1.Analysis of difficulties and strategy construction for ethical follow-up review in clinical application of medical technologies
Yujie NIE ; Rui DENG ; Jiyin ZHOU
Modern Hospital 2025;25(7):1136-1140
By reviewing relevant literature and policies on ethical review of clinical application of medical technologies,this study summarizes the necessity,difficulties,and countermeasures for ethical follow-up review,aiming to provide references for its implementation.The challenges in ethical follow-up review include:lack of top-level design at the national level;absence of standardized responsibility entities,requirements,and criteria for follow-up review;overemphasis on interim inspections while neglecting follow-up review,leading to incomplete ethical oversight;insufficient communication and coordination between relevant administrative departments and ethics committees;and weak awareness,low prioritization,and poor compliance among technology leaders regarding follow-up review.Due to the current fragility of ethical follow-up review in clinical application of medical tech-nologies,ethics committees fail to fully fulfill their patient protection responsibilities.To strengthen follow-up review,the follow-ing strategies are proposed:national-level improvement of regulatory frameworks;enhanced interdepartmental coordination within healthcare institutions to establish collaborative supervision mechanisms;intensified training for ethics committee members to im-prove review capabilities;and proactive transformation of ethics committees from passive to active follow-up review.
2.Efficacy of photo-crosslinked gelatin hydrogel scaffolds loaded with tauroursodeoxycholic acid on knee cartilage defect repair in a rabbit model
Xiang WEI ; Lingfei WEI ; Chunfeng XU ; Yujie GAO ; Ping NIE ; Dedong YU
Journal of Shanghai Jiaotong University(Medical Science) 2025;45(7):829-837
Objective·To investigate the reparative effects of photo-crosslinked gelatin methylacrylated(GelMA)hydrogel scaffolds loaded with tauroursodeoxycholic acid(TUDCA)on cartilage defects in rabbit knee joints.Methods·Photo-crosslinked GelMA hydrogel scaffolds loaded with TUDCA were prepared by the ultraviolet light irradiation method.The physicochemical properties of GelMA hydrogel scaffolds were characterized,and the cumulative release rate of TUDCA was determined.A rabbit knee cartilage defect model was established,and 18 rabbits were randomly assigned into three groups,with six rabbits in each group:the control group(no treatment was applied to the cartilage defect),the GelMA group(the cartilage defect was filled with GelMA hydrogel scaffold),and the GelMA+TUDCA group(the cartilage defect was filled with the GelMA hydrogel scaffold loaded with TUDCA).At 12 weeks postoperatively,the concentrations of two inflammatory factors in synovial fluid,tumor necrosis factor-α(TNF-α)and interleukin-1β(IL-1β),were detected by enzyme-linked immunosorbent assay(ELISA).After euthanasia,knee cartilage samples were harvested for gross observation,safranin O-fast green staining,and toluidine blue staining.The repair of the cartilage defects was evaluated according to the International Cartilage Repair Society(ICRS)and Modified O'Driscoll Score(MODS)systems.Immunohistochemical staining was performed to detect type Ⅱ collagen(COL-Ⅱ)protein in the cartilage tissue,and Western blotting was used to assess the protein levels of aggrecan(ACAN)and COL-Ⅱ.Results·GelMA hydrogel scaffolds exhibited a more compact microstructure after ultraviolet light irradiation,along with an suitable mass swelling ratio and compressive modulus.The TUDCA-loaded photo-crosslinked GelMA hydrogel scaffolds demonstrated effective and sustained TUDCA release,achieving a cumulative release rate of 90.2%±2.5%within 28 d.ELISA results showed that compared to the control and GelMA groups,the concentrations of TNF-α and IL-1β in the synovial fluid of the GelMA+TUDCA group were significantly reduced(P<0.001).In the GelMA+TUDCA group,the cartilage defects were nearly fully repaired,with a smooth surface and good integration with the surrounding tissue.The number of newly formed chondrocytes increased,displaying orderly alignment,and the neocartilage exhibited excellent formation.Both ICRS and MODS scores were significantly higher in the GelMA+TUDCA group than those in the control and GelMA groups(P<0.001).Additionally,the expression levels of ACAN and COL-Ⅱ proteins were significantly elevated in the GelMA+TUDCA group compared to the control and GelMA groups(P<0.001).Conclusion·Photo-crosslinked GelMA hydrogel scaffolds loaded with TUDCA can effectively promote the repair of cartilage defects in rabbit knee joints.
