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.

The incidence of osteoporotic thoracolumbar vertebral fracture (OTLVF) in the elderly is gradually increasing. The kyphotic deformity caused by various factors has become an important characteristic of OTLVF and has received increasing attention. Its clinical manifestations include pain, delayed nerve damage, sagittal imbalance, etc. Currently, the definition and diagnosis of OTLVF with kyphotic deformity in the elderly are still unclear. Although there are many treatment options, they are controversial. Existing guidelines or consensuses pay little attention to this type of fracture with kyphotic deformity. To this end, the Lumbar Education Working Group of the Spine Branch of the Chinese Medicine Education Association and Editorial Committee of Chinese Journal of Trauma organized the experts in the relevant fields to jointly develop Clinical guidelines for the diagnosis and treatment of osteoporotic thoracolumbar vertebral fractures with kyphotic deformity in the elderly ( version 2024), based on evidence-based medical advancements and the principles of scientificity, practicality, and advanced nature, which provided 18 recommendations to standardize the clinical diagnosis and treatment.

Six new (1-6) and seven known depsidones (7-13) were isolated from the culture of an ant (Monomorium chinensis)-derived fungus Spiromastix sp. MY-1. Their structures were elucidated by extensive spectroscopic analysis including high resolution MS, 1D and 2D NMR data. The new bromide depsidones were obtained through supplementing potassium bromide in the fermentation medium of Spiromastix sp. MY-1. All isolated compounds showed various bioactivities against the tested phytopathogenic bacteria. Particularly, new bromide compound 4, named spiromastixone S, exhibited the strongest activity against Xanthomonas oryzae pv. oryzae with a MIC value of 5.2 μmol·^-1.
Animals ; Anti-Bacterial Agents ; Ants ; Bromides ; Depsides ; Fungi ; Lactones ; Microbial Sensitivity Tests ; Molecular Structure

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.

Objective:To summarize the surgical treatment experience of extended thymectomy for myasthenia gravis(MG), and to explore the surgical treatment of MG.Methods:Retrospectively analyzed the clinical data of 527 MG patients undergoing extended thymectomy in our hospital from June 1996 to October 2017, including 242 males and 285 females, aged 5 to 77 years, with a mean age of(52.6±13.7) years old. The course of illness was 12 days to 18 years. There were 22 cases of hyperthyroidism, 7 cases of pure red blood cell aplastic anemia, 1 case each of hypothyroidism, irritable bowel disease, rheumatoid arthritis, ankylosing spondylitis and thrombocytopenia syndrome. There were 272 cases of MG in Osserman Ⅰ, 72 cases inⅡa, 78 cases inⅡb, 81 cases in Ⅲ, and 24 cases in Ⅳ, respectively. The muscle fatigue test and neostigmine test of all patients were positive, and the diagnosis was confirmed by chest CT examination. Meanwhile, summarize the perioperative data and postoperative follow-up.Results:3 cases died during the postoperative period, all of which were thymoma with MG, including 2 cases of Osserman Ⅲ MG and 1 case of Ⅳ MG; 15 cases of postoperative myasthenia crisis, including 2 OssermanⅡb cases, 11 Osserman Ⅲ cases and 2 Osserman Ⅳ cases, also including 7 cases of tracheotomy; 70 cases of plasma exchange, of whom 2 cases of hypotonic syndrome and 2 cases of lower extremity venous thrombosis. The postoperative pathological types were followed by thymic hyperplasia 293 cases(55.60%), thymoma 207 cases(39.28%), thymic cyst 24 cases(4.55%) and thymic atrophy 3 cases(0.57%) in descending order. 378 cases were followed up with an average follow-up of(85.9±58.5)months; MG with complete remission, partial remission, no change and deterioration accounted for 135(35.71%), 192(50.79%), 41(10.85%) and 10(2.65%)cases, respectively. Complete remission rate ranked as Osserman typeⅠ>Ⅱa>Ⅳ>Ⅱb>Ⅲ, the deterioration rate from high to low was Osserman type Ⅲ>Ⅳ>Ⅰ. 18 OssermanⅠcases showed no effects, whose preoperative course of disease> 5-10 years; 1 OssermanⅠcase was worsening who initially was diagnosed with ophthalmic MG and underwent video-assisted thoracoscopic thymectomy. The left thymus lobe was left unresected and developed 6 years later. Another operation was performed to remove the left lobe thymus, confirming the compensatory hypertrophy of the left lobe thymus. Among the worsening patients, 6 died, all of them were thymoma with MG, including 5 cases of type Ⅲ and one case of type Ⅳ. The cause of death was omyasthenia crisis(3 cases), sudden respiratory arrest after 3 months of rapid stopping of brompistigmine(2 cases)and cholinergic crisis(1 case).Conclusion:Standardized extended thymectomy is an effective method for the treatment of MG. Earlier surgery for ocular muscle type MG can effectively reduce the risk of generalization. MG with Osserman Ⅱb or higher is prone to myasthenia crisis. Comprehensive treatments should be taken to reduce MG-related risks. Myasthenia crisis can occur repeatedly in severe patients in the long term after surgery, requiring regular medication and comprehensive MG treatments.

