To understand the current situation of institutional registration in Shaanxi Province after the implementation ofregistration system management in drug clinical trial institutions.Relevant information was collected on...To understand the current situation of institutional registration in Shaanxi Province after the implementation ofregistration system management in drug clinical trial institutions.Relevant information was collected on the“Announcement on the Accreditation of Drug Clinical Trial Institutions”issued by the National Medical Products Administration from 2005 to August 2022,the record management information system of drug and medical device clinical trial institutions,and the drug clinical trial registration and information publicity platform.A retrospective analysis was carried out in terms of institutional development,regional distribution,registered majors,principal investigators,and the number of drug clinical trials.After the implementation of institution registration,the number of drug clinical trial institutions in Shaanxi Province increased by 47.4%,884 principal investigators were registered,the number of registered majors expanded from 58 qualified to 117,and the professional scope increased by 50.4%.The policy of institution registration is conducive to promoting the rational use of medical resources and the development of drug clinical trial institutions and improving the healthy development of the pharmaceutical industry in Shaanxi Province.展开更多
<strong>Objective</strong><span style="font-family:;" "=""><span style="font-family:Verdana;"><strong>:</strong> To explore the establishment and ...<strong>Objective</strong><span style="font-family:;" "=""><span style="font-family:Verdana;"><strong>:</strong> To explore the establishment and roles of study nurses in IBD drug clinical trials. </span><b><span style="font-family:Verdana;">Methods</span></b><span style="font-family:Verdana;">: The management experience of this department’s study nurses in IBD drug clinical trials was retrospectively analyzed. </span><b><span style="font-family:Verdana;">Results</span></b><span style="font-family:Verdana;">: The study nurses played very important roles at all links during the preliminary preparation of IBD drug clinical trials, the whole-process management after project initiation, and the later work of project conclusion. </span><b><span style="font-family:Verdana;">Conclusions</span></b><span style="font-family:Verdana;">: As direct participants in drug clinical trials, study nurses play a very important role in ensuring standardization of the trial process, safeguarding patient’s rights and safety, and assisting investigators in carrying out study works smoothly.</span></span>展开更多
This study aimed to construct a quality management model for phase I clinical drug trials.A cross-sectional survey was conducted and data were collected from 604 respondents at 69 institutions in China engaged in phas...This study aimed to construct a quality management model for phase I clinical drug trials.A cross-sectional survey was conducted and data were collected from 604 respondents at 69 institutions in China engaged in phase I clinical drug trials.Exploratory and confirmatory factor analyses were used to develop the survey tool.Structural equation modeling was used to construct a quality management model for phase I clinical drug trials.The results showed that the final survey tool had good reliability and validity(Cronbach’sα=0.938,root mean square error of approximation=0.074,comparative fit index=0.962,and Tucker—Lewis index=0.955).The model included five dimensions:government regulation,industry management,medical institution management,research team management,and contract research organization(CRO)management.In total,22 measurement items were obtained.The structural equation model indicated government regulation,industry management,medical institution management,and CRO management significantly affected the quality of phase I clinical drug trials(β=0.195,β=0.331,β=0.279,andβ=−0.267,respectively;P<0.05).Research team management had no effect on the quality of trials(β=0.041,P=0.610).In conclusion,the model is valuable for identifying factors influencing phase I clinical drug trials and guiding quality management practices.展开更多
The development of new drugs for therapeutic purposes has become very expensive and time-consuming in American and European countries.It is estimated that on the average 50 to 100 million dollars and 10 or more years ...The development of new drugs for therapeutic purposes has become very expensive and time-consuming in American and European countries.It is estimated that on the average 50 to 100 million dollars and 10 or more years from the time of patenting are required to make a new drug available for general prescription. Every new drug needs to be charac-展开更多
