OBJECTIVE To evaluate the bioequivalence and safety of two k inds of Nadroparin calcium injection in healthy Chinese volunteers by subcutaneous injection. METHODS According to the block randomization method ，24 Chinese healthy adult volunteers were included and divided into TR （test preparation-reference preparation ）group and RT （reference preparation-test preparation）group at a ratio of 1∶1. A randomized ，open-labelled，single-dose and two-cycle crossover study was designed ，the fasting subjects of two groups were given test or reference preparation 6 150 AⅩaIU subcutaneously on the first day of each cycle and exchanged in the second cycle ，and the wash-out period was 7 days. The blood samples were collected at different time points before and after administration. The activity of anti-coagulant factor Ⅹa（Anti-Ⅹa）and Anti- Ⅱa in human plasma were determined by chromogenic substrate method ，and the pharmacodynamic parameters were calculated according to the non-atrioventricular model and the bioequivalence was evaluated. The occurrence of adverse events （AEs）was recorded. RESULTS After administration ，the main pharmacodynamic parameters for Anti- Ⅹa activity of test preparation and reference preparation were as follows ：t1/2 were（4.87±1.06） and（4.03±1.00）h，tmax were 4.50（2.00，8.00）and 5.50（2.50，8.00）h，Anti-Ⅹamax were（0.66±0.12）and（0.56±0.11）IU/mL；main pharmacodynamic parameters of Anti- Ⅱa activity of two preparations were as follows ：t1/2 were（3.64±1.60）and（5.74±7.23）h，tmax were 4.00（2.50，8.00）and 4.00（2.00，8.00）h，Anti-Ⅱamax were both （0.10±0.03）IU/mL. The values of 90％confidence interval of geometric mean ratio of Anti- Ⅹamax，AUEC0－t and AUEC 0－∞ were 110.98％-123.50％，112.11％-121.24％and 111.57％-120.00％， respectively. During experiment ，14 subjects reported 19 cases of mild AEs ，among which hematoma ，purpura and maculopapular rash may be related to drugs ；no serious AEs were observed. CONCLUSIONS The domestic Nadroparin calcium injection is bioequivalent to the reference preparation ，and both of them show good safety.

Objective To understand the contamination status of common food-borne pathogens in foods sold in Changzhou, and to provide evidence for food safety risk assessment and prevention of food-borne diseases. Methods From 2010 to 2020 , 2 513 samples of 17 types of foods were collected in Changzhou area. The detection of pathogenic bacteria was carried out in accordance with the standard operation procedure specified in the ^“Workbook for Surveillance on Food Microorganisms and Pathogenic Factors in Jiangsu Province^”. Results A total of 260 positive samples of common food-borne pathogens were detected in all 2 513 samples with an overall detection rate of 10.30%. Single factor analysis showed that the detection rate of pathogenic bacteria in non-ready-to-eat samples was higher than that in ready-to-eat samples (χ²=148.875，P =0.000). The detection rate of pathogenic bacteria in bulk samples was higher than that in prepackaged ones (χ²=70.956，P=0.000). There is a difference in the detection rate of food-borne pathogens from different types of sampling sites (χ²=65.017，P=0.000). Logistic regression analysis showed that ready-to-eat food, packaging type, and sampling season were significantly correlated with the detection rate of food-borne pathogens. The detection rate of pathogenic bacteria in samples collected in the third or fourth quarters was higher than that in the first quarter. Conclusion The commercial foods sold in Changzhou have a relatively high level of contamination of food-borne pathogenic bacteria, and they should be fully heated and sterilized before consumption. The relevant departments should strengthen supervision and health education in summer and autumn.

Objective To probe into the feasibility and applicability of the foodborne food risk monitoring and sentinel hospital foodborne disease surveillance on the Salmonella serotype identification by liquid phase suspension array. Methods The serotyping of Salmonella isolates was performed by traditional glass agglutination test. Meanwhile, the liquid phase suspension array was operated to analyze the antigen O, H and AT for classification identification. Results From 2012 to 2019, a total of 215 strains of Salmonella were collected divided into 38 serotypes, 96% of them could be analyzed by SSA kit. The results of xMAP were in accordance with the traditional agglutination. 8 of the 11 strains which cannot be checked out by glass agglutination seemed to be easy detected by liquid phase suspension array. Conclusion The liquid phase suspension array has advantages of high throughput, high sensitivity and high specificity. It is able to detect the Salmonella serotype rapidly during a short time. Compared with the traditional serum agglutination method, the liquid phase suspension array has obvious advantages in detection time. It can be useful and important in the break out of foodborne disease caused by Salmonella spp.

