1.Considerations of ethical issues in clinical trials for medical equipments from the perspective of the Belmont Report
Chengdong JI ; Yan JIANG ; Ming ZHU ; Weimin WU ; Juerong ZHOU ; Kan ZHANG
Chinese Journal of Medical Science Research Management 2013;(2):84-88
Clinical trial is the most direct and the most effective way to test the performance of medical equipments.The Belmont Report is the statement of the basic moral principles and guidelines,used to help solve the moral problems produced in scientific researches involving human subjects.This apaper examines the ethical issues in clinical trials for medical equipments from the perspective of the Belmont report.It first introduces the background and basic concepts of Belmont report,background concept and the concept and the basic process of medical equipment clinical trials.Then the three principles of the Belmont Report is presented and how to apply the Report to solve ethical problems arising in medical equipment trials.Application of informed consent risk and benefits assessment,and selection of subjects participants and the distribution of research results to address the ethical issues arising in clinical trials.
2.Effects of Chinese herbal drug-containing serum on oxidative damage and apoptosis of umbilical vein endothelial cells induced by oxidized low-density lipoprotein.
Yu MIAO ; Yuerong JIANG ; Lin YANG ; Chengdong XIA ; Lu ZHANG ; Caifeng WU ; Dazhuo SHI ; Huijun YIN ; Keji CHEN
Journal of Integrative Medicine 2011;9(5):539-545
Objective: To investigate the effects of Chinese herbal drug-containing serum, prepared by administration of Chinese herbal medicine for activating blood (Xiongshao Capsule, XS) or for activating blood and detoxifying (Xiongshao Capsule plus Huanglian Capsule, XSHL) in rats, on cell viability, oxidative damage and apoptosis of human umbilical vein endothelial cells (HUVECs) induced by oxidized low-density lipoprotein (ox-LDL). Methods: Thirty-two rats were randomly divided into 4 groups: control group, positive control group (simvastatin 1.8 mg/kg), activating blood (XS, 0.135 g/kg) group, and activating blood and detoxifying (XS Capsule 0.135 g/kg and Huanglian Capsule 0.135 g/kg, XSHL) group. Corresponding drugs were continuously administered to the rats for 7 days and then drug-containing serum was harvested 1 hour after the last administration. HUVECs isolated from newborn children by collagenase digestion were stimulated by ox-LDL (100 μg/L) and incubated with corresponding drug-containing serum for 24 hours. Untreated HUVECs were also used as a normal control. The morphology and structure of HUVECs were observed by an inverted microscope. Cell viability was measured by methyl thiazolyl tetrazolium method, and cell membrane damage was determined by lactate dehydrogenase (LDH) leakage. Activity of superoxide dismutase (SOD) was examined by spectrophotometry, and content of malondialdehyde (MDA) in the cell lysate was examined by thiobarbituric acid assay. HUVECs were stained with Annexin V-fluorescein isothiocyanate and propidium iodide and analyzed on a flow cytometry to determine apoptosis. Results: Compared with the normal HUVECs, the cell viability and the activity of SOD were significantly decreased while the content of MDA and apoptosis rate were significantly increased after 24-hour ox-LDL stimulation (P<0.01, P<0.05). Simvastatin-, XS-, and XSHL-containing serum significantly promoted the ox-LDL-stimulated HUVEC viability and inhibited early apoptosis (P<0.01, P<0.05), while had no significant effect on LDH leakage. Simvastatin-containing serum and XS-containing serum also showed significant decrease in MDA content and increase in SOD activity, while XSHL-containing serum showed no significant effects. There was no significant difference between the XS-containing serum group and the XSHL-containing serum group. Conclusion: Both sera containing XSHL and XS show protective action against the oxidative damage and apoptosis of HUVECs induced by ox-LDL.
