1.Analysis on the Current Situation and Influencing Factors of Ethical KAP among Clinical Researchers
Lei ZHENG ; Yuxin CHEN ; Jiawei KANG ; Mengwei HU ; Jianyuan WU ; Chunhong WANG ; Jianying HUANG ; Boran LI ; Yuanzhen ZHANG
Chinese Medical Ethics 2023;36(12):1408-1416
【Objective:】 To understand the current situation and influencing factors of ethical knowledge, attitude, and practice (KAP) among clinical researchers, enhance their ethical awareness, and improve the quality of clinical researches. 【Methods:】 A self-designed questionnaire was used to conduct a convenient sampling survey of medical staff who have participated in clinical study. 【Results:】 A total of 6,021 subjects were investigated, with males accounting for 28.46% and females accounting for 71.53%. The average age of them was (37.47±11.46) years old. The total score of ethics and the mean scores of the three dimensions of knowledge, attitude and practice were (70.62±12.99), (59.63±12.50), (79.55±19.62) and (74.92±18.29), respectively. Multiple linear regression analysis showed that researchers with male, tertiary hospitals, doctors, ethics-related part-time jobs, postgraduate education, associate senior title or above, and training experience scored higher (P<0.05). 【Conclusion:】 Ethical attitudes have a significant mediating effect between knowledge and practice, accounting for 62.72% of the total effect. Researchers recognize the importance of ethics, but it is urgent to strengthen their knowledge learning and practical application.
2.Clinical characteristics of orobuccal involuntary movements induced by anticholinergic agents in patients with Parkinson′s disease and literature review
Bin ZHANG ; Jianyuan ZHANG ; Jinglin HU ; Yiming LIU ; Cuiping ZHAO ; Chuanzhu YAN
Chinese Journal of Neurology 2022;55(11):1245-1251
Objective:To study the clinical characteristics of orobuccal involuntary movements (OB) induced by anticholinergic agents.Methods:The clinical characteristics of patients with OB induced by anticholinergic agents in Qilu Hospital (Qingdao) from April 2018 to October 2021 and cases reported in the literature were analyzed in combination with literature review.Results:Seven patients in Qilu Hospital (Qingdao) and 10 cases in the literature were analyzed. Of these 7 patients, 6 were elderly female, with involuntary, repetitive, stereotypical movements of the lips, tongue, and sometimes of the jaw after intake of anticholinergic medication with the latency 21-60 days and the involuntary movements improved 7-30 days after discontinuation of anticholinergic medication. Of 10 cases reported in the literature, 7 were elderly female and 8 only with OB and 2 patients had extremities dyskinesia plus OB. Involuntary movements appeared after latency of 3-93 days following the introduction of anticholinergic drugs and resolved after latency of 2-60 days following their withdrawal.Conclusions:OB induced by anticholinergic agents mostly occur sub-acutely during the treatment of Parkinson′s disease, and can resolve in a short time after withdrawal, which is independent of the dose of levodopa and anticholinergic agents. The aging, female, and anxiety and depression may be the risk factors.
