1. 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.
2.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.
3.Application of B-ultrasound-guided transabdominal villus and amniocentesis in prenatal diagnosis of thalassemia
Lanlan ZHANG ; Fenfang HUANG ; Feifei GONG ; Haiyan CAI ; Xuemei HU ; Yanhua HUANG ; Pei LIANG ; Yijuan CHEN
China Modern Doctor 2024;62(3):13-15
Objective To explore the clinical application of ultrasound-guided transabdominal villus and amniocentesis in the prenatal diagnosis of thalassemia,and to find a suitable method for the prenatal diagnosis of thalassemia in Qinzhou.Methods A total of 531 high-risk pregnant women with severe or intermediate thalassemia during single pregnancy who were treated in the Department of Medical Genetics and Prenatal Diagnosis,Qinzhou Maternal and Child Health Hospital from March 2021 to April 2022 were selected for the study.According to different sampling methods,they were divided into control group(amniocentesis,n=415)and study group(transabdominal villus puncture,n=116).The success rate,complication rate of the two groups were compared.Results The success rate of puncture in the control group was 100%,2 cases were aborted within 2 weeks after surgery,17 cases were diagnosed with severe alpha-thalassemia,10 cases with severe β-thalassemia and 64 cases with intermediate thalassemia,48 cases with moderate and severe thalassemia induced labor.The success rate of puncture in the research group was 100%,10 cases were diagnosed with severe alpha-thalassemia,4 cases with severe β-thalassemia and 17 cases with intermediate thalassemia,and 26 cases with moderate severe thalassemia were induced labor.There was no significant difference in puncture success rate and abortion rate between the two methods(P>0.05).Conclusion Both methods are safe and effective.Transabdominal villus sampling can detect fetal thalassemia in early pregnancy,and it is worth promoting and applying in clinical practice.
4.Expression profile of mRNA sequencing for plasma exosomes among patients with latent tuberculosis infection and active tuberculosis
GAO Jin ; DU Xiaokang ; XIANG Haiyan ; FAN Chaoming ; CAI Chengsong ; PAN Feng
Journal of Preventive Medicine 2024;36(1):70-73, 77
Objective:
To analyse the expression of differential mRNA in the plasma exosomes in patients with latent tuberculosis infection (LTBI) and active tuberculosis (ATB) using high-throughput sequencing, so as to provide insights into differential diagnosis of LTBI and ATB.
Methods:
The plasma samples were collected from the patients treated at The Affiliated Hospital of Hangzhou Normal University, including 16 cases of LTBI and 21 cases of ATB. The exosomes were extracted by Invitrogen extracellular extracts purification kit, and the size and morphology of exosomes were observed by transmission electron microscope (TEM). The exosomes were identified by Western blotting. Total RNA was extracted from plasma exosomes using high-throughput sequencing, differential expression mRNA was identified, and gene ontology (GO) analysis and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway analysis were performed. Two differential mRNAs with the highest differential expression fold were selected, and five patients with ATB and three patients with LTBI were recruited for verification using real-time quantitative PCR.
Results:
The sequencing results of plasma exosomes showed that compared with ATB patients, 2 875 differentially expressed mRNAs were detected in exosomes of LTBI patients, of which 1 002 mRNAs were up-regulated and 1 873 mRNAs were down-regulated. The most significant differentially expressed downregulated and upregulated mRNA were M6PR and RGPD5, respectively. GO analysis and KEGG pathway analysis showed that differential mRNAs were enriched in protein serine kinase activity, rRNA binding molecular function, human cytomegalovirus infection, pancreatic cancer, endometrial cancer, insulin signaling pathway and FoxO signaling pathway. The real-time quantitative PCR showed that the expression of differential mRNA was consistent with sequencing. Compared with ATB patients, the relative expression level of M6PR in plasma exosomes in LTBI patients (0.954±0.212) was downregulated compared with that of ATB patients (2.168±0.226), while the relative expression level of RGPD5 (2.126±0.200) was upregulated compared with that of ATB patients (0.588±0.129) (both P<0.05).
