Objective:To investigate the rates of low disease activity and clinical remission in patients with systemic lupus erythematosus(SLE)in a real-world setting,and to analyze the related factors of low disease activity and clinical remission.Methods:One thousand patients with SLE were enrolled from 11 teaching hospitals.Demographic,clinical and laboratory data,as well as treatment regimes were collec-ted by self-completed questionnaire.The rates of low disease activity and remission were calculated based on the lupus low disease activity state(LLDAS)and definitions of remission in SLE(DORIS).Charac-teristics of patients with LLDAS and DORIS were analyzed.Multivariate Logistic regression analysis was used to evaluate the related factors of LLDAS and DORIS remission.Results:20.7％of patients met the criteria of LLDAS,while 10.4％of patients achieved remission defined by DORIS.Patients who met LLDAS or DORIS remission had significantly higher proportion of patients with high income and longer disease duration,compared with non-remission group.Moreover,the rates of anemia,creatinine eleva-tion,increased erythrocyte sedimentation rate(ESR)and hypoalbuminemia was significantly lower in the LLDAS or DORIS group than in the non-remission group.Patients who received hydroxychloroquine for more than 12 months or immunosuppressant therapy for no less than 6 months earned higher rates of LLDAS and DORIS remission.The results of Logistic regression analysis showed that increased ESR,positive anti-dsDNA antibodies,low level of complement(C3 and C4),proteinuria,low household in-come were negatively related with LLDAS and DORIS remission.However,hydroxychloroquine usage for longer than 12 months were positively related with LLDAS and DORIS remission.Conclusion:LLDAS and DORIS remission of SLE patients remain to be improved.Treatment-to-target strategy and standar-dized application of hydroxychloroquine and immunosuppressants in SLE are recommended.

Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.

Objective To explore the utility of different endoscopic retrograde cholangiopancreatography(ERCP)complexity scales in the training of endoscopists.Methods Clinical data of 237 patients treated by ERCP completed by trainee physicians at two hospitals in Eastern China from February 2022 to February 2023 were prospectively collected.All ERCP cases were classified using previously proposed complexity grading scales,including the American Society of Gastrointestinal Endoscopy(ASGE),Morriston and HOUSE grading scales,compared with the hepatopancreatic ampulla features classification.Successful intubation,successful surgical treatment and complication rates within 48 h were recorded.Results Within each grading,subgroups were divided according to severity,and the comparison of intubation success rates between subgroups in the 3 different grades showed statistically significant differences(P = 0.000).The treatment success rate and intubation success rate had similar findings(P = 0.000).There was no correlation between the complication rate and ASGE grading(P = 0.361),Morriston grading(P = 0.332),and HOUSE grading(P = 0.586).When only cases with primitive papillae were considered,the intubation success rate depended on the complexity grading after the newly added classification of hepatopancreatic ampulla features.In the ASGE group,the success rate of intubation was compared between different subgroups,and the difference was statistically significant(P = 0.004);in the Morriston group,the success rate of intubation was compared between different subgroups,and the success rate of intubation was statistically significant(P = 0.002);in the HOUSE group,the success rate of intubation was compared between different subgroups,and the difference was statistically significant(P = 0.000);In the hepatopancreatic ampulla characteristics group,the difference in intubation success rate was statistically significant when compared between different subgroups(P = 0.000).Similar findings were also found for treatment success rate and intubation success rate(P = 0.000).There was no correlation between the complication rate and ASGE group(P = 0.586),Morriston group(P = 0.443),HOUSE group(P = 0.306),and hepatopancreatic ampulla characteristics group(P = 0.350).Conclusion The use of hepatopancreatic ampulla features as a classification of biliary cannulation complexity is feasible and could be an alternative or additional means of predicting successful biliary cannulation and surgical treatment success and could be used in the future to assess endoscopist training and learning progress and technical standards.

Objective To compare the effect of posterior cruciate ligament retaining(CR)and posterior cruciate substituting(PS)prosthesis in knee arthroplasty.Methods 64 patients with knee osteoarthritis were admitted to our department from June 2021 to June 2022 and whom met the selection criteria were randomly selected and divided into observation group and control group(n = 32).CR prosthesis was used in the observation group,and PS prosthesis was used in the control group.Operation time,postoperative drainage volume,difference of hemoglobin(HGB)before and after operation,postoperative hospital stay,postoperative range of motion at 7 d,14 d,45 d,3 months and 1 year were recorded.ROM,visual analog pain Scale(VAS),Hospital for special surgery(HSS)score,and maximum forward and backward displacement of knee joint and the regular radiographs were also recorded,too.Results The two groups were similar in terms of operation time,postoperative hospital stay,postoperative VAS score and maximum anterior and posterior displacement of knee joint,with P values greater than 0.05,which had no statistical significance.The postoperative drainage volume in the observation group was significantly less than that in the control group,with statistical significance(P＜0.05).The HGB difference of observation group was significantly lower than that of control group,with statistical significance(P＜0.05).There was no statistically significant differ-ence in ROM and HSS scores between the two groups before surgery;the ROM and HSS scores of the control group at 7,14 and 45 days after surgery was better than that of the observation group,with statistical significance(P＜0.05);the ROM and HSS scores of the two groups at 3 months after surgery was not statistically significant.The ROM and HSS scores in the observation group was better than that in the control group at 6 months and 1 year after operation,and the difference was statistically significant(P＜0.05).Conclusions CR prosthesis is superior to PS prosthesis in terms of intraoperative blood loss and post-operative drainage volume,which can reduce surgical risk.Both kinds of prosthesis can achieve good knee stability after surgery,while PS prosthesis has better early clinical effect,while CR prosthesis has better long-term clinical effect.