3.Diagnostic value of CT myocardial perfusion combined with serum cystatin C and galectin-3 for coronary heart disease and its correlation with coronary artery disease
Aitong TAN ; Jianyuan QUAN ; Feng WANG ; Shuangjun LI ; Guoxun HU
Chinese Journal of Postgraduates of Medicine 2021;44(5):385-390
Objective:To investigate the diagnostic value of CT myocardial perfusion combined with serum cystatin C (CysC) and galectin-3 (Gal-3) for coronary heart disease (CHD) and its correlation with coronary artery disease.Methods:The clinical data of 126 patients with CHD (CHD group) and 126 patients with suspected CHD but excluded CHD by coronary angiography (control group) in Shanxi Provincial General Hospital of Armed Police Force from May 2018 to May 2020 were retrospectively analyzed. CT myocardial perfusion myocardial imaging was performed in both groups, and blood perfusion (BF) and mean transit time (MTT) were calculated. The serum Gal-3 was detected by enzyme-linked immunosorbent method, and the serum CysC was detected by immunoturbidimetric method. The changes of indexes in 2 groups and in CHD patients with different degrees of coronary artery stenosis and number of diseased branches were compared. Logistic regression was used to analyze the influencing factors of CHD; Pearson correlation was used to analyze the relationship between BF, MTT, CysC, Gal-3 and the degree of coronary artery stenosis and the number of diseased branches in patients with CHD; the receiver operating characteristic (ROC) curve was drawn, and the effectiveness of each index in diagnosing CHD was analyzed. The area under curve (AUC) was compared by DeLong test, and the combined diagnosis was performed by Logistic binary regression fitting.Results:The BF in CHD group was significantly lower than that in control group: (102.30 ± 9.25) ml/(100 g·min) vs. (119.97 ± 12.08) ml/(100 g·min), the MTT, CysC and Gal-3 were significantly higher than those in control group: (17.23 ± 3.04) s vs. (5.38 ± 1.29) s, (0.98 ± 0.24) mg/L vs. (0.73 ± 0.18) mg/L and (55.27 ± 16.42) ng/L vs. (16.93 ± 5.75) ng/L, and there were statistical differences ( P<0.01). Logistic regression analysis result showed that BF, MTT, CysC and Gal-3 were the influencing factors of CHD ( P<0.01). ROC curve analysis result showed that the AUC of BF, MTT, CysC combined with Gal-3 in the diagnosis of CHD was the largest (0.879), with a specificity of 84.92% and a sensitivity of 80.95%. In patients with CHD, with the aggravation of coronary artery stenosis and the increase of the number of diseased branches, the BF decreased gradually, the MTT, CysC and Gal-3 increased gradually, and there were statistical differences ( P<0.05). Pearson correlation analysis result showed that the BF had negative correlation with the degree of coronary artery stenosis and the number of diseased branches in patients with CHD ( r=-0.592 and -0.573, P<0.01), and the MTT, CysC and Gal-3 had positive correlation with the degree of coronary artery stenosis and the number of diseased branches (MTT: r = 0.695 and 0.674, P<0.01; CysC: r = 0.546 and 0.519, P<0.01; Gal-3: r = 0.628 and 0.609, P<0.01). Conclusions:CT myocardial perfusion imaging indexes (BF and MTT), serum CysC and Gal-3 levels are related to the degree of coronary artery stenosis and the number of diseased branches in patients with CHD. The combined detection of various indicators can improve the diagnostic value and provide a certain basis for clinical diagnosis and treatment and disease monitoring.
4.Discussion on Management Model of Medical Devices for Clinical Trials.
Bo CHEN ; Jianyuan WU ; Hanning HU ; Xiaoqiu YANG ; Jianying HUANG
Chinese Journal of Medical Instrumentation 2020;44(1):88-91
By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.
Clinical Trials as Topic
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Equipment and Supplies/standards*
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Indicators and Reagents/standards*
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Reproducibility of Results
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Research Design/standards*
5. Laparoscopic right posterior liver resection for hepatocellular carcinoma with right hepatic Glisson pedicle transection, a report of 16 cases
Feiwen DENG ; Fengjie WANG ; Jianyuan HU ; Jieyuan LI ; Huanwei CHEN
Chinese Journal of General Surgery 2019;34(9):783-786
Objective:
To explore the safety and efficacy of totally laparoscopic right posterior liver resection for hepatocellular carcinoma (HCC).
Methods:
The clinical data of 16 HCC patients undergoing laparoscopic right posterior liver resection at the First People′s Hospital of Foshan between Apr 2014 and Sep 2018 was retrospectively analyzed.
Results:
14 out of the 16 cases, underwent totally laparoscopic right posterior liver resection by right hepatic Glisson pedicle transection, 2 were converted to open surgery.The operation time was (378±65) min, blood loss was (500±287) ml. There was no transfusion except for 2 cases. The median hospital stay after operation was 8 days . There was no mortality . With the median follow up period of 22 months (range 1 to 54 months). Tumor recurrence was found in one case.
Conclusion
Laparoscopic Glisson′s pedicle transection for right posterior liver resection for hepatocellular carcinoma was safe and effective.
