1.Ethical issues and countermeasures of stem cell research in China
Jialu LI ; Qinghui ZHAO ; Hongming TANG ; Zhongmin LIU
Chinese Journal of Medical Science Research Management 2023;36(2):95-98
Objective:To explore the ethical issues arising from stem cell research in China and propose countermeasures to regulate stem cell research.Methods:This article analyzed the ethical issues arising from stem cells in terms of regulatory systems, source channels, production processes, storage industries, and translational applications.Results:Combining the current ethical situation of stem cell research and the practical exploration of the authors' unit, we proposed countermeasures to address the ethical issues of stem cell research in five aspects, including forming a scientific and effective stem cell ethical regulatory system, building an open and transparent stem cell traceability mechanism, creating a GMP-compliant stem cell production platform, selecting a legal and compliant stem cell storage institution, and conducting ethical stem cell clinical research.Conclusions:It is of great practical significance to strengthen the ethical construction of stem cell research and regulate stem cell transformation research to promote the healthy development of the stem cell industry.
2.Dual metabolic platform to analyze differential metabolites in hepatitis B virus-related liver cirrhosis patients with pre-sarcopenia
Xuechun LIU ; Ge GUAN ; Jingli ZHANG ; Guanghui SONG ; Qinghui NIU ; Jianjian ZHAO ; Lingyun ZHANG ; Xue JING
Chinese Journal of Clinical Nutrition 2023;31(6):343-353
Objective:This study aimed to analyze differential metabolites in patients using a dual metabolic platform and to orientate early nutritional intervention in patients with cirrhosis.Methods:The skeletal muscle index (SMI) was calculated based on computed tomography (CT) measurements of skeletal muscle cross-sectional area at the third lumbar vertebra level. Pre-sarcopenia was diagnosed for males with SMI < 46.96 and for females with SMI < 32.46. Fifteen HBV-related liver cirrhosis patients with pre-sarcopenia were included as Group S while fourteen liver cirrhosis without pre-sarcopenia were Group NS. Liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS) analyses were used to detect differential metabolites and disturbed pathways in the two groups.Results:Five pathways and twenty-eight pathways were defined as disturbed pathways in the plasma of liver cirrhosis patients with pre-sarcopenia by LC-MS and GC-MS, respectively. Most of these pathways are related to amino acid metabolism. Forty-two differential metabolites were imported into the disturbed pathways. Moreover, 3-hydroxypropanal, hydrocinnamic acid, betaine aldehyde, phosphohydroxypyruvic acid, (r)-3-hydroxybutyric acid, and creatinine were identified as potential biomarkers for pre-sarcopenia in HBV-related liver cirrhosis.Conclusions:The study identified a total of 33 pathways and related differential metabolites that were disturbed in HBV-related liver cirrhosis with pre-sarcopenia. The amino acid metabolism, urea cycle, and glyoxylate and dicarboxylate metabolism pathways may be associated with pre-sarcopenia in patients with HBV-related liver cirrhosis. These results provide a direction for nutritional supplementation in liver cirrhosis.
3.Thoughts on promoting the industrialization of stem cells: From the perspective of medical institutions and enterprises
Hongming TANG ; Qinghui ZHAO ; Bin HE ; Erpeng JIANG ; Zhongmin LIU
Chinese Journal of Medical Science Research Management 2021;34(1):46-50
Objective:From the perspective of medical institutions and enterprises, based on the current situation in China, starting from the breakthrough the bottleneck of industrial development, discuss possible measures to promote the industrialization of stem cells.Methods:The factors that affect the stem cell industrialization were studied by sorting and analyzing the current stem cell industrialization policy and environment, current situation and existing problems, etc.Results:From the perspective of medical institutions and enterprises, combined with the connotation and characteristics of the stem cell industry and the author's experience and practice during the past 10 years, it is recommended to consider the promotion of the industrialization of stem cells comprehensively from the three levels that including " three transformations" , " three doubles" and " three integrations" .Conclusions:Integrate and play the role of medical institutions as the main body of stem cell clinical research and enterprises as the main body of stem cell industrialization, strengthen the multi-stakeholder cooperation among government, industry, academia, research and funding agencies, accelerate the development, transformation and application of stem cell products and derivative products.Promoting the coordinated development of the upstream, midstream, downstream and related supporting industries of the stem cell industry is of great practical significance for seizing a new round of industrial translation and historical development opportunities in the biomedical field, seizing the commanding heights of the international stem cell industry, and helping the country's major development strategy.
