1.Development and application of core competency evaluation index system for ethics committee members of drug clinical trial institution
Xiaohua TANG ; Qingqing JIANG ; Haiwei ZHANG ; Weiran MAO ; Yuanyuan YIN ; Jiangdong SUI ; Jun LI ; Xia CHEN
China Pharmacy 2025;36(20):2489-2494
OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution, providing a basis for optimizing the training system for committee members, improving the quality of ethical review, and fully safeguarding the safety and rights of subjects. METHODS Using methods such as literature research and expert consultation, a preliminary core competency evaluation index system was constructed. The Delphi method was employed to revise and validate it, ultimately forming an evaluation index system for the core competencies of ethics committee members. Based on this system, a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide, comparing their importance rating and self-assessment scores of the core competency indexes. RESULTS The evaluation system constructed included 4 primary indicators (ethics and professional knowledge, ethics review ability, communication and expression ability, moral integrity and work style) and 39 secondary indicators (familiarity with the content of clinical trial-related laws and regulations, ability to complete project ethics review and identify ethical defects in research protocols within a short period of time, ability to judge the scientific value of clinical research, etc.). The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge, ethical norms, review efficiency, risk judgment, and problem analysis. The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38. CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members. It can provide a scientific framework for committee member training, qualification certification, and standardized management of ethics committees.
2.Early gait analysis after total knee arthroplasty based on artificial intelligence dynamic image recognition
Ming ZHANG ; Ya-Nan SUI ; Cheng WANG ; Hao-Chong ZHANG ; Zhi-Wei CAI ; Quan-Lei ZHANG ; Yu ZHANG ; Tian-Tian XIA ; Xiao-Ran ZU ; Yi-Jian HUANG ; Cong-Shu HUANG ; Xiang LI
China Journal of Orthopaedics and Traumatology 2024;37(9):855-861
Objective To explore early postoperative gait characteristics and clinical outcomes after total knee arthroplasty(TKA).Methods From February 2023 to July 2023,26 patients with unilateral knee osteoarthritis(KOA)were treated with TKA,including 4 males and 22 females,aged from 57 to 85 years old with an average of(67.58±6.49)years old;body mass in-dex(BMI)ranged from 18.83 to 38.28 kg·m-2 with an average of(26.43±4.15)kg·m-2;14 patients on the left side,12 pa-tients on the right side;according to Kellgren-Lawrence(K-L)classification,6 patients with grade Ⅲ and 20 patients with grade Ⅳ;the courses of disease ranged from 1 to 14 years with an average of(5.54±3.29)years.Images and videos of standing up and walking,walking side shot,squatting and supine kneeling were taken with smart phones before operation and 6 weeks after operation.The human posture estimation framework OpenPose were used to analyze stride frequency,step length,step length,step speed,active knee knee bending angle,stride length,double support phase time,as well as maximum hip flexion angle and maximum knee bending angle on squatting position.Western Ontario and McMaster Universities(WOMAC)arthritis index and Knee Society Score(KSS)were used to evaluate clinical efficacy of knee joint.Results All patients were followed up for 5 to 7 weeks with an average of(6.00±0.57)weeks.The total score of WOMAC decreased from(64.85±11.54)before op-eration to(45.81±7.91)at 6 weeks after operation(P<0.001).The total KSS was increased from(101.19±9.58)before opera-tion to(125.50±10.32)at 6 weeks after operation(P<0.001).The gait speed,stride frequency and stride length of the affected side before operation were(0.32±0.10)m·s-1,(96.35±24.18)steps·min-1,(0.72±0.14)m,respectively;and increased to(0.48±0.11)m·s 1,(104.20±22.53)steps·min-1,(0.79±0.10)m at 6 weeks after operation(P<0.05).The lower limb support time and active knee bending angle decreased from(0.31±0.38)sand(125.21±11.64)° before operation to(0.11±0.04)s and(120.01±13.35)° at 6 weeks after operation(P<0.05).Eleven patients could able to complete squat before operation,13 patients could able to complete at 6 weeks after operation,and 9 patients could able to complete both before operation and 6 weeks after operation.In 9 patients,the maximum bending angle of crouching position was increased from 76.29° to 124.11° before operation to 91.35° to 134.12° at 6 weeks after operation,and the maximum bending angle of hip was increased from 103.70° to 147.25° before operation to 118.61° to 149.48° at 6 weeks after operation.Conclusion Gait analysis technology based on artificial intelligence image recognition is a safe and effective method to quantitatively identify the changes of pa-tients'gait.Knee pain of KOA was relieved and the function was improved,the supporting ability of the affected limb was im-proved after TKA,and the patient's stride frequency,stride length and stride speed were improved,and the overall movement rhythm of both lower limbs are more coordinated.
