Background::A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has previously shown its preliminary efficacy in ST elevation myocardial infarction (STEMI) patients. This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase (rt-PA) in Chinese patients with STEMI.Methods::In this multicenter, randomized, open-label, non-inferiority trial, patients with acute STEMI were randomly assigned (1:1) to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min. The primary endpoint was recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3. The secondary endpoint was clinically justified recanalization. Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events (MACCEs) and safety endpoints.Results::From July 2016 to September 2019, 767 eligible patients were randomly assigned to receive rhTNK-tPA ( n = 384) or rt-PA ( n = 383). Among them, 369 patients had coronary angiography data on TIMI flow, and 711 patients had data on clinically justified recanalization. Both used a –15% difference as the non-inferiority efficacy margin. In comparison to rt-PA, both the proportion of patients with TIMI grade 2 or 3 flow (78.3% [148/189] vs. 81.7% [147/180]; differences: –3.4%; 95% confidence interval [CI]: –11.5%, 4.8%) and clinically justified recanalization (85.4% [305/357] vs. 85.9% [304/354]; difference: –0.5%; 95% CI: –5.6%, 4.7%) in the rhTNK-tPA group were non-inferior. The occurrence of 30-day MACCEs (10.2% [39/384] vs. 11.0% [42/383]; hazard ratio: 0.96; 95% CI: 0.61, 1.50) did not differ significantly between groups. No safety outcomes significantly differed between groups. Conclusion::rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery, a validated surrogate of clinical outcomes, among Chinese patients with acute STEMI.Trial registration::www.ClinicalTrials.gov (No. NCT02835534).

Objective To monitor the susceptibility of clinical isolates to antimicrobial agents in tertiary hospitals in major regions of China in 2022.Methods Clinical isolates from 58 hospitals in China were tested for antimicrobial susceptibility using a unified protocol based on disc diffusion method or automated testing systems.Results were interpreted using the 2022 Clinical &Laboratory Standards Institute(CLSI)breakpoints.Results A total of 318 013 clinical isolates were collected from January 1,2022 to December 31,2022,of which 29.5％were gram-positive and 70.5％were gram-negative.The prevalence of methicillin-resistant strains in Staphylococcus aureus,Staphylococcus epidermidis and other coagulase-negative Staphylococcus species(excluding Staphylococcus pseudintermedius and Staphylococcus schleiferi)was 28.3％,76.7％and 77.9％,respectively.Overall,94.0％of MRSA strains were susceptible to trimethoprim-sulfamethoxazole and 90.8％of MRSE strains were susceptible to rifampicin.No vancomycin-resistant strains were found.Enterococcus faecalis showed significantly lower resistance rates to most antimicrobial agents tested than Enterococcus faecium.A few vancomycin-resistant strains were identified in both E.faecalis and E.faecium.The prevalence of penicillin-susceptible Streptococcus pneumoniae was 94.2％in the isolates from children and 95.7％in the isolates from adults.The resistance rate to carbapenems was lower than 13.1％in most Enterobacterales species except for Klebsiella,21.7％-23.1％of which were resistant to carbapenems.Most Enterobacterales isolates were highly susceptible to tigecycline,colistin and polymyxin B,with resistance rates ranging from 0.1％to 13.3％.The prevalence of meropenem-resistant strains decreased from 23.5％in 2019 to 18.0％in 2022 in Pseudomonas aeruginosa,and decreased from 79.0％in 2019 to 72.5％in 2022 in Acinetobacter baumannii.Conclusions The resistance of clinical isolates to the commonly used antimicrobial agents is still increasing in tertiary hospitals.However,the prevalence of important carbapenem-resistant organisms such as carbapenem-resistant K.pneumoniae,P.aeruginosa,and A.baumannii showed a downward trend in recent years.This finding suggests that the strategy of combining antimicrobial resistance surveillance with multidisciplinary concerted action works well in curbing the spread of resistant bacteria.

