OBJECTIVE To establish a chromatography-mass spectrometry method for simultanenous detection of 3 genotoxic impurities in pantoprazole sodium. METHODS The chromatographic column was octadecylsilane bonded silica gel as filler (Kromasil 100-5, 4.6 mm×25 cm, 5 μm or equivalent column), acetonitrile-0.01 mol·L−1 ammonium acetate(35∶65) as mobile phase, flow rate 0.9 mL·min−1, column temperature 25 ℃; positiveion detection mode, scanning range: 150−450 Da, dryer temperature 350 ℃, dry gas flow rate 10 L·min−1, atomization gas pressure 50 psig, capillary voltage 4 000 V, fragmentation voltage 175 V, cone hole voltage 65 V. The time for entering the mass spectrometry was set to 0−3.5 minutes to waste, 3.5 minutes to retain the main peak-0.5 minutes to MS, and 0.5 minutes to end to waste. RESULTS The concentration of genotoxic impurity 1 had a good linear relationship with peak area between 9.04−27.13 ng·mL−1(r=0.998), the concentration of genotoxic impurity 2 had a good linear relationship with peak area between 8.92−26.75 ng·mL−1(r=0.999), and the concentration of intermediate II had a good linear relationship with peak area between 7.78−23.34 ng·mL−1(r=0.990); the quantitative limit of genotoxic impurity 1 was 9.0430 ng·mL−1, and the detection limit was 0.9043 ng·mL−1; the quantitative limit of genotoxic impurity 2 was 8.9174 ng·mL−1, and the detection limit was 2.9725 ng·mL−1; the quantitative limit of intermediate II was 7.7792 ng·mL−1, and the detection limit was 0.7779 ng·mL−1; the recovery rate of 3 genotoxic impurities ranges from 92.3%−107.0%, with an RSD of 2.0%−7.9%. No three impurities were detected in pantoprazole sodium. CONCLUSION This method can accurately and quantitatively determine three genotoxic impurities of pantoprazole sodium raw material: genotoxic impurity 1, genotoxic impurity 2, and intermediate II. The method has strong specificity, high sensitivity, simple and rapid experimental operation, and can be used for the determination of the above three genotoxic impurities in pantoprazole sodium.

Objective:To investigate the detection status and genotypes distribution characteristics of norovirus(NoV)in environmental sewage from three monitoring points in Fujian province, and to explore the significance of its application to NoV monitoring.Methods:Sewage samples were collected monthly at 5 sampling sites in representative monitoring cities, enriched and concentrated. Partial gene fragments of norovirus VP1 were amplified by reverse transcription-semi nested polymerase chain reaction (RT-snPCR), TA cloned and sequenced. Genotypes were identified based on the sequencing.Results:A total of 56 sewage samples were collected from July 2022 to June 2023. The detection rates of GⅠ and GⅡ were 89.29% (50/56) and 94.64% (53/56), respectively. A total of 7 NoV GⅠ genotypes and 13 GⅡgenotypes were identified. GⅠ.1, GⅠ.4, GⅡ.4 and GⅡ.17 were the dominant genotypes. NoV genotypes detected in different sampling sites were not exactly the same. The detection rate of NoV was low from August to November 2022, and the prevalence of the dominant genotypes was different in different seasons. GⅠ.1 and GⅡ.4 were highly prevalent from August to November 2022, but were replaced by GⅠ.4 and GⅡ.17 from December 2022 to June 2023, respectively. More NoV genotypes were detected in January-June 2023, comparing to the July-December 2022. The dominant genotype GII.17, has multiple clades and new variants have been discovered that are different from the 2014/2015 circulating strains.Conclusions:The detection rates of NoV in environmental sewage were very high, and genotypes were diverse. Environmental sewage surveillance could be an important complementary method for NoV cases surveillance.