Conclusions
There is a difference in mRNA expression of plasma exosomes between patients with LTBI and ATB. M6PR and RGPD5 may become markers for distinguishing plasma exosomes between LTBI and ATB.
5.Interpretation of global lung cancer statistics
Lin CAI ; Chenxin ZHU ; Xinglong ZHANG ; Yi FANG ; Haiyan YANG ; Lanwei GUO
Chinese Journal of Epidemiology 2024;45(4):585-590
Lung cancer remains one of the leading cause of global cancer-related mortality, posing a significant burden of disease. Tobacco exposure stands as the foremost risk factor for lung cancer. Since the 1960, global efforts have gradually been implemented to control tobacco exposure, consequently reducing tobacco exposure levels within populations. This shift in exposure levels may have altered the epidemiological characteristics of lung cancer globally. This study aims to describe global lung cancer incidence data across five dimensions: age, gender, region, stage at diagnosis, and survival status, using global cancer registry data and relevant research findings. The objective is to elucidate the current epidemiological features of lung cancer worldwide, providing a scientific basis for lung cancer prevention and control. Furthermore, this study offers corresponding measures and recommendations for lung cancer prevention and control, aligning with the three-tiered cancer prevention strategy. Findings indicate that the incidence and mortality burden of lung cancer is significantly higher among the elderly population (aged 65 years and above) compared to the working-age population (aged 15-64 years). The aged-standardized incidence rate of lung cancer remains higher in males than in females, but the overall aged-standardized incidence rate of lung cancer in males shows a declining trend, while that in females shows an increasing trend. Regions with high and very high human development index (HDI) exhibit a substantially higher incidence and mortality burden of lung cancer compared to regions with low and very low HDI. Japan ranks highest in the diagnosis of stage Ⅰ lung cancer, with a diagnosis rate of 38.6%. Its age-standardized 5-year net survival rate is relatively high at 32.9%. Despite improvements in the survival status of lung cancer in certain countries like China and Japan, the overall prognosis for lung cancer remains pessimistic. Given the current epidemiological characteristics of lung cancer, reinforcing tobacco control measures and reducing female-specific lung cancer risk factors stand as significant goals for primary prevention. Promoting low-dose computed tomography screening for high-risk population, minimizing false-positive rates in lung cancer screening, and promoting medical system reforms and standardized treatment constitute principal measures for secondary and tertiary lung cancer prevention, respectively.
6.Analysis on disease burden of lung cancer in population in China
Lanwei GUO ; Lin CAI ; Chenxin ZHU ; Xinglong ZHANG ; Yi FANG ; Haiyan YANG
Chinese Journal of Epidemiology 2024;45(5):626-632
Objective:To analyze the incidence, mortality, and survival status and trends of lung cancer in China.Methods:The data of incidence, mortality, disability-adjusted life year (DALY), and survival status and trends of lung cancer in China were collected from GLOBOCAN 2020, Global Burden of Disease Study in 2019 (GBD2019) databases, and the CONCORD-3 project report. Joinpoint 5.0 software was used to analyze the age-standardized incidence rate (ASIR) and age-standardized mortality rate (ASMR) of lung cancer in China from 1990 to 2019. Data management was conducted by using Excel 2016, and relevant graphical representations were generated using the ggplot2 package in software R 4.2.1.Results:In 2020, a total of 815 563 lung cancer cases were newly reported in China with the ASIR of 34.8/100 000, in which 539 181 cases were reported in men, with the ASIR of 47.8/100 000, and 276 382 cases were reported in women, with the ASIR of 22.8/100 000. A total of 714 699 lung cancer deaths were reported in 2020, with the ASMR of 30.2/100 000. Among these deaths, there were 471 546 deaths in men with the ASMR of 41.8/100 000, and 243 153 deaths in women with the ASMR of 19.7/100 000. From 1990 to 2019, the ASIR and ASMR of lung cancer in both men and women showed increasing trends ( P<0.05). However, from 2010 to 2019, the ASIR and ASMR of lung cancer in men showed decreasing trends, with annual percent of change (APC) of -0.17% (95% CI: -0.24% - -0.09%) and -0.69% (95% CI: -0.79% - -0.59%), respectively. The ASIR and ASMR of lung cancer in women showed increasing trends from 2016 to 2019, with APC of 3.33% (95% CI: 2.73% - 3.88%) and 2.61% (95% CI: 1.99% - 3.28%), respectively. The five-year net survival rate for lung cancer was 19.8% in China (95% CI:19.4% - 20.2%) from 2010 to 2014. Conclusions:The morbidity and mortality of lung cancer in China remain at high levels, the prognosis of lung cancer was poor, and the disease burden of lung cancer would become more serious in the context of population aging, so three-level prevention of lung cancer should be implemented to address this problem. In addition, attention should be paid to the increasing trends of ASIR and ASMR of lung cancer in women in recent years. Further investigation of risk factors and targeted prevention are needed to curb the rising trend in the incidence of lung cancer in women.
