1.Comparative Study of Clinical Trial Ethics Between China and Foreign Countries Based on CiteSpace
Jianfang DONG ; Kangqi LI ; Yang YANG ; Zhe WANG ; Weiwei ZHU ; Congxiao LU ; Wenwen ZHENG
Herald of Medicine 2025;44(1):157-164
Objective To provide relevant suggestions for ethical considerations in clinical research by searching literature related to ethics in clinical research using the visualization analysis software CiteSpace,and to analyze and compare the current research status of clinical research ethics at home and abroad.Methods The papers on the application of medical ethics in clinical trials from the core collection of CNKI and Web of Science databases were collected and the bibliometric software CiteSpace was used to draw a knowledge map of domestic and foreign literature.The research hotspots and development trends of medical ethics in clinical trials were analyzed.Results In terms of the process of informed consent,risk minimization,fair selection,and protection on the rights and interests of vulnerable groups,the focus of medical ethics research in China were basically consistent with foreign literature.The difference was that foreign research focused more on ethical education,the quality of life of research participants,and ethical counseling.Otherwise,domestic research focused more on the quality management of clinical trials and the specificity of traditional Chinese medicine research,with research on vulnerable groups mostly focused on children.Conclusion Chinese researchers should strengthen multi-dimensional research on medical ethics in China,and gradually expand their view from ethical review points and management research to applied research solved clinical problems and the specificity of research participants,and increasing the number and dimensions of research.
2.The relationship between SERPINA4 expression and prognosis in metastatic color-ectal cancer
Jianfang GAO ; Xiaotong DONG ; Qing ZHAO ; Yunxiang ZHANG ; Huimin SUN
Chinese Journal of Clinical and Experimental Pathology 2025;41(3):340-344,351
Purpose To investigate the relationship between SERPINA4 expression and clinicopathological fea-tures and prognosis in metastatic colorectal cancer(CRC).Methods EnVision two-step immunohistochemical method was used to detect the expression of SERPINA4 protein in 104 cases of primary and metastatic tumor paraffin tissues of metastatic colorectal cancer and adjacent intestinal normal mucosa,and its relationship with clinicopathological features of patients was analyzed.qRT-PCR was used to detect the expression of SERPINA4 mRNA in 11 pairs of metastatic CRC metastases and paired primary tumor paraffin-embedded tissue samples.The survival of patients was followed up,and the relationship between SERPINA4 expression and patient prognosis was analyzed by Kaplan-Meier method.Re-sults Immunohistochemical results showed that the strong positive expression rate of SERPINA4 was 97.10%in nor-mal mucosa,71.20%in primary lesions,and 39.40%in metastatic lesions.The difference between the three groups was statistically significant(P<0.001).qRT-PCR results showed that SERPINA4 mRNA was lowly expressed in me-tastatic lesions of metastatic CRC(P<0.05).The expression of SERPINA4 in metastatic lesions was significantly cor-related with histological grade,N stage and M stage of the tumor(P<0.05),but not significantly correlated with age,gender,tumor location and T stage of patients(P>0.05).The survival time of patients with metastatic colorectal cancer with high expression of SERPINA4 was longer than that of patients with low expression.Conclusion The ex-pression of SERPINA4 is of great significance in the survival and prognosis of patients with metastatic CRC.
3.The relationship between SERPINA4 expression and prognosis in metastatic color-ectal cancer
Jianfang GAO ; Xiaotong DONG ; Qing ZHAO ; Yunxiang ZHANG ; Huimin SUN
Chinese Journal of Clinical and Experimental Pathology 2025;41(3):340-344,351
Purpose To investigate the relationship between SERPINA4 expression and clinicopathological fea-tures and prognosis in metastatic colorectal cancer(CRC).Methods EnVision two-step immunohistochemical method was used to detect the expression of SERPINA4 protein in 104 cases of primary and metastatic tumor paraffin tissues of metastatic colorectal cancer and adjacent intestinal normal mucosa,and its relationship with clinicopathological features of patients was analyzed.qRT-PCR was used to detect the expression of SERPINA4 mRNA in 11 pairs of metastatic CRC metastases and paired primary tumor paraffin-embedded tissue samples.The survival of patients was followed up,and the relationship between SERPINA4 expression and patient prognosis was analyzed by Kaplan-Meier method.Re-sults Immunohistochemical results showed that the strong positive expression rate of SERPINA4 was 97.10%in nor-mal mucosa,71.20%in primary lesions,and 39.40%in metastatic lesions.The difference between the three groups was statistically significant(P<0.001).qRT-PCR results showed that SERPINA4 mRNA was lowly expressed in me-tastatic lesions of metastatic CRC(P<0.05).The expression of SERPINA4 in metastatic lesions was significantly cor-related with histological grade,N stage and M stage of the tumor(P<0.05),but not significantly correlated with age,gender,tumor location and T stage of patients(P>0.05).The survival time of patients with metastatic colorectal cancer with high expression of SERPINA4 was longer than that of patients with low expression.Conclusion The ex-pression of SERPINA4 is of great significance in the survival and prognosis of patients with metastatic CRC.
