1.Guidelines of ethics review for clinical application of medical technology
Jiyin ZHOU ; Mingjie ZI ; Qi LU ; Hui JIANG
Chinese Medical Ethics 2025;38(1):15-22
Access to the clinical application of medical technology is one of the core institutional contents of medical quality management, involving medical quality assurance, the achievement of patient safety goals, and medical service satisfaction. Medical technology is only permitted for clinical use after its safety and effectiveness have been verified through clinical research, as well as evaluated and reviewed by the medical technology clinical application management committee and ethics committee of this medical and health institution. Based on the relevant laws, regulations, and ethical principles, combined with the experience of ethical review in the clinical application of medical technology from some medical and health institutions, a thematic discussion was held to formulate ethical review guidelines for the clinical application of medical technology for references. These guidelines elaborated on the management system for access to the clinical application of medical technology in medical and health institutions, the system of ethics committees and the requirements of review norms, technical plans and their review points, key points for the implementation of informed consent, technical teams and conditions, and other aspects.
2.An analysis of results of 392 times of CT quality control and room radiological protection testing in Guangdong Province, China
Xiyuan CHENG ; Yanpeng LIAO ; Shupeng LIU ; Chuang WANG ; Meijuan ZHOU
Chinese Journal of Radiological Health 2024;33(1):61-67
Objective To provide a theoretical basis for radiation health supervision through an analysis of the situation of computed tomography (CT) equipment quality control and CT room radiological protection in Guangdong Province, China in recent years. Methods We collected the data of 392 times of CT quality control and radiological protection testing by a third-party radiological health technical service institution in Guangdong Province from 2019 to 2021. We analyzed the levels of CT-owning hospitals, CT manufacturers, CT quality control test results, and the pass rate of radiation protection tests. Results The examined CT scanners were from different levels of hospitals in Guangdong Province, and were manufactured by nine major CT equipment manufacturers at home and abroad. The pass rate of CT room radiological protection was 99.88%, and the ambient dose equivalent rates of five monitoring points exceeded the limit, with four at the control room door and one at the shield wall of the room. The overall pass rate of CT equipment quality control was 99.49%, and the non-conforming parameters were the accuracy of positioning light and the deviation of reconstructed slice thickness. Conclusion In recent years, CT equipment quality control and room radiation protection in Guangdong Province have been at a high level.
3.Clinical Advantages of Traditional Chinese Medicine in Treatment of Pediatric Diseases
Yingke LIU ; Hong CUI ; Jian YANG ; Junhong WANG ; Liqun WU ; Xiaohua JI ; Bing AN ; Xiaomei LIU ; Weilin WAN ; Hong WANG ; Gaojun ZHOU ; Wen ZHANG ; Liyi QIU ; Kai GUO ; Xiaoxiao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(15):224-231
The traditional Chinese medicine (TCM) in pediatric care has a long history,proven efficacy,and distinctive characteristics.The China Association of Chinese Medicine has organized a series of youth salons to discuss the clinical advantages of treating diseases.Experts at this seminar proposed that the superior disease categories in pediatric TCM are significant for showcasing the unique strengths and advantages of TCM in the treatment of pediatric diseases,enhancing diagnostic and treatment levels,inheriting TCM knowledge,promoting the integration of TCM and Western medicine,and meeting patients' needs.The strengths of pediatric TCM are summed up as "having what others do not,excelling at what others have,being special in what others excel at,and ensuring safety in what others specialize in." The scope of superiority in pediatric TCM covers multiple systems,including respiratory,digestive,endocrine,psychological,and dermatological systems.This article summarized the advantages of TCM in treating 13 diseases discussed in the salon,such as upper respiratory tract infections,coughs,pneumonia,allergic rhinitis,bronchial asthma,atopic dermatitis,functional dyspepsia,functional constipation,enuresis,marginal short stature,simple obesity,attention deficit hyperactivity disorder,and tic disorders.The overall advantages were reflected in three aspects:First,the holistic concept and treatment based on syndrome differentiation in TCM highlight the advantage of treating the root causes of diseases,making the treatment methodical and precise.Second,most traditional Chinese herbs are natural and have strong safety profiles.Third,TCM treatment methods are abundant,especially the external treatment methods,which are widely used in pediatrics,highly accepted by parents,and have definite efficacy,as well as good safety and compliance.