Objective To aim at summarizing the role of hospital pharmacists in clinical drug trials in China against the background that hospital pharmacists have already involved in team-based patient care.Methods The roles and...Objective To aim at summarizing the role of hospital pharmacists in clinical drug trials in China against the background that hospital pharmacists have already involved in team-based patient care.Methods The roles and responsibilities of Chinese hospital pharmacists were listed and categorized.Results and Conclusion There has been an upsurge in clinical drug trials in China.Hospital pharmacists play increasingly important roles in all aspects of clinical trials,such as stakeholder liaisons,protocol developers,ethics committee members,research team members,study drug managers,and subject intervention agents.Hospital pharmacists are an integral part of a clinical drug trial multidisciplinary team.Their value is reflected in several pharmacist-led or pharmacist-participating clinical trials as well as the trial project management position within hospitals.Pharmacists should be the designers,researchers,managers and supervisors of clinical drug trials.We expect that all clinical trial projects will include hospital pharmacists in their research teams soon.展开更多
[Objectives]To observe the clinical efficacy and safety of Zhuang Medicine Xiaoyan Zhiyang Formula by retrospective analysis of clinical use.[Methods]A total of 225 cases were collected,including 117 males and 108 fem...[Objectives]To observe the clinical efficacy and safety of Zhuang Medicine Xiaoyan Zhiyang Formula by retrospective analysis of clinical use.[Methods]A total of 225 cases were collected,including 117 males and 108 females,115 cases of contact dermatitis and 110 cases of acute eczema.Zhuang Medicine Xiaoyan Zhiyang Formula was administered to 225 patients with contact dermatitis and acute eczema and the clinical efficacy was evaluated.[Results]After one week of treatment,among 225 patients with contact dermatitis and acute eczema,76 cases were cured(33.78%),133 cases showed marked response(59.11%),16 cases(7.11%)were improved,0 case was ineffective,and the overall response rate was 92.89%.After one week of Zhuang Medicine Xiaoyan Zhiyang Formula treatment,the symptoms of itching,pain and swelling were significantly improved in all patients,and the rash was partially crusted without new symptom,and there were no complications and adverse reactions.[Conclusions]Zhuang Medicine Xiaoyan Zhiyang Formula therapy has a remarkable effect in the treatment of contact dermatitis and acute eczema.展开更多
<strong>Objective:</strong> The study was conducted to understand the situation of patients with inflammatory bowel disease (IBD) to participant clinical trials and to analyze the factors affecting the cli...<strong>Objective:</strong> The study was conducted to understand the situation of patients with inflammatory bowel disease (IBD) to participant clinical trials and to analyze the factors affecting the clinical trial participation of patients with IBD. A clinical experiment guidance will be proved by this study to maximized the benefits to patients and to help the clinical trial to conduct successfully. <strong>Method: </strong>An anonymous questionnaire was designed and was administrated to the patients with IBD who were randomly delivered in the inpatient or outpatient departments. The survey result was analyzed. <strong>Result:</strong> Total 372 available questionnaires were returned. Among these patients, 26.3% patients with IBD indicated willingness to participate, 57.3% indicated a situation dependence, and 41.04% indicated unwillingness. Among the potential factors that may influence the patient’s willingness to participate the clinical, trusted physician’s recommendation, no proved drugs to use and accessing to free medication to release financial burden were statistically significant. <strong>Conclusion:</strong> The overall willingness of IBD patients to participate in drug clinical trials is not high. Among the patients who are willing to participate in clinical trials, the main reasons for their participation are that they trust doctors’ recommendation, can get free medication and examination, and can reduce the economic burden. Efficacy and safety were the main influencing factors in patients who were case-dependent and unwilling to participate in clinical trials.展开更多
Zika virus(ZIKV)is an emerging pathogen associated with neurological complications,such as Guillain–Barrésyndrome in adults and microcephaly in fetuses and newborns.This mosquito-borne flavivirus causes importan...Zika virus(ZIKV)is an emerging pathogen associated with neurological complications,such as Guillain–Barrésyndrome in adults and microcephaly in fetuses and newborns.This mosquito-borne flavivirus causes important social and sanitary problems owing to its rapid dissemination.However,the development of antivirals against ZIKV is lagging.Although various strategies have been used to study anti-ZIKV agents,approved drugs or vaccines for the treatment(or prevention)of ZIKV infections are currently unavailable.Repurposing clinically approved drugs could be an effective approach to quickly respond to an emergency outbreak of ZIKV infections.The well-established safety profiles and optimal dosage of these clinically approved drugs could provide an economical,safe,and efficacious approach to address ZIKV infections.This review focuses on the recent research and development of agents against ZIKV infection by repurposing clinical drugs.Their characteristics,targets,and potential use in anti-ZIKV therapy are presented.This review provides an update and some successful strategies in the search for anti-ZIKV agents are given.展开更多
Fasudil has the potential to prevent liver fibrosis by activating natural killer cells and inhibiting the proliferation of hepatic stellate cells.Fasudil may be a promising clinical therapeutic drug for the prevention...Fasudil has the potential to prevent liver fibrosis by activating natural killer cells and inhibiting the proliferation of hepatic stellate cells.Fasudil may be a promising clinical therapeutic drug for the prevention and treatment of liver fibrosis.展开更多
