OBJECTIVE:To explore the idea and method of post-marketing safety reevaluation of TCM injection in our hospi-tal. METHODS:In case-control study,salvianolate for injection was chosen for practice. 1 000 patients with stable angina receiv-ing Salvianolate for injection in our hospital during May 2012-Oct. 2013 were selected as subjects. The occurrence of ADR/ADE were observed and Logistic regression analysis was conducted by using SPSS 20.0 software. RESULTS:The incidence of ADR/ADE was 0.6%,and rare(0.1%-1%). The ADR/ADE were general and mainly manifested as erythra(66.67%). Skin and its ap-pendants were main organs involved in ADR(66.67%). Logistic regression analysis showed that gender,drug combination and age are risk factors of ADR/ADE. CONCLUSIONS:The post-marketing safety reevaluation of TCM injection not only make up for the deficiency of pre-marketing safety evaluation of TCM injection and find out potential delayed and severe ADR/ADE and drug inter-action,but also provide reference for rational drug use in the clinic and guarantee the safe and rational drug use.

Objective To investigate the relationship between KRAS,NRAS and BRAF gene mutations and clinicopathological parameters in patients with colorectal carcinoma (CRC).Methods By using TagMan real-time PCR method KRAS/NRAS/BRAF hotspot mutations were detected in 260 cases of CRC.The associations between KRAS/NRAS/BRAF mutation status and clinical pathological characteristics were analysed in different groups divided by gender,age,tumor size,tumor differentiation.Results (1) The KRAS hotspot mutations were G12D,G12A,G12R,G12C,G12V,G12S in codon 12 and G13 C,G13D in codon 13.They were identified in 43.1％ CRC.KRAS mutation rate was higher in females than in males (P =0.05) and the mutation rate in patients ≥ 60 years was significantly higher than that in patients ＜ 60 years(P =0.008).The incidence of metastasis and mortality were higher in KRAS mutant than in KRAS wild type (P =0.004,P =0.037).(2)The NRAS hotspot mutations were in codon1 2,13 and 61.They were identified in 4.6％ CRC.NRAS mutation rate was significantly higher in patients ≥ 60 years and well-differentiated tumors (P =0.032,P =0.042).(3) The mutation rate of BRAF V600E in CRC patients was 4.6％.BRAF V600E mutation rate was significantly higher in patients ≥60 years,with distant metastases and tumors ＞ 5 cm (P =0.032,P =0.026,P =0.038).The incidence of metastasis and rucurrence and mortality were higher in BRAF mutant (P =0.030,P =0.002,P =0.007).Conclusions In CRC patients,KRAS mutations correlate with demographic factors,metastasis and mortality,NRAS mutations correlate with age and tumor differentiation,while BRAF mutation correlate with age,tumor size,metastasis,recurrence and mortality.

Objective:To investigate the correlation between platelet distribution width(PDW)and cerebral microbleeds(CMB)in the middle-aged and elderly population.Methods:A total of 2 839 subjects who underwent cranial magnetic resonance imaging(MRI)examination at Lishui Hospital of Zhejiang University from May 2016 to December were enrolled in this cross-sectional study.According to MRI results, subjects were divided into the CMB group(n=525)and the non-CMB group(n=2 314). Clinical data and PDW levels were compared between the two groups.CMB-related factors were analyzed by using a logistic regression equation.A receiver operating characteristics(ROC)curve was drawn to analyze the value of PDW levels in predicting the incidence of CMB.Results:The percentage of males, the proportion of smokers, the number of subjects with diabetes and serum creatinine levels were higher in the CMB group than in the non-CMB group[(55.05%(289/525) vs.45.12%(1 044/2 314), 42.67%(224/525) vs.34.67%(802/2 314), 12.76%(67/525) vs.9.51%(220/2 314), (68.91±21.38)μmol/L vs.(66.45±15.40)μmol/L, all P<0.05]. PDW levels were higher in the CMB group than in the non-CMB group(15.52±2.49)% vs.(14.67±2.90)%, χ2=93.75, P<0.05). Multivariate logistic regression analysis showed that the PDW level was an independent risk factor for CMB in the middle-aged and elderly population( OR=1.13, P<0.05). The area under the ROC curve(AUC)of PDW in predicting the incidence of CMB was 0.582, and with 15.95% as the optimal threshold value, the sensitivity and specificity were 75.0% and 41.8%.Patients were divided into the high PDW sub-group(n=1 691)and the low PDW sub-group(n=1 083)based on the PDW cutoff at 15.95%.The number of CMB and the incidence of CMB were higher in the high PDW group than in the low PDW group(0.75 vs.0.48, 23.3% or 394/1 691 vs.12.1% or 131/1 083, χ2=30.37 and 51.28, P<0.05). Conclusions:PDW levels are high in middle-aged and elderly patients with CMB, and elevated PDW levels are an independent risk factor for CMB.