4.Study on the Prevalence Difference between Northwest Dryness Syndrome and Blood Stasis Syndrome of Coronary Heart Disease and the Correlation with Major Adverse Cardiovascular Events
Xintong LI ; Peng LI ; Changgeng FU ; Linzi LONG ; Jingya ZHOU ; Jiawei HU ; Yutai ZHAO
Journal of Traditional Chinese Medicine 2024;65(12):1255-1261
ObjectiveTo explore the prevalence difference between northwest dryness syndrome and blood stasis syndrome of coronary heart disease (CAD) and their correlations with major adverse cardiovascular events (MACE). MethodsThe medical records including general information and risk factors for vascular diseases (gender, age, smoking history, diabetes history, hypertension history, chronic kidney disease history and body mass index), laboratory indicators (fasting blood glucose, triglyceride, high density lipoprotein cholesterol, etc.) of 499 CAD patients in the Department of Cardiology of the Affiliated Hospital of Traditional Chinese Medicine of Xinjiang Medical University from November 1st, 2015 to September 30th,2020 were collected, and whether they suffered from northwest dryness syndrome or blood stasis syndrome was judged. The incidence of MACE was followed up for one year. The differences of cardiovascular risk factors between the northwest dryness syndrome and blood stasis syndrome of CAD were compared, and the correlation with MACE was analyzed. ResultsAmong the 499 CAD patients, there were 128 cases (25.65%) of simple blood stasis syndrome, 33 cases (6.61%) of simple northwest dryness syndrome, 209 cases (41.88%) of northwest dryness syndrome plus blood stasis syndrome, and 129 (25.85%) cases of not blood statis syndrom either northwest dryness syndrome. Univariate regression analysis showed that smoking history, diabetes history, fasting blood glucose abnormality, triglyceride abnormality, and high density lipoprotein cholesterol abnormality were positively correlated with northwest dryness syndrome in CAD patients (OR>1, P<0.05), while smoking history, abnormal triglyceride and abnormal high density lipoprotein cholesterol were positively correlated with blood stasis syndrome in CAD patients (OR>1, P<0.05). Multivariate regression analysis showed that the history of diabetes, abnormal triglyceride and abnormal high density lipoprotein cholesterol were positively correlated with northwest dryness syndrome of CAD (P<0.05). Smoking history, abnormal triglycerides and abnormal high density lipoprotein cholesterol were positively correlated with blood stasis syndrome (P<0.05). Association rule analysis showed that the confidence of CAD patients with northwest dryness syndrome complicated with blood stasis syndrome was 86.36%, and that of patients with blood stasis syndrome complicated with northwest dryness syndrome was 62.02%. Among the 499 patients, 96 had MACE in one year, accounting for 19.24% of the total. Logistics regression analysis showed that the correlation with incidence of MACE in CAD patients within one year from strong to weak was northwest dryness syndrome plus blood stasis syndrome [OR = 5.113, 95%CI (3.118, 8.387), P<0.001)], blood stasis syndrome[OR = 4.630, 95%CI (2.394, 8.955), P<0.001], northwest dryness syndrome [OR = 4.395, 95%CI (2.642, 7.309), P<0.001]. ConclusionBlood stasis syndrome is the main syndrome type of CAD in Xinjiang Uygur Autonomous Region. CAD patients with northwest dryness syndrome are more likely to have blood stasis syndrome, and most suffer from both northwest dryness syndrome and blood stasis syndrome simultaneously. There is the strongest correlation between northwest dryness syndrome plus blood stasis syndrome and 1-year occurrence of MACE in CAD.