4.Transformation of the key role and related responsibilities of stem cell clinical research in the context of double filling system and the corresponding strategies
Bin HE ; Qinghui ZHAO ; Erpeng JIANG ; Wenjun LE ; Hongming TANG ; Zhongmin LIU
Chinese Journal of Medical Science Research Management 2021;34(3):172-175
Objective:According to the regulatory requirement in China, double filing system including institutional filing and project filing is mandated for conducting stem cell clinical research at medical institutions. Thus, the organization and implementation of stem cell clinical research is different from traditional drug clinical trials. Based on the analysis of the main roles and responsibilities of stem cell clinical research, this article explores countermeasures to promote the legal and regulatory development of stem cell clinical research.Methods:This study sorts out and analyzes the changes in the main roles and responsibilities of stem cell clinical research in the context of double filing system, and conducts analysis on the main-role construction of stem cell clinical research.Results:Combining the institutional practical experience of conducting and managing stem cell clinical research, three key issues are proposed to promote stem cell clinical research, which including the construction of quality inspection platform, optimizing institutional setting and talent training.Conclusions:It is recommended to strengthen the construction of the main roles and responsibilities of stem cell clinical research, which has important practical significance for promoting stem cell clinical research and accelerating the clinical translation and application of stem cells.
5.Strategy exploration on strengthening the quality control of stem cell clinical research
Qinghui ZHAO ; Hongming TANG ; Jialu LI ; Bin HE ; Zhongmin LIU
Chinese Journal of Medical Science Research Management 2021;34(5):393-396
Objective:To study and analyze the problems and challenges of stem cell clinical research quality control, and explore possible strategies to strengthen the quality control of stem cell clinical research.Methods:Analyze the problems of the stem cell clinical research quality control system, and summarize the factors that affect the quality control of stem cell clinical research.Results:In view of the current status analysis of stem cell clinical research quality control, it is recommended to promote stem cells from following five aspects: strengthening and improving the capacity building of clinical research institutions, establishing stem cell clinical quality control system, strengthening the quality control of stem cell preparations, strengthening the team-building of stem cell clinical research investigators, and establishing a stem cell clinical research data platform.Conclusions:Strengthening the quality control of stem cell clinical research is of great significance for accelerating the clinical research and transformational application of stem cells.
6.Establishment of a clinical grade human umbilical cord mesenchymal stem cells bank
Qinghui ZHAO ; Zhihui BAI ; Wenwen JIA ; Hongming TANG ; Zhongmin LIU
International Journal of Biomedical Engineering 2021;44(6):454-459
Objective:To establish a three-level clinical grade human umbilical cord mesenchymal stem cells (hUC-MSCs) bank, including seed cell bank (SCB), master cell bank (MCB) and working cell bank (WCB), and provide hUC-MSCs with controllable quality for clinical research and application.Methods:247 human umbilical cord tissues were isolated, cultured, amplified, subcultured and frozen in GMP laboratory, and the biological characteristics, safety and stability of hUC-MSCs were tested in accordance with the requirements of relevant quality management control specifications.Results:247 strains of hUC-MSCs were isolated and prepared. The prepared hUC-MSCs have good purity and homogeneity without tumorigenicity, show good differentiation ability in biological efficacy, and have strong immunosuppressive effect in the process of co-culture with immune cells. These cells have passed the quality check of National Institute for Food and Drug Control. In this study, a three-level hUC-MSCs bank was established, and it was included into the National Stem Cell Translational Resource Center.Conclusions:A three-level clinical hUC-MSCs bank was successfully established and preliminarily applied to clinical research, which effectively promoted the standardized development of clinical stem cell resource bank and the clinical transformation and application of stem cells in China.
