Objective To establish a method for bacterial endotoxin test of flumazenil bulk drug.Methods According to the bacterial endotoxin test(BET)method in general rule 1143 in the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),flumazenil was dissolved with dimethyl sulfoxide(DMSO)and diluted with BET water.The gel-clot method and kinetic turbidimetric assay were used to carry out the interference test and endotoxin recovery test.Results Flumazenil was dissolved with DMSO to 10 mg·mL-1,and then diluted 100 times or more by BET water,which has no interference effects on the bacterial endotoxin test.Conclusion The BET method established in this study can be used to control the quality of flumazenil by performing bacterial endotoxin tests.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

Rapid and living guidelines are those developed in response to public health emergencies in a short period of time using a scientific and standardized approach. Subsequently， they provide timely and credible recommendations for decision makers through regular and frequent updates of clinical evidence and recommendations. In this paper， we introduced the definition of rapid and living guideline as well as analyzed the basic characteristics of eight rapid and living guidelines in the field of traditional Chinese medicine （TCM） published till 2023 June， summarizing three core methodological issues in relation to how to rapidly develop guidelines， how to formulate recommendations when there is lack of evidence， and how to ensure the timeliness of guidelines. Based on the analysis of current rapid and living guidelines， it is implicated that there is necessity to carry out rapid and living guideline in the field of TCM， and the methodology of rapid integration of multivariate evidence in the field of TCM needs to be further explored； furthermore， it is necessary to further explore the obstacles of implementation of guidelines and promote timely updating， all of which provide certain theoretical references for relevant guideline developers and researchers.

In developing rapid and living guidelines of traditional Chinese medicine （TCM） in response to public health emergencies， it is important that evidence continue to be reviewed， and clinical questions and recommendations updated if necessary， due to the rapid changes in disease progression and the continuous generation of relevant research evidence. This paper proposed that the updating scope in dynamic mode should first be identified； then evidence monitoring should be carried out in four aspects， including clinical research， related guidelines or laws and regulations， disease progression， as well as clinical use of recommendations and clinical needs； finally， based on the results of the evidence monitoring， different options should be made， including revising the clinical questions， updating the evidence and recommendations， and withdrawing the guideline.

Objective Recent studies have indicated potential anti-inflammatory effects of glucagon-like peptide-1 receptor agonists(GLP-1RAs)on asthma,which is often comorbid with type 2 diabetes mellitus(T2DM)and obesity.Therefore,we conducted a meta-analysis to assess the association between the administration of glucagon-like peptide-1(GLP-1)receptor-based agonists and the incidence of asthma in patients with T2DM and/or obesity. Methods PubMed,Web of Science,Embase,the Cochrane Central Register of Controlled Trials,and Clinicaltrial.gov were systematically searched from inception to July 2023.Randomized controlled trials(RCTs)of GLP-1 receptor-based agonists(GLP-1RA,GLP-1 based dual and triple receptor agonist)with reports of asthma events were included.Outcomes were computed as risk ratios(RR)using a fixed-effects model. Results Overall,39 RCTs with a total of 85,755 participants were included.Compared to non-GLP-1 receptor-based agonist users,a trend of reduced risk of asthma was observed in patients with T2DM or obesity using GLP-1 receptor-based agonist treatments,although the difference was not statistically significant[RR=0.91,95%confidence interval(CI):0.68 to 1.24].Further Subgroup analyses indicated that the use of light-molecular-weight GLP-1RAs might be associated with a reduced the risk of asthma when compared with non-users(RR=0.65,95%CI:0.43 to 0.99,P=0.043).We also performed sensitivity analyses for participant characteristics,study design,drug structure,duration of action,and drug subtypes.However,no significant associations were observed. Conclusion Compared with non-users,a modest reduction in the incidence of asthma was observed in patients with T2DM or obesity using GLP-1 receptor-based agonist treatments.Further investigations are warranted to assess the association between GLP-1 receptor-based agonists and the risk of asthma.

