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ObjectiveTo investigate the feasibility of multiparametric MRI （mpMRI） combined with histogram analysis of apparent diffusion coefficient （ADC） in the assessment of patients with variant histology （VH） of urothelial carcinoma （UC）. MethodWe retrospectively analyzed the data of patients pathologically diagnosed with UC who underwent mpMRI in the First Affiliated Hospital of Sun Yat-sen University between March 2015 and March 2023. The patients were divided into VH group （urothelial carcinoma mixed with other histologies） and non-VH group （pure urothelial carcinoma） according to pathological results. We performed propensity score 1：1 nearest-neighbor matching on the two groups based on age and gender and 49 patients were included in each group. The regions of interest （ROIs） of the whole tumor were delineated manually by using ITK-SNAP software and Pyradiomics was applied to extract ADC histogram parameters. We compared the clinicopathological data， MRI morphological features and ADC histogram parameters between the groups. Multivariate logistic regression was used to identify independent risk factors and construct the prediction model. Receiver operating characteristic （ROC） curve analyses were performed to evaluate the diagnostic performance of these parameters for determining VH of UC. ResultsMRI morphological features including the lesion shape， vesical imaging-reporting and data system （Ⅵ-RADS）score， enhancement pattern and suspicious lymph node metastasis were markedly different between the two groups （all P < 0.05）. ADC mean， ADC median， ADC25th， ADC75th， ADC10th and ADC90th were significantly lower in patients with VH than those in non-VH group （all P<0.05）. Multivariate logistic regression analysis showed enhancement pattern， ADC25th， ADC75th and ADC mean were independent predictors （P < 0.05）. The combined model yielded the best predictive performance， with an area under the ROC curve （AUC） of 0.91 （95% CI： 0.83-0.96）. ConclusionsMpMRI combined with whole-tumor histogram analysis of ADC can serve as a reliable method for evaluating the presence of VH in UC， further to assist the clinical decision making.
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Objective:To construct the quality evaluation system for tracheal extubation in the patients undergoing general anesthesia based on zero-defect management theory.Methods:Based on the model of zero-defect theory, literature review, semi-structured interviews, expert consultation and analytic hierarchy process were used to determine the content and weight of each index of the quality evaluation system for tracheal extubation in the patients undergoing general anesthesia.Results:The effective recovery rates of the two rounds of expert consultation questionnaires were 93% and 96% respectively; the expert authority coefficients were 0.946 and 0.947 respectively; the Kendall harmony coefficients were 0.247 and 0.250 respectively ( P<0.001). The final evaluation index system included 3 first-level indicators, 11 second-level indicators and 48 third-level indicators.The consistency coefficients of indicators at all levels were <0.1. Conclusions:The quality evaluation system for endotracheal extubation constructed for patients undergoing general anesthesia is highly scientific and reliable and can provide a basis for the quality evaluation of and continuous improvement in endotracheal extubation in the patients undergoing general anesthesia.
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Objective:To strengthen the quality management of drug clinical trials to ensure that the clinical trial data obtained is true, accurate, complete and standardized.Methods:By review literatures and the data published in NMPA and survey the problems in the drug clinical trials in some hospitals, etc, we summarized the common problems of drug clinical trials in China.At the same time, using PDCA cycle theory, we sorted out the problems in the drug clinical trials in Taizhou People's Hospital, conducted root-cause analysis of the problems, put forward suggestions and measures on how to strengthen the quality management of drug clinical trials.Results:The incidence of quality problems in clinical trials was significantly reduced from 105.6% to 37.4% by formulating relevant incentive policies, strengthening training, strengthening the supervision function of institutions to researchers, and improving the awareness of GCP of researchers.Conclusions:The implementation of PDCA cycle quality management model can effectively improve the quality of drug clinical trials.