Objective To analyze the status of infection and drug resistance of nontuberculous mycobacteria(NTM)and its clinical relevance in Sichuan area.Methods Mycobacteria laboratory specimens from January 2014 to December 20...Objective To analyze the status of infection and drug resistance of nontuberculous mycobacteria(NTM)and its clinical relevance in Sichuan area.Methods Mycobacteria laboratory specimens from January 2014 to December 2015 in Public Health Clinical Center of Chengdu were retrospectively collected and analyzed.NTM identification was performed by gene chip or 16S展开更多
Translationally controlled tumor protein(TCTP) is a highly conserved multifunctional protein localized in the cytoplasm and nucleus of eukaryotic cells. It is secreted through exosomes and its degradation is associate...Translationally controlled tumor protein(TCTP) is a highly conserved multifunctional protein localized in the cytoplasm and nucleus of eukaryotic cells. It is secreted through exosomes and its degradation is associated with the ubiquitin-proteasome system(UPS), heat shock protein 27(Hsp27), and chaperone-mediated autophagy(CMA). Its structure contains three α-helices and eleven β-strands, and features a helical hairpin as its hallmark. TCTP shows a remarkable similarity to the methionine-R-sulfoxide reductase B(Msr B) and mammalian suppressor of Sec4(Mss4/Dss4) protein families, which exerts guanine nucleotide exchange factor(GEF) activity on small guanosine triphosphatase(GTPase) proteins, suggesting that some functions of TCTP may at least depend on its GEF action. Indeed, TCTP exerts GEF activity on Ras homolog enriched in brain(Rheb) to boost the growth and proliferation of Drosophila cells. TCTP also enhances the expression of cell division control protein 42 homolog(Cdc42) to promote cancer cell invasion and migration. Moreover, TCTP regulates cytoskeleton organization by interacting with actin microfilament(MF) and microtubule(MT) proteins and inducing the epithelial-mesenchymal transition(EMT) process. In essence, TCTP promotes cancer cell movement. It is usually highly expressed in cancerous tissues and thus reduces patient survival;meanwhile, drugs can target TCTP to reduce this effect. In this review, we summarize the mechanisms of TCTP in promoting cancer invasion and migration, and describe the current inhibitory strategy to target TCTP in cancerous diseases.展开更多
基金Project of Xi’an Science and Technology Plan(23YXYJ0163)Education and Teaching Reform Research Project of Xi’an Medical University in 2023(S202311840061)+1 种基金First Affiliated Hospital of Xi’an Medical University of China(XYYFY-2023-01)2021 Xi’an Medical University University-Level Science and Technology Innovation Team(2021TD14)。
文摘To understand the current situation of institutional registration in Shaanxi Province after the implementation ofregistration system management in drug clinical trial institutions.Relevant information was collected on the“Announcement on the Accreditation of Drug Clinical Trial Institutions”issued by the National Medical Products Administration from 2005 to August 2022,the record management information system of drug and medical device clinical trial institutions,and the drug clinical trial registration and information publicity platform.A retrospective analysis was carried out in terms of institutional development,regional distribution,registered majors,principal investigators,and the number of drug clinical trials.After the implementation of institution registration,the number of drug clinical trial institutions in Shaanxi Province increased by 47.4%,884 principal investigators were registered,the number of registered majors expanded from 58 qualified to 117,and the professional scope increased by 50.4%.The policy of institution registration is conducive to promoting the rational use of medical resources and the development of drug clinical trial institutions and improving the healthy development of the pharmaceutical industry in Shaanxi Province.
文摘<strong>Objective</strong><span style="font-family:;" "=""><span style="font-family:Verdana;"><strong>:</strong> To explore the establishment and roles of study nurses in IBD drug clinical trials. </span><b><span style="font-family:Verdana;">Methods</span></b><span style="font-family:Verdana;">: The management experience of this department’s study nurses in IBD drug clinical trials was retrospectively analyzed. </span><b><span style="font-family:Verdana;">Results</span></b><span style="font-family:Verdana;">: The study nurses played very important roles at all links during the preliminary preparation of IBD drug clinical trials, the whole-process management after project initiation, and the later work of project conclusion. </span><b><span style="font-family:Verdana;">Conclusions</span></b><span style="font-family:Verdana;">: As direct participants in drug clinical trials, study nurses play a very important role in ensuring standardization of the trial process, safeguarding patient’s rights and safety, and assisting investigators in carrying out study works smoothly.</span></span>
基金This study was supported by the Fundamental Research Funds for the Central Universities(No.5003516009).