Objective:Grasp the status of Zhejiang entry standards, controls and calibrators in recent years and problems.Methods:Through descriptive statistics, cross-tab chi-square, and comparation of means method , we collected and sorted out relevant information about standard products, quality control products and calibrators of the Zhejiang Provincial Biomedical Special Articles Entry Centralized Supervision Platform, and analyzed the basics of standard products, quality control products and calibrators situation, degree of dependence and utilization.Results:The standard products and quality control products imported into Zhejiang province are mainly used for scientific research of biomedical device enterprises. 76.6% of imported standard products, quality control products and calibrators cannot be domestically produced. The main origin of imported standard products and quality control products is the United States, and the main origin of standard products is the United Kingdom.Conclusions:The standard products, quality control products and calibration products imported into Zhejiang province are currently lacking in domestic production capacity. It is recommended to support the research and development and production of domestic standard products, quality control products and calibration products.

Objective:To survey the status quo of family doctor work mode in Shanghai Xuhui district.Methods:Semi-structured and structured in-depth interviews were conducted in Shanghai Xuhui district from April to June 2021, 11 directors, 12 deputy directors in charge and 30 family doctors from 12 community health service centers participated in the survey and completed two stages and four sessions of interviews on the development of the integrated and high-quality family doctor work mode and the ways to realize and the challenges to face. The records of interviews were transcribed, sorted and analyzed using the Colaizzi 7-step analysis method.Results:The survey showed that the family doctor contracting was carried out in a large team mode in the whole district, mainly for the elderly, and most of contracted residents were not included in health management and follow-up services. The team was composed of family doctors and assistants, and the routine outpatient service was the main work pattern, and the regular services also included the chronic disease follow-up and health check-up for elderly. On the issue of how to output high-quality integrated services, the majority of doctors (12/13) believed that the contracted individual should be taken as the unit of fine service, carrying out overall health assessment, optimizing medication plan, lifestyle guidance, one-stop service in hospital, etc.; only one doctor suggested that the family should be the management unit. For upgrading the working mode and service quality, insufficient time and energy were the main obstacle. Public health work occupied a lot of working time, but it seemed not be transformed into favorable resources and conveniences in health management and services. The professional assistants should carry out some responsibility to save family doctor′s time. The survey suggests that informatization, service space, and sufficient drug supply are the keys for ensuring high-quality and high-efficiency integrated services.Conclusion:The organizational structure of the family doctor team in Shanghai Xuhui district is relatively mature, but the integrated and high-quality service output has not yet reached. It is necessary to make regional overall planning and increase efforts to achieve the integration of medical treatment and prevention, so as to gain time for family doctors to carry out high-quality services. At the same time, it is also necessary to cultivate effective family doctor assistants, provide an information work platform that matches the work attributes and goals of family doctors, open up an integrated health management service space, and ensure the full range supply of drugs.

Objective:To systematically evaluate the role of air pollutants in the development and exacerbation of autoimmune rheumatic diseases.Methods:We followed PRISMA guidelines and searched EMBASE, Scopus, PubMed, and Cochrane Library databases using keywords and MeSH terms from inception to July 2019. Observational studies reporting the relationship between autoimmune rheumatic diseases and exposure to certain air pollutants were included. Screening of literature according to established inclusion and exclusion criteria. No meta-analysis but the qualitative analysis was conducted due to the high methodological heterogeneity.Results:A total of 24 studies were included. Rheumatoid arthritis (RA) ( n=6), anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV) ( n=1), ankylosing spondylitis (AS) ( n=1), systemic lupus erythematosus (SLE) ( n=3), childhood-onset systemic lupus erythematosus (cSLE) ( n=3), juvenile idiopathic arthritis (JIA) ( n=2), Kawasaki disease (KD) ( n=4), systemic autoimmune rheumatic diseases (SARD) ( n=4). The results of the study suggested that short-term elevation in particulate matter (PM)2.5 concentration was possibly associated with an increased risk of SLE and cSLE flare-ups, disease activity of AS, JIA and SARDs exacerbation. Studies demonstrated an increased risk of RA with cumulative exposure to carbon monoxide (CO), nitrogen dioxide (NO 2), ozone (O 3), and sulfur dioxide (SO 2). Only one study demonstrated an increased risk of KD admission with elevated O 3 levels. No association was found between AAV and ambient air pollution. Conclusion:Air pollution is likely to be involved in the development and exacerbation of certain autoimmune diseases. At the same time, the mechanism of autoimmune diseases of ambient air pollutants should be actively studied, so as to promote the early prevention of cardiovascular diseases.

