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.
3.Expert consensus on imaging diagnosis and analysis of early correction of childhood malocclusion.
Zitong LIN ; Chenchen ZHOU ; Ziyang HU ; Zuyan ZHANG ; Yong CHENG ; Bing FANG ; Hong HE ; Hu WANG ; Gang LI ; Jun GUO ; Weihua GUO ; Xiaobing LI ; Guangning ZHENG ; Zhimin LI ; Donglin ZENG ; Yan LIU ; Yuehua LIU ; Min HU ; Lunguo XIA ; Jihong ZHAO ; Yaling SONG ; Huang LI ; Jun JI ; Jinlin SONG ; Lili CHEN ; Tiemei WANG
International Journal of Oral Science 2025;17(1):21-21
Early correction of childhood malocclusion is timely managing morphological, structural, and functional abnormalities at different dentomaxillofacial developmental stages. The selection of appropriate imaging examination and comprehensive radiological diagnosis and analysis play an important role in early correction of childhood malocclusion. This expert consensus is a collaborative effort by multidisciplinary experts in dentistry across the nation based on the current clinical evidence, aiming to provide general guidance on appropriate imaging examination selection, comprehensive and accurate imaging assessment for early orthodontic treatment patients.
Humans
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Malocclusion/diagnostic imaging*
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Child
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Consensus
4.Construction of a prognostic model of future asthma exacerbation risk in adults combined with novel biomarkers
Li ZHANG ; Liang LI ; Mei ZHOU ; Qianyun ZHOU ; Qin LIU ; Mei LIANG ; Jihong TANG ; Xiaofeng FU
International Journal of Laboratory Medicine 2025;46(4):435-442
Objective To construct a prognostic model of future asthma exacerbation risk in adults by com-bining novel biomarkers of serum chitinase-3-like protein 1(YKL-40),dipeptidyl peptidase-4(DPP4)and conventional predictors.Methods Patients with asthma in the non-acute exacerbation phase were recruited from the People's Hospital of Yubei District of Chongqing,from March 2022 to May 2023.Baseline clinical da-ta collected included medical history,forced expiratory volume in the first second(FEV1)/forced vital capacity(FVC),percentage of predicted forced expiratory volume in the first second(FEV1%pred),blood eosinophil count(EOS),blood neutrophil count(NEU),fractional exhaled nitric oxide(FeNO),serum YKL-40,and ser-um DPP4,etc.The patients were followed for one year to gather data on asthma acute exacerbations and their timings as defined in this study.A COX proportional hazards regression model was used to construct a prog-nostic model for future asthma exacerbations,with internal validation and results presentation.Results A to-tal of 224 patients with asthma completed the study.During the one-year follow-up period,102 patients experi-enced acute exacerbations as defined in this study.Based on univariate COX regression,stepwise regression for variable selection,clinical significance,and model simplicity,asthma control test(ACT)score group,number of asthma exacerbations in the past year group,log10(YKL-40),log10(FeNO),log10(EOS),and FEV1%pred were the following predictors were included in the final model.The overall C-statistic of the model was 0.795(95%CI:0.754-0.836),the area under the curve at the 52-week follow-up was 0.879(95%CI:0.834-0.924),and the Brier score at the 52-week follow-up was 0.142(95%CI:0.117-0.168).The calibration curve was close to a slope of 1,and bootstrap validation suggested good stability of the prediction model.The model was presented using a Nomogram and a dynamic scoring table in a web APP,which can be used to predict the risk of asthma exacerbations within 52 weeks for individual patients.Conclusion The prediction model based on serum YKL-40,EOS,FeNO,the number of asthma exacerbation in the past year group,FEV1%pred and ACT scores group can accurately predict the probability of acute attacks in 52 weeks of asthma patients.
5.Gluteal tendinitis and primary coxarthrosis may lead to iliotibial band syndrome:a Mendelian randomization study
Chen YAO ; Wenjia LI ; Ruiming PANG ; Jihong ZHOU
Journal of Southern Medical University 2024;44(9):1821-1830
Objective To analyze the causal relationship of gluteal tendinitis and primary coxarthrosis with the occurrence of iliotibial band syndrome using Mendelian randomization.Methods The GWAS data of gluteal tendinitis,primary coxarthrosis and iliotibial band syndrome were screened for high correlation single-nucleotide polymorphisms(SNPs).Mendelian randomization analysis was performed using random-effects inverse variance weighting(IVW),MR-Egger regression,and weighted median method to determine whether gluteal tendinitis and primary coxarthrosis were causally related with iliotibial band syndrome.Heterogeneity test,multiple validity test and sensitivity analysis,and clinical data analysis were used to verify the reliability of the results.Results Both gluteal tendinitis[IVW:OR(95%CI)=1.32(1.03-1.68),P=0.026]and primary coxarthrosis[IVW:OR(95%CI)=1.40(1.06-1.84),P=0.017]was positively correlated with iliotibial band syndrome.Conclusion Gluteal tendinitis and primary coxarthrosis may increase the risk of iliotibial band syndrome.