6.Application of hemihepatic vascular occlusion through hilar plate in laparoscopic hemihepatectomy
Meisheng LI ; Jianyuan HU ; Yingjun CHEN ; Zuojun ZHEN
Chinese Journal of Hepatic Surgery(Electronic Edition) 2018;7(6):473-476
Objective To evaluate the clinical application value of hemihepatic vascular occlusion through hilar plate in laparoscopic hemihepatectomy.Methods Clinical data of 32 patients undergoing laparoscopic hemihepatectomy in the First People's Hospital of Foshan from September 2010 to December 2017 were retrospectively analyzed.The informed consents of all patients were obtained and the local ethical committee approval was received.Among 32 patients,20 cases were male and 12 were female,aged 28-71 years with a median age of 46 years.Laparoscopic left hemihepatectomy was performed in 18 cases and laparoscopic right hemihepatectomy in 14 cases.Intraoperative and postoperative physical conditions were observed.Results 30 cases successfully underwent hemihepatic vascular occlusion through hilar plate,1 case was converted to intrathecal dissection of hepatic artery and portal vein due to local hepatic portal adhesion and 1 case was converted to open surgery due to hepatic portal hemorrhage induced by severe liver cirrhosis.During the process of liver resection,4 cases were converted to open surgery due to massive hemorrhage.The average length of hemihepatic vascular occlusion through hilar plate was (12±5) min,the operation time was (176±52) min and the median intraoperative blood loss was 360 (50-1 400) ml.Postoperative bile leakage occurred in 9 cases,who were cured after adequate drainage.Liver trauma bleeding was observed in 1 case,who was cured after blood transfusion.Postoperative length of hospital stay was (7.1 ±2.6) d.No postoperative liver failure or perioperative death occurred.Conclusions Hemihepatic vascular occlusion through hilar plate is a feasible,efficacious,safe and reliable approach for hepatic blood flow occlusion,which can be applied in laparoscopic hemihepatectomy.
7.Comparative study of laparoscopic and open left hepatectomy for hepatocellular carcinoma
Rongdang FU ; Jieyuan LI ; Fengjie WANG ; Feiwen DENG ; Qiucheng LEI ; Jianyuan HU ; Huanwei CHEN
Chinese Journal of Hepatic Surgery(Electronic Edition) 2018;7(6):477-481
Objective To compare the safety and efficacy of laparoscopic and open left hepatectomy for hepatocellular carcinoma (HCC).Methods Clinical data of 31 patients with HCC who underwent left hepatectomy in the First People's Hospital of Foshan from June 2011 to December 2017 were retrospectively analyzed.Among 31 patients,24 cases were male and 7 female,aged from 11 to 78 years with a median age of 58 years.Patients were divided into laparoscopic left hepatectomy group (laparoscopic group,n=17) and open left hepatectomy group (open group,n=14).The informed consents of all patients were obtained and the local ethical committee approval was received.In laparoscopic group,two-step Endo-GIA laparoscopic left hepatectomy was performed,and conventional hepatectomy was performed in open group.The postoperative length of hospital stay was compared by t test.The intraoperative blood loss was compared by rank-sum test.The incidence of postoperative complications was compared by Chisquare test.Results All patients underwent operation successfully without perioperative death.The median intraoperative blood loss in laparoscopic group was 100(50-500) ml,significantly less than 325(50-900) ml in open group (Z=-2.180,P<0.05).The postoperative length of hospital stay in laparoscopic group was (8.4±2.3) d,significantly shorter than (10.9±2.5) d in the open group (t=-2.869,P<0.05).5 cases developed postoperative pleural effusion in laparoscopic group,and 5 in open group,where no significant difference was observed (x2=0.140,P>0.05).Conclusions Laparoscopic left hepatectomy is safe for HCC and has similar efficacy as open surgery,the intraoperative blood loss is less comparatively and postoperative recovery time is shorter,which can serve as a standard surgical approach in clinical practice.
