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.Acupoint thread-embedding therapy of regulating governor vessel, dispersing lung, and suppressing reflux for gastroesophageal reflux cough: a randomized controlled trial.
Mingjie TANG ; Wen LU ; Xiaoni ZHANG ; Jiawei GAO ; Xinchang WEI ; Jin LU ; Jia ZHU ; Yulu FENG ; Lejing JIAO ; Xiaofang XIA ; Zhi ZHOU ; Zhaoming CHEN
Chinese Acupuncture & Moxibustion 2025;45(8):1047-1052
OBJECTIVE:
To observe the clinical efficacy of acupoint thread-embedding therapy of regulating governor vessel, dispersing lung, and suppressing reflux for gastroesophageal reflux cough (GERC).
METHODS:
A total of 120 GERC patients were randomly assigned to an observation group (60 cases, 1 case dropped out) and a control group (60 cases, 1 case was eliminated). The observation group received acupoint thread-embedding treatment at positive response points of governor vessel. If no such points were detected, the following acupoints were used: Dazhui (GV14), Fenghu (Extra), Shendao (GV11), Lingtai (GV10), and Zhiyang (GV9). Treatment was administered once every two weeks. The control group received oral rabeprazole enteric capsules at 20 mg twice daily. All the treatment was given for 6 weeks. Clinical outcomes were assessed using cough symptom score, reflux disease questionnaire (RDQ) score, and Leicester cough questionnaire (LCQ) score before and after treatment in the two groups. Clinical efficacy was also compared between the two groups.
RESULTS:
After treatment, both groups showed decreased cough symptom scores and the each item scores and total scores of RDQ (P<0.001), and increased LCQ scores (P<0.001) compare with those before treatment. The observation group exhibited lower cough symptom score and chest pain, reflux and total score of RDQ, and higher LCQ score compared to those in the control group (P<0.05). The total effective rate in the observation group was 94.9% (56/59), which was higher than 84.7% (50/59) in the control group (P<0.05).
CONCLUSION
Acupoint thread-embedding therapy of regulating governor vessel, dispersing lung, and suppressing reflux could effectively alleviate cough and reflux symptoms in patients with GERC and improve their quality of life.
Humans
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Acupuncture Points
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Gastroesophageal Reflux/physiopathology*
;
Male
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Female
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Cough/physiopathology*
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Middle Aged
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Aged
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Acupuncture Therapy
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Adult
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Treatment Outcome
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Lung/physiopathology*
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Meridians
3.Relationship between mindful parenting,parenting stress and adolescents'aggressive behaviors:based on actor-partner interdependence model
Si CHEN ; Weiqi MU ; Mingjie ZHOU ; Xucheng GUO
Sichuan Mental Health 2024;37(3):237-242
Background Mindful parenting is related to the physical and mental health of adolescents,but only few empirical studies have been conducted on the mindful parenting and none has addressed on the impact and actor-partner effects of mindful parenting on adolescents' aggressive behaviors via parenting stress.Objective To explore the impact and actor-partner effects of mindful parenting on adolescents' aggressive behaviors via parenting stress,so as to provide references for improvements in family education and interventions on behavioral problems in adolescents.Methods A sample of 907 subjects(including family members and students)from three classes in each of five grades from grade 5 in elementary school to grade 9 in junior high school in Mianyang,Sichuan Province were selected from September 8 to 15,2023.Parents were assessed with Mindfulness In Parenting Questionnaire(MIPQ)and Parenting Stress Index-Short Form(PSI-SF),and students were required to fulfill aggressive behavior scale of Youth Self-Report(YSR).Pearson correlation analysis was utilized to examine the correlation among the above scales.The actor-partner interdependence model was used to analyze the impact of mindful parenting on their own and their spouses' parenting stress,as well as the impact on adolescents' aggressive behaviors via parenting stress.Results A total of 472 families completed the effective questionnaires.Both father and mother's mindful parenting exhibited an actor effect on adolescents' aggressive behaviors via their own parenting stress,with the effect size of-0.018(P=0.002)and-0.026(P=0.012).The partner effect sizes of father's mindful parenting and mother's mindful parenting on adolescents' aggressive behaviors via their spouse's parenting stress were-0.006(P=0.026)and-0.007(P=0.012),respectively.Conclusion Mindful parenting has been proven to have specific indirect impact on adolescents' aggressive behaviors through their own and their spouse's parenting stress,and the actor effect and partner effect are found both significant.
4.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.