3.Analysis of difficulties and strategy construction for ethical follow-up review in clinical application of medical technologies
Yujie NIE ; Rui DENG ; Jiyin ZHOU
Modern Hospital 2025;25(7):1136-1140
By reviewing relevant literature and policies on ethical review of clinical application of medical technologies,this study summarizes the necessity,difficulties,and countermeasures for ethical follow-up review,aiming to provide references for its implementation.The challenges in ethical follow-up review include:lack of top-level design at the national level;absence of standardized responsibility entities,requirements,and criteria for follow-up review;overemphasis on interim inspections while neglecting follow-up review,leading to incomplete ethical oversight;insufficient communication and coordination between relevant administrative departments and ethics committees;and weak awareness,low prioritization,and poor compliance among technology leaders regarding follow-up review.Due to the current fragility of ethical follow-up review in clinical application of medical tech-nologies,ethics committees fail to fully fulfill their patient protection responsibilities.To strengthen follow-up review,the follow-ing strategies are proposed:national-level improvement of regulatory frameworks;enhanced interdepartmental coordination within healthcare institutions to establish collaborative supervision mechanisms;intensified training for ethics committee members to im-prove review capabilities;and proactive transformation of ethics committees from passive to active follow-up review.
4.Efficacy of photo-crosslinked gelatin hydrogel scaffolds loaded with tauroursodeoxycholic acid on knee cartilage defect repair in a rabbit model
Xiang WEI ; Lingfei WEI ; Chunfeng XU ; Yujie GAO ; Ping NIE ; Dedong YU
Journal of Shanghai Jiaotong University(Medical Science) 2025;45(7):829-837
Objective·To investigate the reparative effects of photo-crosslinked gelatin methylacrylated(GelMA)hydrogel scaffolds loaded with tauroursodeoxycholic acid(TUDCA)on cartilage defects in rabbit knee joints.Methods·Photo-crosslinked GelMA hydrogel scaffolds loaded with TUDCA were prepared by the ultraviolet light irradiation method.The physicochemical properties of GelMA hydrogel scaffolds were characterized,and the cumulative release rate of TUDCA was determined.A rabbit knee cartilage defect model was established,and 18 rabbits were randomly assigned into three groups,with six rabbits in each group:the control group(no treatment was applied to the cartilage defect),the GelMA group(the cartilage defect was filled with GelMA hydrogel scaffold),and the GelMA+TUDCA group(the cartilage defect was filled with the GelMA hydrogel scaffold loaded with TUDCA).At 12 weeks postoperatively,the concentrations of two inflammatory factors in synovial fluid,tumor necrosis factor-α(TNF-α)and interleukin-1β(IL-1β),were detected by enzyme-linked immunosorbent assay(ELISA).After euthanasia,knee cartilage samples were harvested for gross observation,safranin O-fast green staining,and toluidine blue staining.The repair of the cartilage defects was evaluated according to the International Cartilage Repair Society(ICRS)and Modified O'Driscoll Score(MODS)systems.Immunohistochemical staining was performed to detect type Ⅱ collagen(COL-Ⅱ)protein in the cartilage tissue,and Western blotting was used to assess the protein levels of aggrecan(ACAN)and COL-Ⅱ.Results·GelMA hydrogel scaffolds exhibited a more compact microstructure after ultraviolet light irradiation,along with an suitable mass swelling ratio and compressive modulus.The TUDCA-loaded photo-crosslinked GelMA hydrogel scaffolds demonstrated effective and sustained TUDCA release,achieving a cumulative release rate of 90.2%±2.5%within 28 d.ELISA results showed that compared to the control and GelMA groups,the concentrations of TNF-α and IL-1β in the synovial fluid of the GelMA+TUDCA group were significantly reduced(P<0.001).In the GelMA+TUDCA group,the cartilage defects were nearly fully repaired,with a smooth surface and good integration with the surrounding tissue.The number of newly formed chondrocytes increased,displaying orderly alignment,and the neocartilage exhibited excellent formation.Both ICRS and MODS scores were significantly higher in the GelMA+TUDCA group than those in the control and GelMA groups(P<0.001).Additionally,the expression levels of ACAN and COL-Ⅱ proteins were significantly elevated in the GelMA+TUDCA group compared to the control and GelMA groups(P<0.001).Conclusion·Photo-crosslinked GelMA hydrogel scaffolds loaded with TUDCA can effectively promote the repair of cartilage defects in rabbit knee joints.