7.Application value of triangular modal construed for planning approach of laparoscopic local resection of liver tumors located in superior part of central liver lobe
Ning FAN ; Yuan GUO ; Liqun WU ; Guofang LIU ; Qinghui NIU ; Chao LIU ; Yang XIN ; Zengqiang DAI ; Yanrong ZHAO ; Yan WANG ; Cong LI ; Yunjin ZANG ; Jinzhen CAI
Chinese Journal of Digestive Surgery 2021;20(8):906-912
Objective:To investigate the application value of triangular modal construed for planning approach of laparoscopic local resection of liver tumors located in superior part of central liver lobe.Methods:The retrospective and descriptive study was conducted. The clinicopathological data of 10 patients who underwent local laparoscopic resection of liver tumors located in superior part of central liver lobe at the Affiliated Hospital of Qingdao University from January to June 2020 were collected. There were 6 males and 4 females, aged from 41 to 63 years, with a median age of 54 years. Preoperative triangular model was constructed for all patients to plan approach of laparoscopic local resection of liver tumors located in superior part of central liver lobe. Observation indicators: (1) preoperative general situations of patients; (2) surgical situations; (3) follow-up. Follow-up was conducted by outpatient examination or telephone interview to detect tumor recurrence and survival of patients up to February 2021. Measurement data with normal distribution were expressed as Mean± SD. Count data were expressed was absolute numbers. Results:(1) Preoperative general situations of patients: hepatocellular carcinoma was found in 7 cases, inthahepatic cholangiocarcinoma was found in 2 cases and ovarian cancer with liver metastasis was found in 1 case. Three cases had tumors located in S4a segment, 2 cases had tumors located in ventral subsegment of S8 segment, 2 cases had tumors located in dorsal subsegment of S8 segment, and 3 cases had tumors across the ventral segment of S4a+S8. The diameter of tumors was (3.4±1.0)cm. (2) Surgical situation: all the 10 patients underwent R 0 resection successfully, with no intraoperative blood transfusion or conversion to open surgery. The operation time of 10 patients was (149±59)minutes, the volume of intraoperative blood loss was (294±163)mL, the minimum surgical margin of specimen was (1.1±0.2)cm. The alanine aminotransferase was (324±151)U/L on the postoperative first day, the aspartic aminotransferase was (401±113)U/L on the postoperative first day, and the duration of postoperative hospital stay was (9±4)days. No bile leakage, hemorr-hage, reoperation or other complications occurred in all patients. (3) Follow-up: 10 patients were followed up for 7?13 months, with a median follow-up time of 11 months. All patients had no margin recurrence or distant metastasis. Conclusion:It is safe and feasible to construct triangular modal for planning approach of local laparoscopic resection of liver tumors located in superior part of central liver lobe.
8.Different treatment regimens for primary central nervous system lymphoma:based on SEER database
Chuanwei YANG ; Xiaohui REN ; Haihui JIANG ; Mingxiao LI ; Xuzhe ZHAO ; Qinghui ZHU ; Yong CUI ; Song LIN
Chinese Journal of Surgery 2021;59(1):52-58
Objectives:To explore the prognostic factors of primary central nervous system lymphoma(PCNSL) and to analyze the efficacy of different treatment methods.Methods:Clinical data of 4 812 patients with PCNSL in SEER database from January 1975 to December 2016 were retrospectively analyzed.Among them, 2 831 were male and 1 981 were female, the ratio of male to female was 1.4∶1.0.There were 2 236 cases(46.47%) under 60 years old, 1 718 cases(35.70%) aged 60 to 74 years old, and 858 cases(17.83%) aged 75 years old or above. Two thousand four hundred and seventeen cases(50.23%) had supratentorial tumors, 299 cases (6.21%) had infratentorial tumors, and 554 cases(11.51%) had multiple brain tumors, 1 542 cases (32.04%) were other or unspecified location.Three thousand five hundred and thirteen cases(73.00%) had diffuse large B-cell lymphoma (DLBCL), 234 cases(4.86%) had non DLBCL, 1 065 cases (22.13%) had other or unspecified types of tumor.The treatment included 2 011 cases (41.77%) of biopsy, 61 cases (1.27%) of subtotal resection(STR), 54 cases (1.12%) of gross total resection(GTR), 2 384 cases (49.54%) of biopsy and chemotherapy, 159 cases (3.30%) of STR and chemotherapy, 144 cases (3.00%) of GTR and chemotherapy.Univariate and multivariate Cox regression models were used to analyze the prognostic factors affecting the overall survival of the patients.Fine-Gray test and competitive risk model were used to analyze the prognostic factors affecting cancer-specific survival.Kaplan-Meier method and Log-rank test was used for survival analysis.Results:Univariate and multivariate Cox regression analyses showed that age, race, marital status, tumor site, pathological subtype, surgery, chemotherapy, combined with other malignant tumors, and HIV infection were the independent prognostic factors affecting the overall survival of PCNSL patients.The results of Fine-Gray test and competitive risk model analyses showed that age, race, marital status, tumor location, pathological subtype, surgical method, chemotherapy, combined with other malignant tumors, and HIV infection were independent prognostic factors affecting cancer-specific survival, while gender and radiotherapy had no significant correlation with cancer-specific survival.Compared with biopsy, PCNSL patients may benefit from surgical resection (STR: HR=0.805, 95% CI:0.656?0.989, P=0.04; GTR: HR=0.521, 95% CI:0.414?0.656, P<0.01).Kaplan-Meier survival analysis showed that the median survival time of biopsy+chemotherapy group was 28 months (95% CI:24.497?31.503), 2 months (95% CI:1.756?2.244) in the biopsy group, 2 months (95% CI:1.410-2.590) in the STR group, 19 months ( 95%CI:0?39.311) in the biopsy+chemotherapy group, 67 months (95% CI:46.187-87.813) in the STR+chemotherapy group, 84 months (95% CI:57.448?110.552) in the GTR+chemotherapy group.The median survival time of patients with different treatment methods was statistically significant ( P<0.01). Conclusions:Surgical resection may improve the prognosis of some PCNSL patients.Patients who have access to receive GTR or STR combined with chemotherapy may have prolonged Cancer-specific survival.