Objective To assess the feasibility and imaging outcomes of unilateral biportal endoscopic technique in the treatment of lumbar foraminal stenosis through contralateral approach.Methods The clinical data of 33 patients with lumbar foraminal stenosis treated with unilateral biportal endoscopic technique from January 2021 to July 2022 were retrospectively analyzed.There were 17 males and 16 females;age ranging from 34 to 72 years old with an average of(56.00±7.89)years old;operation time and perioperative complications were recorded;visual analogue scale(VAS)of pain was recorded,to evaluate the degree of low back pain and lower extremity pain,and Oswestry disability index(ODI)to evaluate the lumbar spine func-tion.At the latest follow-up,the modified Macnab score was used to evaluate the clinical efficacy.Results All patients success-fully completed the operation.The operation time ranged from 47 to 65 minutes,with an average of(56.10±5.19)minutes.The postoperative follow-up ranged from 12 to 18 months,with an average of(14.9±2.3)months.The VAS of low back and lower extermity pain before operation were(7.273±1.442)and(7.697±1.447)scores,ODI was(69.182±9.740)％.Postoperative lumbocrural pain VAS were(3.394±0.966)and(2.818±0.727)scores,ODI was(17.30±4.78)％.At the latest follow-up,VAS of back and lower extermity pain was(2.788±0.650)and(2.394±0.704)scores,ODI was(14.33±350)％.There were signifi-cant differences in VAS of low back and lower extremity pain and ODI before and after operation(P＜0.05).At the latest follow-up,according to the modified Macnab criteria,24 patients got excellent result,5 as good,2 as fair,and 2 as poor.Conclusion Unilateral biportal endoscopic treatment of lumbar foraminal stenosis through the contralateral approach is a safe and efficient method,with few complications,quick postoperative recovery,and satisfactory clinical outcomes.During the follow-up period,no iatrogenic lumbar instability was observed.

Objective To observe the safety and effectiveness of single dose intravenous infusion of tranexamic acid(TX-A)in dual level posterior lumbar interbody fusion(PLIF),and to explore the changes and trends in perioperative white blood cell(WBC),erythrocyte sedimentation rate(ESR),and C-reactive protein(CRP).Methods Between October 2020 and September 2022,46 patients with lumbar degenerative disease were treated with dual level PLIF,including 18 males and 28 females,with an average age of(60.24±10.68)years old,from 34 to 80 years old.They were divided into observation group and control group according to different treatment methods.There were 28 patients in the observation group,including 12 males and 16 females,with an average age of(61.04±9.03)years old.There were 3 cases with lumbar disc herniation(LDH),lumbar spinal stenosis(LSS)18 cases,lumbar spondylolisthesis(LS)7 cases.TXA(1 g/100 ml)was administered intravenously 15 min before skin incision after general anesthesia.The control group consisted of 18 patients,including 6 males and 12 females,with an average age of(59.00±13.04)years old.There were 5 cases with LDH,LSS 9 cases,LS 4 cases,and TXA was not used.The operation time,intraoperative bleeding volume,postoperative drainage volume,postoperative deep vein thrombosis(DVT),postoperative hospital stay,postoperative activated partial thromboplastin time(APTT),prothrombin time(PT),thrombin time(TT),fibrinogen(FIB),platelet(PLT),red blood cell(RBC),hemoglobin(HB),hematocrit(HCT),the first day,the fourth day,the seventh day and the last tested after operation WBC,ESR and CRP were recorded.Results The postop-erative wounds of the patients healed well and there was no DVT.46 patients were followed up from 3 to 6 months.The intraop-erative blood loss was 400.0(300.0,500.0)ml and the postoperative drainage was 260.0(220.0,450.0)ml in the observation group,which were lower than the control group[600.0(400.0,1000.0)ml,395.0(300.0,450.0)ml],P＜0.05.There was no significant difference between the two groups in operation time,postoperative hospital stay,postoperative APTT,PT,TT,FIB,PLT,RBC,HB,HCT,and postoperative WBC,ESR and CRP at different times(P＞0.05).Conclusion Single dose intravenous infusion of TXA can reduce the blood loss of bi-segmental PLIF,and has no significant effect on WBC,ESR and CRP after op-eration.