5.Research on the integrity issues from clinical doctors to clinical researchers
Xuelian BAI ; Jie QIAO ; Mingjie ZI ; Zhihao ZHOU
Chinese Medical Ethics 2024;37(2):184-188
Scientific research is an important part of hospital work,the driving force of hospital construction and development,and the key to the hospital's comprehensive competitiveness and future development potential.Scientific research misconduct,which seriously deviates from the recognized norms of the scientific community,and will cause great harm to groups,society,and the public.It may also lead to the spread of false knowledge,resulting in misconceptions among peers and causing losses.By analyzing the scientific research integrity relationship between clinical doctors and clinical researchers,as well as looking at integrity standards from multiple dimensions,this paper found out the similarities and differences in the extension of integrity between them.Exploring measures to further promote the construction of scientific integrity and ethics,especially increasing the supervisory role of discipline inspection and supervision,which is conducive to the promotion of scientific research in the medical field in China.
6.AIFM1 variants associated with auditory neuropathy spectrum disorder cause apoptosis due to impaired apoptosis-inducing factor dimerization.
Yue QIU ; Hongyang WANG ; Huaye PAN ; Jing GUAN ; Lei YAN ; Mingjie FAN ; Hui ZHOU ; Xuanhao ZHOU ; Kaiwen WU ; Zexiao JIA ; Qianqian ZHUANG ; Zhaoying LEI ; Mengyao LI ; Xue DING ; Aifu LIN ; Yong FU ; Dong ZHANG ; Qiuju WANG ; Qingfeng YAN
Journal of Zhejiang University. Science. B 2023;24(2):172-184
Auditory neuropathy spectrum disorder (ANSD) represents a variety of sensorineural deafness conditions characterized by abnormal inner hair cells and/or auditory nerve function, but with the preservation of outer hair cell function. ANSD represents up to 15% of individuals with hearing impairments. Through mutation screening, bioinformatic analysis and expression studies, we have previously identified several apoptosis-inducing factor (AIF) mitochondria-associated 1 (AIFM1) variants in ANSD families and in some other sporadic cases. Here, to elucidate the pathogenic mechanisms underlying each AIFM1 variant, we generated AIF-null cells using the clustered regularly interspersed short palindromic repeats (CRISPR)/CRISPR-associated protein 9 (Cas9) system and constructed AIF-wild type (WT) and AIF-mutant (mut) (p.T260A, p.R422W, and p.R451Q) stable transfection cell lines. We then analyzed AIF structure, coenzyme-binding affinity, apoptosis, and other aspects. Results revealed that these variants resulted in impaired dimerization, compromising AIF function. The reduction reaction of AIF variants had proceeded slower than that of AIF-WT. The average levels of AIF dimerization in AIF variant cells were only 34.5%‒49.7% of that of AIF-WT cells, resulting in caspase-independent apoptosis. The average percentage of apoptotic cells in the variants was 12.3%‒17.9%, which was significantly higher than that (6.9%‒7.4%) in controls. However, nicotinamide adenine dinucleotide (NADH) treatment promoted the reduction of apoptosis by rescuing AIF dimerization in AIF variant cells. Our findings show that the impairment of AIF dimerization by AIFM1 variants causes apoptosis contributing to ANSD, and introduce NADH as a potential drug for ANSD treatment. Our results help elucidate the mechanisms of ANSD and may lead to the provision of novel therapies.
Humans
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Apoptosis Inducing Factor/metabolism*
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NAD/metabolism*
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Dimerization
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Apoptosis
7.AIFM1 variants associated with auditory neuropathy spectrum disorder cause apoptosis due to impaired apoptosis-inducing factor dimerization
QIU YUE ; WANG HONGYANG ; PAN HUAYE ; GUAN JING ; YAN LEI ; FAN MINGJIE ; ZHOU HUI ; ZHOU XUANHAO ; WU KAIWEN ; JIA ZEXIAO ; ZHUANG QIANQIAN ; LEI ZHAOYING ; LI MENGYAO ; DING XUE ; LIN AIFU ; FU YONG ; ZHANG DONG ; WANG QIUJU ; YAN QINGFENG
Journal of Zhejiang University. Science. B 2023;24(2):172-184,中插22-中插31
Auditory neuropathy spectrum disorder (ANSD) represents a variety of sensorineural deafness conditions characterized by abnormal inner hair cells and/or auditory nerve function, but with the preservation of outer hair cell function. ANSD represents up to 15% of individuals with hearing impairments. Through mutation screening, bioinformatic analysis and expression studies, we have previously identified several apoptosis-inducing factor (AIF) mitochondria-associated 1 (AIFM1) variants in ANSD families and in some other sporadic cases. Here, to elucidate the pathogenic mechanisms underlying each AIFM1 variant, we generated AIF-null cells using the clustered regularly interspersed short palindromic repeats (CRISPR)/CRISPR-associated protein 9 (Cas9) system and constructed AIF-wild type (WT) and AIF-mutant (mut) (p.T260A, p.R422W, and p.R451Q) stable transfection cell lines. We then analyzed AIF structure, coenzyme-binding affinity, apoptosis, and other aspects. Results revealed that these variants resulted in impaired dimerization, compromising AIF function. The reduction reaction of AIF variants had proceeded slower than that of AIF-WT. The average levels of AIF dimerization in AIF variant cells were only 34.5%?49.7% of that of AIF-WT cells, resulting in caspase-independent apoptosis. The average percentage of apoptotic cells in the variants was 12.3%?17.9%, which was significantly higher than that (6.9%?7.4%) in controls. However, nicotinamide adenine dinucleotide (NADH) treatment promoted the reduction of apoptosis by rescuing AIF dimerization in AIF variant cells. Our findings show that the impairment of AIF dimerization by AIFM1 variants causes apoptosis contributing to ANSD, and introduce NADH as a potential drug for ANSD treatment. Our results help elucidate the mechanisms of ANSD and may lead to the provision of novel therapies.