Objective:To evaluate the diagnostic performance of radiomics model based on contrast-enhanced ultrasound(CEUS) in predicting pathological complete response(pCR) after neoadjuvant chemoradiotherapy(nCRT) in patients with locally advanced rectal cancer(LARC).Methods:One hundred and six patients with LARC who underwent total mesorectal excision after nCRT between April 2018 and April 2023 in the First Affiliated Hospital of Guangxi Medical University were retrospectively included, the patients were randomly divided into a training set of 63(14 pCR patients) and a validation set of 43(12 pCR patients) in a 6∶4 ratios. Radiomics features were extracted from the tumors′ region of interest of CEUS images based on PyRadiomics. Intra-class correlation coefficient(ICC), Mann-Whitney U test, and least absolute shrinkage and selection operator(LASSO) algorithms were used to reduce features dimension. Finally, 7 radiomics features relevanted to pCR were selected to construct an ultrasomics model using elastic network regression, based on the R language. A combined model was constructed by jointing clinical feature. The performance of the models was assessed with the area under the ROC curve(AUC). Results:The AUC of the ultrasomics model and the combined model was 0.695(95% CI=0.532-0.859) and 0.726(95% CI=0.584-0.868) respectively in the training set. The AUC of the ultrasomics model and the combined model was 0.763(95% CI=0.625-0.902) and 0.790(95% CI=0.653-0.928) respectively in the validation set. Both univariate and multivariate Logistic regression analyses showed that CA199( P<0.05) and ultrasomics score( P<0.001) could be an independent predictor of pCR after nCRT in patients with LARC. Conclusions:The CEUS-based radiomics scores has certain predictive value for whether LARC patients achieve pCR after nCRT, and may provide a non-invasive imaging biomarker for predicting LARC patients achieve pCR after nCRT.

Objective:To investigate the safety and efficacy of sacral neuromodulation(SNM)therapy for the treatment of lower urinary tract dysfunction(LUTD)in elderly patients.Methods:Clinical data of 91 elderly patients with LUTD from multiple medical institutions who received SNM during the period from January 2012 to December 2016 were retrospectively analyzed.Patients were divided into four groups: the interstitial cystitis(IC)group(n=28), the neurogenic bladder(NB)group(n=36), the overactive bladder syndrome(OAB)group(n=13)and the idiopathic dysuria(ID)group(n=14). Different sets of evaluation parameters were used for different diseases.Patients’ baseline data and data in stage I(test phase)and stage Ⅱ(permanent SNM)were recorded, statistically analyzed and compared.Results:Ninety-one people underwent SNM treatment.Of them, 53 patients received permanent implants(stage Ⅱ), and the total conversion rate of stage I to stage Ⅱ was 58.2%(53/91). Patients receiving permanent implants(stage Ⅱ)had a preoperative period ranging from 3 months to 30 years, and were followed up for 2 to 58 months after treatment, with an average follow-up of 19.6 months.The improvement rates in stage I for urinary urgency, daily urination frequency, daily nocturnal urination frequency, maximum urine volume, daily average urine volume, daily urine leakage frequency, and quality of life score were 35.4%, 31.6%, 33.7%, 32.6%, 49.2%, 43.2% and 13.2%, respectively.The improvement rates in stage Ⅱ for urinary urgency, daily urination frequency, daily nocturnal urination frequency, maximum urine volume, daily average urine volume, daily urine leakage frequency, and quality of life score were 43.2%, 40.0%, 37.8%, 50.5%, 70.5%, 70.4% and 43.2%, respectively.Three adverse events occurred, including 1 case of recurrent symptoms, 1 case of moderate infection, and 1 case of electrical lead dislocation.Conclusions:Sacral nerve stimulation has definitive and consistent curative effects on LUTD in elderly people.The follow-up time should be extended to further study the safety of sacral nerve stimulation.

