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.Direct stimulation of acupuncture at extraocular muscle attachment point for 13 cases of acquired extraocular muscle palsy.
Shuiling CHEN ; Zhuting RU ; Wanyu ZHOU ; Wu SUN ; Fangfang TAO ; Hang SHI ; Yuehong LI ; Liqun CHU
Chinese Acupuncture & Moxibustion 2025;45(12):1735-1738
OBJECTIVE:
To observe the effect of the direct stimulation of acupuncture at extraocular muscle attachment point on acquired extraocular muscle palsy.
METHODS:
Thirteen patients with acquired extraocular muscle palsy were treated with acupuncture directly at extraocular muscle (paralytic muscle) attachment point. Firstly, the intraocular conjunctival sac drops of topical anesthetic (procaine hydrochloride eye drops) were administered, 0.2 mL each time, once every 10 minutes, for a total of 3 times. Acupuncture was delivered immediately after the third drop. The sterile acupuncture needle for single use, 0.25 mm×25 mm, was inserted at the anatomical location of the corneal limbal attachment of paralytic extraocular muscle, with an angle of 10° to 15° formed between the needle tip and extraocular muscle, and a depth of 0.3 mm to 0.5 mm. Pivoted by the needle tip, the eyeball was moved passively towards the direction of normal action of orbital muscle, 30 to 50 times until the patient felt soreness of the eyeball; afterwards, the needle was removed. After acupuncture, levofloxacin eye drops were administered once (0.2 mL) at the affected eye. The treatment was given twice a week, and completed when diplopia disappeared. Before and after treatment, the diplopia and the synoptophore circumference were observed respectively.
RESULTS:
After 7 to 24 (15.46±5.56) times of direct stimulation with acupuncture at extraocular muscle attachment point, the symptoms of diplopia disappeared in 13 patients, the eye position restored to orthophoria, and the circumference of synoptophore was reduced to be (4.04±0.82)° from (19.38±3.98)° detected before treatment (P<0.05).
CONCLUSION
Acupuncture directly at extraocular muscle attachment can attenuate diplopia and improve ocular muscle function in patients with acquired extraocular muscle palsy.
Humans
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Acupuncture Therapy
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Male
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Female
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Middle Aged
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Adult
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Oculomotor Muscles/physiopathology*
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Aged
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Acupuncture Points
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Ophthalmoplegia/physiopathology*
3.Novel paradigms in KRAS targeting: Unveiling strategies to combat drug resistance.
Xiyuan LUO ; Feihan ZHOU ; Yuemeng TANG ; Xiaohong LIU ; Ruilin XIAO ; Minzhi GU ; Jialu BAI ; Decheng JIANG ; Gang YANG ; Lei YOU ; Yupei ZHAO
Chinese Medical Journal 2025;138(18):2243-2267
The Kirsten rat sarcoma viral oncogene homolog ( KRAS ) mutation is one of the most prevalent activating alterations in cancer. It indicates a poor overall prognosis due to its highly invasive nature. Although several KRAS inhibitors have been developed in recent years, a significant clinical challenge has emerged as a substantial proportion of patients eventually develop resistance to these therapies. Therefore, identifying determinants of drug resistance is critical for guiding treatment strategies. This review provides a comprehensive overview of the mutation landscape and molecular mechanisms of KRAS activity in various cancers. Meanwhile, it summaries the progress and prospects of small molecule KRAS inhibitors undergoing clinical trials. Furthemore, this review explores potential strategies to overcome drug resistance, with the ultimate goal of steering toward patient-centric precision oncology in the foreseeable future.
Humans
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Drug Resistance, Neoplasm/drug effects*
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Proto-Oncogene Proteins p21(ras)/metabolism*
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Mutation/genetics*
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Neoplasms/genetics*
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Antineoplastic Agents/therapeutic use*
4.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
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Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires
5.Effect of Kuanxiong Aerosol on Perioperative Coronary Microcirculation in Patients with Unstable Angina Undergoing Elective PCI: A Pilot Randomized Controlled Trial.
Zi-Hao LIU ; Wen-Long XING ; Hong-Xu LIU ; Ju-Ju SHANG ; Ai-Yong LI ; Qi ZHOU ; Zhen-Min ZHANG ; Zhi-Bao LI ; Ke-Ji CHEN
Chinese journal of integrative medicine 2025;31(3):206-214
OBJECTIVE:
To evaluate the immediate effect of Kuanxiong Aerosol (KXA) on perioperative coronary microcirculation in patients with unstable angina (UA) suffering from elective percutaneous coronary intervention (PCI).
METHODS:
From February 2021 to July 2023, UA inpatients who underwent PCI alone in the left anterior descending (LAD) branch were included. Random numbers were generated to divide patients into the trial group and the control group at a ratio of 1:1. The index of coronary microcirculation resistance (IMR) was measured before PCI, and the trial group was given two sprays of KXA, while the control group was not given. IMR was measured again after PCI, cardiac troponin I (cTnI) and creatine kinase isoenzyme-MB (CK-MB) were detected before and 24 h after surgery, and major cardiovascular adverse events (MACEs) were recorded for 30 days. The data statistics and analysis personnel were blinded.
RESULTS:
Totally 859 patients were screened, and 62 of them were involved into this study. Finally, 1 patient in the trial group failed to complete the post-PCI IMR and was excluded, 30 patients were included for data analysis, while 31 patients in the control group were enrolled in data analysis. There was no significant difference in baseline data (age, gender, risk factors, previous history, biochemical index, and drug therapy, etc.) between the two groups. In addition, differences in IMR, cTnI and CK-MB were not statistically significant between the two groups before surgery. After PCI, the IMR level of the trial group was significantly lower than that of the control group (19.56 ± 14.37 vs. 27.15 ± 15.03, P=0.048). Besides, the incidence of perioperative myocardial injury (PMI) was lower in the trial group, but the difference was not statistically significant (6.67% vs. 16.13%, P=0.425). No MACEs were reported in either group.
CONCLUSIONS
KXA has the potential of improving coronary microvascular dysfunction. This study provides reference for the application of KXA in UA patients undergoing elective PCI. (Registration No. ChiCTR2300069831).
Humans
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Percutaneous Coronary Intervention
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Male
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Microcirculation/drug effects*
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Female
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Angina, Unstable/physiopathology*
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Pilot Projects
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Middle Aged
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Aged
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Drugs, Chinese Herbal/pharmacology*
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Aerosols
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Troponin I/blood*
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Coronary Circulation/drug effects*
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Elective Surgical Procedures
6.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.
7.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.
8.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.
9.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.
10.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.

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