5.Current Situation,Existing Problems and Solving Strategies of the Assessment of Medical Ethics and Styles in the Examination of Doctors' Qualification
Hua GUO ; Yu HAN ; Kai REN ; Zhihao ZHOU ; Mingjie ZI ; Yujiao SONG ; Min ZHU ; Lili XYU ; Yi LI ; Tingting WANG ; Linyong YU
Journal of Traditional Chinese Medicine 2024;65(12):1292-1295
This paper discussed the current education status on medical ethics and styles and the assessment condition in the examination of doctors' qualification, as well as the existing problems and potential solutions by reviewing domestic and foreign literature and summarizing the practice experience. Traditionally, medical ethics and styles have always been integrated into clinical medical practice in China. However, under the modern medical education system, it is challenged to integrate traditional education on medical ethics and styles with the rules of modern medical knowledge. By summarizing the education and assessment status of medical ethics and styles in the examination of doctors' qualification, it is found that the current examination is relatively poor in the evaluation content, and the way of evaluation is not diverse, with lack of curriculum of medical humanities. The solutions suggested are enriching relevant examination content, introducing more and comprehensive evaluation method, and establishing more medical humanities-related courses.
6.FANG Dingya's Experience in Staged Treatment of Sjögren's Syndrome based on Dryness Toxin Theory
Haoyu ZHANG ; Shuhua HAN ; Fei DONG ; Liyan DU ; Xin WANG ; Caiyun ZHOU ; Jinyang TANG
Journal of Traditional Chinese Medicine 2024;65(15):1550-1554
This paper summarized the experience of Professor FANG Dingya in staged treatment of Sjögren's syndrome from the perspective of dryness toxin. It is believed that the cause of Sjögren's syndrome is externally-contracted dryness, consumption of essence and fluid, congenital and acquired essence deficiency, depleted essence and insufficient blood, and the core mechanism is internal accumulation of dryness toxin. The treatment can be divided into three stages, that is dryness toxin transforming into fire-heat, damp-heat and phlegm-stasis, from the perspective of dryness metal qi transformation. It is emphasized to dispel pathogen mainly, to clear and moisten with yin-nourishing medicinals in supplementation, and to treat by stages based on syndrome differentiation. For dryness toxin with fire-heat, it is suggested to moisten dryness, resolve toxins and subdue fire, with self-made Runzao Jiedu Decoction (润燥解毒汤) in modification. For dryness toxin with damp-heat, the method of nourishing yin, clearing heat and draining dampness should be used, and Chunze Decoction (春泽汤) in modification is suggested. For dryness toxin with phlegm-stasis, it is recommended to unblock collaterals, disperse phlegm and dissipate stasis, with self-made Sanyu Xiaotan Decoction (散瘀消痰汤) in modification.
7.Research progress of the correlation between fundus tessellation with ocular and systemic diseases as well as its identification and quantification based on artificial intelligence
International Eye Science 2024;24(10):1615-1619
Fundus tessellation, commonly observed in individuals with myopia and among the elderly, represents a fundus alteration easily discernible and assessable. Long-term monitoring has revealed that fundus tessellation may persist unchanged for extended periods or progress, potentially leading to more severe fundus lesions and diminished visual quality. The clinical significance of fundus tessellation is not only as an early indicator and predictor of myopic macular degeneration(MMD), but also, to some extend, as a helpful assistance in early identification and mechanism research of the other ocular and systemic disease, including glaucoma, diabetic retinopathy, age-related macular degeneration, cognitive impairment, and Down syndrome. Currently, artificial intelligence(AI)has achieved remarkable results in detecting, grading, and quantifying fundus tessellation. Therefore, this paper discusses the ocular and systemic diseases related to changes in fundus tessellation, their underlying mechanisms, and advancements in AI-based identification and quantification of fundus tessellation, aiming to contribute to future research endeavors.
