compliant vaccinees,and in combination with all validated techniques for IMIs,and the use of ZTT limitedly if specific well-developed muscles are indicated.All the technique's limitations are exposed.Conclusions:Future research directions are presented by including the author's study designs to provide indirect evidence for the validity of the rationale of the slow injection technique using scientific methods,and for the conduction of future randomized controlled trials(RCTs)focused on revisiting the adoption of ZTT in a dynamic and integrated immunizations protocol in anterolateral thigh(ALT),ventrogluteal(VG),and also in the deltoid muscle,in the specific cases analyzed.
文摘Globally, over 300 million people are living with viral he-patitis with approximately 1.3 million deaths per year. In 2016, World Health Assembly adopted the Global Health Sector Strategy on viral hepatitis to eliminate hepatitis by 2030. Different World Health Organization member countries are working on hepatitis control strategies to achieve hepatitis elimination. So far, only 12 countries are on track to achieve hepatitis elimination targets. The aim of the study was to give an update about the progress and challenges to achieving hepatitis elimination by 2030. According to the latest data, 87% of infants had received the three doses of hepatitis B virus （HBV） vaccination in the frst year of their life and 46% of infants had received a timely birth dose of HBV vaccination.There is a strong need to improve blood and injection safety. Rates of hepatitis B and C diagnosis are very low and only 11% of hepatitis B and C cases are diagnosed. There is a dire need to speed up hepatitis diagnosis and find the missing millions of people living with viral hepatitis. Up to 2016, only 3 million hepatitis C cases have been treated. Pricing of hepatitis C virus drugs is also reduced in many countries. The major hurdle to ach-ieve hepatitis elimination is lack of finances to support hepatitis programs. None of the major global donors are committed to invest in the fght against hepatitis. It will be very diffcult for the low and middle-income countries to fund their hepatitis control program. Hepatitis elimination needs strong fnancial and political commitment, support from civil societies, and support from pharmaceutical and medical companies around the globe.
基金Supported by National Science and Technology Major Projects for "Major New Drugs Innovation and Development":Study on Key Technologies of Post-marketing Evaluation for Chinese Medicine(No.2009ZX09502-030)
文摘OBJECTIVE:Toidentify the potential risk factors associated with Shenqifuzheng injection(SFI), a solution made of Dangshen(Radix Codonopsis) and Huangqi(Radix Astragali Mongolici), for the timely provision of information to regulatory authorities.METHODS: A comprehensive analysis of the production process, quality standards, pharmacology,post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions(ADR), case analyses, and systematic reviews,intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital in-formationsystem(HIS).RESULTS: Sub-acute toxicity tests suggesting that a dose of 15 mL/kg(concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85‰. From March to November 2013,of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI ata dosageanda treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash,chills,feeling cold,palpitation,dyspnea,edemaofa lower extremity, palpebral edema, and superficial vein in flammation,among others.CONCLUSION: This study introduces "get full access" to the flow of information on medicines regarding their ADR incidence rate and characteristics and factors.It supports the safety of SFI for clinical, research, and production uses based on objec-tive, reliable, and scientific information to provide safe medication.
基金Supported by the Ninth-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(No.Z0406)the Seventh Science Foundation of China Academy of Chinese Medical Sciences(No.ZZ070817)+1 种基金National Natural Science Foundation of China(General Program,No.81202776)China Postdoctoral Science Foundation project(No.2014T70202)
文摘The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in China’s mainland recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for efficacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this field both in China and abroad are urgently needed.
