1.Dispersion effect of bone cement after vertebroplasty using individualized unilateral external pedicle approach and bilateral pedicle approach
Lichuang ZHANG ; Wen YANG ; Guangjiang DING ; Peikun LI ; Zhongyu XIAO ; Ying CHEN ; Xue FANG ; Teng ZHANG
Chinese Journal of Tissue Engineering Research 2025;29(4):800-808
BACKGROUND:According to existing clinical studies,vertebroplasty treatment with both the external pedicle approach and the pedicle approach can improve the pain and quality of life of patients with spinal compression fractures.Compared with the pedicle approach,the external pedicle approach has a freer puncture angle,and good bone cement dispersion effect can be obtained by adjusting the puncture angle. OBJECTIVE:To compare the impact of vertebroplasty through individualized unilateral external pedicle approach and bilateral pedicle approach on the treatment of spinal compression fractures by quantifying the dispersion effect of bone cement. METHODS:A total of 80 patients with thoracolumbar compression fracture were divided into two groups by random number table method.The bilateral pedicle group(n=40)underwent vertebroplasty through a bilateral pedicle approach,while the unilateral external pedicle group(n=40)underwent individualized vertebroplasty through a unilateral external pedicle approach.Anteroposterior and lateral X-rays of the affected vertebrae from two groups of patients were photographed to assess effect and type of bone cement dispersion within 3 days after surgery.Visual analog scale score,tenderness threshold around fracture,and Oswestry dysfunction index were assessed before,1,7 days,and 1 month after surgery. RESULTS AND CONCLUSION:(1)Dispersion effect of bone cement in unilateral external pedicle group was better than that in bilateral pedicle group(P<0.001),and the amount of bone cement perfusion was higher than that in bilateral pedicle group(P<0.001).In the bilateral pedicle group,the bone cement dispersion types were mainly concentrated in type Ⅰ and type Ⅲ,while in the unilateral external pedicle group,the bone cement dispersion types were mainly concentrated in type I and type Ⅱ,and there was a significant difference in bone cement dispersion types between the two groups(P<0.001).(2)Postoperative visual analog scale scores and Oswestry disability index of both groups were lower than those before surgery(P<0.001),and postoperative tenderness threshold around fracture showed a trend of decreasing first and then increasing.At the same time point after treatment,there were no significant differences in visual analog scale score,Oswestry disability index,and tenderness threshold around fracture between the two groups(P>0.05).(3)The results indicate that individualized vertebroplasty via unilateral external pedicle approach can achieve better bone cement dispersion,and the treatment effect is consistent with the vertebroplasty via classical bilateral pedicle approach.
2. Investigation and analysis of the current status of clinical research nurses
Liming CHEN ; Wenyan ZHAO ; Rui DING ; Yi FANG ; Haiyan ZHANG ; Fan HUANG ; Cai CAO
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):455-459
AIM: To investigate and analyze the current situation and needs of clinical research nurses in China, in order to provide scientific basis for constructing a training system for research nurses, promoting standardized training, and achieving standardized management for them. METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China. The contents of the questionnaire mainly included the general information, professional experience and work content of the research nurses, the sense of accomplishment and training needs of clinical trial work. RESULTS: Among the 102 research nurses surveyed, 92.15% have a bachelor's degree or above; 53.92% of those have intermediate or higher professional titles; 74.51% of them are part-time research nurse. Among professional experiences, 19.61% have more than 10 years of clinical trial experience; 47.06%, 40.20%, and 21.17% of surveyed research nurses were authorized to participate in clinical trial drug management, sample management, and quality control; 70.59% of research nurses have a high sense of achievement in their daily work. In terms of education and training needs, clinical trial related laws and regulations, standardized training for clinical trial protocol implementation, and good clinical practice (GCP) are the three most important aspects. CONCLUSION: Clinical research nurses in China have a relatively high level of education and nursing experience, but there is still a large gap in the amount of professional full-time clinical research nurses in China. Due to the rapid development of innovative drugs and devices, as well as the urgent need to improve the clinical research system, it is necessary to establish a training, assessment, and evaluation system for research nurses that is in line with China's national conditions in order to improve the professional level of research nurses, and improve the quantity and quality of clinical trial research on innovative drugs and devices in China.