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BACKGROUND@#According to the amyloid, tau, neurodegeneration research framework classification, amyloid and tau positive (A+T+) mild cognitive impairment (MCI) individuals are defined as prodromal Alzheimer disease. This study was designed to compare the clinical and biomarker features between A+T+MCI individuals who progressed to progressive MCI (pMCI) and those who remained stable MCI (sMCI), and to identify relevant baseline clinical biomarker and features that could be used to predict progression to dementia within 2 years.@*METHODS@#We stratified 197 A+T+MCI individuals into pMCI (n = 64) and sMCI (n = 133) over 2 years. Demographics and cognitive assessment scores, cerebrospinal fluid (CSF), and neuroimaging biomarkers (18F-florbetapir positron emission tomography mean standardized uptake value ratios [SUVR] and structural magnetic resonance imaging [MRI]) were compared between pMCI and sMCI at baseline, 12- and 24-month follow-up. Logistic regression models then were used to evaluate clinical baseline and biomarker features that predicted dementia progression in A+T+MCI.@*RESULTS@#pMCI individuals had higher mean 18F-florbetapir SUVR, CSF total-tau (t-tau), and p-tau181P than those in sMCI individuals. pMCI individuals performed poorer in cognitive assessments, both global and domain specific (memory, executive, language, attention, and visuospatial skills) than sMCI. At baseline, there were significant differences in regions of interest of structural MRI between the two groups, including bilateral amygdala, hippocampus and entorhinal, bilateral inferior lateral ventricle, left superior and middle temporal, left posterior and caudal anterior cingulate (P < 0.05). Baseline CSF t-tau levels and cognitive scores of Montreal cognitive assessment, functional assessment questionnaire, and everyday cognition by the patient's study partner language domain could predict progression to dementia in A+T+MCI within 2 years.@*CONCLUSIONS@#In future clinical trials, specific CSF and cognitive measures that predict dementia progression in A+T+MCI might be useful risk factors for assessing the risk of dementia progression.
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Humans , Alzheimer Disease , Amyloid beta-Peptides , Biomarkers , Cognitive Dysfunction , Disease Progression , Peptide Fragments , Positron-Emission TomographyABSTRACT
Background/Aims@#The treatment goal of ulcerative colitis (UC) has been changed to achieve endoscopic remission (ER). However, there is insufficient clinical evidence to determine whether a step-up treatment should be performed to achieve ER in clinical remission (CR) without ER, and there are inadequate data on the need to consider the distribution and severity of residual inflammation. This retrospective study aimed to evaluate the prognostic significance of the distribution and severity of residual inflammation in UC patients in CR. @*Methods@#A total of 131 UC patients in CR who underwent endoscopic evaluation for more than three times between January 2000 and December 2018 were reviewed. The patients were allocated by the endoscopic healing state and the distribution of inflammation to ER (n=31, 23.7%), residual nonrectal inflammation with patchy distribution (NRI) (n=17, 13.0%) or residual rectal involvement with continuous or patchy distribution (RI) (n=83, 63.3%) groups. We reviewed clinical characteristics, endoscopic findings, and factors associated with poor outcome-free survival (PFS). @*Results@#In UC patients in CR, PFS was significantly higher in the ER and NRI groups than in the RI group (p=0.003). Patients in the ER and NRI groups had similar PFS (p=0.647). Cox proportional hazard model showed only RI (hazard ratio, 5.76; p=0.027) was associated with a higher risk of poor outcome. @*Conclusions@#We suggest that escalation of treatment modalities may be selectively performed in consideration of the residual mucosal inflammation pattern, even if ER has not been achieved, in UC patients with CR.
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Background/Aims@#The treatment goal of ulcerative colitis (UC) has been changed to achieve endoscopic remission (ER). However, there is insufficient clinical evidence to determine whether a step-up treatment should be performed to achieve ER in clinical remission (CR) without ER, and there are inadequate data on the need to consider the distribution and severity of residual inflammation. This retrospective study aimed to evaluate the prognostic significance of the distribution and severity of residual inflammation in UC patients in CR. @*Methods@#A total of 131 UC patients in CR who underwent endoscopic evaluation for more than three times between January 2000 and December 2018 were reviewed. The patients were allocated by the endoscopic healing state and the distribution of inflammation to ER (n=31, 23.7%), residual nonrectal inflammation with patchy distribution (NRI) (n=17, 13.0%) or residual rectal involvement with continuous or patchy distribution (RI) (n=83, 63.3%) groups. We reviewed clinical characteristics, endoscopic findings, and factors associated with poor outcome-free survival (PFS). @*Results@#In UC patients in CR, PFS was significantly higher in the ER and NRI groups than in the RI group (p=0.003). Patients in the ER and NRI groups had similar PFS (p=0.647). Cox proportional hazard model showed only RI (hazard ratio, 5.76; p=0.027) was associated with a higher risk of poor outcome. @*Conclusions@#We suggest that escalation of treatment modalities may be selectively performed in consideration of the residual mucosal inflammation pattern, even if ER has not been achieved, in UC patients with CR.
