1.Comparative Research on Regulatory Requirements of Radiotherapy Equipment Across Countries.
Chao SUN ; Yue YU ; Hong FANG ; Jingting DU ; Yu TANG
Chinese Journal of Medical Instrumentation 2025;49(1):42-47
OBJECTIVE:
To lay a foundation for formulating clinical evaluation and regulatory policies regarding radiotherapy equipment in China.
METHODS:
Comprehensive retrieval and comparison of the regulatory requirements for radiotherapy equipment from regulatory agencies in the United States, the European Union, and China are conducted, and their similarities and differences are analyzed.
RESULTS:
For mature radiotherapy systems in the European and American regions, the comparison of performance parameters serves as an important basis for determining whether a product can be marketed. Both the European Union and China regard the clinical evaluation report as a crucial part of the medical device review and submission process.
CONCLUSION
Identifying clear state of the art standards, performance parameters, and clinical indicator parameters, and establishing relevant technical guidelines are important directions for promoting the standardized development of radiotherapy equipment supervision.
Radiotherapy/standards*
;
United States
;
China
;
European Union
2.Bibliometric analysis and reflections on the current status of traditional Chinese medicine systematic reviews and Meta-analysis in the past decade
Jiaying WANG ; Yi ZHAO ; Ru DUAN ; Jingting LIU ; Yun WU ; Jisheng ZHANG ; Xuemei XIANG ; Yifei GU ; Yu TIAN ; Yawen CAO ; Bin LI ; Xianliang WANG ; Jingyuan MAO
Chinese Journal of Pharmacoepidemiology 2025;34(1):57-68
Objective To understand the current status of traditional Chinese medicine(TCM)systematic reviews/Meta-analysis over the past 10 years.Methods Cochrane Database of Systematic Reviews,PubMed,Web of Knowledge,CNKI,SinoMed,WanFang Data,VIP databases,as well as the Cochrane Register and PROSPERO registration platform were searched to collect TCM-related systematic reviews/Meta-analysis published between January 2015 and December 2024.Literature was screened,and standardization of institutions,countries,and journals was performed.Data cleaning was conducted,and trends in publication years,high-frequency diseases,journals,institutions,and highly cited papers were analyzed.Results A total of 11,174 papers were included,involving approximately 56,656 authors from 1,422 institutions across 44 countries,covering 1,300 journals and 1,070 diseases.The top five institutions in terms of publications were Beijing University of Chinese Medicine(954 papers),Guangzhou University of Chinese Medicine(928 papers),China Academy of Chinese Medical Sciences(537 papers),Tianjin University of Chinese Medicine(460 papers),and Chengdu University of Chinese Medicine(393 papers).Foreign institutions with the highest publication volumes were concentrated in South Korea,Iran,and Australia.The most frequently published Chinese journal was Zhongyi Clinical Research with 332 papers,while the most published English journal was Evidence-Based Complementary and Alternative Medicine with 311 papers.There were 282 single-author papers involving 271 authors,and the most cited paper was referenced 323 times,The three most frequently studied diseases were diabetes(267 papers,2.39%),angina pectoris(214 papers,1.92%),and osteoarthritis(210 papers,1.88%).Non-pharmacological interventions such as acupuncture(1,265 papers,11.32%),auricular therapy(101 papers,0.90%),and Tai Chi(98 papers,0.88%)were most frequently reported.In pharmacological interventions,studies on Tripterygium wilfordii tablets(76 papers,0.68%)and Danhong injection(54 papers,0.48%)were more common.Conclusion The systematic reviews/Meta-analysis method is widely used in the field of TCM,and the field continues to grow.Active academic teams,institutions,and journals have emerged.Over the past decade,there has been a considerable body of evidence in Chinese systematic reviews on TCM for chronic diseases such as diabetes,angina pectoris,and osteoarthritis.In English-language studies,non-pharmacological therapies like acupuncture have been more widely reported,and some high-impact studies have emerged.However,challenges remain,such as issues with research transparency and methodological standardization.Future efforts should focus on establishing transparent systems and quality control mechanisms to further enhance the reliability,accuracy,and dissemination of TCM evidence-based research.