3.Clinical significance of nucleolar antinuclear antibodies associated with the nucleolar immunofluorescence pattern in autoimmune disease
Congcong DING ; Xi WANG ; Fang LIN ; Le YU ; Hui CHEN ; Ke DONG
International Journal of Laboratory Medicine 2024;45(1):29-33
Objective To explore the clinical significance of nucleolar antinuclear antibodies(ANA)in re-lated diseases.Methods This study was a retrospective study.Clinical samples of 71780 patients who visited the hospital from January 2017 to May 2022 were collected.Indirect immunofluorescence was used to detect ANA in clinical samples.Statistical analysis was conducted on the positivity rate of nucleolar ANA in clinical patients,as well as the relevant clinical information and laboratory characteristics of patients with autoimmune diseases(AID)with nucleolar ANA positivity.Results Among 71780 patients who underwent routine ANA testing,16778 were positive for ANA,with a positive rate of 23.37%.Among them,there were 1 708 cases of nucleolar type,accounting for 2.38%of all routine ANA tests,and the proportion of ANA positive cases was 10.18%.There was a statistically significant difference in the positive rate of nucleolar ANA between patients of different genders in the>20-<50 year old group and the ≥ 50 year old group(P<0.05),while there was no statistically significant difference in the positive rate of nucleolar ANA between patients of different genders in the ≤ 20 year old group(P>0.05).There was a statistically significant difference in the positivity rate of nucleolar ANA among women of different age groups(P<0.05),among them,the highest positive rate of nucleolar ANA was found in women aged between 20 and 50 years old.There was no statistically significant difference in the positive rate of nucleolar ANA among males of different age groups(P>0.05).The positivi-ty rate of ANA was the highest among patients in the Department of Rheumatology and Immunology(70.35%),but nucleolar ANA positivity was mainly seen in departments such as Reproductive Medicine Cen-ter(12.90%),Respiratory Medicine(12.40%),and Neurology(11.29%),and the difference in positivity rates between departments was statistically significant(P<0.05).Out of 1 708 nucleolar ANA positive indi-viduals,420 underwent ANA titers,including 34 AID patients and 386 non AID patients.There was no statis-tically significant difference in nucleolus positive titers between non AID patients and AID patients(P>0.05).Conclusion The nucleolus type is a common fluorescence pattern in ANA positive individuals,and there are gender and age differences in ANA positive individuals.The positive rate and titer of nucleolar ANA vary among different AID diseases.Combined with other immune function indicators,and it is helpful for early differential diagnosis of AID.
4.Effect of Irradiation Sterilization on the Quality of Rubus Chingii Hu
Ziqian CAI ; Wenting ZHANG ; Ting DONG ; Xinmei CHENG ; Lifeng HANG ; Sheng DING ; Zengxi GUO ; Cuifen FANG ; Bilian CHEN
Chinese Journal of Modern Applied Pharmacy 2024;41(9):1222-1228
OBJECTIVE
To study the effect of 60Co-γ irradiation on the sterilization effect and main components of Rubus chingii Hu.
METHODS
Irradiated Rubus chingii Hu by 0, 6, 10, 15, 30 kGy doses of 60Co-γ, used the microbial count method to determine the microbial level of Rubus chingii Hu before and after irradiation. Analyzed the components of Rubus chingii Hu by high resolution mass spectrometry, investigated the effects of irradiation on the quality of Rubus chingii Hu by comparing the components of Rubus chingii Hu samples before and after irradiation, analyzing the quantitative results of ellagic acid and kaempferol 3-O-yunxiangoside, and evaluating the similarity of fingerprints.
RESULTS
The results of microbial examination of Rubus chingii Hu after different doses of irradiation all met the requirements, cluster analysis and principal component analysis of 20 components showed no significant difference. And there was no significant difference in the contents of ellagic acid and kaempferol 3-O-glucoside before and after irradiation. The similarity of fingerprints before and after irradiation was between 0.995 and 1.000.
CONCLUSION
Irradiation can effectively control the microbial level in Rubus chingii Hu, and there is no significant effect on the chemical composition of Rubus chingii Hu, the results provide a basis for the application of irradiation in the sterilization process of Rubus chingii Hu.
