1.Platelet-rich plasma and hydrogel for spinal cord injury
Wenqi ZHAO ; Haichi YU ; Yiru SONG ; Tianyang YUAN ; Qinyi LIU
Chinese Journal of Tissue Engineering Research 2025;29(10):2189-2200
BACKGROUND:A large number of articles have reported the effect and mechanism of platelet-rich plasma and hydrogel in the treatment of spinal cord injury,but few articles have summarized their treatment strategies for spinal cord injury. OBJECTIVE:To summarize the pathological process of spinal cord injury and the strategies of repairing spinal cord injury with platelet-rich plasma and hydrogel alone and in combination. METHODS:PubMed and CNKI databases were searched for articles published from inception to March 2024 by computer.The Chinese search terms were"spinal cord injury,platelet-rich plasma,hydrogel."The English search terms were"spinal cord injury,spinal cord,platelet-rich plasma,hydrogel,angiogenesis,neuralgia,combination therapy."Articles were screened according to inclusion and exclusion criteria,and 128 articles were finally included for review and analysis. RESULTS AND CONCLUSION:(1)The classification of platelet-rich plasma is complex and diverse,and the effects of platelet-rich plasma in the repair treatment of spinal cord injury are various,but they all show certain positive effects,that is,they can promote axon regeneration,stimulate angiogenesis,and treat neuropathic pain and so on.(2)The effect of platelet-rich plasma is mainly due to the growth factors contained in platelet-rich plasma.(3)There are many types of hydrogels,which mainly play the role of filling,simulating extracellular matrix,carrying drugs and biological products,and carrying cells as scaffolds in the repair treatment of spinal cord injury.(4)Compared with single therapy,combination therapy of platelet-rich plasma and hydrogel can promote nerve regeneration and spinal cord function recovery more effectively.
2.Mechanisms of tumor immune microenvironment remodeling in current cancer therapies and the research progress.
Yuanzhen YANG ; Zhaoyang ZHANG ; Shiyu MIAO ; Jiaqi WANG ; Shanshan LU ; Yu LUO ; Feifei GAO ; Jiayue ZHAO ; Yiru WANG ; Zhifang XU
Chinese Journal of Cellular and Molecular Immunology 2025;41(4):372-377
The cellular and molecular components of the tumor immune microenvironment (TIME) and their information exchange processes significantly influence the trends of anti-tumor immunity. In recent years, numerous studies have begun to evaluate TIME in the context of previous cancer treatment strategies. This review will systematically summarize the compositional characteristics of TIME and, based on this foundation, explore the impact of current cancer therapies on the remodeling of TIME, aiming to provide new insights for the development of innovative immune combination therapies that can convert TIME into an anti-tumor profile.
Tumor Microenvironment/immunology*
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Humans
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Neoplasms/therapy*
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Immunotherapy/methods*
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Animals
4.Analysis of the Causes of Subject Screening Failures in Clinical Trials of Antineoplastic Drugs and Protocol Nerfing Indicators
Shuopeng JIA ; Hailan MA ; Huiyao HUANG ; Jingxiao ZHU ; Anqi YU ; Yiru HOU ; Yu TANG ; Hong FANG ; Ning LI
Herald of Medicine 2025;44(3):497-502
Objective To analyze the reasons for the failure of subject screening in clinical trials of antineoplastic drugs and the impact of natriuretic criteria on the entry of subjects into clinical trials,to explore the strategies to improve the suc-cessful enrolment of screened subjects,and to provide reference bases for research institutes and sponsors in the formulation of na-triuretic criteria.Methods This study selected data from 40 drug clinical trials conducted at the Drug Clinical Trial Research Center of the Cancer Hospital of the Chinese Academy of Medical Sciences from January 1,2016,to June 30,2022.It statistically described the collected data on the frequency and percentage composition of screening failures among participants and the inclu-sion and exclusion criteria in the protocols.Results A total of 425 subjects were screened out of 40 clinical trial programmers covering 8 tumor types,with the majority being<65 years of age(333,78.4%),of which the most important reasons included vol-untary withdrawal(71,16.7%),tumor metastasis(52,12.2%),failure to recover from treatment of pre-existing disease(38,8.9%),failure of bone marrow function(19,4.5%),and non-compliant liver function(15,3.5%).Among the nadir indicators,the age of the subjects(100%),ECOG score(97.5%),bone marrow function(ANC:95.0%,PLT:97.5%,HB:97.5%),liver function(T-BiL:95.0%,ALT:87.5%,AST:95.0%),renal function(CR:80.0%),and viral screening(HIV:80.0%,HBV:70.0%,HCV:62.5%)were relatively stringent.Conclusion The main reasons for subject screening failure in clinical trials in oncology in our hospital are voluntary withdrawal,brain metastasis,and failure of their biochemical test standards,which are close-ly related to the setting of clinical trial nadir criteria.Therefore,an in-depth understanding of subjects'characteristics,accurate set-ting of appropriate nadir criteria,continuous improvement of trial design,and strengthening of communication with subjects to pro-vide more relevant information will help to improve the screening success rate of clinical trials.