3.Research and advance of hydrogel-promoted endometrial repair in intrauterine adhesions
Haoming WU ; Yao WANG ; Yuanmeng CHEN ; Huili ZHU ; Kainan LI ; Chengdong XIONG ; Xulin HU
Chinese Journal of Tissue Engineering Research 2024;28(17):2774-2781
BACKGROUND:The key to preventing the recurrence of intrauterine adhesions is to reconstruct the endometrium with normal function.The latest breakthrough in the treatment of recurrent intrauterine adhesions in and outside China is the use of degradable materials to prepare hydrogels to prevent the recurrence of adhesions. OBJECTIVE:To review the research advance in hydrogel-promoted endometrial repair in intrauterine adhesions. METHODS:PubMed,Web of Science,China National Knowledge Infrastructure(CNKI),and WanFang databases were searched systematically,with the keywords"intrauterine adhesions,endometrial injury,endometrium regeneration,hydrogel"in Chinese and English.Relevant articles published in each database from January 1990 to March 2023 were collected. RESULTS AND CONCLUSION:In recent years,research on hydrogel-promoted endometrial repair in uterine adhesions in and outside China has made some progress and plays an important role in the prevention and treatment of intrauterine adhesions and the promotion of endometrial repair:(1)As an important carrier in tissue engineering,hydrogel itself has excellent biocompatibility,biodegradability and three-dimensional network structure,which can be better applied in the treatment of intrauterine adhesions.(2)The hydrogel-based carrier system can promote the proliferation and differentiation of endometrial epithelial cells by transporting drugs/biologics/stem cells,and restore normal uterine morphology to prevent adhesion recurrence.(3)Hyaluronic acid hydrogels can not only meet good biocompatibility,but also promote the proliferation and differentiation of endometrial epithelial cells,and will be hydrolyzed by corresponding enzymes in utero,without affecting the normal metabolism of the body.They are currently commonly used uterine anti-adhesion agents in the clinic and are also the most commonly used hydrogel carriers in tissue engineering research.(4)Poloxamer hydrogel with excellent temperature-sensitive properties can rapidly gelate into the body,quickly form a physical barrier,and can play a slow-release effect on carrying substances and provide a platform for cell growth/adhesion.(5)There are broad prospects for the preparation of therapeutic hydrogels using materials with different characteristics,such as temperature-sensitive hydrogels,pH-responsive hydrogels and photosensitive hydrogels,but there are still many problems to be solved,such as the safety of the hydrogel system,whether the degradation products cause immune reactions,and whether they have an impact on the normal body's menstrual period.A large number of animal experiments and clinical trials are needed to verify its safety and efficacy,and continuously improve the treatment strategy.
4.Recent advance in quantitative MRI in glymphatic systems of the brain
Yali ZHAO ; Hongyu WU ; Linhan ZHAI ; Weiqiang LIANG ; Huan LIU ; Chengdong PENG ; Qiuxia WANG ; Jing ZHANG
Chinese Journal of Neuromedicine 2022;21(3):316-320
The glymphatic system, as "waste" clearance pathway in the brain, plays a critical role in maintaining the homeostasis of the brain cell microenvironment. It has been found that changes in the glymphatic system are common in many neurological diseases. MRI is currently the only technology that can achieve human glymphatic imaging, and has the advantages of high soft tissue resolution and sensitivity to tracers. Quantitative MRI can objectively evaluate the changes of inflow and outflow of glymphatic system. Therefore, in this review, we introduce the application of quantitative MRI technology in the glymphatic system in detail, aiming to provide help for the diagnosis and treatment of diseases related to glymphatic system.
5.Expression of Translationally Controlled Tumor Protein (TCTP) Gene of Dirofilaria immitis Guided by Transcriptomic Screening.
Yan FU ; Jingchao LAN ; Xuhang WU ; Deying YANG ; Zhihe ZHANG ; Huaming NIE ; Rong HOU ; Runhui ZHANG ; Wanpeng ZHENG ; Yue XIE ; Ning YAN ; Zhi YANG ; Chengdong WANG ; Li LUO ; Li LIU ; Xiaobin GU ; Shuxian WANG ; Xuerong PENG ; Guangyou YANG
The Korean Journal of Parasitology 2014;52(1):21-26
Dirofilaria immitis (heartworm) infections affect domestic dogs, cats, and various wild mammals with increasing incidence in temperate and tropical areas. More sensitive antibody detection methodologies are required to diagnose asymptomatic dirofilariasis with low worm burdens. Applying current transcriptomic technologies would be useful to discover potential diagnostic markers for D. immitis infection. A filarial homologue of the mammalian translationally controlled tumor protein (TCTP) was initially identified by screening the assembled transcriptome of D. immitis (DiTCTP). A BLAST analysis suggested that the DiTCTP gene shared the highest similarity with TCTP from Loa loa at protein level (97%). A histidine-tagged recombinant DiTCTP protein (rDiTCTP) of 40 kDa expressed in Escherichia coli BL21 (DE3) showed immunoreactivity with serum from a dog experimentally infected with heartworms. Localization studies illustrated the ubiquitous presence of rDiTCTP protein in the lateral hypodermal chords, dorsal hypodermal chord, muscle, intestine, and uterus in female adult worms. Further studies on D. immitis-derived TCTP are warranted to assess whether this filarial protein could be used for a diagnostic purpose.