Objective To investigate the efficacy and safety of hybrid surgery for the recanalization of carotid artery occlusion after stenting.Methods Clinical data and results of 17 patients with occlusion after carotid artery stenting and treated with hybrid surgery from June 2016 to April 2023 at the Department of Neurosurgery Cerebral Blood Flow Reconstruction Center of Xuanwu Hospital,Capital Medical University were retrospectively analyzed.According to whether the recanalization was successful,17 patients were divided into the the successful recanalization group and the failed recanalization group.Successful recanalization was defined as achieving modified thrombolysis in cerebral infarction(mTICI)grade ≥2b and residual stenosis＜50％.Baseline data(age,sex,body mass index,smoking history,alcohol consumption history,hypertension history,diabetes history,hyperlipidemia history,coronary heart disease history),clinical data(National Institutes of Health Stroke Scale[NIHSS]score at admission,fasting blood glucose,low density lipoprotein,high density lipoprotein,total cholesterol,triglyceride,occlusion side and segment,combination with severe stenosis or occlusion of the contralateral carotid artery,opening of the anterior communicating artery,opening of the posterior communicating artery,compensation of the external and internal carotid artery,compensation of the pia artery,stump morphology,and time from imaging diagnosis of occlusion to recanalization)were documented and compared between groups.The recanalization of occlusive vessels and perioperative complications were recorded.Imaging and clinical follow-up were performed 3,6 months and≥1 year after surgery.Results Among the 17 patients,the ratio of successful recanalization was 13/17.One patient had re-occlusion after operation,which was re-opened after thrombolysis,but neck hematoma with dyspnea occurred,and recovered after emergency operation.There was no postoperative stroke or death.The incidence of perioperative complications was 1/17.Compared with the successful recanalization group,the levels of high density lipoprotein and total cholesterol in the failed recanalization group were higher,and the differences between the groups were statistically significant(high density lipoprotein[1.3±0.3]mmol/L vs.[0.9±0.3]mmol/L,t=-2.139;total cholesterol:[4.2±0.8]mmol/L vs.[3.1±0.7]mmol/L,t=-2.649;both P＜0.05);There were no significant differences in other baseline data and clinical data(all P＞0.05).Imaging follow-up was completed in 9 of the 13 patients in the successful recanalization group,and the follow-up time was 3.8-36.9 months,with a median follow-up time of 22.8(12.8,34.7)months.Among them,1 patient(1/9)developed restenosis of recanalization vessels at 33.0 months after surgery and underwent stent implantation again.Conclusions The preliminary analysis showed that the occlusion after carotid artery stenting had better recanalization success and lower perioperative complications.In patients with chronic occlusion after carotid stenting,the application of a hybrid surgery for opening may be attempted under multimodal imaging assessment.

Klebsiella pneumoniae(KPn),as a conditioned pathogen that causes calf pneumonia,has caused serious harm to cattle industry,but the harm of Klebsiella pneumoniae to calves in Xin-jiang region is still unclear.In this study,to investigate the prevalence of KPn,its harm and some biological characteristics of pneumonia calves in Xinjiang,nasal swabs of pneumonia calves in some areas were collected aseptically,KPn isolation and identification were performed by routine meth-od,and 16S rDNA sequence evolutionary tree analysis was performed.The drug resistance was de-tected by K-B method,and a strain carrying multiple virulence was selected for mice median lethal dose test.The serotype,virulence gene and drug resistance gene of the strain were detected by PCR.The results showed that the detection rate of Klebsiella pneumoniae in nasal swabs of 218 pneumonia calves from Aksu,Changji and Yili regions of Xinjiang was as follows:14.68％(32/218),including 28.33％(17/60)in Aksu Prefecture,24.00％(6/25)in Changji Prefecture and 6.77％(9/133)in Yili Prefecture,they were divided into two serotypes,namely K1(7/32)and K5(5/32).A total of 13 KPn virulence genes were detected,mainly mrkD,ureA,wabG,uge and en-tB.LD50 was 2.38X 107cfu/mL.Drug susceptibility test and drug resistance gene detection showed that the isolated strain showed multiple drug resistance,and the resistance genes mainly carried blasHv and floR.16S rDNA sequence evolutionary tree results showed that the isolated strain had high homology with the isolates from Italy,Beijing and Shanghai of China.The detection rate of KPn in nasal swabs of pneumonia calves in Xinjiang region is high.The dominant serotypes are K1 and K5.The isolates carry a variety of virulence genes and have strong virulence.All of them are KPn strains producing ESBLs,suggesting that Klebsiella pneumoniae in Xinjiang region of China have a certain potential harm to calves.