5.Application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms: a scoping review
Xiaobo REN ; Changyun WEI ; Yiru WANG ; Yu LIU ; Yongling LIU ; Zirong TIAN
Chinese Journal of Modern Nursing 2025;31(34):4636-4642
Objective:To summarize the application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms.Methods:Following the scoping review framework of Arksey and O'Malley, literature on the application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms was electronically retrieved from databases including the Cochrane Library, Embase, PubMed, Web of Science, CINAHL, IEEE Xplore, China Biology Medicine disc, Wanfang Data, and China National Knowledge Infrastructure. The search period was from database establishment to August 5, 2025.Results:A total of 21 articles were included. Types of head and neck neoplasms included oropharyngeal cancer, nasopharyngeal cancer, oral cancer, tongue cancer, laryngeal cancer, hypopharyngeal cancer, and others. The application forms of digital health technologies involved virtual reality technology, telemedicine systems, interactive mobile health APPs/digital health platforms, and wearable devices. Interactive mobile health apps/digital health platforms were currently the most widely adopted form, with some applications integrating wearable devices for physiological data monitoring. The main components of the intervention included guiding swallowing training methods, training monitoring/supervision and feedback, swallowing function screening/assessment, and health education.Conclusions:The application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms is still in its early stages, but its advantages in enhancing rehabilitation accessibility and promoting patient adherence have already begun to emerge. Nevertheless, it also faces challenges such as limited user-friendliness, insufficient personalized feedback, and a lack of humanistic care. It is necessary to further explore and develop personalized, precision-oriented intelligent swallowing rehabilitation systems tailored to the specific needs of swallowing rehabilitation for head and neck cancer patients. High-quality clinical studies should be conducted to validate long-term efficacy, thereby providing intelligent solutions for clinical nursing practices in swallowing rehabilitation for these patients.
6.Application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms: a scoping review
Xiaobo REN ; Changyun WEI ; Yiru WANG ; Yu LIU ; Yongling LIU ; Zirong TIAN
Chinese Journal of Modern Nursing 2025;31(34):4636-4642
Objective:To summarize the application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms.Methods:Following the scoping review framework of Arksey and O'Malley, literature on the application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms was electronically retrieved from databases including the Cochrane Library, Embase, PubMed, Web of Science, CINAHL, IEEE Xplore, China Biology Medicine disc, Wanfang Data, and China National Knowledge Infrastructure. The search period was from database establishment to August 5, 2025.Results:A total of 21 articles were included. Types of head and neck neoplasms included oropharyngeal cancer, nasopharyngeal cancer, oral cancer, tongue cancer, laryngeal cancer, hypopharyngeal cancer, and others. The application forms of digital health technologies involved virtual reality technology, telemedicine systems, interactive mobile health APPs/digital health platforms, and wearable devices. Interactive mobile health apps/digital health platforms were currently the most widely adopted form, with some applications integrating wearable devices for physiological data monitoring. The main components of the intervention included guiding swallowing training methods, training monitoring/supervision and feedback, swallowing function screening/assessment, and health education.Conclusions:The application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms is still in its early stages, but its advantages in enhancing rehabilitation accessibility and promoting patient adherence have already begun to emerge. Nevertheless, it also faces challenges such as limited user-friendliness, insufficient personalized feedback, and a lack of humanistic care. It is necessary to further explore and develop personalized, precision-oriented intelligent swallowing rehabilitation systems tailored to the specific needs of swallowing rehabilitation for head and neck cancer patients. High-quality clinical studies should be conducted to validate long-term efficacy, thereby providing intelligent solutions for clinical nursing practices in swallowing rehabilitation for these patients.