8.Effects of rapid drug sensitivity testing for multidrug-resistant bacteria on the prognosis of patients with severe intra-abdominal infection
Jiajie WANG ; Jiayang LI ; Wenqi WU ; Mingjie QIU ; Cunxia WU ; Zhitao ZHOU ; Meilin WU ; Sai TIAN ; Lei WU ; Jinpeng ZHANG ; Zherui ZHANG ; Ruixia TIAN ; Zhiwu HONG ; Huajian REN ; Gefei WANG ; Xiuwen WU ; Jian'an REN
Chinese Journal of Gastrointestinal Surgery 2023;26(9):847-852
Objective:To examine the clinical value of rapid detection of drug-resistant bacteria by immunochromatography and the effects of rapid detection on the prognosis of patients with severe intra-abdominal infection complicated by carbapenem-resistant Enterobacteriaceae (CRE) bloodstream infection.Methods:This was a retrospective cohort study. We analyzed clinical data of 73 patients with severe abdominal infections with sepsis or septic shock complicated by CRE bloodstream infection admitted to the general surgery department of Jinling Hospital between February 2022 and February 2023. Patients were divided into a colloidal gold immunochromatographic assay (GICA) group (17 patients) and conventional testing group (56 patients) based on whether a GICA for CRE had been performed on the patients' first blood culture sample during the diagnosis and treatment process. There were no statistically significant differences between the GICA and conventional testing groups in age ([55.9±17.3] vs. [47.6±16.4] years), sex ([16 men vs. one woman ] vs. [41 men vs. 15 women]), median Charlson comorbidity index (3.0[2.0,4.0] vs. 3.0[2.0, 4.8]), septic shock (10 vs. 39), or acute kidney injury (8 vs. 40) (all P>0.05). Both groups routinely underwent traditional bacterial identification and drug susceptibility testing. Additionally, patients in the GICA group were tested directly for positive blood cultures using a GICA carbapenemase test kit. The main outcomes were mortality rates on Days 28 and 90 after the first identification of CRE bloodstream infection in both groups. We also compared the microbial clearance rate, duration of hospitalization and intensive care unit stay, and time from onset of CRE bloodstream infection to initiation of targeted and appropriate antibiotics between the two groups. Results:The rate of microbial clearance of bloodstream infection was significantly greater in the GICA group than in the conventional testing group (15/17 vs. 34/56 [60.7%], χ 2=4.476, P=0.034), whereas the 28-day mortality tended to be lower in the GICA than conventional testing group [5/17 vs. 44.6% [25/56], χ 2=1.250, P=0.264). The 90-day mortality (8/17 vs. 53.6% [30/56], χ 2=0.222, P=0.638), median duration of hospitalization (37.0 [18.0, 46.5] days vs. 45.5 [32.2, 64.8] days, Z=-1.867, P=0.062), and median duration of intensive care unit stay (18.0 [6.5, 35.0] days vs. 32.0 [5.0, 51.8] days, Z=-1.251, P=0.209). The median time between the onset of bloodstream infection and administration of antibiotics was 49.0 (38.0, 69.0) hours in the GICA group, which is significantly shorter than the 163.0 (111.8, 190.0) hours in the conventional testing group ( Z=-5.731, P<0.001). The median time between the onset of bloodstream infection and administration of appropriate antibiotics was 40.0 (34.0, 80.0) hours in the GICA group, which is shorter than in the conventional testing group (68.0 [38.2, 118.8]) hours; however, this difference is not statistically significant ( Z=-1.686, P=0.093). Conclusions:GICA can provide information on carbapenemase- producing pathogens faster than traditional drug sensitivity testing, enabling early administration of the optimal antibiotics. The strategy of 'carbapenemase detection first' for managing bacterial infection has the potential to improve prognosis of patients and reduce mortality rate.