6.Exploration of the misunderstandings,challenges,and countermeasures of exemption from ethical review from the perspective of medical and health institutions
Honglei NIAN ; Hui JIANG ; Jihong LI ; Min LIU ; Jiyin ZHOU
Chinese Medical Ethics 2024;37(4):408-414
In the implementation of exemption from ethical review,medical institutions equate exemption from ethical review with no ethical review or simple review,misunderstand the scope of exemption from ethical review,confuse the concepts of de-identification and anonymization,and equate privacy with personal information.The implementation faced challenges such as the coordination of conditions for exempt review with other regulations,the lack of clear decision-making subjects for exempting from ethical review,the legality and compliance of using general informed consent for biological samples and information data,as well as non-traceability and the risk of being re-identified of anonymous information for exemption from ethical review.Measures such as improving relevant laws and regulations,perfecting the construction and management of information databases and biological sample libraries,strengthening the project management and process supervision of exemption from ethical review,and implementing scientific review can ensure the legal and compliant implementation of exemption from ethical review by medical and health institutions.
7.Strolling through the glorious years of Alveolar Surgery, bravely stepping onto the path of practice and innovation
Yiming WANG ; Yang XUE ; Jihong ZHAO ; Jian PAN ; Duohong ZOU ; Nianhui CUI ; Wei ZHANG ; Qizhang WANG ; Zhizheng LI ; Yuqiong ZHOU ; Kaijin HU
Chinese Journal of Stomatology 2024;59(4):301-311
This article summarizes and organizes relevant publications in journals, along with a review of medical history, systematically summarizing the development process of dental alveolar surgery in China. The initial establishment phase (1935—1952) marked the starting point of Chinese Alveolar Surgery. Despite the impact of wars, it laid the foundation for subsequent research and practice. During the early development phase (1953—1966), the "Chinese Journal of Stomatology" was founded, which promoted the development of Alveolar Surgery. Research focused on tooth extraction methods and complications. Tooth Transplantation and Preprosthetic Surgery gradually began to take off. The stagnant phase (1967—1977) occurred due to the interruption of international exchanges, leading to an almost complete halt in the development of Alveolar Surgery. Entering the rapid catch-up phase (1978—1985), Alveolar Surgery scholars in China began striving to overcome the stagnation of the previous decade. While some progress was made, no significant innovative achievements emerged. In the scientific development phase (1986—2010), clinical research, basic experiments, and paper writing in modern Chinese Alveolar Surgery began to adhere to scientific standards with the rise of experimental medicine. The exploration and innovation stage (2011—2023) is the current development phase, during which Chinese Aveolar Surgery has reached its peak, making substantial progress in technology, clinical practices, and basic research, gradually reaching or even surpassing international advanced levels. Looking back at the development history in China, we can find the wisdom and hard work of the older generation of Alveolar Surgery scholars. However, contemporary challenges and issues, such as standardizing technology, promoting clinical practices, and talent cultivation, need to be addressed by present-day Alveolar Surgery professionals as they forge ahead.
8.Gluteal tendinitis and primary coxarthrosis may lead to iliotibial band syndrome:a Mendelian randomization study
Chen YAO ; Wenjia LI ; Ruiming PANG ; Jihong ZHOU
Journal of Southern Medical University 2024;44(9):1821-1830
Objective To analyze the causal relationship of gluteal tendinitis and primary coxarthrosis with the occurrence of iliotibial band syndrome using Mendelian randomization.Methods The GWAS data of gluteal tendinitis,primary coxarthrosis and iliotibial band syndrome were screened for high correlation single-nucleotide polymorphisms(SNPs).Mendelian randomization analysis was performed using random-effects inverse variance weighting(IVW),MR-Egger regression,and weighted median method to determine whether gluteal tendinitis and primary coxarthrosis were causally related with iliotibial band syndrome.Heterogeneity test,multiple validity test and sensitivity analysis,and clinical data analysis were used to verify the reliability of the results.Results Both gluteal tendinitis[IVW:OR(95%CI)=1.32(1.03-1.68),P=0.026]and primary coxarthrosis[IVW:OR(95%CI)=1.40(1.06-1.84),P=0.017]was positively correlated with iliotibial band syndrome.Conclusion Gluteal tendinitis and primary coxarthrosis may increase the risk of iliotibial band syndrome.