5.Remyelination Regulated by microRNAs in Neurodegenerative Diseases: A Review
Manjing LI ; Qi LI ; Qingsen RAN ; Kunni CHEN ; Xinke DU ; Lina YANG ; Chunxia NIE ; Qing YANG ; Yujie LI ; Ying CHEN ; Yajie WANG ; Xiaogang WENG ; Weiyan CAI ; Xiaoxin ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(1):223-231
Demyelination of the central nervous system often occurs in neurodegenerative diseases, such as multiple sclerosis (MS). The myelin sheath, a layer of myelin membrane wrapping the axon, plays a role in the rapid conduction and metabolic coupling of impulses for neurons. The exposure of the axon will lead to axonal degeneratio, and further neuronal degeneration, which is the main cause of dysfunction and even disability in patients with demyelinating neurodegenerative diseases. In addition to the demyelination of mature myelin sheath, remyelination disorder is also one of the major reasons leading to the development of the diseases. The myelin sheath is composed of oligodendrocytes (OLs) derived from oligodendrocyte progenitor cells (OPCs) which are differentiated from neural stem cells (NSCs). The process of myelin regeneration, i.e., remyelination, is the differentiation of NSCs into OLs. Recent studies have shown that this process is regulated by a variety of genes. MicroRNAs, as important regulators of neurodegenerative diseases, form a complex regulatory network in the process of myelin regeneration. This review summarizes the main molecular pathways of myelin regeneration and microRNAs involved in this process and classifies the mechanisms and targets. This review is expected to provide a theoretical reference for the future research on the treatment of demyelinating diseases by targeting the regulation of microRNAs.
6.Efficacy and Safety of Submucosal Tunneling Endoscopic Resection for Treatment of Giant Esophageal Leiomyoma
Jianshuai CUI ; Yuxiao ZHAO ; Yujie ZENG ; TUKEDAER TUWUNIKE ; Zhanguo NIE
Chinese Journal of Gastroenterology 2023;28(9):551-554
Background:At present,the detection rate of esophageal leiomyoma is increasing year by year,among which giant esophageal leiomyoma(GEL)can be caused by secondary compression,malignant and even death.The safety and effectiveness of submucosal tunnel endoscopic resection(STER)in the treatment of GEL need to be further verified.Aims:To assess the safety and efficacy of STER in the treatment of GEL.Methods:Fifteen patients who underwent endoscopic ultrasound and STER surgery from June 2020 to June 2023 at General Hospital of Xinjiang Military Region,and postoperative pathological biopsy confirmed GEL to assess the efficacy,complications,tumor recurrence and follow-up.Results:In 15 patients with GEL,8 were male and 7 female;GEL was completely resected and the margin was clean;the maximum tumor diameter was 8.5 cm;mean operation time of 52 minutes;fewer adverse events and no delayed bleeding;all underwent conservative treatment;mean hospital stay of 6 days;and no discomfort and recurrence in the postoperative follow-up.Conclusions:STER is safe and effective in the treatment of GEL.
7.IgD multiple myeloma: report of 1 case and review of literature
Han XU ; Shumin NIE ; Junxia HUANG ; Tianlan LI ; Yan GAO ; Chunxia MAO ; Shanshan LIU ; Yujie XU ; Jingjing ZHOU ; Jingjing XIAO ; Mengying WANG ; Fanjun MENG ; Xianqi FENG
Journal of Leukemia & Lymphoma 2022;31(2):107-110
Objective:To investigate the clinical features of IgD multiple myeloma (MM) and the effect and prognosis of daratumumab-based combination therapy.Methods:The clinicopathological data of a IgD MM patient with disease progression and extramedullary infiltration treated with daratumumab in the Affiliated Hospital of Qingdao University in December 2019 were retrospectively analyzed.Results:The 74-year-old woman was diagnosed as IgD MM by bone marrow aspiration and immunofixation electrophoresis. The patient was given VD (bortezomib, dexamethasone), RD (lenalidomide, dexamethasone) and ID (ixazomib, dexamethasone) regimens. In June 2020, the patient developed multiple subcutaneous nodules, and she was assessed as progressive disease with extensive extramedullary infiltration. After treated with daratumumab-PAD (liposomal doxorubicin, bortezomib, dexamethasone) regimen, the patient's subcutaneous nodules were significantly reduced and partially disappeared, and the general condition was significantly improved. But the patient was in a cachexia state and finally died of the irregular treatment and disease progression.Conclusions:IgD MM has a low incidence and a short survival period, and there is no uniform standard treatment. The early application of daratumumab combined with proteasome inhibitors, immunomodulators, cytotoxic drugs and hematopoietic stem cell transplantation may improve the overall survival of patients.