5.Investigation and analysis of the current status of clinical research nurses
Liming CHEN ; Haiyan ZHANG ; Fan HUANG ; Wenyan ZHAO ; Rui DING ; Cai CAO ; Yi FANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):455-459
AIM:To investigate and analyze the current situation and needs of clinical research nurses in China,in order to provide scientific basis for constructing a training system for research nurs-es,promoting standardized training,and achieving standardized management for them.METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China.The contents of the questionnaire mainly included the general infor-mation,professional experience and work content of the research nurses,the sense of accomplish-ment and training needs of clinical trial work.RE-SULTS:Among the 102 research nurses surveyed,92.15%have a bachelor's degree or above;53.92%of those have intermediate or higher professional titles;74.51%of them are part-time research nurse.Among professional experiences,19.61%have more than 10 years of clinical trial experience;47.06%,40.20%,and 21.17%of surveyed research nurses were authorized to participate in clinical tri-al drug management,sample management,and quality control;70.59%of research nurses have a high sense of achievement in their daily work.In terms of education and training needs,clinical trial related laws and regulations,standardized training for clinical trial protocol implementation,and good clinical practice(GCP)are the three most important aspects.CONCLUSION:Clinical research nurses in China have a relatively high level of education and nursing experience,but there is still a large gap in the amount of professional full-time clinical re-search nurses in China.Due to the rapid develop-ment of innovative drugs and devices,as well as the urgent need to improve the clinical research system,it is necessary to establish a training,as-sessment,and evaluation system for research nurs-es that is in line with China's national conditions in order to improve the professional level of research nurses,and improve the quantity and quality of clinical trial research on innovative drugs and devic-es in China.
6.Investigation and analysis of the current status of clinical research nurses
Liming CHEN ; Haiyan ZHANG ; Fan HUANG ; Wenyan ZHAO ; Rui DING ; Cai CAO ; Yi FANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):455-459
AIM:To investigate and analyze the current situation and needs of clinical research nurses in China,in order to provide scientific basis for constructing a training system for research nurs-es,promoting standardized training,and achieving standardized management for them.METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China.The contents of the questionnaire mainly included the general infor-mation,professional experience and work content of the research nurses,the sense of accomplish-ment and training needs of clinical trial work.RE-SULTS:Among the 102 research nurses surveyed,92.15%have a bachelor's degree or above;53.92%of those have intermediate or higher professional titles;74.51%of them are part-time research nurse.Among professional experiences,19.61%have more than 10 years of clinical trial experience;47.06%,40.20%,and 21.17%of surveyed research nurses were authorized to participate in clinical tri-al drug management,sample management,and quality control;70.59%of research nurses have a high sense of achievement in their daily work.In terms of education and training needs,clinical trial related laws and regulations,standardized training for clinical trial protocol implementation,and good clinical practice(GCP)are the three most important aspects.CONCLUSION:Clinical research nurses in China have a relatively high level of education and nursing experience,but there is still a large gap in the amount of professional full-time clinical re-search nurses in China.Due to the rapid develop-ment of innovative drugs and devices,as well as the urgent need to improve the clinical research system,it is necessary to establish a training,as-sessment,and evaluation system for research nurs-es that is in line with China's national conditions in order to improve the professional level of research nurses,and improve the quantity and quality of clinical trial research on innovative drugs and devic-es in China.
7.Investigation and analysis of the current status of clinical research nurses
Liming CHEN ; Haiyan ZHANG ; Fan HUANG ; Wenyan ZHAO ; Rui DING ; Cai CAO ; Yi FANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):455-459
AIM:To investigate and analyze the current situation and needs of clinical research nurses in China,in order to provide scientific basis for constructing a training system for research nurs-es,promoting standardized training,and achieving standardized management for them.METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China.The contents of the questionnaire mainly included the general infor-mation,professional experience and work content of the research nurses,the sense of accomplish-ment and training needs of clinical trial work.RE-SULTS:Among the 102 research nurses surveyed,92.15%have a bachelor's degree or above;53.92%of those have intermediate or higher professional titles;74.51%of them are part-time research nurse.Among professional experiences,19.61%have more than 10 years of clinical trial experience;47.06%,40.20%,and 21.17%of surveyed research nurses were authorized to participate in clinical tri-al drug management,sample management,and quality control;70.59%of research nurses have a high sense of achievement in their daily work.In terms of education and training needs,clinical trial related laws and regulations,standardized training for clinical trial protocol implementation,and good clinical practice(GCP)are the three most important aspects.CONCLUSION:Clinical research nurses in China have a relatively high level of education and nursing experience,but there is still a large gap in the amount of professional full-time clinical re-search nurses in China.Due to the rapid develop-ment of innovative drugs and devices,as well as the urgent need to improve the clinical research system,it is necessary to establish a training,as-sessment,and evaluation system for research nurs-es that is in line with China's national conditions in order to improve the professional level of research nurses,and improve the quantity and quality of clinical trial research on innovative drugs and devic-es in China.