3.Bibliometric analysis and reflections on the current status of traditional Chinese medicine systematic reviews and Meta-analysis in the past decade
Jiaying WANG ; Yi ZHAO ; Ru DUAN ; Jingting LIU ; Yun WU ; Jisheng ZHANG ; Xuemei XIANG ; Yifei GU ; Yu TIAN ; Yawen CAO ; Bin LI ; Xianliang WANG ; Jingyuan MAO
Chinese Journal of Pharmacoepidemiology 2025;34(1):57-68
Objective To understand the current status of traditional Chinese medicine(TCM)systematic reviews/Meta-analysis over the past 10 years.Methods Cochrane Database of Systematic Reviews,PubMed,Web of Knowledge,CNKI,SinoMed,WanFang Data,VIP databases,as well as the Cochrane Register and PROSPERO registration platform were searched to collect TCM-related systematic reviews/Meta-analysis published between January 2015 and December 2024.Literature was screened,and standardization of institutions,countries,and journals was performed.Data cleaning was conducted,and trends in publication years,high-frequency diseases,journals,institutions,and highly cited papers were analyzed.Results A total of 11,174 papers were included,involving approximately 56,656 authors from 1,422 institutions across 44 countries,covering 1,300 journals and 1,070 diseases.The top five institutions in terms of publications were Beijing University of Chinese Medicine(954 papers),Guangzhou University of Chinese Medicine(928 papers),China Academy of Chinese Medical Sciences(537 papers),Tianjin University of Chinese Medicine(460 papers),and Chengdu University of Chinese Medicine(393 papers).Foreign institutions with the highest publication volumes were concentrated in South Korea,Iran,and Australia.The most frequently published Chinese journal was Zhongyi Clinical Research with 332 papers,while the most published English journal was Evidence-Based Complementary and Alternative Medicine with 311 papers.There were 282 single-author papers involving 271 authors,and the most cited paper was referenced 323 times,The three most frequently studied diseases were diabetes(267 papers,2.39%),angina pectoris(214 papers,1.92%),and osteoarthritis(210 papers,1.88%).Non-pharmacological interventions such as acupuncture(1,265 papers,11.32%),auricular therapy(101 papers,0.90%),and Tai Chi(98 papers,0.88%)were most frequently reported.In pharmacological interventions,studies on Tripterygium wilfordii tablets(76 papers,0.68%)and Danhong injection(54 papers,0.48%)were more common.Conclusion The systematic reviews/Meta-analysis method is widely used in the field of TCM,and the field continues to grow.Active academic teams,institutions,and journals have emerged.Over the past decade,there has been a considerable body of evidence in Chinese systematic reviews on TCM for chronic diseases such as diabetes,angina pectoris,and osteoarthritis.In English-language studies,non-pharmacological therapies like acupuncture have been more widely reported,and some high-impact studies have emerged.However,challenges remain,such as issues with research transparency and methodological standardization.Future efforts should focus on establishing transparent systems and quality control mechanisms to further enhance the reliability,accuracy,and dissemination of TCM evidence-based research.