Mannheimia haemolytica is an important pathogen causing respiratory diseases in sheep,and the development of an inactivated vaccine of sheep origin against Mannheimia haemolytica is an effective means of prevention and control of this pathogen.In this study,Mannheimia haemo-lytica isolated from the diseased material collected from a sheep farm was screened for the most suitable vaccine strain by mouse pathogenicity test,and the inactivated vaccine was prepared by combining four antigenic amounts(106,107,108,109 CFU/mL)with three adjuvants(ISA 201 ad-juvant,ISA 206 adjuvant,and aluminum adjuvant),which were used in immunization and attack protection tests,and then screened for immunity and attack protection tests.Immunization and at-tack protection tests were conducted to screen the optimal antigen amount and adjuvants for inacti-vated vaccine preparation.Finally,the vaccine was prepared under the optimal conditions and the dynamic changes of antibody levels in immunized sheep were observed.The results showed that a total of 24 strains of Mannheimia haemolytica of sheep origin were isolated,among which 12 strains of serotype A1 were the dominant serotypes for the infection in this sheep farm;one strain of Mannheimia haemolytica of sheep origin of type A1(Mh1)was screened and obtained as the strain for vaccine preparation.Its LD50 for mice was 3.16 × 107 CFU/mL,with strong pathogenici-ty,and could cause pathological damage such as inflammatory cell infiltration of varying degrees in heart,liver,spleen,lung and kidney tissues;the results of the immunization and attack protection test showed that the optimal antigenic amount of the inactivated vaccine was 109CFU/mL,and the most suitable adjuvant was ISA 201,which stimulated the production of the highest antibody level and provided 100％protection for the mice.The protection rate of mice reached 100％,and good humoral immunity could be induced after immunizing sheep.The inactivated Mannheimia haemo-lytica type A1 vaccine prepared in this study has good immunoprotection effect,and lays a good foundation for the further development of commercial vaccine against Mannheimia haemolytica of sheep origin.

Objective:To evaluate the clinical and prognostic value of prothrombin time(PT)and activated partial thromboplastin time(APTT)in newly diagnosed patients with multiple myeloma(MM).Methods:The clinical data of 116 newly diagnosed MM patients in the Second Hospital and Third Hospital of Shanxi Medical University from October 2014 to March 2022 were analyzed retrospectively,and the patients were divided into two groups:normal PT and APTT group and prolonged PT or APTT group.The differences in sex,age,classification,staging,bleeding events,laboratory indicators[including hemoglobin(Hb),platelet count(PLT),serum calcium,serum albumin(ALB),lactate dehydrogenase(LDH),serum creatinine and β 2-microglobulin],and cytogenetic characteristics between the two groups of patients were compared.The effect of prolonged PT or APTT on survival of patients with MM was analyzed.Results:Compared with patients in normal PT and APTT group,patients in prolonged PT or APTT group were more likely to experience bleeding events(x2=5.087,P=0.024),with lower ALB levels(x2=4.962,P=0.026)and PLT levels(x2=4.309,P=0.038),and higher serum calcium levels(x2=5.056,P=0.025).The positive rates of del17p,del13q and 1q21+in prolonged PT or APTT group were higher than those in normal PT and APTT group,but the difference was not statistically significant(P＞0.05).K-M survival analysis showed that the prolonged PT or APTT group had a shorter median progression-free survival(PFS)(P=0.032)and overall survival(OS)(P=0.032).Multivariate Cox analysis showed that prolonged PT or APTT(HR=2.1 16,95％CI:1.025-4.372,P=0.043)and age ≥65 years(HR=2.403,95％CI:1.195-4.836,P=0.014)were independent risk factor for OS in newly diagnosed MM patients.However,prolonged PT or APTT had no significant effect on PFS of newly diagnosed MM patients(HR=1.162,95％CI:0.666-2.026,P=0.597).Conclusion:Newly diagnosed MM patients with prolonged PT or APTT have worse clinical indicators,shorter PFS and OS.Prolonged PT or APTT is an independent risk factor for OS in MM patients.