Objective: To study the correlation between the level of serum Chitinase-3-like protein 1 (CHI3L1) and the significant liver fibrosis and liver cirrhosis in patients with chronic liver disease, and to evaluate its diagnostic value. Methods: 165 patients with chronic liver disease were selected, liver histopathological examination was performed to detect serum CHI3L1 concentration. Four indexes of hepatic fibrosis (type III procollagen, collagen IV, laminin, hyaluronic acid), aspartate aminotransferase/platelet ratio index (APRI) and FIB-4 (fibrosis- 4) scores were based on the pathological findings of liver biopsy and compared the advantages and disadvantages of serum CHI3L1 with other methods for the diagnosis of hepatic fibrosis and liver cirrhosis. A multivariate regression analysis model was created, and receiver operating characteristic curve was analyzed. Results: The level of serum CHI3L1 increased with increase of fibrosis stage and was highest in liver cirrhosis stage. In the period of S0 to 1, the levels of S2 to 3 and S4 were 62.82 (41.40 ~ 87.20), 70.94 (48.47 to 122.60) and 141.06 (78.18 ~ 197.40), and there were statistically significant differences between the groups (P < 0.001). The area under the curve for the diagnosis of significant liver fibrosis was 0.68 (0.60 to 0.77), and 0.74 (0.65 to 0.83) for cirrhosis in CHI3L1. Multivariate regression analysis showed that CHI3L1 was an independent predictor of significant fibrosis and cirrhosis. The combined diagnostic model based on CHI3L1, collagen IV and FIB-4 scores further improved the diagnostic value. The area under the curve for the diagnosis of significant fibrosis and cirrhosis was 0.79 (0.72 to 0.86) and 0.80 (0.73 to 0.87), respectively. Conclusion CHI3L1 has a good diagnostic value in patients with chronic liver disease with significant fibrosis and liver cirrhosis. The diagnostic model in combination with other markers like Collagen IV and FIB-4 scores could further improve the diagnostic value and is worthy of further study.

Objective To evaluate the clinical significance of transvaginal color Doppler ultrasound for the differential diagnosis of benign and malignant ovarian cysts. Methods Patients who were diagnosed with clinically suspected or palpable adnexal masses and underwent gray-scale ultrasonography, transvaginal color Doppler ultrasonography, and ultrasound-guided fine-needle aspiration cytology (FNAC) during the period from 2018 to 2021 were enrolled in this study. The pulsatility index (PI) and resistance index (RI) were estimated, and an ovarian cyst with the lowest PI value of < 1.0 or the lowest RI value of < 0.4 was considered as malignant. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of gray-scale ultrasound and transvaginal color Doppler ultrasound for the differential diagnosis of benign and malignant ovarian cysts were estimated with FNAC as the gold standard. Results A total of 180 patients with ovarian cysts were recruited, and FNAC revealed that 81 of them had malignant lesions and 99 of them had benign lesions. The transvaginal color Doppler ultrasonograms showed that 75 patients (92.59%) with malignant lesions had blood-flow signals in their cysts and 42 patients (42.24%) with benign lesions had blood-flow signals in their cysts, with a significant difference in the proportion between the two groups (χ² = 49.29, P < 0.01). Among the 75 patients with blood-flow signals in malignant ovarian cysts, 75 had PI < 1.0 and 24 had RI < 0.4; among the 42 patients with blood-flow signals in benign ovarian cysts, 15 had PI < 1.0 and no one had RI < 0.4; there were significant differences in the proportions of PI < 1.0 and RI < 0.4 between the two groups (χ² = 62.68, P < 0.01; χ² = 16.91, P < 0.01). In addition, compared with the combination of gray-scale ultrasound and transvaginal color Doppler ultrasound, gray-scale ultrasound alone had significantly lower sensitivity (51.85% vs 81.48%; χ² = 16.00, P < 0.01), specificity (75.76% vs 93.94%; χ² = 12.73, P < 0.01), PPV (63.64% vs 91.67%; χ² = 15.90, P < 0.01), and NPV (65.79% vs 86.11%; χ² = 12.44, P < 0.01) for the differential diagnosis of benign and malignant ovarian cysts. Conclusion Gray-scale ultrasound is effective for diagnosing ovarian cysts; however, gray-scale ultrasound combined with transvaginal color Doppler ultrasound can improve the differential diagnosis of benign and malignant ovarian cysts.

Objective To summarize the general characteristics and identification considerations of appraisal of post-traumatic epilepsy （PTE） in forensic clinical expertise. Methods Descriptive statistics were made on the general situations （age and sex）, injury sites, PTE grading, clinical manifestations and blood drug concentrations of 30 cases of PTE. Chi-square test was performed on the differences of sex composition, age group incidences, injury sites, clinical manifestations and PTE grading. Fisher's exact probability method was used to test the differences in clinical manifestations and PTE grading of each site and the differences in PTE grading of different clinical manifestations. Results PTE occurred more frequently among 21 to 40 year olds, more in males than in females, and more frequently in the temporal lobe and frontal lobe. The clinical manifestations were mostly partial seizures and the PTE grading was mostly mild PTE. There were no statistical significance in the differences in distribution of clinical manifestations and PTE grading of injury sites （P>0.05）. The difference in the PTE grading of different clinical manifestations had no statistical significance （P>0.05）. The blood drug concentration of the three identified people did not reach the effective concentration, which affected the final identification opinion. Conclusion In the identification of PTE, in addition to strictly grasping the necessary factors of identification, such as the history of craniocerebral trauma, and epileptic seizures, it is also suggested that attention should be paid to the detection of blood drug concentration. Overall analysis and comprehensive evaluation should be made.
Adult ; Craniocerebral Trauma ; Epilepsy, Post-Traumatic ; Female ; Humans ; Incidence ; Male ; Retrospective Studies ; Young Adult