8.Exploration and practice of using counterpart support resources to improve scientific research level of recipient hospitals
Beibei LI ; Jianhua WU ; Abudukeremu AILAIMUGULI· ; Yaru NIE ; Yujie ZHANG ; Tao CEN
Chinese Journal of Medical Science Research Management 2021;34(6):412-416
Objective:Exploring the " bottle neck" factors in the scientific research management of recipient hospitals, making good use of counterpart support resources to help identifying appropriate, tailored strategies of scientific research management that might improve the research capacity of recipient hospitals.Methods:Data were collected according to questionnaire survey and on-site interview, ABC classification method were used to perform statistical analysis, and " bottleneck" factors that constraint the scientific research work of the recipient hospital were summarized.Results:" Insufficient scientific research skills and lacking of talents" and " lacking of scientific research environment and recognition" are the two most prominent factors that negatively affect the scientific research capacity building of the recipient hospitals, followed closely by " the out-dated scientific research policies and lacking support from the hospital leadership" , insufficient of research platform or resources including research funding, as well as other factors. Based on such findings, this article took the First People's Hospital of Kashgar (Guangdong counterpart support) as an example, and tried to discuss some corresponding measures on how to make good use of counterpart support resources.Conclusions:The ABC classification method were used to identify the main " bottleneck" factors, and a series of effective measures that help to making good use of counterpart support resources were explored. As a result, the efficiency of the scientific research management of the recipient hospitals, which in terms of management methods, management concepts and management models, were improved.
9.Effects of driving pressure-guided individualized positive end-expiratory pressure on intraoperative pulmonary function in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy
Yujie MENG ; Lixia NIE ; Zhiping CAO ; Zhelu FAN ; Rui ZHANG ; Xuesen SU ; Xin YUAN ; Shouyuan TIAN
Chinese Journal of Geriatrics 2020;39(8):931-935
Objective:To investigate the effects of driving pressure(DP)-guided individualized positive end-expiratory pressure(PEEP)on intraoperative pulmonary function in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy.Methods:This was a retrospective case-control study.A total of 40 elderly patients undergone robot-assisted radical resection of prostate cancer were enrolled and divided into the control group and the DP-guided group(n=20, each group)based on the random number table method.Data on the peak inspiratory pressure(PIP)at time points including 4 min after the first PEEP set(T1), 4 min, 1 hour, 2 hours(T2-4)after the second PEEP set, and 1 min after closing abdomen(T5), lung compliance(Crs), PEEP and the partial pressure of carbon dioxide in end expiratory gas(PetCO 2)were recorded and compared between the two groups.Blood gas analysis was conducted, and the oxygenation index(OI), alveolar-arterial oxygen tension difference(A-aDO 2)and the dead space volume/tidal volume(Vd/Vt)were calculated. Results:Compared with the control group, Crs, OI and PaO 2 were increased and DP, Vd/Vt, A-aDO 2 and PaCO 2 were decreased in the DP-guided group at each time point( P<0.05). PIP showed no significant difference between the two groups at each time point( P>0.05). Compared with T1, PIP and DP were increased and Crs was decreased( P<0.05)in both groups at T2-T4( P<0.05). At T5, PIP was increased in both groups( P<0.05), Crs was decreased and DP was increased in the control group( P<0.05), while Crs and DP had no significant difference in the DP group at T1( P>0.05). OI and PaO 2 showed no significant difference between the two groups at T2-T5( P>0.05). Vd/Vt and PaCO 2 were increased in both groups at T3-T5( P<0.05). Compared with T1 levels, A-aDO 2 was increased in the control group at T3-T5( P<0.05)and in the DP group at T4( P<0.05). Conclusions:DP-guided individualized PEEP can reduce the occurrence of intraoperative atelectasis, improve intraoperative respiratory mechanical state and gas exchange, reduce the risk of potential ventilator-related lung injury and has good lung-protective effects of PEEP in elderly patients undergoing robot-assisted laparoscopic prostatectomy.