Objective:To estimate the influence of metabolic parameters in 18F-FDG PET/CT and clinically relevant indicators on the prognosis of patients with cervical cancer. Methods:A total of 174 patients with cervical cancer (age (53.6±11.1) years) who underwent baseline 18F-FDG PET/CT examination in the Affiliated Hospital of Qingdao University from May 2011 to December 2020 were retrospectively collected. Metabolic parameters (metabolic tumor volume of primary lesion (MTV p), total lesion glycolysis of primary lesion (TLG p), MTV sum of total lesions (MTV total) in the whole body, TLG sum of total lesions (TLG total)) and clinical parameters (International Federation of Gynecology and Obstetrics (FIGO) stage, tumor maximum diameter ( Dmax), et al) were collected. Cox regression and Kaplan-Meier method were performed to evaluate the prognostic and predictive values of those parameters. Results:The follow-up time was 6-120 months, during which 52 patients (29.9%, 52/174) developed progression. The 5-year overall survival (OS), progression-free survival (PFS), local control (LC) and distant metastasis-free survival (DMFS) rates were 83.3%(145/174), 70.1%(122/174), 75.3%(131/174) and 82.8%(144/174), respectively. Cox regression showed that FIGO stage and MTV total were independent factors for predicting PFS, OS and LC (hazard ratio ( HR): 1.005-11.605, all P<0.05). FIGO stage and TLG total were independent factors for predicting DMFS ( HR: 1.002-12.258, all P<0.05). Conclusion:MTV total and FIGO stage are effective predictors of patients with cervical squamous cell carcinoma.

Objective:To evaluate the role of histogram analysis based on amide proton transfer weighted (APTw) and apparent diffusion coefficient (ADC) imaging in predicting alpha-thalassemia/mental retardation syndrome X-linked ( ATRX) mutation in isocitrate dehydrogenase ( IDH)-mutant WHO grading 2/3 gliomas. Methods:Seventy-eight patients with IDH-mutant WHO grading 2/3 gliomas, admitted to and confirmed by surgical pathology in Department of Functional Neurosurgery, Neurosurgery Center, Zhujiang Hospital, Southern Medical University from June 2017 to October 2023, including 52 with ATRX wild and 26 with ATRX mutant-type, were selected. Preoperative 3D-APTw and ADC imaging data were collected; after post-processing, the lesions were segmented using lesion outlining method based on inclusion of peri-tumor edema and lesion outlining method based on tumor entity, respectively; after that, the histogram features (the 10 th percentile, 90 th percentile, maximum, mean, median, minimum, skewness, kurtosis, entropy, range, uniformity, and variance) were extracted from 3D-APTw and ADC imaging, respectively. Univariate Logistic regression was used to compare the differences in histogram features between patients in the ATRX mutant group and ATRX wild-type group, and multivariate Logistic regression was used to screen