Animal Structures/chemistry
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Animals
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Antibodies, Helminth/blood
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Antigens, Helminth/chemistry/*genetics/immunology/*isolation & purification
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Cloning, Molecular
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Dirofilaria immitis/chemistry/*genetics/immunology
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Disease Models, Animal
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Dogs
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Escherichia coli/genetics
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Gene Expression
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Molecular Sequence Data
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Molecular Weight
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Recombinant Fusion Proteins/chemistry/genetics/immunology/isolation & purification
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Sequence Analysis, DNA
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Tumor Markers, Biological/chemistry/*genetics/immunology/*isolation & purification
6.FARSB stratifies prognosis and cold tumor microenvironment across different cancer types: an integrated single cell and bulk RNA sequencing analysis.
Ziran ZHANG ; Jiale TAN ; Zihang YU ; Chengdong LIU ; Jian WANG ; Dehua WU ; Xue BAI
Journal of Southern Medical University 2023;43(5):667-679
OBJECTIVE:
Immunotherapy has brought significant clinical benefits to a subset of patients, but has thus far been disappointing in the treatment of immunologically "cold" tumors. Existing biomarkers that can precisely identify these populations are insufficient. In this context, a potential cold tumor microenvironment (TME) marker FARSB was investigated to reveal its impact on TME and patients' response to immunotherapy across pan-cancer.
METHODS:
The expression levels and mutational landscape of FARSB in pan-cancer were investigated. Kaplan-Meier and univariate Cox regression analyses were applied to analyze the prognostic significance of FARSB. Pathways affected by FARSB were investigated by gene set enrichment and variation analysis. The relationship between FARSB expression and immune infiltration was examined using the TIMER2 and R packages. Single-cell RNA sequencing (scRNA-seq) data of several cancer types from GSE72056, GSE131907, GSE132465, GSE125449 and PMID32561858 were analyzed to validate the impact of FARSB on the TME. The predictive effect of FARSB on immunotherapy efficacy was explored in 3 immune checkpoint inhibitors (ICIs)- treated cohorts (PMID32472114, GSE176307, and Riaz2017).
RESULTS:
FARSB expression was significantly higher in 25 tumor tissues than in normal tissues and was associated with poor prognosis in almost all tumor types. FARSB expression exhibited a strong association with several DNA damage repair pathways and was significantly associated with TP53 mutation in lung adenocarcinoma (P < 0.0001, OR=2.25). FARSB characterized a typical immune desert TME and correlated with impaired expression of chemokines and chemokines receptors. Large-scale scRNA-seq analysis confirmed the immunosuppressive role of FARSB and revealed that FARSB potentially shapes the cold TME by impeding intercellular interactions. In 3 ICI-treated cohorts, FARSB demonstrated predictive value for immunotherapy.
CONCLUSION
This study provides a pan-cancer landscape of the FARSB gene by integrated single-cell and bulk DNA sequencing analysis and elucidates its biological function to promote DNA damage repair and construct the immune desert TME, suggesting the potential value of FARSB as a novel marker for stratifying patients with poor immunotherapeutic benefits and "cold" TME.
Humans
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Tumor Microenvironment
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Prognosis
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Adenocarcinoma of Lung/genetics*
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Lung Neoplasms/genetics*
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Sequence Analysis, RNA
7.Short-term follow-up results of inflatable mediastinoscopy combined with laparoscopy versus video-assisted thoracoscopic surgery combined with laparoscopy for esophageal cancer
Yunhao FANG ; Zihao CHEN ; Rongqiang WEI ; Kenan HUANG ; Xinyu DING ; Chengdong LIU ; Zhifei XU ; Bin WU ; Hua TANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(02):239-242
Objective To investigate the short-term follow-up results of inflatable mediastinoscopy combined with laparoscopy in the treatment of esophageal cancer. Methods Clinical data of 102 patients with esophageal cancer who underwent minimally invasive esophagectomy were enrolled in our hospital from January 2017 to January 2019. Patients were divided into two groups according to different surgical methods, including a single-port inflatable mediastinoscopy combined with laparoscopy group (group A, n=59, 53 males and 6 females, aged 63.3±7.6 years, ranging from 45 to 75 years) and a video-assisted thoracoscopy combined with laparoscopy group (group B, n=43, 35 males and 8 females, aged 66.7±6.7 years, ranging from 50-82 years). The short-term follow-up results of the two groups were compared. Results Compared with the group A, the rate of postoperative pulmonary complication of the group B was significantly lower (18.64% vs. 4.65%, P<0.05). There was no significant difference between the two groups in other postoperative complications (P>0.05). The 6-month, 1-year, and 2-year survival rates were 96.61%, 89.83%, and 73.33%, respectively in the group A, and were 95.35%, 93.02%, and 79.17%, respectively in the group B. There was no significant difference in short-term survival rate after operation (P>0.05). Conclusion In the treatment of esophageal cancer, the incidence of pulmonary complications of inflatable mediastinoscopy combined with laparoscopy is lower than that of traditional video-assisted thoracoscopy combined with laparoscopy, and there is no significant difference in other postoperative complications or short-term survival rate between the two methods. Inflatable mediastinoscopy combined with laparoscopy for radical esophageal cancer is a relatively safe surgical method with good short-term curative effects, and long-term curative effects need to be further tested.