5.Progress on clinical drug trials of esophageal squamous cell carcinoma in China from 2012 to 2021
Dawei WU ; Huiyao HUANG ; Qi ZHU ; Yue YU ; Ziwei LI ; Xinyu MENG ; Jingting DU ; Man GA ; Shuangman MIAO ; Shujun XING ; Yu TANG ; Ning LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2022;29(12):1601-1606
Objective To summarize the progress and trend on clinical drug trials of esophageal squamous cell carcinoma in China. Methods Based on the clinical drug trial registration and information disclosure platform and the drug data query system of the National Medical Products Administration, the characteristics of clinical trials, investigational drugs and listed drugs of esophageal squamous cell carcinoma in China from 2012 to 2021 were analyzed. Results From 2012 to 2021, a total of 49 clinical drug trials of esophageal squamous cell carcinoma were registered in China, accounting for 1.6% of all clinical trials of anticancer drugs. Among them, there were 39 (79.6%) trials initiated by domestic pharmaceutical enterprises, 6 (12.2%) for adjuvant and neoadjuvant treatment, and 9 (18.4%) for local treatment. There were differences in the treatment line distribution between global and domestic enterprise-initiated trials (P=0.032). The above trials covered 29 investigational drugs, including 23 (79.3%) targeted drugs, most of which targeted programmed death-1, programmed death-ligand 1 and epidermal growth factor receptor. From 2012 to 2021, there were 2 drugs for esophageal squamous cell carcinoma listed in China, both of which were approved for the first-line and second-line treatment. Conclusion Great achievements have been made in the clinical development of esophageal squamous cell carcinoma drugs in China. It is suggested that domestic enterprises increase the investment of esophageal squamous cell carcinoma, pay attention to adjuvant and local treatment, explore novel targets and drug categories, and focus on the details of pivotal trials.
6. Interpretation of the Clinical Practice Guidelines for the Nursing Management of Percutaneous Endoscopic Gastrostomy and Jejunostomy in adult patients
Jingting HE ; Jiaohua YU ; Xiaoxia YANG ; Huan JIN ; Yang LUO
Chinese Journal of Practical Nursing 2019;35(24):1841-1845
Percutaneous endoscopic gastrostomy (PEG) and percutaneous endoscopic Jejunostomy (PEJ) are common channels for enteral nutrition input. In the past five years, there are no relevant nursing guidelines and reviews in China. In August 2018, Wound, Ostomy and Continence Nurses Society (WOCN) issued the Clinical Practice Guidelines for Nursing Management of Percutaneous Endoscopic Gastrostomy and Jejunostomy in Adults, including preoperative preparation, surgical procedure and postoperative monitoring of gastrostomy and Jejunostomy. The management of enteral nutrition tube, the use of enteral nutrition and drugs, the prevention of medication errors, the treatment of early and late complications, the education of patients and their caregivers, and the replacement of catheters are all recommended. This article interpreted the guideline in order to provide reference for clinical nursing of gastrostomy and Jejunostomy.
7.Biological function and mechanism of CMTM family
Chinese Journal of Cancer Biotherapy 2019;26(4):463-467
CMTM家族作为一个新的基因家族,在免疫、生殖等系统以及多种肿瘤的发病机制中起到重要作用。CMTM家族中, CMTM1可影响细胞增殖,导致肿瘤发生;与非小细胞肺癌(NSCLC)患者的化疗耐药和预后有关。CMTM2通过AP-1、CREB通 路一定程度上影响HIV-1转录,同时在男性生殖系统中起重要作用。CMTM3等位基因失活或甲基化使其丧失对细胞增殖的负 性调控能力,是胃癌独立的预后指标。CMTM4调控细胞周期影响肿瘤细胞增殖,通过对PD-L1的协同保护参与免疫逃逸。 CMTM5在许多肿瘤中沉默表达,参与肿瘤发生发展相关的信号通路。CMTM6协同PD-L1参与免疫逃逸,是潜在的免疫治疗靶 点。CMTM7在NSCLC中通过Rab5控制EGFR-AKT信号影响肿瘤发展,且与胃癌发展相关。CMTM8通过MARVEL区域影响 EGFR和相关信号通路,调控细胞增殖、分化和凋亡等。上述重要发现,为研究肿瘤的发生发展及肿瘤基因治疗提供了新思路。
8.Expression and clinical significance of CMTM6 in lung adenocarcinoma tissues
Chinese Journal of Cancer Biotherapy 2019;26(5):544-549