Objective:To evaluate a novel distraction reductor in the surgical treatment of unstable distal radius fractures with metaphyseal volar comminution.Methods:From January 2019 to December 2020, 27 patients with unstable distal radius fracture complicated with metaphyseal volar comminution were treated at Department of Orthopaedics, Zhoupu Hospital Affiliated to Shanghai University of Medicine & Health Sciences. They were 6 males and 21 females, with an age of (69.4±9.4) years. All fractures were unilateral and closed, involving the right side in 17 cases and the left side in 10 cases. All patients were treated by internal fixation with an anatomical locking plate through the volar approach and the novel distraction reductor was used to reduce the fracture ends. Regular imaging examinations were performed to evaluate the reduction, maintenance and union of fractures after surgery. One year after operation, the curative efficacy was assessed by evaluation of the range of wrist motion, Disabilities of the Arm, Shoulder and Hand (DASH) score, Gartland-Werley score and Bartra radiology score.Results:All the operations went on successfully with a duration of (92.3±8.9) min. All the incisions healed primarily. The follow-up time was (15.9±2.9) months. The radial height, palmar tilt, ulnar inclination and articular surface step-off immediately after operation [(11.23±1.51) mm, 12.10°±3.44°, 20.54°±3.44°, and (0.95±0.42) mm] were not significantly lost compared with those one year after operation [(11.22±1.55) mm, 12.07°±3.44°, 20.51°±3.33°, and (0.93±0.40) mm] (all P>0.05). One year after operation, the range of wrist motion was good with dorsiflexion of 59.7°±5.5°, palm flexion of 63.0°±9.1°, pronation of 66.5°±5.5°, supination of 61.2°±5.6°, radial deviation of 22.7°±4.8°, and ulnar deviation of 30.3°±6.1°; DASH score was 13.5±5.5; Bartra radiology score was 88.6±6.5, giving an excellent and good rate of 88.9% (24/27);Gartland-Werley score was 2.7±2.1, giving an excellent and good rate of 92.6% (25/27). Follow-ups observed no poor fracture healing, internal fixation failure, tendon or nerve injury or traumatic arthritis. Conclusion:In the surgical treatment of unstable distal radius fractures with metaphyseal volar comminution, the novel distraction reductor can lead to ideal reduction of displaced fractures and effectively correct the shortening caused by volar cortex comminution to achieve satisfactory functional effects in clinic.

Objective : To analyze the genome structure and genetic characteristics of IncpGRT1 plasmids from Pseud⁃ omonas , and elucidate its potential transmission risk . Methods : The genomic DNA of the clinical isolate 15420352 was extracted after purification and preservation of the strain , and then the whole genome was sequenced , and then the type of the plasmid was identified . Sequence annotation and comparison of the backbone region and the accessory modules were performed on all five same type sequenced plasmids , including one plasmid p420352 - strA in this study and four from GenBank . The plasmids were annotated by RAST , Plasmidfinder , Blast , ResFinder , and ISfinder. The ORFs of the plasmid were annotated and drug resistance genes were found . Results : All five plasmids were classified as new IncpGRT1 type plasmids . The IncpGRT1 backbone genes or gene loci were in all five plasmids , and they contained an auxiliary replicon besides the primary IncpGRT1 replicon . Five IncpGRT1 plasmids carried at least three different accessory modules , including the srp region , the msr region , and a Tn5053 family transposon . Three resistance genes strA , strB , and mer were obtained in these plasmids , which were involved in resistance to two categories of antibiotics and heavy metals . We also found that these plasmids carried at least one virulence gene msr and five key transporters srp , emrE , mod , phn , and lpt , which could improve the environmental adaptability of the strains . Conclusion The IncpGRT1 plasmids have become the important vector for the accumulation and spread of some drug resistance genes and virulence genes in Pseudomonas , and have improved the environmental adaptability of the strain.

