1.Challenges, countermeasures, and key points of ethics review in investigator-initiated clinical trials of unlisted products
Honglei NIAN ; Jihong LI ; Jiyin ZHOU
Chinese Medical Ethics 2025;38(1):31-39
Investigator-initiated clinical trials (IIT) are an important part of scientific and technological activities involving human study participants. Among them, high-quality IIT can be used to support the marketing and registration application of drugs, medical devices, and other products when conditions permit. Currently, there is a huge gap between IIT and industry-initiated clinical trials. The use of unlisted products in IIT has problems, such as lack of regulatory support, insufficient research funding support, the need to improve the ability of clinical research management departments, the weakness of professional clinical research teams, and the difficulty of ethics review to match the demands. The challenges could be addressed by improving regulations and conducting pilot trials on a small scale, guaranteeing adequate research funding, strengthening the construction of clinical research management systems, building professional clinical research teams, ensuring the quality of ethical reviews and strict follow-up reviews, shifting from ethical reviews to a system for protecting research participants, and reinforcing training for researchers. Ethics committees should strictly review key points, such as the risk-benefit ratio, informed consent, research funding, compensation for damages, qualifications and equipment of research team members, and management of conflict of interest.
2.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine: Pulmonary Nodules
Mingwei YU ; Huairui ZHANG ; Xinghan ZHANG ; Xiao LI ; Rengui WANG ; Zhiqiang LONG ; Zhen WANG ; Bo PANG ; Jianwei HUO ; Wei CHEN ; Yong ZHU ; Baoli LIU ; Yanni LOU ; Ganlin ZHANG ; Jiayun NIAN ; Mei MO ; Xiaoxiao ZHANG ; Guowang YANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(6):238-245
In recent years, the incidence of pulmonary nodules has kept rising. To give full play to the advantages of traditional Chinese medicine (TCM) in the treatment of pulmonary nodules and identify the breakthrough points of integrating TCM with Western medicine, the China Association of Chinese Medicine organized medical experts in TCM and western medicine to carry out in-depth discussion regarding this disease. The discussion encompassed the modern medical advances, TCM theories of etiology and pathogenesis, the role and advantages of TCM in the whole course management of pulmonary nodules, contents and methods of research on pulmonary nodules, and science popularization work, aiming to provide a reference for clinical practice and scientific research. After discussion, the experts concluded that the occurrence of pulmonary nodules was rooted in the deficiency of the lung and spleen and triggered by phlegm dampness, blood stasis, and Qi stagnation. TCM can treat pulmonary nodules by controlling and reducing nodules, improving physical constitution, ameliorating multi-system nodular diseases, reducing anxiety and avoiding excessive diagnosis and treatment, and serving as an alternative for patients who are unwilling or unfit for surgical treatment. At present, the optimal diagnosis and treatment strategy for pulmonary nodules has not been formed, which needs to be further studied from multiple perspectives such as clinical epidemiology, biology, and evidence-based medicine. The primary task of current research is to find out the advantages, effective prescriptions, and target populations and determine the effective outcomes of TCM in the treatment of pulmonary nodules. At the same time, basic research should be carried out to explore the etiology and biological behaviors of pulmonary nodules. The expert consensus on the diagnosis and treatment of pulmonary nodules with integrated TCM and Western medicine needs to be continuously revised to guide clinicians to conduct standardized, scientific, and accurate effective diagnosis and treatment.
3.Functional near infrared imaging of college students on speech fluency tasks in traumatized
ZHENG Minxiao, ZHU Dongmei, WEI Qiang, XIANG Nian, QIU Min, XIAO Qiang, LI Xiaonan, ZHANG Yan
Chinese Journal of School Health 2024;45(3):375-378
Objective:
The study aims to explore the neural mechanism of cognitive differences in college students with posttraumatic stress disorder under verbal fluency task based on functional near infrared spectroscopy (fNIRS), so as to provide neuroimaging support for the evaluation, diagnosis and treatment of posttraumatic stress disorder(PTSD).
Methods:
Posttaumatic Stress Disorder Checklist Combat(PCL-C) was used to screen the subjects, including 21 students in PTSD group (PCL-C≥38) and 30 students in control group from September to Novenber in 2020. A 53 channel near infrared spectroscopy device was used to collect cerebral blood oxygen signals under the verbal fluency task, and correlation analysis, Mann Whitney U test and independent sample t test were performed on the results.