文摘This study aimed to construct a quality management model for phase I clinical drug trials.A cross-sectional survey was conducted and data were collected from 604 respondents at 69 institutions in China engaged in phase I clinical drug trials.Exploratory and confirmatory factor analyses were used to develop the survey tool.Structural equation modeling was used to construct a quality management model for phase I clinical drug trials.The results showed that the final survey tool had good reliability and validity(Cronbach’sα=0.938,root mean square error of approximation=0.074,comparative fit index=0.962,and Tucker—Lewis index=0.955).The model included five dimensions:government regulation,industry management,medical institution management,research team management,and contract research organization(CRO)management.In total,22 measurement items were obtained.The structural equation model indicated government regulation,industry management,medical institution management,and CRO management significantly affected the quality of phase I clinical drug trials(β=0.195,β=0.331,β=0.279,andβ=−0.267,respectively;P<0.05).Research team management had no effect on the quality of trials(β=0.041,P=0.610).In conclusion,the model is valuable for identifying factors influencing phase I clinical drug trials and guiding quality management practices.
文摘The development of new drugs for therapeutic purposes has become very expensive and time-consuming in American and European countries.It is estimated that on the average 50 to 100 million dollars and 10 or more years from the time of patenting are required to make a new drug available for general prescription. Every new drug needs to be charac-
文摘Objective To aim at summarizing the role of hospital pharmacists in clinical drug trials in China against the background that hospital pharmacists have already involved in team-based patient care.Methods The roles and responsibilities of Chinese hospital pharmacists were listed and categorized.Results and Conclusion There has been an upsurge in clinical drug trials in China.Hospital pharmacists play increasingly important roles in all aspects of clinical trials,such as stakeholder liaisons,protocol developers,ethics committee members,research team members,study drug managers,and subject intervention agents.Hospital pharmacists are an integral part of a clinical drug trial multidisciplinary team.Their value is reflected in several pharmacist-led or pharmacist-participating clinical trials as well as the trial project management position within hospitals.Pharmacists should be the designers,researchers,managers and supervisors of clinical drug trials.We expect that all clinical trial projects will include hospital pharmacists in their research teams soon.
基金Supported by Scientific Research Project of Guangxi Zhuang Autonomous Region Food and Drug Administration(2021 Guangxi Drug Safety Scientific Research Project)"Safety Evaluation of Zhuang Medicine Xiaoyan Zhiyang Formula for the Treatment of Acute Eczema and Contact Dermatitis and Other Skin Diseases"State Administration of Traditional Chinese Medicine High-level Key Discipline Construction Project of Traditional Chinese Medicine-Ethnic Minority Pharmacy(Zhuang Pharmacy)(zyyzdxk-2023165)+2 种基金Guangxi Traditional Chinese Medicine Multidisciplinary Innovation Team Project(GZKJ2309)Funding Project of High-level Talent Cultivation and Innovation Team of Guangxi University of Traditional Chinese Medicine(2022A008)Key R&D Projects of Guangxi Science and Technology Department(Gui Ke AB21196057).
文摘[Objectives]To observe the clinical efficacy and safety of Zhuang Medicine Xiaoyan Zhiyang Formula by retrospective analysis of clinical use.[Methods]A total of 225 cases were collected,including 117 males and 108 females,115 cases of contact dermatitis and 110 cases of acute eczema.Zhuang Medicine Xiaoyan Zhiyang Formula was administered to 225 patients with contact dermatitis and acute eczema and the clinical efficacy was evaluated.[Results]After one week of treatment,among 225 patients with contact dermatitis and acute eczema,76 cases were cured(33.78%),133 cases showed marked response(59.11%),16 cases(7.11%)were improved,0 case was ineffective,and the overall response rate was 92.89%.After one week of Zhuang Medicine Xiaoyan Zhiyang Formula treatment,the symptoms of itching,pain and swelling were significantly improved in all patients,and the rash was partially crusted without new symptom,and there were no complications and adverse reactions.[Conclusions]Zhuang Medicine Xiaoyan Zhiyang Formula therapy has a remarkable effect in the treatment of contact dermatitis and acute eczema.