Objective To assess the state of schistosomiasis elimination in 6 districts of Changzhou City, Jiangsu Province, so as to provide the evidence for the formulation of consolidation measures. Methods Three towns (streets) were selected according to the schistosomiasis epidemic degree in each district, and one village was sampled from each town. The on-site assessment was carried out between 2016 and 2017, including Oncomelania hupensis snail survey, population investigation and domestic animal investigation. In addition, the related data and materials were evaluated and the monitoring ability was assessed. Results In the history, there were 54 endemic towns, 368 endemic villages in Changzhou City, with a total area of 3 934.79 hm² of historic snail spots, and 114 990 schistosomiasis cases so far. In the field assessment in 6 districts, a total of 26 environments were surveyed, with the surveyed area of 36.23 hm², and there were no living snails captured in each village. A total of 18 199 people were examined for schistosome infection, 255 were blood test positive, and the sero-positive rate was 1.40%. The stool examination was done in 255 sero-positive cases, and no cases were stool-positive. A total of 779 domestic animals were investigated, including 200 cattle, 179 sheep and 400 pigs, and no infections were detected. The files regarding the snail status and schistosomiasis epidemic situation, and the monitoring data were complete and accurate in 6 districts. The annual investment funds for schistosomiasis prevention were 3 120 000 Yuan in Changzhou City, and the number of staff working for schistosomiasis prevention was 86 totally, which could meet the requirements of high quality monitoring. Conclusions All 6 districts of Changzhou City have met the requirements of schistosomiasis elimination.

Brain Ischemia ; Cell Polarity ; Humans ; Ischemic Stroke ; Microglia ; Stroke/therapy*

Objective To analyze serotype distribution, drug resistance, quinolone resistance gene carrying status and genetic relationship of foodborne Salmonella and human Salmonella isolates in Changzhou from 2012 to 2018, to provide scientific basis for the prevention and control of Salmonella. Methods The serum type was identified by serum agglutination and liquid chip. The antibiotic sensitivity was determined by micro broth dilution method. The quinolone antibiotic resistance gene was determined by gene sequencing method. The multilocus sequence typing ( MLST ) typing was performed on quinolone-resistant Salmonella, and the genetic relationship was analyzed by BioNumerics 8.0. Results A total of 10 and 36 serotypes were detected in 46 foodborne Salmonella strains and 152 human Salmonella strains, respectively. The dominant serotypes were Indiana Salmonella and Salmonella typhimurium. Erythromycin resistance rate was the highest in both Salmonella strains, and the proportion of multidrug-resistant bacteria was 93.47 % ( 43 / 46 ) and 80.92 % ( 123 / 152 ), respectively. 38 strains of quinolone-resistant foodborne Salmonella GyrA subunit mainly occurred double mutations Asp87Asn, Ser83Phe, ParC subunit mainly occurred single mutation Ser80Arg, 119 strains of quinolone-resistant human Salmonella qnrS gene detection rate was higher, reached 68.1 % ( 81 / 119 ) ; The dominant ST types of quinolone-resistant Salmonella from two sources were ST17 and ST19, respectively. Conclusions The antibiotic sensitivity of the two Salmonella resistant strains from Changzhou was the same ; Synergistic drug resistance, but both quinolone resistance genemutations and carry inconsistent ; The ST type distribution of quinolone resistant strains isalso inconsistent, and the genetic relationship is far. It is suggested that the probability of Salmonella resistant bacteria infection caused by food transmission in our region is small, and the treatment of the two should be differentiated.

Post traumatic epilepsy （PTE） refers to the epileptic seizures after traumatic brain injury. Organic damage can be found by imaging examination, and abnormal electroencephalogram can be detected via electroencephalogram examination which has the similar location of the brain injury. PTE has the characteristics of low incidence, absence of case reports, and easy to exaggerate the state of illness, which add difficulties to the forensic identification. This paper reviews the status of epidemiology, pathogenesis, clinical treatment and forensic identification for PTE.
Brain Injuries, Traumatic/physiopathology* ; Electroencephalography ; Epilepsy ; Epilepsy, Post-Traumatic/pathology* ; Forensic Pathology ; Humans ; Incidence