8.5'-tiRNA-Gln inhibits hepatocellular carcinoma progression by repressing translation through the interaction with eukaryotic initiation factor 4A-I.
Chengdong WU ; Dekai LIU ; Lufei ZHANG ; Jingjie WANG ; Yuan DING ; Zhongquan SUN ; Weilin WANG
Frontiers of Medicine 2023;17(3):476-492
tRNA-derived small RNAs (tsRNAs) are novel non-coding RNAs that are involved in the occurrence and progression of diverse diseases. However, their exact presence and function in hepatocellular carcinoma (HCC) remain unclear. Here, differentially expressed tsRNAs in HCC were profiled. A novel tsRNA, tRNAGln-TTG derived 5'-tiRNA-Gln, is significantly downregulated, and its expression level is correlated with progression in patients. In HCC cells, 5'-tiRNA-Gln overexpression impaired the proliferation, migration, and invasion in vitro and in vivo, while 5'-tiRNA-Gln knockdown yielded opposite results. 5'-tiRNA-Gln exerted its function by binding eukaryotic initiation factor 4A-I (EIF4A1), which unwinds complex RNA secondary structures during translation initiation, causing the partial inhibition of translation. The suppressed downregulated proteins include ARAF, MEK1/2 and STAT3, causing the impaired signaling pathway related to HCC progression. Furthermore, based on the construction of a mutant 5'-tiRNA-Gln, the sequence of forming intramolecular G-quadruplex structure is crucial for 5'-tiRNA-Gln to strongly bind EIF4A1 and repress translation. Clinically, 5'-tiRNA-Gln expression level is negatively correlated with ARAF, MEK1/2, and STAT3 in HCC tissues. Collectively, these findings reveal that 5'-tiRJNA-Gln interacts with EIF4A1 to reduce related mRNA binding through the intramolecular G-quadruplex structure, and this process partially inhibits translation and HCC progression.
Humans
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Carcinoma, Hepatocellular/pathology*
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Liver Neoplasms/pathology*
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Eukaryotic Initiation Factor-4A/genetics*
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Cell Line
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RNA, Transfer/metabolism*
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RNA
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Cell Proliferation
9.Expert consensus on rehabilitation strategies for traumatic spinal cord injury
Liehu CAO ; Feng NIU ; Wencai ZHANG ; Qiang YANG ; Shijie CHEN ; Guoqing YANG ; Boyu WANG ; Yanxi CHEN ; Guohui LIU ; Dongliang WANG ; Ximing LIU ; Xiaoling TONG ; Guodong LIU ; Hongjian LIU ; Tao LUO ; Zhongmin SHI ; Biaotong HUANG ; Wenming CHEN ; Qining WANG ; Shaojun SONG ; Lili YANG ; Tongsheng LIU ; Dawei HE ; Zhenghong YU ; Jianzheng ZHANG ; Zhiyong HOU ; Zengwu SHAO ; Dianying ZHANG ; Haodong LIN ; Baoqing YU ; Yunfeng CHEN ; Xiaodong ZHU ; Qinglin HANG ; Zhengrong GU ; Xiao CHEN ; Yan HU ; Liming XIONG ; Yunfei ZHANG ; Yong WANG ; Lei ZHANG ; Lei YANG ; Peijian TONG ; Jinpeng JIA ; Peng ZHANG ; Yong ZHANG ; Kuo SUN ; Tao SHEN ; Shiwu DONG ; Jianfei WANG ; Hongliang WANG ; Yong FENG ; Zhimin YING ; Chengdong HU ; Ming LI ; Xiaotao CHEN ; Weiguo YANG ; Xing WU ; Jiaqian ZHOU ; Haidong XU ; Bobin MI ; Yingze ZHANG ; Jiacan SU
Chinese Journal of Trauma 2020;36(5):385-392
TSCI have dyskinesia and sensory disturbance that can cause various life-threaten complications. The patients with traumatic spinal cord injury (TSCI), seriously affecting the quality of life of patients. Based on the epidemiology of TSCI and domestic and foreign literatures as well as expert investigations, this expert consensus reviews the definition, injury classification, rehabilitation assessment, rehabilitation strategies and rehabilitation measures of TSCI so as to provide early standardized rehabilitation treatment methods for TSCI.