8.A Multicenter, Randomized, Double-blind, and Placebo-parallel Controlled Trial of Tibetan Medicine Ruyi Zhenbaowan in Treatment of Knee Osteoarthritis
Chunquan SUN ; Yanming XIE ; Jinghua GAO ; Weiheng CHEN ; Lianxin WANG ; Shangquan WANG ; Xiangdong TIAN ; Zujian XU ; Yuxin ZHENG ; Mingwang ZHOU ; Chungen LI ; Zhanwang XU ; Jiayi GUO ; Shuangqing DU ; Qigang CHEN ; Quan JI ; Zhiqiang BAI ; Jing XIAO ; Wanli QI ; Weiyi YANG ; Jingxiao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):57-67
ObjectiveThis study aimed to evaluate the clinical efficacy of Ruyi Zhenbaowan(RYZBW)in the treatment of initial and early knee osteoarthritis (KOA) through a prospective multicenter,randomized,double-blind,and placebo-parallel controlled trial. MethodFrom October 13th, 2021 to December 25th, 2021, 240 KOA subjects meeting the acceptance criteria were enrolled in 15 sub-centers including Wangjing Hospital, Chinese Academy of Chinese Medical Sciences, and they were randomly divided into observation group and control group, with 120 cases in each group. The intervention measures for the observation group were RYZBW + health education, and the intervention measures for the control group were RYZBW placebo + health education. The intervention period in both groups was four weeks, and they were followed up for four weeks after the intervention. The primary outcome measure was the total score of Western Ontario and McMaster University Osteoarthritis Index score (WOMAC score), and the secondary outcome measures were the response rate of visual scale (VAS) pain score, WOMAC sub item scores (joint pain, joint stiffness, and joint function), quality of life (SF-12) score, and traditional Chinese medicine (TCM) syndrome score. Result(1) Efficacy evaluation. The marginal model results showed that the observation group was better than the control group in improving the WOMAC total score and WOMAC pain score in the treatment of KOA with RYZBW, and the difference was statistically significant (P<0.05). There was no significant difference between the two groups in improving VAS score response rate, WOMAC function score, WOMAC stiffness score, SF12-PCS (quality of life-physical health) score, SF12-MCS (quality of life-mental health) score, and TCM syndrome score. (2) Subgroup analysis. ① In terms of VAS score response rate, the response rate of the observation group was higher than that of the control group for subjects with baseline VAS score of (4, 5], and the difference was statistically significant (P<0.05). ② In terms of TCM syndrome score, for subjects aged [56, 60] and [61, 65], the decrease in total TCM syndrome score in the observation group was better than that in the control group, and the difference was statistically significant (P<0.05). ConclusionTibetan medicine RYZBW has good clinical efficacy in improving WOMAC total score, VAS score response rate, WOMAC pain score, WOMAC function score, and TCM syndrome score for patients with initial and early KOA, which can fill the lack of Tibetan medicine RYZBW in the treatment of KOA and make a demonstration study for the inheritance and development of ethnic medicine.
9.Effect of Jiuxin Pill (救心丸)on Exercise Tolerance and Quality of Life in Patients of Stable Angina Pectoris:A Randomized,Double-Blind,Placebo-Controlled,Multi-Center Clinical Trial
Xianliang WANG ; Mingjun ZHU ; Daimei NI ; Jianguang WU ; Yitao XUE ; Chenglong WANG ; Xiaohua DAI ; Qian LIN ; Jun LI ; Zhiqiang ZHAO ; Shuai WANG ; Yingfei BI ; Tongzuo LIU ; Zhou ZHOU ; Jingyuan MAO
Journal of Traditional Chinese Medicine 2024;65(24):2549-2557
ObjectiveTo evaluate the effect and safety of Jiuxin Pill (救心丸) on exercise tolerance and quality of life in patients with stable angina pectoris (SAP). MethodsA randomised, double-blind, placebo-controlled, multicentre study design was used to enroll 170 patients of SAP from nine centres, which were divided into 85 patients each in the trial group and control group with 1∶1 ratio. Both groups maintained the original western medicine treatment plan, and added Jiuxin Pill or placebo respectively, 2 pills (0.05 g) each time twicely for 28 days. The main outcomes were total exercise time (TED) in the exercise treadmill test and Seattle Angina Questionnaire (SAQ) scores including physical limitation (PL), angina stability (AS), angina frequency (AF), treatment satisfaction (TS), and disease perception (DP). The secondary outcomes were exercise treadmill test indicators including heart rate recovery in 1 min (HRR1), metabolic equivalents (METs), maximum magnitude of ST-segment depression, and the Borg rating of perceived exertion scale, the average number