Results:
The difference in the total average score of PCL-C Scale between PTSD group and the control group(46.38±6.96,25.57±6.09) was statistically significant ( t=11.33, P <0.05). Correlation analysis showed that Avg-HbO in left dorsolateral prefrontal lobe was negatively correlated with PCL-C Score ( r=-0.37, P <0.05). Mann Whitney U test showed that in the left dorsolateral prefrontal lobe (Ch6), the Avg-HbO change in PTSD group [0.19(-0.09, 0.86)mmol/(L〖KG*7〗·mm)] was significantly lower than the control group [0.79( 0.37 , 1.47)mmol/(L ·mm)] ( Z=2.16, P <0.05), which was statistically significant.
Conclusions
The degree of PTSD was negatively correlated with the index of oxygenated hemoglobin in the left dorsolateral prefrontal lobe, and the oxygenated hemoglobin content in the PTSD group was lower than that in the normal group. In the future, fNIRS may be used to collect blood oxygen signals from the left dorsolateral prefrontal lobe in cognitive tasks to provide imaging evidence for the identification of PTSD.
4.Visualization Analysis of Artificial Intelligence Literature in Forensic Research
Yi-Ming DONG ; Chun-Mei ZHAO ; Nian-Nian CHEN ; Li LUO ; Zhan-Peng LI ; Li-Kai WANG ; Xiao-Qian LI ; Ting-Gan REN ; Cai-Rong GAO ; Xiang-Jie GUO
Journal of Forensic Medicine 2024;40(1):1-14
Objective To analyze the literature on artificial intelligence in forensic research from 2012 to 2022 in the Web of Science Core Collection Database,to explore research hotspots and developmen-tal trends.Methods A total of 736 articles on artificial intelligence in forensic medicine in the Web of Science Core Collection Database from 2012 to 2022 were visualized and analyzed through the litera-ture measuring tool CiteSpace.The authors,institution,country(region),title,journal,keywords,cited references and other information of relevant literatures were analyzed.Results A total of 736 articles published in 220 journals by 355 authors from 289 institutions in 69 countries(regions)were identi-fied,with the number of articles published showing an increasing trend year by year.Among them,the United States had the highest number of publications and China ranked the second.Academy of Forensic Science had the highest number of publications among the institutions.Forensic Science Inter-national,Journal of Forensic Sciences,International Journal of Legal Medicine ranked high in publica-tion and citation frequency.Through the analysis of keywords,it was found that the research hotspots of artificial intelligence in the forensic field mainly focused on the use of artificial intelligence technol-ogy for sex and age estimation,cause of death analysis,postmortem interval estimation,individual identification and so on.Conclusion It is necessary to pay attention to international and institutional cooperation and to strengthen the cross-disciplinary research.Exploring the combination of advanced ar-tificial intelligence technologies with forensic research will be a hotspot and direction for future re-search.
5.Exploration of Thoughts and Possible Therapeutic Mechanism of Treating Male Infertility from the Perspective of Spleen and Kidney by Regulating Intestinal Flora
Nian-Wen HUANG ; Bin WANG ; Ji-Sheng WANG ; Huan-Zhou BI ; Juan-Long FENG ; Long-Ji SUN ; Hai-Song LI
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(3):776-781
Based on the literature study,the thoughts and possible therapeutic mechanism in treating male infertility from the perspective of spleen and kidney by regulating intestinal flora were explored.Disturbance of intestinal flora is one of the important factors leading to the development of male infertility,and the spleen and kidney have certain similarities to intestinal flora in the physiological function and pathological changes.Moreover,tonifying the kidney and strengthening the spleen can regulate the intestinal flora by fostering the growth of beneficial bacteria,inhibiting the reproduction of pathogenic bacteria,and protecting the barrier of the intestinal mucosa.Therefore,the possible therapeutic mechanisms in treating male infertility with the prescriptions for tonifying the kidney and strengthening the spleen to regulate intestinal flora are as follows:inhibiting the expression of inflammatory factors to reduce the inflammatory reaction of testicular tissues;improving the antioxidant capacity to alleviate the damage of spermatozoa caused by oxidative stress,and improving the bad mood to alleviate the impact of psychological stress on the reproductive system.The exploration of the thoughts for treating male infertility from the perspective of spleen and kidney by regulating intestinal flora may provide a new entry point for modern Chinese medicine clinical treatment of male infertility.
6.Recent advance in neuroprotectants combined with reperfusion in acute ischemic stroke
Yawei GU ; Xu CHU ; Qiang LI ; Hongguang FAN ; Yinhua DONG ; Lijun WANG ; Nian CHEN
Chinese Journal of Neuromedicine 2024;23(3):291-295
Acute ischemic stroke (AIS) is a kind of central nervous system disease that seriously threatens human health and life. Current treatment for AIS is mainly reperfusion. However, the time-sensitive of reperfusion limits its clinical application, and a considerable part of patients within the time window cannot achieve the expected effect after reperfusion; related complications of reperfusion have not been completely solved. So far, some clinical trials have confirmed that neuroprotectants are useful supplements and adjuncts to reperfusion. This paper reviews the recent advance in neuroprotectants combined with reperfusion in AIS to provide references for AIS treatment.