7.Current status of global colorectal cancer prevalence, prevention and control
Lanwei GUO ; Xinglong ZHANG ; Lin CAI ; Chenxin ZHU ; Yi FANG ; Haiyan YANG ; Hongda CHEN
Chinese Journal of Oncology 2024;46(1):57-65
Objective:This paper provides a brief overview of the epidemiology of colorectal cancer in China and around the world, and discusses how to prevent colorectal cancer to reduce its disease burden.Method:Using the official database of GLOBOCAN 2020, the China Cancer Registry Annual Report compiled by the National Cancer Center, and data from CONCORD-3.Data management was performed by Microsoft Excel 2016 and R 4.2.1 Relevant graphs were generated using the ggplot2 package for result visualization.Result:An estimated 1 931 590 people were diagnosed with colorectal cancer worldwide in 2020 with an age-standardized incidence rate of 19.5 per 100 000. There were about 935 173 deaths caused by colorectal cancer internationally, with an age-standardized mortality rate of 9.0 per 100 000. Overall, colorectal cancer was the fourth most commonly diagnosed cancer and the third leading cause of cancer-related death worldwide in 2020. In China, the age-standardized incidence rate and mortality rate of colorectal cancer was 17.3 per 100 000 and 7.8 per 100 000, respectively. Gender differences in trends were observed, with a decreasing trend in incidence and mortality among females and an increasing trend in incidence and mortality among males. The primary risk factors for colorectal cancer include age, genetic factors, gastrointestinal disorders, dietary habits, and lifestyle et al.Conclusions:Colorectal cancer poses a significant burden globally and in China. The occurrence of colorectal cancer is closely related to physiology, genetics, behavioral habits, lifestyle, and disease factors. To better control the colorectal cancer burden with the lowest cost, specific measures should be taken to reduce exposure to established risk factors. By combining the disease prevention and control strategies of tertiary prevention in China with the characteristic factors of colorectal cancer, the incidence and mortality of colorectal cancer may be effectively controlled.
8.Global burden of lung cancer in 2022 and projected burden in 2050
Lanwei GUO ; Chenxin ZHU ; Lin CAI ; Xinglong ZHANG ; Yi FANG ; Hongda CHEN ; Haiyan YANG
Chinese Medical Journal 2024;137(21):2577-2582
Background::Lung cancer is the most common cancer and a leading cause of cancer-related deaths globally. The aim of this study was to evaluate the incidence and mortality of lung cancer worldwide in 2022 and to project the number of new cases and deaths due to lung cancer in China and the United States in 2050.Methods::In this study, data from the GLOBCAN 2022 database were used to analyze lung cancer incidence and mortality. The current status of lung cancer incidence and deaths was described by country/region, sex, age, and the human development index (HDI), and future lung cancer incidence and deaths in China and the United States were projected for 2050.Results::Globally, an estimated 2,480,675 new lung cancer cases and 1,817,469 lung cancer-related deaths occurred in 2022, with age-standardized incidence rates (ASIRs) and age-standardized mortality rates (ASMRs) of 23.6/100,000 and 16.8/100,000, respectively. In China, the ASIR and ASMR for male lung cancer patients were approximately 1.7 times and 2.7 times greater than those for female lung cancer patients, respectively. The ASIR and ASMR in high-HDI countries were approximately 8.5 times and 6.5 times those in low-HDI countries, respectively. It is estimated that in 2050, there will be approximately 1120 thousand new cases and 960 thousand deaths among Chinese men, 680 thousand new cases and 450 thousand deaths among Chinese women, approximately 170 thousand new cases and 110 thousand deaths among American men, and 160 thousand new cases and 90 thousand deaths among American women.Conclusions::There are significant differences in the incidence and mortality of lung cancer among different regions and sexes. Therefore, sex factors need to be considered in the prevention, screening, and treatment strategies of lung cancer, and the implementation of tertiary prevention measures for lung cancer, especially primary and secondary prevention, needs to be actively promoted.