3.Correlation between apparent diffusion coefficient of sacroiliac joint and SPARCC score in ankylosing spondylitis patients with different grade sacroiliac joint inflammation
Ziwei ZHANG ; Jiawei WANG ; Qi ZENG ; He SUI ; Yu LI ; Chen LIANG ; Zhaoshu HUANG ; Xia ZHU ; Lingling SONG
Chinese Journal of Medical Imaging Technology 2024;40(9):1390-1394
Objective To observe the correlation between apparent diffusion coefficient(ADC)of sacroiliac joint and spondyloarthritis research consortium of Canada(SPARCC)score in ankylosing spondylitis(AS)patients with different grade sacroiliac joint inflammation.Methods MR examinations of sacroiliac joint were prospectively performed in 35 AS patients(AS group)and 30 healthy controls(HC group).The grade of sacroiliac joint inflammation and SPARCC score in AS group were evaluated according to MRI findings,and the patients were then further divided into bone marrow oedema(BMO)subgroup(n=19)and non-BMO subgroup(n=16)according to whether BMO presented under articular surface or not,and ADC of sacroiliac joint(ADCsacroiliac)were measured.Receiver operating characteristic curve was drawn,the area under the curve(AUC)was calculated to evaluate the efficacy of ADCsacroiliac for assessing AS sacroiliac joint inflammation grade.Pearson correlation analysis was performed to analyze the correlation between ADCsacroiliac and SPARCC score in AS patients with different grade sacroiliac joint inflammation.Results ADCsacroiliac in BMO subgroup and non-BMO subgroup was(4.85±1.44)×10-4 and(4.30±0.64)×10-4 mm2/s,respectively,being not significantly different(P>0.05)but both higher than that in HC group([3.32±1.36]×10-4 mm2/s,both P<0.05).The sensitivity of ADCsacroiliac for assessing grade of sacroiliac joint inflammation in AS patients was 49.44%,51.94%,73.06%and 60.50%,with specificity of 75.00%,78.92%,83.33%and 66.67%,respectively,and AUC of 0.613,0.712,0.837 and 0.645,respectively.ADCsacroiliac was moderately-highly positively correlated with SPARCC score of AS patients with Ⅱ and Ⅲgrade sacroiliac joint inflammation(r=0.580,0.933,both P<0.05),but no obvious correlation was detected between ADCsacroiliac and SPARCC score of AS patients with Ⅰ or Ⅳ grade sacroiliac joint inflammation(both P>0.05).Conclusion ADCsacroiliac was positively correlated with SPARCC scores of AS patients with Ⅱ and Ⅲ grade sacroiliac joint inflammation,which could be regarded as a reliable quantitative parameter for monitoring sacroiliac joint BMO.
4.Research progress of application and management of home blood pressure monitoring
Hongping SUI ; Rui WANG ; Tingting LI ; Genya SHI ; Tongtong JIANG ; Tieying SHI ; Yunlong XIA
Chinese Journal of Nursing 2023;58(22):2801-2806
Hypertension has a high global prevalence rate,which is the main preventable risk factor for cardiovascular disease.Home blood pressure monitoring plays an important role in diagnosis,adjustment of treatment strategies and long-term follow-up of hypertension.However,there are still enormous challenges for the popularization and standardized application of home blood pressure monitoring.Therefore,this review article describes indication,standardized implementation protocol,current status and influencing factors of implementation and management forms of home blood pressure monitoring.It can provide a reference for promoting the implementation of practical guidelines for home blood pressure monitoring and optimizing the application of home blood pressure monitoring.
5.The combination of ciprofloxacin and indomethacin suppresses the level of inflammatory cytokines secreted by macrophages in vitro.
Ke LIU ; Jing YU ; Yu XIA ; Lei-Ting ZHANG ; Sui-Yan LI ; Jun YAN
Chinese Journal of Traumatology 2022;25(6):379-388
PURPOSE:
The combined use of antibiotics and anti-inflammatory medicine to manage bacterial endotoxin-induced inflammation following injuries or diseases is increasing. The cytokine level produced by macrophages plays an important role in this treatment course. Ciprofloxacin and indomethacin, two typical representatives of antibiotics and anti-inflammatory medicine, are cost-effective and has been reported to show satisfactory effect. The current study aims to investigate the effect of ciprofloxacin along with indomethacin on the secretion of inflammatory cytokines by macrophages in vitro.