7.A case of emergency transcatheter aortic valve replacement treatment for aortic stenosis complicated with acute heart failure shock in primary hospital
Huan GUO ; Yu-Dong LI ; Nian-Guo DONG ; Xiao-Ke SHANG ; Yu-Cheng ZHONG ; Chang-Dong ZHANG ; Ling-Bo ZHANG
Chinese Journal of Interventional Cardiology 2024;32(5):291-294
Aortic valve stenosis,as a common heart valve disease,progresses rapidly and has a poor clinical prognosis.In the case of combined acute heart failure,the pumping function of the heart is severely impaired,which may lead to a significant decrease in cardiac output,resulting in a state of shock.Transcatheter aortic valve replacement(TAVR)has become a first-line treatment for elderly patients with aortic valve stenosis since its first successful case in 2002.In China,with the advancement of technology and the strengthening of physician training,the capacity of grassroots hospitals in TAVR treatment is increasing.This case reports a patient with severe aortic valve stenosis accompanied by acute heart failure and shock status who received emergency TAVR treatment at a grassroots hospital.Due to limitations in conditions,TAVR was urgently implemented without extracorporeal circulation and extracorporeal membrane oxygenation support.The patient's blood pressure immediately rose to 105/65 mmHg after valve dilation during surgery,and the postoperative symptoms were significantly relieved.Follow up color Doppler ultrasound showed that the stenosis was relieved and the heart function was significantly improved.The success of this surgery provides a reference for emergency TAVR treatment in patients with severe aortic valve stenosis and heart failure in grassroots hospitals.
8.Inhibition of inflammation and bone destruction in mice with colla-gen-induced arthritis by Zushima Plaster
Juanjuan YANG ; Haolin LI ; Tianning YANG ; Weigang CHENG ; Zhendong WANG ; Fangmei JIN ; Fanghong NIAN ; Xiaojun SU ; Jiaqiang WANG ; Haiping WANG ; Haidong WANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(9):979-987
AIM:To investigate the inhibitory ef-fect of Zushima ointment on inflammation and bone destruction in CIA mice.METHODS:SPF grade male DBA/1 mice were used,6 were random-ly selected as the normal group,and 18 CIA mice that were successfully modelled were randomly di-vided into the model group,the plaster group(1.0 g/kg),and the fuselage group(0.12 g per time)ac-cording to the random number table method,6 mice in each group,and each administered group was given medication according to the body mass,and saline was given to both the normal and model groups.The normal group and the model group were given saline,and breathable adhesive paper was applied once a day for 4 h/session for 4 consec-utive weeks.The arthritis scoring index was used to observe the changes of arthritis symptoms and ar-thritis index scores of mice in each group.Micro-CT was used to observe the damage of hind paw of mice,real-time fluorescence PCR was used to de-tect the mRNA expression of IL-17,IL-1β and TNF-αin ankle joint tissues,and immunohistochemistry was used to detect the expression of OPG and RANKL proteins in ankle joint tissues,and hematox-ylin-eosin(HE)staining was used to observe the pathological changes of synovial tissues after the treatment.The pathological changes of synovial tis-sue were observed after hematoxylin-eosin(HE)staining,and the changes of osteoclasts in ankle joint tissue were observed by anti-tartaric acid phosphatase(TRAP)method.RESULTS:Compared with the normal group,the arthritis index score of the model mice was significantly higher(P<0.05).Micro-CT showed severe bone erosion in the hind paws of the mice,destruction of the bone surface and reduction of bone volume.The expression of IL-17,IL-1β and TNF-α mRNA(PCR)in the ankle joint tissues was significantly higher(P<0.05).Im-munohistochemistry showed that the relative ex-pression of OPG protein in the ankle joint tissues was reduced(P<0.05).Immunohistochemistry showed a decrease in the relative expression of OPG protein(P<0.01)and an increase in the rela-tive expression of RANKL protein(P<0.01).HE re-sults showed moderate inflammatory cell infiltra-tion,swelling of synovial cells,massive formation of vascular opacities and synovial hyperplasia;an increase in the number of osteoclasts,roughness of the surface of articular cartilage tissue,severe bone destruction and thinning of the cartilage lay-er.Compared with the model group,the arthritic symptoms of mice in the cream group and the futa-lin group were relieved and the arthritis index score was reduced;the bone density of the mice's hind paws improved,effectively relieving osteopo-rosis;the expression of IL-17,IL-1β and TNF-αmRNA(PCR)in the ankle joint tissue was signifi-cantly reduced(P<0.05);the immunohistochemical results showed that the relative expression of OPG protein was increased(P<0.05),the relative expres-sion of RANKL protein decreased(P<0.01).HE re-sults showed that synovial cell enlargement was significantly improved,mild inflammatory cell infil-tration,synovial hyperplasia was not obvious;the number of broken bone was reduced,articular car-tilage destruction was significantly improved and relieved,and the thickness of cartilage layer was significantly increased.CONCLUSION:Ancestral hemp poultice relieves local symptoms of RA,re-duces the expression of inflammatory factors and attenuates the inflammatory response,possibly by inhibiting osteoclast differentiation and activation through modulation of the OPG/RANKL signalling axis,which further ameliorates the biological ef-fects of articular bone and cartilage destruction.