9.Analysis of risk factors for death after acute Stanford type A aortic dissection compli-cated with organ malperfusion
Haiyan XIE ; Hongyu LI ; Juan CHEN ; Yanli DENG ; Chun CAI ; Wuyun JIANG
Chinese Journal of Arteriosclerosis 2024;32(3):217-227
Aim To investigate the risk factors of death after acute Stanford type A aortic dissection(ATAAD)complicated with malperfusion syndrome(MPS).Methods 244 patients with ATAAD complicated with MPS who ad-mitted to Nanchong Central Hospital from June 2020 to June 2023 were selected as the study objects.The postoperative survival of the patients was followed up and they were classified into survival group(156 cases)and death group(88 ca-ses).After propensity score matching(PSM)was applied in 1 ∶1 matching,there were 54 cases in both groups.Uni-variate and Logistic regression analysis was performed to analyze the risk factors of postoperative death in patients with ATA-AD complicated with MPS.Area under curve(AUC)of receiver operating characteristics(ROC)was used to analyze the prognosis of ATAAD complicated with MPS.The prediction model was established by using the regression equation y=1-1/(1+e-z)and the stability of the model was verified by cross-checking method.Results After matching,compared with the survival group(n=54),in the death group(n=54),the proportion of sex(male),the proportion of alcohol con-sumption,acute physiology and chronic health status Ⅱ(APACHE Ⅱ)score,sequential organ failure(SOFA)score,al-anine aminotransferase(ALT),aspartate aminotransferase(AST),total serum bilirubin(TSB),cholinesterase,serum creatinine(SCr),blood urea nitrogen(BUN),N-terminal pro-brain natriuretic peptide(NT-proBNP),D-dimer(D-D),white blood cell(WBC),neutrophile granulocyte(NEU),fibrinogen degradation product(FDP),platelet(PLT),fi-brinogen(FIB),C-reactive protein(CRP),hypersensitive troponin,operation time,ICU stay time,ventilator stay time,hospital stay,distal extremity hypoperfusion,renal hypoperfusion were significantly increased(P<0.05).Logistic analy-sis displayed that gender(male),history of drinking,NT-proBNP ≥271.86 ng/L,D-D≥0.74 mg/L and NEU≥13.06× 109 L-1 were independent risk factors in ATAAD patients complicated with MPS for postoperative death(P<0.05).The combination of NT-proBNP,D-D,gender(male),alcohol drinking history and NEU(referred to as"five factors")had the highest value in predicting ATAAD patients with MPS.The AUC of its ROC curve was 0.979(95%CI:0.937~0.984),the sensitivity was 94.3%,and the specificity was 91.8%,which was higher than the independent predictor.The best critical value predicted by the five factors was 5.02.The survival rate of the group>5.02 was significantly high-er than that of the group ≤5.02.Log Rank test P<0.01.A prediction model was established based on the important factors of postoperative death in ATAAD patients with MPS.The results showed that the model had good prediction accu-racy.Conclusion NT-proBNP≥271.86 ng/L,D-D≥0.74 mg/L,gender(male),history of alcohol consumption,and NEU≥×109 L-1 were independent risk factors for long-term prognosis in patients with ATAAD combined with MPS,and their combined application could effectively increase the accuracy of prognosis assessment.
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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