the independent predictors for ATRX mutation (a Logistic regression prediction model was constructed). Predictive values of independent predictors and Logistic regression prediction models in ATRX mutation were evaluated by receiver operating characteristic (ROC) curve. Results:(1) With lesion outlining method based on inclusion of peri-tumor edema, univariate analysis indicated significant difference between ATRX mutant group and ATRX wild-type group in 9 histogram features: relative 3D-APTw minimum, 3D-APTw skewness, relative ADC 90 th percentile, relative ADC mean, relative ADC median, ADC kurtosis, ADC skewness, ADC uniformity, and ADC entropy ( P<0.05). With lesion outlining method based on tumor entity, univariate analysis indicated significant difference between ATRX mutant group and ATRX wild-type group in 9 histogram features: relative 3D-APTw 90 th percentile, 3D-APTw skewness, relative ADC 90 th percentile, relative ADC mean, relative ADC median, ADC kurtosis, ADC skewness, ADC uniformity and ADC entropy ( P<0.05). (2) With lesion outlining method based on inclusion of peri-tumor edema, multivariate Logistic regression showed that 3D-APTw skewness and ADC kurtosis were the independent predictor for ATRX mutation in IDH mutant WHO grading 2/3 glioma patients ( OR=0.168, 95% CI: 0.034-0.800, P=0.025; OR=0.508, 95% CI: 0.319-0.807, P=0.004). The constructed Logistic regression prediction model was P(Y=1|X)=1/1+e -(1.827-1.785×3D-APTw skewness-0.678×ADC kurtosis). With lesion outlining method based on tumor entity, multivariate Logistic regression showed that 3D-APTw skewness and ADC kurtosis were independent predictors for ATRX mutation in IDH mutant WHO grading 2/3 glioma patients ( OR=0.164, 95% CI: 0.034-0.791, P=0.024; OR=0.496, 95% CI: 0.312-0.788, P=0.003); the constructed Logistic regression prediction model was P(Y=1|X)=1/1+e -(1.585-1.810×3D-APTw skewness-0.702×ADC kurtosis). (3) ROC curve analysis showed that, with lesion outlining method based on inclusion of peri-tumor edema, area under ROC curve (AUC) of 3D-APTw skewness and ADC kurtosis was 0.725 (95% CI: 0.608-0.842, P=0.001) and 0.794 (95% CI: 0.685-0.904), respectively ( P<0.001); AUC of Logistic regression prediction model was 0.836 (95% CI: 0.729-0.942, P<0.001), and its sensitivity and specificity were 73.10% and 90.40% when the best threshold was 0.505. ROC curve showed that, with lesion outlining method based on tumor entity, AUC of 3D-APTw skewness and ADC kurtosis was 0.705 (95% CI: 0.587-0.823, P=0.003) and 0.808 (95% CI: 0.704-0.913), respectively ( P<0.001); AUC of Logistic regression prediction model was 0.844 (95% CI: 0.739-0.949, P<0.001), and its sensitivity and specificity were 84.60% and 80.80% when the best threshold was 0.399. Conclusion:Histogram analysis based on 3D-APTw and ADC imaging can predict ATRX mutation in IDH mutant WHO grading 2/3 gliomas to a certain extent.