8.Investigation and analysis of the current status of clinical research nurses
Liming CHEN ; Haiyan ZHANG ; Fan HUANG ; Wenyan ZHAO ; Rui DING ; Cai CAO ; Yi FANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):455-459
AIM:To investigate and analyze the current situation and needs of clinical research nurses in China,in order to provide scientific basis for constructing a training system for research nurs-es,promoting standardized training,and achieving standardized management for them.METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China.The contents of the questionnaire mainly included the general infor-mation,professional experience and work content of the research nurses,the sense of accomplish-ment and training needs of clinical trial work.RE-SULTS:Among the 102 research nurses surveyed,92.15%have a bachelor's degree or above;53.92%of those have intermediate or higher professional titles;74.51%of them are part-time research nurse.Among professional experiences,19.61%have more than 10 years of clinical trial experience;47.06%,40.20%,and 21.17%of surveyed research nurses were authorized to participate in clinical tri-al drug management,sample management,and quality control;70.59%of research nurses have a high sense of achievement in their daily work.In terms of education and training needs,clinical trial related laws and regulations,standardized training for clinical trial protocol implementation,and good clinical practice(GCP)are the three most important aspects.CONCLUSION:Clinical research nurses in China have a relatively high level of education and nursing experience,but there is still a large gap in the amount of professional full-time clinical re-search nurses in China.Due to the rapid develop-ment of innovative drugs and devices,as well as the urgent need to improve the clinical research system,it is necessary to establish a training,as-sessment,and evaluation system for research nurs-es that is in line with China's national conditions in order to improve the professional level of research nurses,and improve the quantity and quality of clinical trial research on innovative drugs and devic-es in China.
9.Investigation and analysis of the current status of clinical research nurses
Liming CHEN ; Haiyan ZHANG ; Fan HUANG ; Wenyan ZHAO ; Rui DING ; Cai CAO ; Yi FANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):455-459
AIM:To investigate and analyze the current situation and needs of clinical research nurses in China,in order to provide scientific basis for constructing a training system for research nurs-es,promoting standardized training,and achieving standardized management for them.METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China.The contents of the questionnaire mainly included the general infor-mation,professional experience and work content of the research nurses,the sense of accomplish-ment and training needs of clinical trial work.RE-SULTS:Among the 102 research nurses surveyed,92.15%have a bachelor's degree or above;53.92%of those have intermediate or higher professional titles;74.51%of them are part-time research nurse.Among professional experiences,19.61%have more than 10 years of clinical trial experience;47.06%,40.20%,and 21.17%of surveyed research nurses were authorized to participate in clinical tri-al drug management,sample management,and quality control;70.59%of research nurses have a high sense of achievement in their daily work.In terms of education and training needs,clinical trial related laws and regulations,standardized training for clinical trial protocol implementation,and good clinical practice(GCP)are the three most important aspects.CONCLUSION:Clinical research nurses in China have a relatively high level of education and nursing experience,but there is still a large gap in the amount of professional full-time clinical re-search nurses in China.Due to the rapid develop-ment of innovative drugs and devices,as well as the urgent need to improve the clinical research system,it is necessary to establish a training,as-sessment,and evaluation system for research nurs-es that is in line with China's national conditions in order to improve the professional level of research nurses,and improve the quantity and quality of clinical trial research on innovative drugs and devic-es in China.
10.Investigation and analysis of the current status of clinical research nurses
Liming CHEN ; Haiyan ZHANG ; Fan HUANG ; Wenyan ZHAO ; Rui DING ; Cai CAO ; Yi FANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(4):455-459
AIM:To investigate and analyze the current situation and needs of clinical research nurses in China,in order to provide scientific basis for constructing a training system for research nurs-es,promoting standardized training,and achieving standardized management for them.METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China.The contents of the questionnaire mainly included the general infor-mation,professional experience and work content of the research nurses,the sense of accomplish-ment and training needs of clinical trial work.RE-SULTS:Among the 102 research nurses surveyed,92.15%have a bachelor's degree or above;53.92%of those have intermediate or higher professional titles;74.51%of them are part-time research nurse.Among professional experiences,19.61%have more than 10 years of clinical trial experience;47.06%,40.20%,and 21.17%of surveyed research nurses were authorized to participate in clinical tri-al drug management,sample management,and quality control;70.59%of research nurses have a high sense of achievement in their daily work.In terms of education and training needs,clinical trial related laws and regulations,standardized training for clinical trial protocol implementation,and good clinical practice(GCP)are the three most important aspects.CONCLUSION:Clinical research nurses in China have a relatively high level of education and nursing experience,but there is still a large gap in the amount of professional full-time clinical re-search nurses in China.Due to the rapid develop-ment of innovative drugs and devices,as well as the urgent need to improve the clinical research system,it is necessary to establish a training,as-sessment,and evaluation system for research nurs-es that is in line with China's national conditions in order to improve the professional level of research nurses,and improve the quantity and quality of clinical trial research on innovative drugs and devic-es in China.


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