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Pelvic fractures are high-energy injuries, often accompanied by damage to the adjacent tissues and organs. For patients with pelvic trauma, active treatment is required early in the injury, because mortality can increase if appropriate treatment is not provided. In most cases, however, minimally invasive surgery is considered because extensive surgery cannot be performed due to the patient's condition. Percutaneous fixation of the pubis has been introduced because it can be applied easily to achieve the stability of the anterior part of the pelvis. Although many studies introduced percutaneous fixation of pubic bone fractures, most describe screw fixation for nondisplaced fractures. When treating displaced fractures with percutaneous screw fixation, it is difficult for the guide pin or drill bit to avoid the joint surface. Using a bent guide pin could allow easy insertion of the cannulated screw while avoiding the articular surface.
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Objective:By sorting out the occurrence of the risk outcomes of scientific research project in the hospital, conducting root-cause analysis, the risk management theory, process and methodologies are introduced into the management system of hospital scientific research projects to reduce the occurrence of risk outcome of scientific research projects.Methods:Through literature review and the reflection of daily scientific research management practice, the risk characteristics of clinical scientific research projects were systematically summarized, comparative analysis were conducted to explore the effectiveness before and after the introduction of risk management, and the practical experiences of scientific research project risk management were summarized.Results:There are mainly six types of internal and external risks in hospital scientific research projects, which lead to project termination, project modifications, project delays, assessment index adjustments, budget adjustments and other risk issues. By establishing scientific research project risk management environment, standardizing risk management procedures, as well as establishing risk-monitoring and early warning information system, the introduction of risk management system enables more effective control of scientific research project risks in hospitals.Conclusions:The application of risk management in the management of scientific research projects in hospitals has showed positive impact. The risk management of scientific research projects in hospitals has certain practical value and feasibility. The exploration of risk management theories and methods should be continued to promote the high-quality development of hospital scientific research project management.
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Objective:To explore the collaborative development of drug clinical trial institutions and Contract Research Organizations from the perspective of " government-application-industry-academia-research" , and facilitate faster and better conducting of clinical trials.Methods:Based the combination of literature review and the working practice in drug clinical trial management, problems existed during the implementation of clinical trials were summarized, and then the collaborative development of drug clinical trial institutions and Contract Research Organizations were discussed from the perspective of " government-application-industry-academia-research" partnership.Results:Problems identified during the implementation of clinical trials including uneven capacity of CROs, lack of effective supervision department and insufficient cooperation with clinical trial institutions, which resulted difficulties in sharing clinical trial resources and also negatively impacted the quality of clinical trials. Some proposals were offered in this article, including making good use of the " visible hand" of the government to strengthen the supervision of CROs, accelerating the construction of innovation alliance between clinical trial institutions and CROs, establishing the incentive mechanism of collaborative development and the talent team construction, strengthening the personnel professional training.Conclusions:The application of " government-application-industry-academia-research" model in clinical trials would promote the collaboration between drug clinical trial institutions and Contract Research Organizations, which play important roles in the development of clinical trials.
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OBJECTIVE@#To compare and analyze the difference between the injuries of recreational skiers in public ski resorts and those of skiing athletes in official competitions, and to explore the suggestions of medical insurance for these two types of skiers.@*METHODS@#The injury data of recreational skiers in Chongli District, Zhangjiakou City, Hebei Province during 2018-2019 and 2019-2020 snow seasons, and the injury data of skiers in two official international skiing competitions during 2019-2020 snow season and domestic test events in Chongli District of 2021 Winter Olympic Games were analyzed retrospectively, and the similarities and differences were compared.@*RESULTS@#A total of 1 187 injuries occurred to recreational skiers in the two public ski resorts during the 2018-2019 snow season, with an injury rate of 0.3%.There were 1 277 injury sites in total, and the most frequent injury sites were head and neck (230 cases, 18.0%), followed by knee joint (204 cases, 16.0%) and lower extremity (131 cases, 10.3%). Thirty-one skiers were injured in the two official international skiing competitions in the 2019-2020 and 2020-2021 snow season, and in the domestic test competitions in the 2021 Winter Olympic Games, and the injury rates were 11.5%, 17.2% and 12.0%, respectively. There were 37 injury sites in total, among which 11 (29.7%) were in the head and neck, followed by 6 (16.2%) in the knee joint and 5 (13.6%) in the chest, rib and abdomen.@*CONCLUSION@#In order to better guarantee the safety of skiers and timely provide corresponding medical help, safety facilities and technical guidance should be added to the snow resort for leisure skiing, and medical stations should be set up in the snow resort. As the formal ski racing for skiing athletes during the game has 30 to 80 times higher injury ratesthan recreational skiers, and compared with the recreational skiing, head and neck injury rate is higher, and the damage is much heavier, more complete first aid facilities and experienced medical workers are, needed so the field should be equipped with the circuit inside the quantities, track fixed outside the clinic, surrounding referral hospitals set up trauma centers to provide athletes with more timely medical care.