ObjectiveTo understand the concentration of heavy metal cadmium and cadmium in portunus and mantis shrimp， and to timely identify food safety problems and potential hazards. MethodsPortunus and mantis shrimp samples from different provinces were collected and categorized based on different regions and locations， and some samples were made from tissue parts. Graphite furnace atomic absorption spectrometry was used to detect cadmium items， the cadmium exposure of portunus and mantis shrimp was evaluated simultaneously ResultsThe detection rate of cadmium in 124 batches of portunus sold in Shanghai was 100% （124/124）， the detection rate of cadmium in 63 batches of mantis shrimp sold in the market was also 100% （63/63）. The cadmium content varied in different tissue parts， and the cadmium enrichment in hepatopancreas was the highest in the edible parts of portunus and mantis shrimp. The average detection value， 50th percentile value， 95th percentile value of cadmium in the hepatopancreas of portunus accounted for 52.64%， 49.28% and 98.65% of the PTMI， respectively. The average detection value， 50th percentile value and 95th percentile value of cadmium in the hepatopancreas of mantis shrimp accounted for 30.76%， 32.04% and 46.16% of the PTMI， respectively. ConclusionThe average residual levels of heavy metal cadmium in portunus and mantis shrimp are within the safe range.

Objective:To observe the changes of macular morphology and blood flow after minimally invasive vitrectomy (PPV) in patients with severe non-proliferative diabetic retinopathy (sNPDR).Methods:A prospective clinical study. From January 2020 to April 2021, 17 consecutive sNPDR patients with 17 eyes who were diagnosed and received PPV treatment at the Zhongshan Ophthalmic Center of Sun Yat-sen University were included in the study. There were 12 males with 12 eyes and 5 females with 5 eyes; the average age was 55 years old; the average duration of diabetes was 11 years; the average glycosylated hemoglobin was 7.9%. Before the operation and 1, 3, and 6 months after the operation, all the affected eyes underwent best corrected visual acuity (BCVA), standard 7-field fundus color photography, and optical coherence tomography angiography (OCTA). An OCTA instrument was used to scan the macular area of the affected eye with in the range of 3 mm×3 mm to measure the central subfoveal thickness (CST), the thickness of the ganglion cell complex (GCC) in the macular area, the thickness of the retinal nerve fiber layer (RNFL), and the superficial capillary plexus (SCP) vessel density and perfusion density in the macular area, macular avascular zone (FAZ) area, a-circularity index (AI). Before the operation and 6 months after the operation, the least significant difference test was used for the pairwise comparison.Results:Before the operation, 1, 3, and 6 months after the operation, the FAZ area of the macular area were 0.34±0.14, 0.35±0.10, 0.37±0.10, 0.36±0.13 mm 2, respectively; AI were 0.52±0.13, 0.54±0.11, 0.57±0.10, 0.60±0.11; CST was 282.6±66.7, 290.4±70.9, 287.2±67.5, 273.2± 49.6 μm; GCC thickness were 77.1±15.5, 74.3±13.9, 72.6±16.2, 78.5±18.3 μm; the thickness of RNFL was 97.9±13.8, 101.3±14.6, 97.7±12.0, 96.1±11.4 μm, respectively. The overall blood flow density of SCP in the macula were (16.79±1.43)%, (16.71±1.82)%, (17.30±2.25)%, (17.35±1.22)%; the overall perfusion density were 0.32±0.02, 0.32±0.03, 0.33±0.03, 0.33±0.02, respectively. After the operation, the CST increased first and then decreased; the thickness of RNFL increased 1 month after the operation, and then gradually decreased. Comparison of the parameters before and 6 months after the operation showed that the AI improved, and the difference was statistically significant ( P=0.049); the difference in FAZ area and the thickness of CST, GCC, and RNFL was not statistically significant ( P=0.600, 0.694, 0.802, 0.712); There was no statistically significant difference in the retina SCP blood flow density and perfusion density in the macular area ( P=0.347, 0.361). Conclusion:Compared with before surgery, there is no significant change in macular structure and blood flow density in sNPDR patients within 6 months after minimally invasive PPV.