4.Comparative Study of Clinical Trial Ethics Between China and Foreign Countries Based on CiteSpace
Jianfang DONG ; Kangqi LI ; Yang YANG ; Zhe WANG ; Weiwei ZHU ; Congxiao LU ; Wenwen ZHENG
Herald of Medicine 2025;44(1):157-164
Objective To provide relevant suggestions for ethical considerations in clinical research by searching literature related to ethics in clinical research using the visualization analysis software CiteSpace,and to analyze and compare the current research status of clinical research ethics at home and abroad.Methods The papers on the application of medical ethics in clinical trials from the core collection of CNKI and Web of Science databases were collected and the bibliometric software CiteSpace was used to draw a knowledge map of domestic and foreign literature.The research hotspots and development trends of medical ethics in clinical trials were analyzed.Results In terms of the process of informed consent,risk minimization,fair selection,and protection on the rights and interests of vulnerable groups,the focus of medical ethics research in China were basically consistent with foreign literature.The difference was that foreign research focused more on ethical education,the quality of life of research participants,and ethical counseling.Otherwise,domestic research focused more on the quality management of clinical trials and the specificity of traditional Chinese medicine research,with research on vulnerable groups mostly focused on children.Conclusion Chinese researchers should strengthen multi-dimensional research on medical ethics in China,and gradually expand their view from ethical review points and management research to applied research solved clinical problems and the specificity of research participants,and increasing the number and dimensions of research.
5.Correlation between tumor abnormal protein level and molecular typing and clinicopathological characteristics in breast cancer
Yunting LI ; Xiaotong DONG ; Jianfang GAO ; Yunxiang ZHANG
Chinese Journal of Clinical and Experimental Pathology 2024;40(3):273-278
Purpose To investigate the relationship be-tween the level of tumor abnormal protein(TAP)and the molec-ular subtypes and clinicopathological features of breast cancer,and to analyze the value of TAP in breast cancer screening,di-agnosis and prognosis prediction.Methods The clinical data of 357 breast cancer patients were collected,and the elbow venous blood was collected to detect the TAP condensate area.Immuno-histochemical(IHC)EnVision two-step method was used to de-tect the expression of AR,ER,PR,HER2,p53 and Ki67,and FISH to detect HER2 gene.The relationship between TAP ex-pression and clinicopathological features,molecular subtypes and clinical stages of breast cancer was analyzed,and the rele-vant literature was reviewed.Results Among 357 breast cancer patients,9 cases(2.52%)were TAP negative,36 cases(10.08%)were weakly positive,312 cases(87.40%)were strongly positive,and the positive rate of TAP was 97.48%.AR was positive in 321 cases and negative in 36 cases,ER was pos-itive in 256 cases and negative in 101 cases,PR was positive in 214 cases and negative in 143 cases,HER2 was strongly posi-tive in 98 cases,weakly positive in 214 cases and negative in 45 cases,p53 was positive in 146 cases and negative in 211 cases,Ki67 index was ≥20%in 276 cases and<20%in 81 case.A total of 155 cases of IHC HER2(2+)breast cancer were tested by FISH:140 cases were negative and 15 cases were positive.The expression level of TAP in patients of ≥50 years old expres-sionas significantly higher than that in patients of<50 years old(P<0.05).The expression level of TAP in patients with high Ki67 proliferation index was significantly higher than that in pa-tients with low Ki67 proliferation index(P<0.05).There was a significant difference in TAP expression between patients with different molecular subtypes(P<0.05).Tap expression was higher in triple-negative breast cancer patients than in non-tri-ple-negative breast cancer patients(P<0.05),and it was high-er in Luminal B breast cancer patients than in non-Luminal B breast cancer patients(P<0.05).There was a significant difference in TAP expression between patients with different clin-ical stages(P<0.05),and TAP expression level was positively correlated with clinical stage in breast cancer.Conclusion TAP detection can improve the diagnostic accuracy of breast cancer,and has a certain correlation with the survival rate and prognosis of breast cancer patients.