7.Analysis of the Causes of Subject Screening Failures in Clinical Trials of Antineoplastic Drugs and Protocol Nerfing Indicators
Shuopeng JIA ; Hailan MA ; Huiyao HUANG ; Jingxiao ZHU ; Anqi YU ; Yiru HOU ; Yu TANG ; Hong FANG ; Ning LI
Herald of Medicine 2025;44(3):497-502
Objective To analyze the reasons for the failure of subject screening in clinical trials of antineoplastic drugs and the impact of natriuretic criteria on the entry of subjects into clinical trials,to explore the strategies to improve the suc-cessful enrolment of screened subjects,and to provide reference bases for research institutes and sponsors in the formulation of na-triuretic criteria.Methods This study selected data from 40 drug clinical trials conducted at the Drug Clinical Trial Research Center of the Cancer Hospital of the Chinese Academy of Medical Sciences from January 1,2016,to June 30,2022.It statistically described the collected data on the frequency and percentage composition of screening failures among participants and the inclu-sion and exclusion criteria in the protocols.Results A total of 425 subjects were screened out of 40 clinical trial programmers covering 8 tumor types,with the majority being<65 years of age(333,78.4%),of which the most important reasons included vol-untary withdrawal(71,16.7%),tumor metastasis(52,12.2%),failure to recover from treatment of pre-existing disease(38,8.9%),failure of bone marrow function(19,4.5%),and non-compliant liver function(15,3.5%).Among the nadir indicators,the age of the subjects(100%),ECOG score(97.5%),bone marrow function(ANC:95.0%,PLT:97.5%,HB:97.5%),liver function(T-BiL:95.0%,ALT:87.5%,AST:95.0%),renal function(CR:80.0%),and viral screening(HIV:80.0%,HBV:70.0%,HCV:62.5%)were relatively stringent.Conclusion The main reasons for subject screening failure in clinical trials in oncology in our hospital are voluntary withdrawal,brain metastasis,and failure of their biochemical test standards,which are close-ly related to the setting of clinical trial nadir criteria.Therefore,an in-depth understanding of subjects'characteristics,accurate set-ting of appropriate nadir criteria,continuous improvement of trial design,and strengthening of communication with subjects to pro-vide more relevant information will help to improve the screening success rate of clinical trials.
8.International comparison and assessment of the quality of drug clinical trial implementation in China based on scientific regulatory system
Hong FANG ; Yiru HOU ; Huiyao HUANG ; Dawei WU ; Shuopeng JIA ; Yu TANG ; Ning LI
Chinese Journal of Oncology 2024;46(10):987-993
Objective:To analyze the international status and level of clinical trial quality in China, and explore the advantages and value of scientific regulation of clinical research quality in China.Methods:The data is sourced from the relevant reports publicly released by the National Medical Products Administration (NMPA), the inspection reports and announcements published by the Center for Food and Drug Inspection of the NMPA, the inspection data displayed on the official website of the U.S. Food and Drug Administration (FDA), as well as clinical diagnosis and treatment guidelines issued by the National Comprehensive Cancer Network (NCCN) of United States and the Chinese Society of Clinical Oncology (CSCO) (data as of July 21, 2023). This data provides an analysis of the regulatory status of the implementation of clinical drug trials in China, inspection data, and the approval and market entry of new oncology drugs and feedback from their practical application.Results:The clinical trial quality inspection systems of China and the United States are generally aligned, with similar inspection subjects, focus areas, and public disclosure pathways. However, each has its characteristics in terms of inspection targets and types. The quality of clinical trial data in China has been continuously improving. Between 2009-2015 and 2016-July 2023, China underwent 25 and 20 FDA Bioresearch Monitoring (BIMO) inspections, respectively. The inspection results showing "No Action Indicated" (NAI) improved from 48.0% to 85.0%, while "Voluntary Action Indicated" (VAI) decreased from 44.0% to 15.0%. Official Action Indicated (OAI) measures were required in 2009 and 2012. Compared to the 2009-2015 period, there has been a clear upward trend in the quality of clinical trial data since 2016. From 2016 to July 2023, the number of new oncology drugs developed by Chinese pharmaceutical companies and included in professional guidelines has steadily increased. Specifically, 37 drugs (58.7%) were included in the 2022 edition of the CSCO guidelines, and 15 drugs (23.8%) were included in the 2023 edition of the NCCN guidelines, with 10 of these drugs featured in both guidelines.Conclusions:The implementation quality of clinical trials in China has gained a certain level of international recognition and competitiveness. This progress is attributed to national macro-level guidance, a unique institutional model, and clinical practices aligned with international standards. In the future, it will be necessary to further strengthen the scientific regulatory system and enhance clinical research capabilities to continue advancing the high-quality development of clinical trials.