Objectives:To assess the efficacy of cord blood-assisted haploid peripheral blood stem cell transplantation (haplo-cord-PBSCT) versus unrelated donor peripheral blood stem cell transplantation (UD-PBSCT) in the treatment of malignant hematological diseases.Methods:A retrospective analysis was performed on one hundred and four patients with malignant hematological diseases who underwent haplo-cord-PBSCT and fifty-two patients who underwent UD-PBSCT at Xiangya Hospital of Central South University between January 2016 and December 2021.Results:①The median implantation time for neutrophils in the haplo-cord-PBSCT and UD-PBSCT groups was 13 (9–22) days and 13 (10–24) days, respectively ( P=0.834), whereas the median implantation time for platelets was 15 (7–103) days and 14 (8-38) days, respectively ( P=0.816). The cumulative implantation rate of neutrophils at 30 days after transplantation in the haplo-cord-PBSCT group and the UD-PBSCT group was 100% ( P=0.314), and the cumulative platelet implantation rate at 100 days after transplantation was 95.2% (95% CI 88.3% - 98.1% ) and 100% ( P=0.927), respectively. 30 days after transplantation, both groups of patients achieved complete donor chimerism, and no umbilical cord blood stem cells were implanted. ②The cumulative incidence rates of grade Ⅱ-Ⅳ acute GVHD within 100 days after transplantation in the haplo-cord-PBSCT group and the UD-PBSCT group were 29.1% (95% CI 20.1% –38.1% ) and 28.8% (95% CI 17.2% –41.6% ( P=0.965), respectively. The cumulative incidence rates of grade Ⅲ/Ⅳ acute GVHD were 7.8% (95% CI 3.6% –14.0% ) and 9.6% (95% CI 3.5% –19.5% ) ( P=0.725). The cumulative incidence rates of 2-year chronic GVHD in the haplo-cord-PBSCT group and the UD-PBSCT group were 45.3% (95% CI 36.1% -56.1% ) and 35.1% (95% CI 21.6% –44.1% ), respectively ( P=0.237). The cumulative incidence rates of severe chronic GVHD at 2 years after transplantation were 13.6% (95% CI 7.6% -21.3% ) and 12.9% (95% CI 5.1% -24.3% ), respectively ( P=0.840). ③The 2-year CIR after transplantation in the haplo-cord-PBSCT group and UD-PBSCT group were 12.8% (95% CI 7.0% –20.5% ) and 10.0% (95% CI 3.6% –20.2% ), respectively ( P=0.341), and the NRM were 14.7% (95% CI 8.4% –22.6% ) and 16.2% (95% CI 7.4% –28.0% ), respectively ( P=0.681). ④The 2-year OS rates in the haplo-cord-PBSCT and UD-PBSCT groups after transplantation were 82.2% (95% CI 74.8% –90.3% ) and 75.5% (95% CI 64.2% -88.7% ), respectively ( P=0.276). The 2-year DFS rates were 69.9% (95% CI 61.2% –79.8% ) and 73.8% (95% CI 62.4% -87.3% ), respectively ( P=0.551). The 2-year rates of GVHD-free/recurrence-free survival (GRFS) were 55.3% (95% CI 44.8% -64.8% ) and 64.7% (95% CI 52.8% –79.3% ), respectively ( P=0.284) . Conclusion:The findings of this study indicate that haplo-cord-PBSCT and UD-PBSCT have comparable efficacy and safety in the treatment of malignant hematological diseases and can be used as an alternative treatment options.

Objective To develop a portable medical oxygen purity analyzer capable of real-time detection of multi-compo-nent gases in medical oxygen or aviation oxygen to ensure the safety of oxygen consumption.Methods The portable medical oxygen purity analyzer with STM3F103RC as the main controller involved in a management module,an oxygen detection module,a carbon monoxide/chlorine detection module,a flow/carbon dioxide detection module and a dew point detection module as its hardware components,which had its human-machine interface programmed with DGUS supervision,control and data acquisition(SCADA)software and system program developed with C language under Keil MDK environment.The performance verification of the analyzer developed was carried out in terms of oxygen detection error and stability and errors for measuring carbon monoxide,chlorine and carbon dioxide.Results The analyzer showed high precision when used to detect oxygen with high volume fraction,with long-term stability and the absolute error restrained within±0.1％;the erros for measuring carbon monoxide,chlorine and carbon dioxide were all limited within±5％FS to meet the desired requirements.Condusion The portable medical oxygen purity analyzer developed with high precision,stability and portability can be used for detection of medical oxygen and aviation oxygen.[Chinese Medical Equipment Journal,2024,45(3):36-40]