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Humans , Athletic Injuries/epidemiology , Lower Extremity , Retrospective Studies , Skiing , Trauma CentersABSTRACT
Objective:To affirm the importance of clinical trial kick-off meeting and improve the meeting quality.Methods:According to the literature review of latest laws and regulations, combined with working experiences in clinical trial management, this article tried to identify possible problems that might occur before, during and after the kick-off meeting, analyze how to better manage the kick-off meeting, and propose suggestions for possible solutions.Results:Newly approved clinical trial institutions may face challenges such as lack of training, unclear responsibilities, lack of attention to quality control of professional department and post-meeting management. Thus, a series of suggestions were proposed, including more substantial communication and tailored training should be in place before the kick-off meeting, responsibilities for each stakeholder should be clarified during the meeting with specific concern of the professional quality control, in addition, meeting minutes and related materials should be well documented after the meeting.Conclusions:Clinical trial kick-off meeting is crucial that clinical trials institutions should pay more attention and work for better administration of such meetings.
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Clinical residual biological specimens are invaluable for medical research and can be reused for medical research. This paper expounded the possibility, necessity and applied range of the medical research reuse of clinical residual biological specimens and put forward some suggestions on how to standardly supervise clinical residual biological specimens for medical research reuse. The authors raised four aspects of concern: how to strengthen the management of ethical review; how to establish strict privacy protection and information confidentiality system; how to keep samples reasonably to ensure clinical examination; and how to ensure the compliance treatment of residual biological specimens after reuse, so as to promote clinical residual biological specimens more normatively and effectively used in medical research.
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A total of 207 general practitioners who participated in the "Beijing-Hong Kong Community Health Service Training Demonstration Center Project" training from 2013 to 2017 were selected for this questionnaire survey. A self-designed questionnaire was used, which contained the basic information of the trainees, the training purpose, the shortcomings of training, the satisfaction and suggestions for training. Total 192 valid questionnaires were retrieved with a recovery rate of 92.8%. The in-depth personal interviews were conducted among 8 trainees who served as key trainers in community health service centers and 4 managers from their institutions, to investigate the subsequent application of the learning results after they returning to work. The survey showed that the reasons of participating in training were knowledge updates (165, 85.94%), competence requirements (128, 66.67%), and due to administration decision (127, 66.15%). The highest comprehensive scores of training needs were improvement of general practice thinking ability (4.63), followed by clinical diagnosis and treatment ability (4.44), and general practice skills (3.97). For teaching contents, participants were most interested in diagnosis ability (4.03) and clinical operative techniques (3.20). For the training form, the participants more favored the case discussion method (80.73%, 155/192), clinical practice (52.08%, 100/192) and community practice (38.02%,73/192). The trainees were highly satisfied with the overall training organization, training time, training form, and training teachers of the Beijing-Hong Kong training project, and had a good grasp of the training content. Half of trainees (97, 50.52%) thought that the main shortcomings of training was the discrepancy between training content and practical work. Interviewees showed that after the training, the team management, communication skills and disease management ability for some minor specialties had been significantly improved; the enthusiasm for scientific research had been stimulated; they had a certain managerial thinking; and were able to apply what they leant in community health service. In summary, the training project has reached the initial training goals to promote the comprehensive ability of trainees.
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During the prevention and control of new coronavirus pneumonia, Fangzhuang community health service center gave full play the advantages of internet technology, developed and implemented the Intelligent Family Doctors Optimized Coordination Model for epidemic prevention in the community. An epidemic prevention and control team was established in the center, the team carried out the epidemic prevention and control with the opening of health records and by using "doctors around" APP. The center also opened the intelligent voice return visits, the 24-hour service hotline, and WeChat public column to provide consultation for the community residents; it also strentherned pre-check triage, realized the medical insurance sharing and the other measures. All these measures enabled the residents to have a correct understanding of the epidemic situation, eased their psychological panic, enhanced their sense of gain, and made residents more convenient to seek medical treatment nearby reducing interpersonal contact and aggregation, reduced the risk of cross-infection, and achieved accurate health management among community residents during COVID-19 epidemic.