Objective:To investigate the clinical efficacy of middle-preserving pancreatectomy (MPP).Methods:The retrospective and descriptive study was conducted. The clinicopathological data of two patients who underwent MPP in Fujian Provincial Hospital from July 2019 to October 2019 were collected. Case 1 was a 52-year-old woman with multiple serous cystic neoplasms of the pancreatic head and tail. Case 2 was a 20-year-old man with chronic pancreatitis and multiple pancreatic duct stones. After comprehensive evaluation, two patients were performed laparoscopic pancreatic head tumor resection+ pancreatic tail resection+ splenectomy+ pancreaticojejunostomy and duodenum-preserving pancreatic head resection+ pancreatic tail resection+ lithotomy by longitudinal pancreatic duct incision+ side-to-side pancreaticojejunostomy, respectively. Observation indicators: surgery, operation time, volume of intraoperative blood loss, blood transfusion, postoperative fasting blood glucose, postoperative complications, duration of postoperative hospital stay, postoperative pathological examination, and follow-up. Follow-up was performed using outpatient examination and telephone interview to detect new-onset diabetes mellitus, pancreatic enzyme replacement therapy and disease recurrence up to March 2020.Results:Two patients successfully underwent MPP. The operation time of case 1 and case 2 were 470 minutes and 400 minutes, the volume of intraoperative blood loss were 200 mL and 100 mL, respectively. No blood transfusion was performed in either patient. The postoperative fasting blood glucose fluctuated between 5.4 and 11.8 mmol/L in case 1, and fluctuated between 5.9 and 11.3 mmol/L in case 2. Case 1 developed abdominal infection after operation, and was discharged after anti-infective treatment. Case 2 had good recovery with no complication. No pancreatic fistula or perioperative death occurred in two patients. The duration of postoperative hospital stay were 12 days and 8 days of case 1 and case 2, respectively. The pathological examination of case 1 showed serous cystadenoma of the pancreatic head and pancreatic tail. The pathological examination of case 2 showed that slightly dilated pancreatic ducts of the pancreatic head and tail with multiple stones and chronic inflammatory cells infiltration around the pancreatic ducts. The length of pancreas preserved was 8.5 cm and 8.3 cm of case 1 and case 2 on postoperative computed tomography (CT) reexamination. Two patients were followed up for 5 months and 7 months, respectively. During the follow-up, both patients had no new-onset diabetes and they didn′t require pancreatic enzyme replacement therapy. Both patients underwent upper abdominal CT examination at postoperative 5 months, which showed good blood supply in middle pancreas and no signs of recurrence of cystadenoma or stones.Conclusions:MPP is a safe and feasible procedure for the treatment of multifocal pancreatic lesions. The procedure can eradicate the lesions and ensure good control of blood glucose in patients.

Objective:To investigate the effects of urinary nickel exposure on insulin resistance, islet function and diabetes risk in adults aged 18 years and above in China.Methods:Based on the China National Human Biomonitoring from 2017 to 2018, a total of 500 diabetes patients were randomly selected as the case group, and the matched euglycemic control were selected by 1∶1 matching ratio. The urinary and venous blood samples of the subjects were collected, and the urinary nickel levels and serum glucose metabolism indexes such as fasting blood glucose and fasting insulin were detected, and the insulin resistance index (HOMA-IR), β cell function index (HOMA-β), and adjusted HOMA-β were calculated by using homeostasis model assessment. A multivariate logistic regression model was used to analyze the association between urinary nickel level and diabetes risk. Multiple linear regression models were used to evaluate the association of urinary nickel level with HOMA-IR, HOMA-β and adjusted HOMA-β.Results:The sex ratio of controls and cases was 1∶1. The multivariate logistic regression model showed that after adjusting for factors such as education level, smoking status, alcohol consumption, rice and meat intakes, family history of diabetes, BMI, total cholesterol level, hypertension, and urinary creatinine, compared with T1 group, the ORs of diabetes risk in the T2 and T3 groups were 1.36 (95% CI: 0.98-1.89) and 1.60 (95% CI: 1.14-2.24), respectively. The multiple linear regression model showed a positive association between urinary nickel levels and the elevated HOMA-IR, the β value of HOMA-IR in the T3 group was 0.12 (95% CI: 0.01-0.25) compared with the T1 group and each one-unit increase in the log-transformed urinary nickel level (2.71 μg/L) was associated with a 0.06 elevation in HOMA-IR (95% CI: 0.02-0.10). Meanwhile, the urinary nickel levels were negative associated with the adjusted HOMA-β, the β value of adjusted HOMA-β in the T3 group were -0.26 compared with the T1 group (95% CI: -0.41- -0.11), and each one-unit increase in the log-transformed urinary nickel level (2.71 μg/L) was associated with a -0.09 decrease in adjusted HOMA-β(95% CI: -0.14- -0.04). Conclusion:Higher urinary nickel level is positively correlated with elevated insulin resistance and diabetes risk while negatively correlated with the function of pancreatic islet β cells in adults in China.