8.Pure laparoscopic right hemihepatectomy for hepatocellular carcinoma via the anterior approach
Huanwei CHEN ; Feiwen DENG ; Fengjie WANG ; Jieyuan LI ; Jianyuan HU
Chinese Journal of Hepatobiliary Surgery 2017;23(8):509-512
Objective To study the feasibility and safety of pure laparoscopic right hemihepatectomy for hepatocellular carcinoma via the anterior approach.Methods The data of five patients with hepatocellular carcinoma who underwent pure laparoscopic right hemihepatectomy at the First People's Hospital of Foshan between December 2013 and December 2016 were retrospectively analyzed.Patients'operation time,blood loss,blood transfusion rate,surgical margins,hospital stay,complication and short term outcomes were reviewed.Results All the five patients completed pure laparoscopic right hemihepatectomy without conversion to open surgery.The average (range) operation time was 6.0 (5 ~ 8) h.The average blood loss was 340 (110 ~ 600) ml.No patient received blood transfusion.The average surgical margin was 2.4 (1 ~4.5) cm.The average postoperative hospital stay was 7 (4 ~ 15) d.The average follow-up was 22 (2 ~38) months.Three patients experienced postoperative complications,which included ascites,pleural effusion,and ascites accompanied by biliary leakage,respectively.The last patient recovered well from drainage.No liver failure,cancer recurrence or death was noted.Conclusions This study demonstrated that pure laparoscopic right hemihepatotectomy via the anterior approach is a minimally invasive procedure which has the advantage of fast postoperative recovery.It was feasible and safe to treat hepatocellular carcinoma with favorable short-term outcomes.
9.Laparoscopic hepatic caudate lobe resection: a report of 7 patients
Huanwei CHEN ; Feiwen DENG ; Fengjie WANG ; Jianyuan HU ; Jieyuan LI
Chinese Journal of Hepatobiliary Surgery 2017;23(5):304-306
Objective To study the feasibility and safety of laparoscopic hepatic caudate lobe resec tion.Methods The clinical data of seven patients who underwent laparoscopic hepatic caudate lobe resection in our hospital were retrospective analyzed.There were 3 male and 4 female patients.The mean age was 45.3 years.The primary diseases included hepatic haemangioma (n =2),metastatic liver cancer (n =2),hepatocellular carcinoma (n =1),recurrent hepatocellular carcinoma (n =1) and hepatic adenoma (n =1).The total blood loss,operation time,hospital stay after surgery and complication were analyzed.Results The surgery was successful in all these 7 patients and no patients required any conversion to open surgery.Five patients underwent partial caudate lobe resection,and the remaining 2 underwent combined left hemi hepatectomy with partial caudate lobe resection.The operation time ranged from 200 to 250 minutes with a mean of 235 minutes.The intraoperative blood loss ranged from 40 to 600 ml with a mean of 188 ml.There was no postoperative bleeding and bile leakage.The resections were all R0 resections.Conclusions Laparoscopic hepatic caudate lobe resection was safe and feasible in appropriate patients.Familiarity with anatomy of the liver caudate lobe and skilled laparoscopic techniques are important to carry out this surgery.
10.Experience summary of combined liver and kidney procurement from pediatric organ donation
Feiwen DENG ; Huanwei CHEN ; Zuojun ZHEN ; Jieyuan LI ; Fengjie WANG ; Jianyuan HU
Organ Transplantation 2017;8(5):392-395,405
Objective To summarize the clinical experience of combined liver and kidney procurement from pediatric organ donation. Methods Clinical data of 6 pediatric donors undergoing combined liver and kidney procurement in the First People's Hospital of Foshan from October 2011 to December 2016 were collected and relevant clinical experience was summarized. Results According to the diagnostic criteria for brain death (for children) established by Brain Injury Evaluation Quality Control Center of National Health and Family Planning Commission, 6 pediatric donors received combined liver and kidney procurement for organ donation under the status of brain death. Modified liver-kidney perfusion was performed by external iliac arterial intubation using No.7 suction catheter, or arteria iliaca communis intubation using 24 F catheter for the perfusion of portal vein and abdominal aorta, thoracic aorta occlusion. The operation time was 55-60 min. A total of 6 liver grafts and 12 renal grafts were harvested, which were successfully applied in clinical liver and renal transplantation. No primary nonfunction was observed in the liver or renal grafts. Conclusions Timely assessment of brain death, rigorous and cautious measures for organ maintenance and modified techniques for combined liver and kidney procurement play a key role in the success of combined liver and kidney procurement from pediatric organ donation.

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