文摘<strong>Objective:</strong> The study was conducted to understand the situation of patients with inflammatory bowel disease (IBD) to participant clinical trials and to analyze the factors affecting the clinical trial participation of patients with IBD. A clinical experiment guidance will be proved by this study to maximized the benefits to patients and to help the clinical trial to conduct successfully. <strong>Method: </strong>An anonymous questionnaire was designed and was administrated to the patients with IBD who were randomly delivered in the inpatient or outpatient departments. The survey result was analyzed. <strong>Result:</strong> Total 372 available questionnaires were returned. Among these patients, 26.3% patients with IBD indicated willingness to participate, 57.3% indicated a situation dependence, and 41.04% indicated unwillingness. Among the potential factors that may influence the patient’s willingness to participate the clinical, trusted physician’s recommendation, no proved drugs to use and accessing to free medication to release financial burden were statistically significant. <strong>Conclusion:</strong> The overall willingness of IBD patients to participate in drug clinical trials is not high. Among the patients who are willing to participate in clinical trials, the main reasons for their participation are that they trust doctors’ recommendation, can get free medication and examination, and can reduce the economic burden. Efficacy and safety were the main influencing factors in patients who were case-dependent and unwilling to participate in clinical trials.
基金This work was supported by CAMS Major Collaborative Innovation Project(No.2016-I2M-1-011)National Natural Science Foundation of China(No.81773784)+2 种基金Beijing Nova Program(No.Z181100006218075)Basic Scientific Research Program of CAMS(No.2018RC350005)Drug Innovation Major Project(No.2018ZX09711001-002-002).
文摘Zika virus(ZIKV)is an emerging pathogen associated with neurological complications,such as Guillain–Barrésyndrome in adults and microcephaly in fetuses and newborns.This mosquito-borne flavivirus causes important social and sanitary problems owing to its rapid dissemination.However,the development of antivirals against ZIKV is lagging.Although various strategies have been used to study anti-ZIKV agents,approved drugs or vaccines for the treatment(or prevention)of ZIKV infections are currently unavailable.Repurposing clinically approved drugs could be an effective approach to quickly respond to an emergency outbreak of ZIKV infections.The well-established safety profiles and optimal dosage of these clinically approved drugs could provide an economical,safe,and efficacious approach to address ZIKV infections.This review focuses on the recent research and development of agents against ZIKV infection by repurposing clinical drugs.Their characteristics,targets,and potential use in anti-ZIKV therapy are presented.This review provides an update and some successful strategies in the search for anti-ZIKV agents are given.
文摘Fasudil has the potential to prevent liver fibrosis by activating natural killer cells and inhibiting the proliferation of hepatic stellate cells.Fasudil may be a promising clinical therapeutic drug for the prevention and treatment of liver fibrosis.
文摘Objective To analyze the status of infection and drug resistance of nontuberculous mycobacteria(NTM)and its clinical relevance in Sichuan area.Methods Mycobacteria laboratory specimens from January 2014 to December 2015 in Public Health Clinical Center of Chengdu were retrospectively collected and analyzed.NTM identification was performed by gene chip or 16S
基金funded by the National Natural Science Foundation of China(No.31672377)。
文摘Translationally controlled tumor protein(TCTP) is a highly conserved multifunctional protein localized in the cytoplasm and nucleus of eukaryotic cells. It is secreted through exosomes and its degradation is associated with the ubiquitin-proteasome system(UPS), heat shock protein 27(Hsp27), and chaperone-mediated autophagy(CMA). Its structure contains three α-helices and eleven β-strands, and features a helical hairpin as its hallmark. TCTP shows a remarkable similarity to the methionine-R-sulfoxide reductase B(Msr B) and mammalian suppressor of Sec4(Mss4/Dss4) protein families, which exerts guanine nucleotide exchange factor(GEF) activity on small guanosine triphosphatase(GTPase) proteins, suggesting that some functions of TCTP may at least depend on its GEF action. Indeed, TCTP exerts GEF activity on Ras homolog enriched in brain(Rheb) to boost the growth and proliferation of Drosophila cells. TCTP also enhances the expression of cell division control protein 42 homolog(Cdc42) to promote cancer cell invasion and migration. Moreover, TCTP regulates cytoskeleton organization by interacting with actin microfilament(MF) and microtubule(MT) proteins and inducing the epithelial-mesenchymal transition(EMT) process. In essence, TCTP promotes cancer cell movement. It is usually highly expressed in cancerous tissues and thus reduces patient survival;meanwhile, drugs can target TCTP to reduce this effect. In this review, we summarize the mechanisms of TCTP in promoting cancer invasion and migration, and describe the current inhibitory strategy to target TCTP in cancerous diseases.