METHODS:
Primary murine peritoneal macrophages and RAW 264.7 cells were administrated with lipopolysaccharide (LPS) for 24 h. The related optimal dose and time point of ciprofloxacin or indomethacin in response to macrophage inflammatory response inflammation were determined via macrophage secretion induced by LPS. Then, the effects of ciprofloxacin and indomethacin on the secretory functions and viability of various macrophages were determined by enzyme-linked immunosorbent assay and flow cytometry analysis, especially for the levels of interleukin (IL)-1β, IL-6, IL-10, and tumor necrosis factor (TNF)-α. The optimal dose and time course of ciprofloxacin affecting macrophage inflammatory response were determined by testing the maximum inhibitory effect of the drugs on pro-inflammatory factors at each concentration or time point.
RESULTS:
According to the levels of cytokines secreted by various macrophages (1.2 × 106 cells/well) after administration of 1 μg/mL LPS, the optimal dose and usage timing for ciprofloxacin alone were 80 μg/mL and 24 h, respectively, and the optimal dose for indomethacin alone was 10 μg/mL. Compared with the LPS-stimulated group, the combination of ciprofloxacin and indomethacin reduced the levels of IL-1β (p < 0.05), IL-6 (p < 0.05), IL-10 (p < 0.01)), and TNF-α (p < 0.01). Furthermore, there was greater stability in the reduction of inflammatory factor levels in the combination group compared with those in which only ciprofloxacin or indomethacin was used.
CONCLUSION
The combination of ciprofloxacin and indomethacin suppressed the levels of inflammatory cytokines secreted by macrophages in vitro. This study illustrates the regulatory mechanism of drug combinations on innate immune cells that cause inflammatory reactions. In addition, it provides a new potential antibacterial and anti-inflammatory treatment pattern to prevent and cure various complications in the future.
Humans
;
Mice
;
Animals
;
Cytokines
;
Lipopolysaccharides/pharmacology*
;
Interleukin-10
;
Indomethacin/therapeutic use*
;
Interleukin-6/therapeutic use*
;
Ciprofloxacin/therapeutic use*
;
Macrophages
;
Tumor Necrosis Factor-alpha
;
Inflammation/drug therapy*
;
Anti-Inflammatory Agents/therapeutic use*
;
Anti-Bacterial Agents/therapeutic use*
6.Chinese expert consensus on diagnosis, treatment and prevention of venous thrombus embolism associated with chest trauma (2022 version)
Kaibin LIU ; Yi YANG ; Hui LI ; Yonten TSRING ; Zhiming CHEN ; Hao CHEN ; Xinglong FAN ; Congrong GAO ; Chundong GU ; Yutong GU ; Guangwei GUO ; Zhanlin GUO ; Jian HU ; Ping HU ; Hai HUANG ; Lijun HUANG ; Weiwei HE ; Longyu JIN ; Baoli JING ; Zhigang LIANG ; Feng LIN ; Wenpan LIU ; Danqing LI ; Xiaoliang LI ; Zhenyu LI ; Haitao MA ; Guibin QIAO ; Zheng RUAN ; Gang SUI ; Dongbin WANG ; Mingsong WANG ; Lei XUE ; Fei XIA ; Enwu XU ; Quan XU ; Jun YI ; Yunfeng YI ; Jianguo ZHANG ; Dongsheng ZHANG ; Qiang ZHANG ; Zhiming ZHOU ; Zhiqiang ZOU
Chinese Journal of Trauma 2022;38(7):581-591
Chest trauma is one of the most common injuries. Venous thromboembolism (VTE) as a common complication of chest trauma seriously affects the quality of patients′ life and even leads to death. Although there are some consensus and guidelines on the prevention and treatment of VTE at home and abroad, the current literatures lack specificity considering the diagnosis, treatment and prevention of VTE in patients with chest trauma have their own characteristics, especially for those with blunt trauma. Accordingly, China Chest Injury Research Society and editorial board of Chinese Journal of Traumatology organized relevant domestic experts to jointly formulate the Chinese expert consensus on the diagnosis, treatment and prevention of chest trauma venous thromboembolism associated with chest trauma (2022 version). This consensus provides expert recommendations of different levels as academic guidance in terms of the characteristics, clinical manifestations, risk assessment, diagnosis, treatment, and prevention of chest trauma-related VTE, so as to offer a reference for clinical application.
7.Safety and the short-term efficacy of bendamustine in the conditioning regimen for autologous stem cell transplantation in patients with lymphoma.
Li Cai AN ; Ying Hui LIU ; Jing Yao WANG ; Jun Jie MA ; Jun Qing XU ; Kai Min LI ; Rong Xia WEI ; Jing Rui SUI ; Xiang Yan FENG ; Xiao Qian LIU ; Li Ming CHEN ; Xiao Xia CHU
Chinese Journal of Hematology 2022;43(1):63-65
8.Iridoids of wine-processed Corni Fructus.