Objective:To systematically evaluate the efficacy of live Bifidobacterium preparations combined with entecavir in the treatment of hepatitis B virus-related cirrhosis.Methods:PubMed, Web of Science, CNKI, Wanfang, VIP, and other databases were searched electronically until October 2020. Randomized controlled clinical trials in the treatment of hepatitis B virus-related cirrhosis with live Bifidobacterium preparations combined with entecavir were included for statistical analysis. The relative risk ( RR) was used as the effect size for the count data. Measurement data were expressed as mean difference ( MD) or standardized mean difference ( SMD) to represent the effect size. 95% confidence intervals (95% CI) were calculated for each effect size. The I2 statistic and P-values were used to evaluate the heterogeneity of the included literature. The fixed effect model was used for analysis if I2≤50%, P > 0.1; otherwise, the random effect model was used for meta-analysis. Results:A total of 865 patients from nine studies were included. Among them, 434 cases were in the live Bifidobacterium preparation combined with the entecavir treatment group and 431 cases in the entecavir group. The results showed that compared with the entecavir group, the live bifidobacterium preparation combined with the entecavir treatment group had significantly reduced the four indicators of liver fibrosis: serum hyaluronic acid (HA) ( SMD = -1.87 ng/ml, 95% CI: -2.32 ~ 1.41, P < 0.01), laminin (LN) ( SMD = -1.62 ng/ml, 95% CI: -2.04 ~ 1.19, P < 0.01), type III procollagen peptide (PC-III) ( SMD = -0.98, 95% CI: -1.26 ~ 0.7, P < 0.01), type IIIcollagen (III-C) ( SMD = -1.14 ng/ml, 95% CI: -1.73 ~ 0.55, P < 0.01), portal vein diameter ( SMD = -0.91 mm, 95% CI: -1.27 ~ 0.55, P < 0.01) and spleen thickness ( MD = -3.26mm, 95% CI: -3.95 ~ 2.58, P < 0.01). However, there was no statistically significant difference in the negative conversion rate of hepatitis B virus DNA (HBV DNA) between the two groups of patients. Conclusion:Compared to the entecavir treatment group, the live Bifidobacterium preparation combined with entecavir showed apparent severity improvement and enhanced clinical efficacy in patients with hepatitis B virus-related cirrhosis.

Objective:To analyze the clinical characteristics in patients with persistent positive pharyngeal swab of 2019 novel coronavirus Omicron variant and results of nucleic acid testing of anal swabs to provide basis for prevention and control measures.Methods:This study included 93 patients whose pharyngeal swab nucleic acid test were persistent positive and admitted to the ward of Daping Hospital in the National Exhibition and Convention Center (Shanghai) Makeshift Hospital from May 1 to May 24, 2022. The gender, age, underlying diseases, vaccination status, clinical symptoms, interval between infection onset and anal sampling, length of hospital stay, the nucleic acid test result of pharyngeal swabs and anal swabs and the time turning negative were collected and analyzed.Results:The age of 93 patients ranged from 8 to 72 years old with a median of (46.0±16.0) years old. Among them, 30 cases (32.3%) were male and 63 cases (67.7%) were female. Sixty-five patients (69.9%) received 2-3 shots of vaccine, 2 patients (2.1%) received 1 shot, and 26 patients (28.0%) did not receive any vaccination. Twenty patients (21.5%) had underlying diseases, of which hypertension (13 cases, 14.0%) and type 2 diabetes mellitus (6 cases, 6.5%) were the most common. Twenty-four patients (25.8%) had asymptomatic infection and the rest (69 cases, 74.2%) had mild symptoms. Cough (50 cases, 53.8%) and sore throat (28 cases, 30.1%) were the most common clinical manifestations of the upper respiratory tract in these patients. Only 6 patients (6.5%) had gastrointestinal symptoms (including diarrhea in 5 patients and diarrhea with vomiting in 1 patient). Pharyngeal and anal swabs were collected simultaneously from all 93 patients at 8-16th days [(11.55±2.27) days] after 2019 novel coronavirus Omicron variant infection. The pharyngeal swabs were positive in 79 patients (85.0%) and the anal swabs were positive in 5 patients (5.4%). The time of pharyngeal swabs turning negative was (14.7±2.9) days, and that of anal swab turning positive was (14.2±1.9) days. The median length of hospital stay was (16.7±2.9) days.Conclusions:In patients with persistent positive nucleic acid of the 2019 novel coronavirus Omicron variant, there were more mild infection than asymptomatic. The upper respiratory tract symptoms such as cough and sore throat were the most. The likelihood of transmission of 2019 novel coronavirus Omicron variant through the digestive tract may be low. The correlation between gastrointestinal symptoms and 2019 novel coronavirus Omicron variant RNA in the digestive tract is uncertain.