9.Effects of rapid drug sensitivity testing for multidrug-resistant bacteria on the prognosis of patients with severe intra-abdominal infection
Jiajie WANG ; Jiayang LI ; Wenqi WU ; Mingjie QIU ; Cunxia WU ; Zhitao ZHOU ; Meilin WU ; Sai TIAN ; Lei WU ; Jinpeng ZHANG ; Zherui ZHANG ; Ruixia TIAN ; Zhiwu HONG ; Huajian REN ; Gefei WANG ; Xiuwen WU ; Jian'an REN
Chinese Journal of Gastrointestinal Surgery 2023;26(9):847-852
Objective:To examine the clinical value of rapid detection of drug-resistant bacteria by immunochromatography and the effects of rapid detection on the prognosis of patients with severe intra-abdominal infection complicated by carbapenem-resistant Enterobacteriaceae (CRE) bloodstream infection.Methods:This was a retrospective cohort study. We analyzed clinical data of 73 patients with severe abdominal infections with sepsis or septic shock complicated by CRE bloodstream infection admitted to the general surgery department of Jinling Hospital between February 2022 and February 2023. Patients were divided into a colloidal gold immunochromatographic assay (GICA) group (17 patients) and conventional testing group (56 patients) based on whether a GICA for CRE had been performed on the patients' first blood culture sample during the diagnosis and treatment process. There were no statistically significant differences between the GICA and conventional testing groups in age ([55.9±17.3] vs. [47.6±16.4] years), sex ([16 men vs. one woman ] vs. [41 men vs. 15 women]), median Charlson comorbidity index (3.0[2.0,4.0] vs. 3.0[2.0, 4.8]), septic shock (10 vs. 39), or acute kidney injury (8 vs. 40) (all P>0.05). Both groups routinely underwent traditional bacterial identification and drug susceptibility testing. Additionally, patients in the GICA group were tested directly for positive blood cultures using a GICA carbapenemase test kit. The main outcomes were mortality rates on Days 28 and 90 after the first identification of CRE bloodstream infection in both groups. We also compared the microbial clearance rate, duration of hospitalization and intensive care unit stay, and time from onset of CRE bloodstream infection to initiation of targeted and appropriate antibiotics between the two groups. Results:The rate of microbial clearance of bloodstream infection was significantly greater in the GICA group than in the conventional testing group (15/17 vs. 34/56 [60.7%], χ 2=4.476, P=0.034), whereas the 28-day mortality tended to be lower in the GICA than conventional testing group [5/17 vs. 44.6% [25/56], χ 2=1.250, P=0.264). The 90-day mortality (8/17 vs. 53.6% [30/56], χ 2=0.222, P=0.638), median duration of hospitalization (37.0 [18.0, 46.5] days vs. 45.5 [32.2, 64.8] days, Z=-1.867, P=0.062), and median duration of intensive care unit stay (18.0 [6.5, 35.0] days vs. 32.0 [5.0, 51.8] days, Z=-1.251, P=0.209). The median time between the onset of bloodstream infection and administration of antibiotics was 49.0 (38.0, 69.0) hours in the GICA group, which is significantly shorter than the 163.0 (111.8, 190.0) hours in the conventional testing group ( Z=-5.731, P<0.001). The median time between the onset of bloodstream infection and administration of appropriate antibiotics was 40.0 (34.0, 80.0) hours in the GICA group, which is shorter than in the conventional testing group (68.0 [38.2, 118.8]) hours; however, this difference is not statistically significant ( Z=-1.686, P=0.093). Conclusions:GICA can provide information on carbapenemase- producing pathogens faster than traditional drug sensitivity testing, enabling early administration of the optimal antibiotics. The strategy of 'carbapenemase detection first' for managing bacterial infection has the potential to improve prognosis of patients and reduce mortality rate.
10. Comparison of common parameter estimation methods in NONMEM 7.5.1®: A case study of ibuprofen injection in Chinese healthy adult population
Mingjie LUO ; Jie ZHOU ; Runhan LIU ; Zhenlei WANG ; Runhan LIU ; Zhenlei WANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2023;28(3):290-298
NONMEM

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