9.One case of comprehensive treatment of acute severe ammonia-induced intoxication with extracorporeal membrane oxygenation
Yiru SHAO ; Daikun HE ; Lianhuan JIN ; Yu DUN ; Jie SHEN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2024;42(9):700-704
Acute ammonia-induced intoxication is a kind of acute irritant gas poisoning, which mainly causes systemic inflammatory reaction and immune dysfunction through direct and indirect lung injury, leading to chemogenic pulmonary edema and acute respiratory distress syndrome (ARDS). The mechanism of its toxic injury is complex, and the fatality rate of patients increases significantly once ARDS occurs. In this paper, the patient with acute and severe ammonia-induced intoxication was successfully treated by extracorporeal membrane oxygenation (ECMO) combined with fiberoptic bronchoscopy and other critical technologies, and achieved good results. By analyzing the diagnosis and treatment process of severe ammonia-induced intoxication complicated with ARDS patients, this paper summarizes the clinical characteristics of ammonia-induced intoxication injury, and the application opportunities of ECMO and various critical medical technologies, so as to facilitate the efficient intervention and treatment of ammonia-induced intoxication according to the clinical opportunity and improve the survival rate of patients.
10.International comparison and assessment of the quality of drug clinical trial implementation in China based on scientific regulatory system
Hong FANG ; Yiru HOU ; Huiyao HUANG ; Dawei WU ; Shuopeng JIA ; Yu TANG ; Ning LI
Chinese Journal of Oncology 2024;46(10):987-993
Objective:To analyze the international status and level of clinical trial quality in China, and explore the advantages and value of scientific regulation of clinical research quality in China.Methods:The data is sourced from the relevant reports publicly released by the National Medical Products Administration (NMPA), the inspection reports and announcements published by the Center for Food and Drug Inspection of the NMPA, the inspection data displayed on the official website of the U.S. Food and Drug Administration (FDA), as well as clinical diagnosis and treatment guidelines issued by the National Comprehensive Cancer Network (NCCN) of United States and the Chinese Society of Clinical Oncology (CSCO) (data as of July 21, 2023). This data provides an analysis of the regulatory status of the implementation of clinical drug trials in China, inspection data, and the approval and market entry of new oncology drugs and feedback from their practical application.Results:The clinical trial quality inspection systems of China and the United States are generally aligned, with similar inspection subjects, focus areas, and public disclosure pathways. However, each has its characteristics in terms of inspection targets and types. The quality of clinical trial data in China has been continuously improving. Between 2009-2015 and 2016-July 2023, China underwent 25 and 20 FDA Bioresearch Monitoring (BIMO) inspections, respectively. The inspection results showing "No Action Indicated" (NAI) improved from 48.0% to 85.0%, while "Voluntary Action Indicated" (VAI) decreased from 44.0% to 15.0%. Official Action Indicated (OAI) measures were required in 2009 and 2012. Compared to the 2009-2015 period, there has been a clear upward trend in the quality of clinical trial data since 2016. From 2016 to July 2023, the number of new oncology drugs developed by Chinese pharmaceutical companies and included in professional guidelines has steadily increased. Specifically, 37 drugs (58.7%) were included in the 2022 edition of the CSCO guidelines, and 15 drugs (23.8%) were included in the 2023 edition of the NCCN guidelines, with 10 of these drugs featured in both guidelines.Conclusions:The implementation quality of clinical trials in China has gained a certain level of international recognition and competitiveness. This progress is attributed to national macro-level guidance, a unique institutional model, and clinical practices aligned with international standards. In the future, it will be necessary to further strengthen the scientific regulatory system and enhance clinical research capabilities to continue advancing the high-quality development of clinical trials.

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