9.Investigation and disposal of a skin anthrax outbreak in the 164th Regiment,9th Division,Xinjiang Production and Construction Corps
Yong-Nian ZHAO ; Yue WANG ; Wei LIU ; Li-Li DUAN ; Gai-Mei DONG ; Delina·Sairike
Chinese Journal of Zoonoses 2024;40(6):595-598
Field epidemiological investigation and treatment of a human skin anthrax outbreak were performed,including tracing of the infection source,case searching,management of close contacts,sampling and testing,and on-site elimination.Additional training and public outreach,and anthrax prevention and control measures are recommended.This case involved a sporadic outbreak of human skin anthrax,with sick cattle as the source of infection.On July 20,our patient slaughtered a cow at his home without taking any protective measures.Three days earlier,he had been stabbed at the second joint of the middle finger of his right hand,and he became infected with anthrax bacilli through the wound.Fever appeared on the day after expo-sure,and on the fourth day(July 24),a black scab mass of approximately(3X3)cm was visible at the wound site,without rupture or discharge of pus.He was hospitalized with fever at the 164th Regiment Hospital,Tacheng People's Hospital,Tacheng District People's Hospital,and Tacheng Jingcheng Hospital.His stay at the Tacheng District People's Hospital was from the 24th to 25th.He had seven close contacts,none of whom were infected,and no common exposures were identified.On the 27th,the PCR results for smear samples around the black scab were positive,the serum antibody results were positive,and the fecal samples were negative.The PCR test results for five environmental specimens were negative,and the isolation and culture results for bone surface specimens from dead cattle were positive.Strengthened efforts are necessary in training and public education regarding zoonotic disease prevention and control;establishment of local corps integration and joint prevention and control;and detection and mitigation of epi-demics in early stages.
10.ADCY7,GPR86,GRIN2D,and RGS4 for Predicting Progression of Gastric Precancerous Lesions
Yang LI ; Yuanyuan NIAN ; Xianmei MENG
Chinese Journal of Gastroenterology 2024;29(1):3-9
Background:Currently,there are no effective biomarkers for predicting the progression of gastric precancerous lesions or screening early gastric cancer in clinical practice.Aims:To explore the expressions of adenylate cyclase 7(ADCY7),G protein-coupled receptor GPR86,glutamate receptor,ionotropic,N-methyl D-aspartate 2D(GRIN2D)and regulator of G protein signaling 4(RGS4)in various gastric mucosal lesions and their predictive value for progression of gastric precancerous lesions.Methods:Expressions of ADCY7,GPR86,GRIN2D,and RGS4 were detected by immuno-histochemistry,real-time PCR and Western blotting in Correa cascade(chronic non-atrophic gastritis,chronic atrophic gastritis,low-and high-grade intraepithelial neoplasia,and mucosal and submucosal early gastric cancer)and cancerous and para-cancerous tissues,among which,the differences in expression levels of these four factors were analyzed.Results:There was an increasing tendency in expression levels of ADCY7,GPR86,GRIN2D,and RGS4 from gastritis,intra-epithelial neoplasia to early gastric cancer.Except for GRIN2D expression between intraepithelial neoplasia and early gastric cancer,significant differences could be observed in any two groups(all P<0.001).Both mRNA and protein expression levels of GRP86 and GRIN2D were significantly higher in cancerous tissue than in adjacent tissue>5 cm(all P<0.05).Protein expression of RGS4 was significantly higher in cancerous tissue than in adjacent tissue>5 cm,but its mRNA expression presented an opposite trend(all P<0.05).Significant difference between cancerous tissue and adjacent tissue>5 cm in ADCY7 expression was only existed at protein level(P<0.05).Conclusions:Alterations of the expression levels of ADCY7,GPR86,GRIN2D,and RGS4 in Correa cascade and cancerous and para-cancerous tissues suggest that they are involved in the occurrence and development of gastric precancerous lesions,and might be used as predictors for progression of gastric precancerous lesions.


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