BACKGROUND: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in adults with type 2 diabetes (T2D). The aim of this study was to determine the CV risk in Chinese patients with T2D based on the 2019 European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD) guidelines on diabetes, pre-diabetes, and CV diseases. METHODS: A total of 25,411 patients with T2D, who participated in the study of China Cardiometabolic Registries 3B study, were included in our analysis. We assessed the proportions of patients in each CV risk category according to 2019 ESC/EASD guidelines. RESULTS: Based on the 2019 ESC/EASD guidelines, 16,663 (65.6%), 1895 (7.5%), and 152 (0.6%) of patients were included in "very high risk," "high risk," and "moderate risk" categories, respectively. The proportions of patients in each category varied based on age, sex, body mass index, and duration. While 58.7% (9786/16,663) of elderly patients were classified to "very high risk" group, 89.6% (3732/4165) of patients with obesity were divided into "very high risk" group. Almost all patients with a duration of diabetes >10 years had "very high risk" or "high risk." However, 6701 (26.4%) of Chinese T2D patients, who had shorter duration, and one or two risk factors, could not be included in any category (the "unclear risk" category). CONCLUSIONS In China, most patients with T2D have "very high" or "high" CV risk based on 2019 ESC/EASD guidelines. However, the risk of patients in "unclear risk" group needs to be further classified.
Adult ; Aged ; Cardiovascular Diseases/epidemiology* ; Cross-Sectional Studies ; Diabetes Mellitus, Type 2 ; Heart Disease Risk Factors ; Humans ; Risk Factors

Objective:To investigate the current status of discharged patients at risk of pressure injury and analyze risk factors of pressure injury.Methods:Using the convenient sampling method, 54 medical alliance units of Chongqing Fuling Central Hospital were selected for a cross-sectional survey. Patients at risk of pressure injury when discharged from the hospital and their caregivers were selected as the research objects from August 2019 to June 2020. The general demographic data sheet, clinical test data sheet, Braden Pressure Ulcer Risk Assessment Scale, Barthel index, and Family Caregiver Task Inventory (FCTI) were used for investigation. In this study, a total of 409 questionnaires were issued and 409 were effectively received, with an effective recovery of 100%.Results:There were 224 patients (54.8%) at light risk of pressure injury, 74 patients (18.1%) at moderate risk, 89 patients (21.8%) at high risk and 22 (5.4%) patients at extreme risk. The differences in general demographic data, clinical test data and self-care ability grade of 409 patients were statistically significant ( P<0.05) . The FCTI scores of caregivers for patients with different risk levels were compared, and the difference was statistically significant ( P<0.05) . The results of ordered logistic regression analysis showed that white blood cell count ( OR=1.103, 95% CI: 1.006-1.209, P=0.035) , care ability of caregivers ( OR=1.060, 95% CI: 1.017-1.104, P=0.005) , fecal incontinence ( OR=14.112, 95% CI: 2.505-79.497, P=0.003) , indwelling catheter ( OR=3.111, 95% CI: 1.332-7.269, P=0.009) , severe dependence ( OR=15.705, 95% CI: 2.655-92.918, P=0.002) were risk factors for the risk of pressure injury in discharged patients. Conclusions:Among discharged patients with Braden score less than or equal to 18 points, there are 45.2% (185/409) patients with moderate risk of pressure injury and above. It is necessary to focus on discharged patients with high levels of white blood cells, weak care ability of caregivers, indwelling catheters and self-care ability of heavy dependence grade to prevent pressure injuries.

Objective:To explore ultrasonographic diagnostic characteristics of ovarian epithelial tumors and establish prediction models.Methods:The ultrasonographic images of 427 cases from multicenter with ovarian epithelial tumors confirmed by pathology from January 2015 to July 2019 were retrospectively analyzed according to the International Ovarian Tumor Analysis (IOTA). Ultrasonographic signs with distinguishing significance were obtained through univariate analysis and included into multivariate Logistic regression analysis to obtain important ultrasonagraphic indicators for distinguishing borderline, benign and malignant ovarian tumors, and to establish prediction models.Results:The microcystic pattern of papillary projections and solid components was the diagnostic characteristic between borderline and benign, malignant ovarian epithelial tumors( OR value 10.97 and 19.22, respectively). Irregular morphology, septa thickness, solid lesions, rich blood supply and ascites were diagnostic characteristics between benign and malignant tumors, with the irregular morphology having the highest value. Irregular morphology, large papillary, septa thickness and rich blood supply could be used to identify borderline and malignant tumors. At the same time, irregular morphology was the valuable sign to distinguish borderline and benign tumors. In this study, the total coincidence rate of the proposed model was 72.4%, among which the predicted coincidence rate of the borderline model was 57.2%, 78.6% for benign, and 80.7% for malignant. Conclusions:The microcystic pattern of papillary projections and solid components are the specific sonographic characteristics of borderline ovarian tumors. Irregularity, solid lesions, rich blood supply and ascites have important value in differentiating ovarian epithelial tumors. The prediction models of benign, malignant and borderline ovarian tumors in this study have higher diagnostic efficacy.