Objective:To evaluate the effects of vaccine switch on the levels of neutralizing antibody (NA) of poliovirus in children aged<12 years.Methods:Subjects aged<12 years from 9 districts in Fujian province were chosen by stratified cluster and complete random sampling method. Blood samples were collected for testing NA of poliovirus by microcell neutralization.Results:A total of 2 134 subjects aged<12 years were selected. The positive rate of NA against PVⅠand Ⅲ were 98.64% and 95.83%; and geometric mean titers (GMTs) were 1∶259.35 and 1∶105.14, respectively. The GMTs presented a trend of decreasing as age increased. Compared to trivalent oral poliovirus vaccine (tOPV), bivalent oral poliovirus vaccine (bOPV) and inactivated poliovirus vaccine (IPV) induced higher GMTs of NA against poliovirusⅠand Ⅲ respectively. Among 182 children aged<5 years, the positive rate of NA against PVⅠ, Ⅱ, Ⅲ were 97.25%, 76.37% and 92.86%. There were statistical differences among the three types ( χ2=44.44, P=0.000). The rate of NA against PVⅡwas significantly lower than those ofⅠand Ⅲ (Ⅱ vs. I: χ2=34.65, P=0.000; Ⅱ vs. Ⅲ: χ2=18.99, P=0.000). And the GMTs of NA against PV Ⅰ, Ⅱ, Ⅲ were 1∶368.96、1∶23.06 and 1∶183.10, which were significantly different ( F=156.54, P=0.000). The GMT of PVⅠwas the highest, PV Ⅲ was the second, PVⅡ was lowest (pairwise comparison showed values of P all were 0.000). The analysis of general linear model showed that the interval between the date of last immunization and the date of sample collection would affect the GMTs of PVⅠand Ⅲ, different vaccine models would affect only the GMT of PV Ⅰ. The age maybe was a confounding factor. But no factors would affect the GMT of PV Ⅱ. Conclusions:After the vaccine switch, the level of NA against PVⅠand PV Ⅲ were still maintaining high level, but the level of PVⅡamong children<5 years was at relatively low level, which indicated that the surveillance should be strengthened.

Objective:To investigate the triggering factors of ischemic stroke and their correlation with stroke severity and traditional risk factors.Methods:The clinical data of patients with ischemic stroke within 2 weeks of the onset were collected retrospectively. They were divided into two groups according to the questionnaire of triggering factors. The demographic and baseline data of the two groups were compared. According to the National Institutes of Health Stroke Scale (NIHSS) score, the patients were divided into low NIHSS score group (≤8) and high NIHSS score group (>8). The demographic and baseline data were compared. Multivariate logistic regression analysis was used to determine the independent related factors of the existence of triggering factors in patients with ischemic stroke and the correlation between the existence of triggering factors and the severity of stroke. Results:A total of 217 patients were enrolled in the study. Their age was 63.4±12.8 years and 148 were male (68.2%). One hundred and nine patients had at least one triggering factor. Common triggering factors were sleep disorders (46.8%), infection (18.4%), and missed medication (13.8%). Multivariate logistic regression analysis showed that after adjusting for confounding factors, diabetes mellitus (odds ratio [ OR]2.496, 95% confidence interval [ CI]1.347-4.626; P=0.047), large artery atherosclerosis ( vs. small vessel occlusion: OR 2.168, 95% CI 1.060-4.343; P=0.034) and baseline NIHSS score (the fourth quartile vs. the first quartile: OR 2.320, 95% CI 1.043-5.162; P=0.039) were independently associated with the existence of triggering factors in patients with ischemic stroke, and any of the triggering factors was independently associated with stroke severity ( OR 2.042, 95% CI 1.106-3.770; P=0.023). Conclusion:Diabetes and the severity of stroke are associated with the existence of triggering factors in patients with ischemic stroke. Stroke severity in ischemic stroke patients with triggering factors is more severe.