Hong-Bin LI ; Qing-Mei FENG ; Ling-Xia ZHANG ; Jing WANG ; Jun CHI ; Zhi-Min WANG ; Li-Ping DAI ; Sui-Qing CHEN
China Journal of Chinese Materia Medica 2022;47(5):1273-1278
A new iridoid glycoside, cornushmf A(1) and nine known iridoids(2-10) were isolated from the water extract of the wine-processed Corni Fructus by various column chromatographies. Their chemical structures were identified by comprehensive spectroscopic methods as 7β-O-(2″-formylfuran-5″-methylene)-morroniside(1), 7-dehydrologanin(2), sweroside(3), 7β-O-methylmorroniside(4), 7α-O-methylmorroniside(5), 7β-O-ethylmorroniside(6), 7α-O-ethylmorroniside(7), cornuside(8), sarracenin(9), and loganin(10).
Cornus/chemistry*
;
Drugs, Chinese Herbal/chemistry*
;
Iridoids
;
Wine
9.Multidisciplinary Treatment on a Case of ROSAH Syndrome
Linqing ZHONG ; Mingsheng MA ; Ruifang SUI ; Xia HONG ; Feng FENG ; Li HUO ; Menghua DAI ; Qiang XU ; Hongmei SONG
JOURNAL OF RARE DISEASES 2022;1(3):289-295
A 15-year-old female was referred to the hospital with intermittent fever, where multiple systemic abnormalities were found, such as splenomegaly, secondary hypersplenism, retinitis pigmentosa, and ectodermal dysplasia. Medical history revealed that she had suffered recurrent respiratory infections, blurred vision at night, and dysplasia of teeth and nail beds since childhood. Then she was suspected to be experiencing ROSAH syndrome, a rare disease newly recognized in recent years, which was finally confirmed by gene sequencing results. During a course of treatment with tumor necrosis factor inhibitors, recurrent fever with elevated inflammatory markers reappeared, and the child developed headaches. To guide the comprehensive treatment and improve the patient's quality of life, the multidisciplinary team in Peking Union Medical College Hospital discussed together and directed the following treatment.
10.Clinical study on individual protection after 125I seed implantation for abdominal and pelvic tumors
Jianmin LI ; Linbin PANG ; Chengdi YING ; Guohua CHEN ; Haishui XIA ; Xin YANG ; Qi MENG ; Aixia SUI ; Juan WANG ; Hongtao ZHANG
Chinese Journal of Radiological Medicine and Protection 2021;41(12):946-950
Objective:To study the radiation dose rate and effective dose in ambient environment due to 125I seed implantation in the treatment of the patients suffering abdominal and pelvic tumors, so as to provide reference for occupational protection of different groups. Methods:Within 24 hours after operation, the radiation dose rate to 42 patients with abdominal and pelvic tumor with 125I seed implantation was monitored by using pocket dosimeter. The relationships between the total activity in the implanted particles and the measured dose rate, as well as between the implanted depth and the dose rate under the standard activity, were obtained by curve fitting. According to the formula, the relationship between the dose rate and the warning time was calculated. Results:The dose rates at 30 cm, 50 cm and 100 cm of vertical particle implantation site were (6.92±2.87), (4.10±1.62) and (1.30±0.48) μSv/h, respectively ( χ2=73.71, P<0.05). The dose rates on the left and right sides were (0.378±0.156) and (0.384±0.153) μSv/h at 30 cm, (0.170±0.089) and (0.17±0.086) μSv/h at 50 cm, (0.039 ±0.014) and (0.043±0.017) μSv/h at 100 cm, respectively ( χ2=76.19, 76.33, P<0.05). There was a linear relationship between the dose rate at the vertical particle implantation site and the total activity in the implanted particles, and between the dose rate and the implantation depth under the standard activity. The relationship between the warning time and the dose rate to adults in the same bed, co-workers, minors in the same bed and pregnant women were as follows: t ( d)=-106.616+ 83.779ln D( t), t ( d)=26.556+ 85.933ln D ( t), t( d)=3.088+ 85.017ln D( t). Conclusions:After 125I seed implantation, the radiation dose in the ambient environment is low, ensuring the radiation safety; and the measured dose rate decreases with the decrease in the total activity in the implanted particle and the increase in the implantation depth; at the same time, the warning time for different groups is calculated according to the measured dose rate or the total activity in the implanted particle and the depth of the implanted particle, so as to carry out individualized protection.

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