of angina attacks per week, withdrawal and reduction rate of nitroglycerin, traditional Chinese medicine syndrome scores, incidence of major adverse cardiovascular events. Safety indicators were evaluated and the occurrence of adverse events during the trial was recorded. Data was collected before treatment, day 28±2 in treatment period, and follow-up at day 56 which is 28±2 days after treatment period finished. ResultsEighty-four and eighty-five patients respectively from trial group and control group were included to the full analysis set (FAS) and safety analysis set (SS). Compared with the group before treatment and with the control group after treatment, the trial group had higher TED, HRR1, and METs, and lower maximum magnitude of ST-segment depression and Borg rating of perceived exertion scores after treatment (P<0.01). Compared with the group before treatment and with the control group after treatment and at follow-up, the total SAQ score and scores of AS, AF, TS and DP of the trial group after treatment and at follow-up elevated, while the average number of angina attacks per week and traditional Chinese medicine syndrome scores reduced (P<0.01). There was no statistically significant difference in the withdrawal and reduction rate of nitroglycerin between groups (P>0.05). Major adverse cardiovascular events occurred in 1 case (1/84, 1.19%) in the trial group and 1 case (1/85, 1.18%) in the control group, and the difference between groups was not statistically significant (P>0.05). A total of 3 cases of adverse events occurred in the trial group (3/84, 3.57%), and a total of 6 cases of adverse events occurred in the control group (6/85, 7.06%), and there was no statistically significant difference in the incidence of adverse events between groups (P>0.05). ConclusionIn the treatment of SAP, Jiuxin Pill combined with conventional western medicine can further enhance exercise tolerance, improve quality of life, and demonstrate great safety.
10.Study on regulatory mechanism of nitric oxide on calcium transient state in skeletal muscle cells of adult zebrafish
Xinyu LIU ; Weiming XIE ; Xinghua LIU ; Zhanfei LI ; Xiyuan ZHOU
Chongqing Medicine 2024;53(12):1761-1767
Objective To use the high-speed fluorescence photography to investigate the regulatory effect of nitric oxide(NO)on calcium transient state in skeletal muscle cells of adult zebrafish.Methods The skeletal muscle cells were separated and extracted from adult zebrafish and then incubated with Fluo-4 and AM fluorescent probe.The fluorescence change of calcium transient state in zebrafish free skeletal muscle cells after single electrical stimulation was recorded by a high-speed fluorescence camera,and the biophysical pa-rameters related to the intracellular calcium transient state were quantitatively calculated.The experimental groups were divided into the control group,S-nitroso-n-acetyl-DL-penicillamine(SNAP)group and n-nitroso-L-arginine methyl ester(L-NAME)group.NO donor SNAP and non-specific nitric oxide synthase(NOS)in-hibitor L-NAME were used to investigate the regulatory effect of NO on calcium transient state in adult skele-tal muscle cells of zebrafish.The experimental groups were redivided into the control group,N-ethylmaleimide(NEM)group,1H-[1,2,4]dioxalin and[4,3-a]quinoxalin-1-one(ODQ)group,SNAP group and SNAP+ODQ group.The regulatory mechanism of NO on calcium transients state in adult zebrafish skeletal muscle cells was investigated by using sGC-cGMP-PKG pathway inhibitor ODQ and S-nitrosation inhibitor NEM.Re-sults The fluorescence changes of calcium transient state in adult zebrafish skeletal muscle cells could be re-corded by high speed fluorescence photography and the biophysical parameters related to intracellular calcium transients state were calculated.Compared to the control group,the calcium transient state of skeletal muscle cells in the SNAP group was significantly decreased,while the calcium transient state of skeletal muscle cells in the L-NAME group was significantly enhanced compared to the control group.The calcium transient state of skeletal muscle cells in the ODQ group was significantly stronger than that in the control group,while there was no statistical difference in the related parameters of calcium transient state between the NEM group and control group.The calcium transient state of skeletal muscle cells in the SNAP+ODQ group was also signifi-cantly stronger than that in the SNAP group.Conclusion NO could negatively regulate the process of calcium transient state in adult zebrafish skeletal myocytes by the sGC-cGMP-PKG pathway.

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