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The community is the first line of endemic prevention and control. Facing the challenge of epidemic outbreak, Fangzhuang Community Health Service Center applied the intelligent family doctor model to carry out joint community prevention and control of coronavirus disease 2019 (COVID-19) epidemic. The intelligent family doctor model is a people-centered, information-based approach, which integrates community resources to carry out health education, counseling and public opinion guidance. With this model the community health service center can effectively screen and follow up the key groups to strengthen the joint prevention and control of COVID-19; at the same time it also can manage the chronic disease and the elderly care. This article introduces the intelligent family doctor model, and analyzes its advantages and existing problems, to provide references for community epidemic prevention and control.
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The community is the first line of endemic prevention and control. Facing the challenge of epidemic outbreak, Fangzhuang Community Health Service Center applied the intelligent family doctor model to carry out joint community prevention and control of coronavirus disease 2019 (COVID-19) epidemic. The intelligent family doctor model is a people-centered, information-based approach, which integrates community resources to carry out health education, counseling and public opinion guidance. With this model the community health service center can effectively screen and follow up the key groups to strengthen the joint prevention and control of COVID-19; at the same time it also can manage the chronic disease and the elderly care. This article introduces the intelligent family doctor model, and analyzes its advantages and existing problems, to provide references for community epidemic prevention and control.
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Atypical fractures associated with prolonged bisphosphonate (BP) therapy rarely occur outside the femur, and the diagnostic criteria, appropriate treatment principles, and fixation methods for atypical ulnar fractures have not been established. The authors experienced the use of internal fixation with a metal plate and a new internal fixation method with an intramedullary nail in the treatment of an atypical ulnar fracture in a patient who had been on BP therapy for 10 to 20 years. This paper reports findings along with a review of the relevant literature.
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Humans , Femur , Fractures, Stress , Methods , Osteoporosis , UlnaABSTRACT
The subtrochanteric area is the place where mechanical stress is most concentrated in the femur. When a fracture happens, bone union is delayed and nonunion often occurs. The recommended treatment for atypical fractures is an anatomical reduction of the fracture site as the frequency of nonunion is higher than that of ordinary fractures. Various reduction methods have been suggested, and good results have been obtained. On the other hand, the occurrence of posterior displacement of the distal fragment during the insertion of an intramedullary nail is often overlooked. This is probably because the bone marrow of the femur tends to form an elliptical shape in the anteroposterior direction. The author attempted to insert a blocking screw into the distal part of the fracture to prevent posterior displacement of the distal fragment while performing intramedullary nailing of the femur fracture and achieved a good reduction state easily.
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Bone Marrow , Femur , Fracture Fixation, Intramedullary , Hand , Stress, MechanicalABSTRACT
Radiotherapy is an important method in the treatment of gynecological malignant tumors,but it also causes great damage to female reproductive and endocrine function.This article reviews the effects of radiotherapy on reproductive and endocrine function in women and protective methods.
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The aim of the present study is to evaluate the vasodilation effects of Tongmai Yangxin Pills (TMYX) on rat mesenteric artery as well as its mechanism of action. The relaxation effects of TMYX extracts with different concentrations were determined on isolated rat mesenteric artery in normal condition as well as pretreating by phenylephrine and KCl. Vascular relaxation effects of TMTX were also determined in mesenteric artery preincubated with L-ANME and indomethacin or in endothelium denuded mesenteric artery. Moreover, effects of TMYX by 50 mg·L⁻¹ on NO secretion and the phosphorylation of eNOS in a cellular model of human umbilical vein endothelial cell (HUVEC) pretreated with or without L-NAME were also observed. The experimental results showed that TMYX has no obvious effect on vasodilation of arteries in normal or KCl pretreated condition, while it can dose-dependently relax the rat mesenteric artery with intact endothelium stimulated with phenylephrine at a maximal diastolic rate of (64.71±10.03)%. After preincubating with L-NAME for 15 min or removal of mesenteric artery endothelium, the maximal diastolic rate was decreased to (35.77±8.93)% and (25.85±10.84)% respectively. However, preincubating with indomethacin had no inhibitory effect on TMYX induced vascular relaxation. Meanwhile, TMYX at 50 mg·L⁻¹ could increase the expression of P-eNOS and the secretion of NO in HUVEC. L-NAME significantly inhibited NO release and phosphorylation of eNOS induced by TMYX. The results suggested TMYX exerted endothelium-dependent relaxation effects against PE-induced contractions of isolated rat mesenteric artery through NO-cGMP signaling pathway.