Objective: To evaluate the expression of CKLF-like MARVEL transmembrane domain containing member 6 (CMTM6) in lung adenocarcinoma tissues, and to explore its correlation with the clinicopathologic features and prognosis of patients. Methods: Eighty-six pairs of cancer tissues and para-cancer tissues from patients that pathologically confirmed with lung adenocarcinoma were collected during September 2004 and June 2009 at the Third Affiliated Hospital of Soochow University. The expression levels of CMTM6 in above mentioned tissues were detected by immunohistochemistry. Serum of 52 patients with confirmed lung adenocarcinoma was collected before and after surgery, and serum of 32 healthy subjects was also collected. The levels of CMTM6 and PD-L1 in peripheral blood before and after surgery were measured and analyzed by ELISA. Chi-square test was used to analyze the relationship between CMTM6 expression and clinicopathological features; Kaplan-Meier method and Log-Rank test were used to analyze the survival data of patients. Results: CMTM6 was widely expressed in lung adenocarcinoma tissues; 30% of the tumor tissues showed an up-regulation as compared with para-cancer tissues, and 70% showed no difference. CMTM6 expression was associated with clinical stage and distant metastasis (all P<0.05), but not significantly associated with age, gender, tumor size, and T stage (P>0.05). Kaplan-Meier survival analysis showed the survival rate of patients with high CMTM6 expression was significantly lower than those with stable expression (P=0.014), and among patients at stage Ⅲ, the survival rate of patients with high CMTM6 expression was significantly lower than those with stable CMTM6 expression (P=0.001). Cox regression model analysis of multiple factors showed CMTM6 expression was an independent risk factor for the prognosis of patients with lung adenocarcinoma. CMTM6 expression in pre-surgery serum, post-surgery serum and healthy donors’serum showed statistically significant differences (P<0.05), which was significantly correlated with tumor size and age of the patients. Spearman correlation analysis showed a significant correlation between serum CMTM6 and PD-L1 expression level (r=0.623, P<0.01). Conclusion: CMTM6 is an independent risk factor for the prognosis of lung adenocarcinoma patients. It plays an important role in the occurrence and development of lung adenocarcinoma and it is a potential tumor suppressor gene.
9.Reflections on simulation-based medical education
Jingwei LI ; Pixia LIANG ; Wei YU ; Huisheng YUAN ; Jingting LUO ; Naiqian JIN ; Yuzheng LI ; Rong XU ; Yi REN ; Lei WANG
Chinese Journal of Medical Education Research 2019;18(8):775-778
Simulation-based medical education can ensure medical safety, reduce medical errors and improve students' clinical skills. At present, the main problems in medical teaching are the conflict between doctors and patients, the contradiction between medical teaching and ethics, the shortage of teaching resources and the lack of a universal assessment standard. The advantages of simulation-based medical education are its safety, repeatability, standardization, controllability, relative authenticity, and the cultivation of humanistic spirit and teamwork for students. Simulation-based medical education has two major limits. First, its teaching effect relies on the function and quality of each model. Second, simulation cannot replace clinical practice. This article proposes the following ways and means for promoting the simulation-based medical education: training of faculty is the core, establishment of courses is the focus, cooperation and communication is an important way to promote development, and phased and refined development is the future direction.
10.The efficacy of active cycle of breathing techniques on promoting lung recruitment in postthoracic surgery patients with lung cancer
Jingting HE ; Jiaohua YU ; Sihua WANG
Journal of Clinical Surgery 2018;26(3):208-211
Objective To evaluate the effect of active cycle of breathing techniques(ACBT) on promoting lung recruitment in post-thoracic surgery patients with lung cancer. Methods Totally 100 cases of patients with lung cancer were collected and randomly divided into two groups(the control group and the observation group) with 50 cases in each group. The additional ACBT was applied≥3 times per day in the control group compared with the observation group. The main observation indexes(pulmonary function and arterial blood gas, etc) and the secondary indexes(vital signs and pain score, etc) of the patients were collected at different time period. Results The main observation index and the secondary index of the patients in the control group gained an advantage over those in the observation group(P<0.05). No obvious adverse events occurred. Conclusion ACBT applied in the post-thoracic surgery patients with lung cancer is safe and effective. It can improve the cleaning efficiency of respiratory secretion, promote lung recruitment and fastly recover the pulmonary function and save medical costs.

Result Analysis
Print
Save
E-mail