Antineoplastic Combined Chemotherapy Protocols ; Bendamustine Hydrochloride/therapeutic use* ; Etoposide ; Hematopoietic Stem Cell Transplantation ; Humans ; Lymphoma/therapy* ; Melphalan ; Transplantation Conditioning ; Transplantation, Autologous

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

Osteoporotic thoracolumbar fracture in the elderly will seriously reduce their quality of life and life expectancy. For osteoporotic thoracolumbar fracture in the elderly, spinal reconstruction is necessary, which should comprehensively consider factors such as the physical condition, fracture type, clinical characteristics and osteoporosis degree. While there lacks relevant clinical norms or guidelines on selection of spinal reconstruction strategies. In order to standardize the concept of spinal reconstruction for osteoporotic thoracolumbar fracture in the elderly, based on the principles of scientificity, practicality and progressiveness, the authors formulated the Clinical guideline for spinal reconstruction of osteoporotic thoracolumbar fracture in elderly patients ( version 2022), in which suggestions based on evidence of evidence-based medicine were put forward upon 10 important issues related to the fracture classification, non-operative treatment strategies and surgical treatment strategies in spinal reconstruction after osteoporosis thoracolumbar fracture in the elderly, hoping to provide a reference for clinical treatment.

Objective: To investigate the association between trimethylamine-N-oxide (TMAO) and the degree of coronary atherosclerosis in coronary heart diseases (CHD) patients with type 2 diabetes mellitus. Methods: Consecutive patients, who underwent coronary angiography due to suspected CHD in Beijing Hospital from November 2016 to January 2018, were screened in this cross-sectional study. According to blood glucose level, previous medical history and coronary angiography results, they were divided into CHD without type2 diabetes mellitus(CHD-nDM) group and CHD with type2 diabetes mellitus(CHD-DM) group. Plasma TMAO levels in each group were measured by LC-MS/MS. Spearman correlation analysis was used to evaluate the correlation between TMAO and the number of diseased vessels and Gensini scores. Multivariate logistic regression was used to analyze the correlation between TMAO and high Gensini scores. Results: A total of 590 patients were enrolled in the study, including 238 patients in CHD-DM group and 352 patients in CHD-nDM group. Patients were older, body mass index, blood pressure level, prevalence of history of hypertension and statins use were higher in CHD-DM group than in CHD-nDM group (all P<0.05). The proportion of patients with multivessel disease (2 or more vessels) was also higher in CHD-DM group than in CHD-nDM group (P<0.001). Gensini score was higher in CHD-DM group than in CHD-nDM group (P<0.05). Fasting blood glucose, glycosylated hemoglobin and urea were significantly higher, while low-density lipoprotein cholesterol and hemoglobin were significantly lower in CHD-DM group than in CHD-nDM group (all P<0.05). The levels of TMAO was significantly higher in CHD-DM group than in CHD-nDM group (P<0.001). Spearman correlation analysis showed that TMAO was positively correlated with the number of diseased vessels, Gensini score, age and blood glucose level (r=0.178, 0.189, 0.260, 0.111, respectively, all P<0.01). Multivariate logistic regression analysis showed that, TMAO level was still positively correlated with high Gensini score in CHD-DM group (OR=2.25, 95%CI 1.16-4.38, P=0.017), but not in CHD-nDM group (OR=1.29, 95%CI 0.72-2.31, P=0.386) after adjusting for age, sex, body mass index, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol, triglyceride, history of hypertension, hyperlipidemia, smoking and statin use. Conclusions: In CHD patients with tupe 2 diabetes mellitus, the plasma TMAO level is significantly increased and is independent and positively correlated with the degree of coronary artery disease.

Acupuncture Points ; Acupuncture Therapy ; Cardiovascular System ; Extracellular Fluid ; Humans