9.Sufu mutation promotes malignant progression of lung adenocarcinoma by regulating Gli1
Jihong LIU ; Hu LUO ; Xinglin YI ; Xiangdong ZHOU
Journal of Army Medical University 2024;46(10):1142-1149
Objective To explore the effect of Sufu on lung adenocarcinoma by observing its mutation and the changes in Gli1 transcription after its mutation.Methods cBioPortal for Cancer Genomics was used to obtain the mutation status of Sufu in lung cancer.Four Sufu single base mutation vectors were constructed and transfected into lung adenocarcinoma cell lines A549 and H1975 to establish cells with Sufu overexpression and knockout.Wounding healing assay was employed to determine the effect of Sufu on cell migration,and RT-qPCR,immunofluorescence assay and dual luciferase reporter gene assay were utilized to explore the changes in Gli1 transcription after Sufu mutation.Results cBioPortal data showed that the mutation rate of Sufu in lung cancer was 11.76%in squamous cell carcinoma(2/17),0.96%in adenocarcinoma(6/625),1.01%in small cell lung cancer(4/396),and 0.69%in non-small cell lung cancer(77/11 227).The median survival of lung cancer patients was significantly decreased in those with Sufu mutation than those without(38.00 vs 54.34 months,HR=1.943,P<0.05).A549 cells were sensitive to Sufu knockout,and it resulted in significant increase of the transcription level of Gli1(P<0.05).Overexpression of Sufu inhibited cell migration ability in both A549 and H1975 cells(P<0.05).Sufu mutation had no significant influence on the location of Gli1 in the cells.The Sufu-T411M mutation up-regulated the the transcription level of Gli1(P<0.05).Conclusion Sufu has an inhibitory effect on lung adenocarcinoma metastasis,and can be regarded as a potential target for lung adenocarcinoma metastasis.
10.Surveillance of bacterial resistance in tertiary hospitals across China:results of CHINET Antimicrobial Resistance Surveillance Program in 2022
Yan GUO ; Fupin HU ; Demei ZHU ; Fu WANG ; Xiaofei JIANG ; Yingchun XU ; Xiaojiang ZHANG ; Fengbo ZHANG ; Ping JI ; Yi XIE ; Yuling XIAO ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Jingyong SUN ; Qing CHEN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yunmin XU ; Sufang GUO ; Yanyan WANG ; Lianhua WEI ; Keke LI ; Hong ZHANG ; Fen PAN ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Wei LI ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Qian SUN ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanqing ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Wenhui HUANG ; Juan LI ; Quangui SHI ; Juan YANG ; Abulimiti REZIWAGULI ; Lili HUANG ; Xuejun SHAO ; Xiaoyan REN ; Dong LI ; Qun ZHANG ; Xue CHEN ; Rihai LI ; Jieli XU ; Kaijie GAO ; Lu XU ; Lin LIN ; Zhuo ZHANG ; Jianlong LIU ; Min FU ; Yinghui GUO ; Wenchao ZHANG ; Zengguo WANG ; Kai JIA ; Yun XIA ; Shan SUN ; Huimin YANG ; Yan MIAO ; Mingming ZHOU ; Shihai ZHANG ; Hongjuan LIU ; Nan CHEN ; Chan LI ; Jilu SHEN ; Wanqi MEN ; Peng WANG ; Xiaowei ZHANG ; Yanyan LIU ; Yong AN
Chinese Journal of Infection and Chemotherapy 2024;24(3):277-286
Objective To monitor the susceptibility of clinical isolates to antimicrobial agents in tertiary hospitals in major regions of China in 2022.Methods Clinical isolates from 58 hospitals in China were tested for antimicrobial susceptibility using a unified protocol based on disc diffusion method or automated testing systems.Results were interpreted using the 2022 Clinical &Laboratory Standards Institute(CLSI)breakpoints.Results A total of 318 013 clinical isolates were collected from January 1,2022 to December 31,2022,of which 29.5%were gram-positive and 70.5%were gram-negative.The prevalence of methicillin-resistant strains in Staphylococcus aureus,Staphylococcus epidermidis and other coagulase-negative Staphylococcus species(excluding Staphylococcus pseudintermedius and Staphylococcus schleiferi)was 28.3%,76.7%and 77.9%,respectively.Overall,94.0%of MRSA strains were susceptible to trimethoprim-sulfamethoxazole and 90.8%of MRSE strains were susceptible to rifampicin.No vancomycin-resistant strains were found.Enterococcus faecalis showed significantly lower resistance rates to most antimicrobial agents tested than Enterococcus faecium.A few vancomycin-resistant strains were identified in both E.faecalis and E.faecium.The prevalence of penicillin-susceptible Streptococcus pneumoniae was 94.2%in the isolates from children and 95.7%in the isolates from adults.The resistance rate to carbapenems was lower than 13.1%in most Enterobacterales species except for Klebsiella,21.7%-23.1%of which were resistant to carbapenems.Most Enterobacterales isolates were highly susceptible to tigecycline,colistin and polymyxin B,with resistance rates ranging from 0.1%to 13.3%.The prevalence of meropenem-resistant strains decreased from 23.5%in 2019 to 18.0%in 2022 in Pseudomonas aeruginosa,and decreased from 79.0%in 2019 to 72.5%in 2022 in Acinetobacter baumannii.Conclusions The resistance of clinical isolates to the commonly used antimicrobial agents is still increasing in tertiary hospitals.However,the prevalence of important carbapenem-resistant organisms such as carbapenem-resistant K.pneumoniae,P.aeruginosa,and A.baumannii showed a downward trend in recent years.This finding suggests that the strategy of combining antimicrobial resistance surveillance with multidisciplinary concerted action works well in curbing the spread of resistant bacteria.

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