Objective:We isolated and identified the genotypes and molecular characteristics of the imported B3 measles virus (MeV) in Fujian province in 2018.Methods:Throat swab specimens were collected from clinically diagnosed measles patients and tested for viral RNA, using the real-time reverse transcription-polymerase chain reaction after the RNA extraction. Reverse transcription-polymerase chain reaction method was undertaken to amplify the 634 nucleotide acids of 3-terminal of the nucleoprotein gene. A phylogenetic tree was constructed and similarities in homology assessed.Results:We successfully isolated and obtained two measles virus strains and eighteen viral nucleic acid sequences. The Fujian strains were clustered within the same genotype group of WHO genotype B3 reference strains. Compared to the major circulating measles strain genotype B3 in the world, two Fujian strains MV18-41 and MV18-42 showed 100.0 % nucleic acid homology to HongKong.CHN/35.18 strain which was isolated from Hong Kong in 2018. The remaining 16 Fujian strains showed the highest homology (99.9 %) with the Mvs/Osaka.JPN/38.18/B3 strain isolated from Japan in 2018. Compared with other 23 WHO genotype reference strains, homology on both nucleotide and amino acid of the Fujian strain and the B1 genotype reference strain were the smallest, as 95.1 %-95.4 % and 95.3 %, respectively. The differences of homology between the Fujian strain and H1 genotype reference strain were the largest, as 88.7 %-89.0 % and 87.3 %, respectively. In addition, there were 13 mutation sites between the Fujian strain and the vaccine strain (Shanghai-191) at the 150 amino acid position of carboxy terminus on N protein, However, these sites did not cause functional changes in the protein region. Conclusions:In Fujian province, two strains of B3 genotype measles virus were obtained successfully, which were considered to be new genotype measles virus found in 2018. These findings showed it is necessary to strengthening the monitoring program on imported cases for better control and eliminate the measles virus.

Objective:To analyze the complete genome sequence characteristics of genotype G mumps virus isolated from Putian city, Fujian province in 2015.Methods:Two mumps virus strains isolated in Putian city, Fujian province in 2015 were selected for the study and named as MuV15-01 and MuV15-23.The whole genome of the isolated strains was amplified by reverse transcription-polymerase chain reaction (Rt-PCR). The genetic differences and antigen site variation of the isolated strain were analyzed by comparing the sequences of vaccine strain and other genotypes strains.Results:The total length of genome of MuV isolates was 15, 384 nucleotides. The nucleotide differences between isolates and other genotypes of mumps virus based on the whole genome ranged between 3.7% and 6.0%. The maximum and minimum difference was found between isolates and genotype A (the vaccine strains), and genotype B to N strains, respectively. Among the nucleotide sequences encoding different viral proteins, SH gene had the largest variation, while M and L genes were the most conserved. There were 7 and 11 amino acid mutations in the known antigen related sites of N gene and HN gene, respectively. Compared with the vaccine strain, the isolated strain added an additional N-glycosylation site to the 464 site of the HN gene.Conclusions:Genetic variations were detected in the epidemic mumps virus strains in Putian, Fujian, compared with other mumps genotypes and vaccine strains based on the whole genome. These resluts indicate that the monitoring for genetic differences between epidemic mumps strains and vaccine strains should be further strengthened.