10.Risk factors and prognoses analysis of new-onset atrial fibrillation in patients with acute myocardial infarction
Yanyan JIN ; Rong BAI ; Ming YE ; Hui AI ; Yujie ZENG ; Shaoping NIE
Chinese Journal of Internal Medicine 2019;58(2):133-138
Objective To explore the risk factors and prognoses of new-onset atrial fibrillation (NOAF) in patients with acute myocardial infarction (AMI).Methods A total of 468 patients with AMI were admitted into Beijing Anzhen Hospital for emergency pereutaneous coronary intervention (PCI).According to the NOAF occurred during hospitalization,the patients were divided into two groups:the NOAF (n=37) group and the non-NOAF (n=431) group.Parameters including general clinical conditions,coronary lesions,echocardiography,biochemical markers,C-reactive protein (CRP),N-terminal pro-brain natriuretic peptide (NT-pro-BNP),and myocardial markers were collected.In-hospital mortality and incidence of in-hospital main adverse cardiovascular and cerebrovascular events (MACCE) were compared between the two groups.Logistic multivariate regression analyses were performed for the association between the risk factors and NOAF.Results The incidence of NOAF was 7.9% in AMI patients undergoing emergency PCI.There were no significant differences in door-to-balloon time,weight,platelet counts,baseline serum creatinine (SCr),postoperative SCr,triglyceride,total cholesterol,low density lipoprotein cholesterol,high density lipoprotein cholesterol,uric acid,glycosylated hemoglobin A1c,preoperative medication,number of lesions,thrombus aspiration,location of myocardial infarction,and history of hypertension,diabetes,peripheral vascular disease and old myocardial infarction between the two groups.The percentage of women was in the NOAF group (32.4% vs.16.7%,P<0.05) and subjects in this group were significantly elder than those in the non-NOAF groups [(66±10) years vs.(571±11) years,P<0.001].Moreover,the levels of no-reflow rate (40.5% vs.12.6%,P<0.001),CRP [25.2 (15.43,29.97)mg/L vs.5.21 (2.33,16.98) mg/L,P<0.001],white blood cell counts [(11.19±3.44)× 109 vs.(9.91 ±3.23)× 109,p=0.022],NT-pro-BNP [(652.6± 108.8) ng/L vs.(258.3±105.9) ng/L,P<0.001],and troponin I (TnI) [20.41(1.78,87.89) μg/L vs.7.72(1.29,36.39) μg/L,P=0.006] were significantly higher in the NOAF group than in the non-NOAF group,while left ventricular ejection fraction [(47.70± 7.34)% vs.(53.35 ± 8.05)%,P<0.001],and hemoglobin [137.0(125.5,146.0) g/L vs.144.0(133.0,156.0) g/L,P=0.042] were significantly lower in the NOAF group than the non-NOAF group.Patients in the NOAF group had significantly longer hospital stay than those in the non-NOAF group [(8.7± 5.6) d vs.(6.0± 2.3) d,P=0.007].The in-hospital mortality (8.1% vs 1.4% P=0.004) and the incidence of in-hospital MACCE (37.8% vs.7.7%,P<0.001) in the NOAF group were significantly higher than those in the non-NOAF group.Logistic multivariate regression analyses showed that age (HR 1.083,95%CI 1.028-1.141,P=0.003),CRP (HR 1.116,95%CI 1.049-1.187,P=0.001),NT-pro-BNP (HR 1.463,95%CI 1.001-4.064,P=0.001) and no-reflow (HR 4.388,95%CI 1.006-19.144,P=0.049) were independent predictors of NOAF after AMI.Conclusions Age,elevated levels of CRP,NT-pro-BNP,and the absence of no-reflow are risk factors for incident NOAF in patients with AMI in hospital.

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