6.A community-based serological cohort study on incidence of seasonal influenza virus infection in Macheng city from winter 2019 to spring 2020
Jinsong FAN ; Jianbo ZHAN ; Yue CHEN ; Shaobo DONG ; Jian LU ; Junfeng GUO ; Xiaojing LIN ; Yu LAN ; Kun QIN ; Jianfang ZHOU ; Bing HU ; Cuiling XU
Chinese Journal of Experimental and Clinical Virology 2024;38(3):311-318
Objective:To determine incidence of seasonal influenza virus infection in the community and to analyze the factors influencing seasonal influenza virus infection.Methods:This study recruited residents aged 6-59 years to build a cohort in 15 villages/streets in Macheng city in November 2019. Meanwhile, a cross-sectional baseline survey was conducted immediately to collect sera, information on demographics and child protection knowledge, behaviors, as well as attitudes using a questionnaire from the participants enrolled in the cohort (i.e., before the influenza epidemic season). In July 2020, a cross-sectional follow-up survey was conducted to collect sera once again (i.e., after the influenza season). Paired sera from the two cross-sectional surveys were tested for influenza virus-specific antibodies by hemagglutination inhibition (HI) test or micro-neutralization (MN) test using a circulating representative strain of each subtype/lineage of influenza virus as the test antigen. The infections with influenza virus subtype/lineage was confirmed if there was a four-fold or more increase in titers of antibodies against circulating representative strain of the subtype/lineage of influenza virus. Factors influencing infection with influenza A (H3N2) and B/Victoria viruses were analyzed using univariable and multivariable logistic regression.Results:In November 2019, 800 study participants were enrolled in the cohort, including 340 children aged 6-17 years and 460 adults aged 18-59 years; 605 study participants (including 224 children and 381 adults) were followed up in July 2020 and their paired sera were obtained before and after the influenza season. 25.3% (153/605) of the participants were confirmed to be infected with at least one subtype/lineage of seasonal influenza virus by HI and MN tests. The overall incidence of influenza viruses of all subtypes/lineages in children was 44.2% (95% CI: 37.6%-50.8%) which was significantly higher than the incidence of 14.1% in adults (95% CI: 10.7%-17.7%). Children had the highest incidence of influenza A (H3N2) virus infection, followed by B/Victoria. MN or HI antibody titers in A (H3N2)[ OR=0.88 (95% CI: 0.84-0.93)] and B/Victoria[ OR=0.97 (95% CI: 0.95-0.99)] before the influenza season were significantly associated with whether children were infected with that subtype/lineage of influenza virus. Conclusions:The residents aged 6-59 years in Macheng city had a substantial incidence of seasonal influenza virus infection during the influenza season from winter 2019 to spring 2020. Notably, almost half of children aged 6-17 years have been infected with seasonal influenza virus. Higher titers of HI/MN antibodies against seasonal influenza virus before the influenza season would be likely to reduce the risk of infection with influenza A (H3N2) and B/Victoria.
7.Comprehensively Evaluate the Quality of Hypericum Sampsonii by QAMS Multi-component Quantification and PCA,OPLS-DA,EW-TOPSIS Analysis
Jianfang ZHANG ; Zongliang CHEN ; Yingying DONG
Journal of Zhejiang Chinese Medical University 2024;48(11):1363-1376
[Objective]To establish a method for simultaneous determination of 12 components of Hypericum sampsonii from different producing areas,and evaluate its quality by chemometrics and entropy weight-technique for order preference by similarity to an ideal solution(EW-TOPSIS).[Methods]The analysis was performed on a Agilent 5 TC-C18 column with mobile phase consisting of 0.5% phosphoric acid-acetonitrile solution(gradient elution)at a flow rate of 1.0 mL·min-1.The detection wavelength was set at 254 nm and 210 nm.Relative correction factor(RCF) for rutoside,hyperoside,quercetin,kaempferol,3,8'-biapigenin,euxanthone,1,3-dihydroxy-5-methoxy-xanthone,norathyriol,emodin,physcion,hyperforin and mangiferin was established with mangiferin as internal reference,and the contents were calculated,and 12 components were determined by external standard method(ESM) method.Chemical mode identification and EW-TOPSIS method were used to establish the quality evaluation model of Hypericum sampsonii,and the overall quality was evaluated comprehensively.[Results]The methodological examination results of the external standard method all met the requirements of Chinese Pharmacopoeia.There was no significant difference in the content results between the QAMS method and the ESM.The principal component analysis(PCA) results showed that 18 batches of samples were clustered into 3 categories;the orthogonal partial least squares-discriminant analysis(OPLS-DA) analysis results showed that 18 batches of samples were significantly classified,and 5 differential biomarkers that caused differences in the quality of Hypericum sampsonii from different regions were screened out;EW-TOPSIS analysis results showed that the overall quality of Hypericum sampsonii from Sichuan,Guizhou and Guangxi provinces were better.[Conclusion]The established HPLC-QAMS method for simultaneous determination of 12 components in Hypericum sampsonii are convenient and accurate.Chemical mode identification and EW-TOPSIS method are objective and comprehensive,which can be used for the overall quality evaluation of Hypericum sampsonii.