9.Different treatment regimens for primary central nervous system lymphoma:based on SEER database
Chuanwei YANG ; Xiaohui REN ; Haihui JIANG ; Mingxiao LI ; Xuzhe ZHAO ; Qinghui ZHU ; Yong CUI ; Song LIN
Chinese Journal of Surgery 2021;59(1):52-58
Objectives:To explore the prognostic factors of primary central nervous system lymphoma(PCNSL) and to analyze the efficacy of different treatment methods.Methods:Clinical data of 4 812 patients with PCNSL in SEER database from January 1975 to December 2016 were retrospectively analyzed.Among them, 2 831 were male and 1 981 were female, the ratio of male to female was 1.4∶1.0.There were 2 236 cases(46.47%) under 60 years old, 1 718 cases(35.70%) aged 60 to 74 years old, and 858 cases(17.83%) aged 75 years old or above. Two thousand four hundred and seventeen cases(50.23%) had supratentorial tumors, 299 cases (6.21%) had infratentorial tumors, and 554 cases(11.51%) had multiple brain tumors, 1 542 cases (32.04%) were other or unspecified location.Three thousand five hundred and thirteen cases(73.00%) had diffuse large B-cell lymphoma (DLBCL), 234 cases(4.86%) had non DLBCL, 1 065 cases (22.13%) had other or unspecified types of tumor.The treatment included 2 011 cases (41.77%) of biopsy, 61 cases (1.27%) of subtotal resection(STR), 54 cases (1.12%) of gross total resection(GTR), 2 384 cases (49.54%) of biopsy and chemotherapy, 159 cases (3.30%) of STR and chemotherapy, 144 cases (3.00%) of GTR and chemotherapy.Univariate and multivariate Cox regression models were used to analyze the prognostic factors affecting the overall survival of the patients.Fine-Gray test and competitive risk model were used to analyze the prognostic factors affecting cancer-specific survival.Kaplan-Meier method and Log-rank test was used for survival analysis.Results:Univariate and multivariate Cox regression analyses showed that age, race, marital status, tumor site, pathological subtype, surgery, chemotherapy, combined with other malignant tumors, and HIV infection were the independent prognostic factors affecting the overall survival of PCNSL patients.The results of Fine-Gray test and competitive risk model analyses showed that age, race, marital status, tumor location, pathological subtype, surgical method, chemotherapy, combined with other malignant tumors, and HIV infection were independent prognostic factors affecting cancer-specific survival, while gender and radiotherapy had no significant correlation with cancer-specific survival.Compared with biopsy, PCNSL patients may benefit from surgical resection (STR: HR=0.805, 95% CI:0.656?0.989, P=0.04; GTR: HR=0.521, 95% CI:0.414?0.656, P<0.01).Kaplan-Meier survival analysis showed that the median survival time of biopsy+chemotherapy group was 28 months (95% CI:24.497?31.503), 2 months (95% CI:1.756?2.244) in the biopsy group, 2 months (95% CI:1.410-2.590) in the STR group, 19 months ( 95%CI:0?39.311) in the biopsy+chemotherapy group, 67 months (95% CI:46.187-87.813) in the STR+chemotherapy group, 84 months (95% CI:57.448?110.552) in the GTR+chemotherapy group.The median survival time of patients with different treatment methods was statistically significant ( P<0.01). Conclusions:Surgical resection may improve the prognosis of some PCNSL patients.Patients who have access to receive GTR or STR combined with chemotherapy may have prolonged Cancer-specific survival.
10.Present situation and enlightenment of continuing education of dental hygienists in America
Zhiguo DING ; Huaqiang ZHAO ; Lu TANG ; Gang LI ; Qinghui MENG ; Linqi ZHANG
Chinese Journal of Practical Nursing 2020;36(11):807-811
Introducing the continuing education of the dental hygienist in eight states of the U.S.,to understand the the category of practice,professional ability,curriculum, teaching methods and teaching evaluation standard. To analyze the continuing education in eight states to provide a reference for constructing a curriculum system that is suitable for China.

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