8.Comprehensively Evaluate the Quality of Hypericum Sampsonii by QAMS Multi-component Quantification and PCA,OPLS-DA,EW-TOPSIS Analysis
Jianfang ZHANG ; Zongliang CHEN ; Yingying DONG
Journal of Zhejiang Chinese Medical University 2024;48(11):1363-1376
[Objective]To establish a method for simultaneous determination of 12 components of Hypericum sampsonii from different producing areas,and evaluate its quality by chemometrics and entropy weight-technique for order preference by similarity to an ideal solution(EW-TOPSIS).[Methods]The analysis was performed on a Agilent 5 TC-C18 column with mobile phase consisting of 0.5% phosphoric acid-acetonitrile solution(gradient elution)at a flow rate of 1.0 mL·min-1.The detection wavelength was set at 254 nm and 210 nm.Relative correction factor(RCF) for rutoside,hyperoside,quercetin,kaempferol,3,8'-biapigenin,euxanthone,1,3-dihydroxy-5-methoxy-xanthone,norathyriol,emodin,physcion,hyperforin and mangiferin was established with mangiferin as internal reference,and the contents were calculated,and 12 components were determined by external standard method(ESM) method.Chemical mode identification and EW-TOPSIS method were used to establish the quality evaluation model of Hypericum sampsonii,and the overall quality was evaluated comprehensively.[Results]The methodological examination results of the external standard method all met the requirements of Chinese Pharmacopoeia.There was no significant difference in the content results between the QAMS method and the ESM.The principal component analysis(PCA) results showed that 18 batches of samples were clustered into 3 categories;the orthogonal partial least squares-discriminant analysis(OPLS-DA) analysis results showed that 18 batches of samples were significantly classified,and 5 differential biomarkers that caused differences in the quality of Hypericum sampsonii from different regions were screened out;EW-TOPSIS analysis results showed that the overall quality of Hypericum sampsonii from Sichuan,Guizhou and Guangxi provinces were better.[Conclusion]The established HPLC-QAMS method for simultaneous determination of 12 components in Hypericum sampsonii are convenient and accurate.Chemical mode identification and EW-TOPSIS method are objective and comprehensive,which can be used for the overall quality evaluation of Hypericum sampsonii.
9.The application of gluteal implant and autologous fat grafting in gluteal augmentation and complication management
Jianfang ZHAO ; Dong LI ; Yang AN
Chinese Journal of Plastic Surgery 2021;37(9):1063-1067
Buttock is an important element of body curve and a reflection of female attractiveness. Common surgical procedures of gluteal augmentation include prosthesis implantation, autologous fat grafting, hyaluronic acid injection, autologous flap transfer, et al. Precise preoperative evaluation, accurate operating procedures and proper postoperative management are extremely important for better result and patient satisfaction of the operation. The current review briefly summarizes two of the most common treatment options of gluteal augmentation and emphasizes the management of perioperative complications.
10.The application of gluteal implant and autologous fat grafting in gluteal augmentation and complication management
Jianfang ZHAO ; Dong LI ; Yang AN
Chinese Journal of Plastic Surgery 2021;37(9):1063-1067
Buttock is an important element of body curve and a reflection of female attractiveness. Common surgical procedures of gluteal augmentation include prosthesis implantation, autologous fat grafting, hyaluronic acid injection, autologous flap transfer, et al. Precise preoperative evaluation, accurate operating procedures and proper postoperative management are extremely important for better result and patient satisfaction of the operation. The current review briefly summarizes two of the most common treatment options of gluteal augmentation and emphasizes the management of perioperative complications.

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