Objective:To evaluate the values of 18F-PI-2620 PET/CT brain imaging with SUV ratio (SUVR) in the assessment of tau protein deposition in the brain of patients with different cognitive disorders and its correlation with cognition. Methods:This was a cross-sectional study. From December 2019 to November 2022, a total of 67 subjects including 54 patients with Alzheimer′s disease (AD; 21 males, 33 females, age (68.6±7.8) years), 7 patients with mild cognitive impairment (MCI; 1 male, 6 females, age (63.1±11.2) years) and 6 healthy controls (HC; 4 males, 2 females, age (69.0±5.8) years) were enrolled retrospectively in Renji Hospital. All participants were examined by 18F-PI-2620 PET/CT. SUVRs of brain regions were obtained, including frontal lobe, temporal lobe, occipital lobe, parietal lobe, insular lobe, whole brain, as well as 10 independent brain ROIs (amygdala, orbitofrontal cortex, cingulate gyrus, superior occipital gyrus, superior parietal gyrus, inferior angular gyrus, precuneus, inferior temporal gyrus, entorhinal cortex and parahippocampal gyrus), with inferior cerebellum cortex as the reference region. All participants were estimated by cognitive scales(mini-mental state examination (MMSE) and Montreal cognitive assessment (MoCA)). One-way analysis of variance and the least significant difference t test were used to compare the differences of SUVR in each brain region among HC, MCI and AD groups. ROC curve analysis was used to determine the optimal cut-off values of SUVR in each brain region for the differential diagnosis of AD-MCI and AD-HC. Pearson correlation analysis was employed to examine the correlations of SUVR with cognitive scale scores. Results:The SUVR of whole brain was 1.40±0.31 in AD group, 1.08±0.19 in MCI group, and 1.01±0.12 in HC group. SUVR analysis in the whole brain and each brain region could distinguish AD from HC, AD from MCI ( F values: 1.76-10.09, t values: 2.98-7.47, all P<0.05), but could not distinguish HC from MCI ( t values: 0.17-1.53, all P>0.05). ROC curve analysis showed that the best cut-off value of SUVR was 1.18 for whole brain (AUC=0.89), 1.13 for amygdala (AUC=0.94) and 1.26 for parahippocampal gyrus (AUC=0.94) for differential diagnosis of AD and HC, which was 1.06 for whole brain (AUC=0.82), 1.18 for amygdala (AUC=0.88) and 1.28 (AUC=0.88) for infratemporal gyrus to differential diagnosis of AD and MCI. SUVRs of the whole brain, frontal, occipital, parietal, temporal and insula were significantly negatively correlated with MMSE and MoCA cognitive scale scores ( r values: from -0.64 to -0.40, all P<0.05). Conclusions:SUVR quantitative analysis in 18F-PI-2620 PET imaging can assist the differential diagnosis of AD and HC, AD and MCI. The SUVRs of whole brain and five lobes show negative correlations with MMSE and MoCA scores.

People frequently struggle to juggle their work, family, and social life in today’s fast-paced environment, which can leave them exhausted and worn out. The development of technologies for detecting fatigue while driving is an important field of research since driving when fatigued poses concerns to road safety. In order to throw light on the most recent advancements in this field of research, this paper provides an extensive review of fatigue driving detection approaches based on electroencephalography (EEG) data. The process of fatigue driving detection based on EEG signals encompasses signal acquisition, preprocessing, feature extraction, and classification. Each step plays a crucial role in accurately identifying driver fatigue. In this review, we delve into the signal acquisition techniques, including the use of portable EEG devices worn on the scalp that capture brain signals in real-time. Preprocessing techniques, such as artifact removal, filtering, and segmentation, are explored to ensure that the extracted EEG signals are of high quality and suitable for subsequent analysis. A crucial stage in the fatigue driving detection process is feature extraction, which entails taking pertinent data out of the EEG signals and using it to distinguish between tired and non-fatigued states. We give a thorough rundown of several feature extraction techniques, such as topology features, frequency-domain analysis, and time-domain analysis. Techniques for frequency-domain analysis, such wavelet transform and power spectral density, allow the identification of particular frequency bands linked to weariness. Temporal patterns in the EEG signals are captured by time-domain features such autoregressive modeling and statistical moments. Furthermore, topological characteristics like brain area connection and synchronization provide light on how the brain’s functional network alters with weariness. Furthermore, the review includes an analysis of different classifiers used in fatigue driving detection, such as support vector machine (SVM), artificial neural network (ANN), and Bayesian classifier. We discuss the advantages and limitations of each classifier, along with their applications in EEG-based fatigue driving detection. Evaluation metrics and performance assessment are crucial aspects of any detection system. We discuss the commonly used evaluation criteria, including accuracy, sensitivity, specificity, and receiver operating characteristic (ROC) curves. Comparative analyses of existing models are conducted, highlighting their strengths and weaknesses. Additionally, we emphasize the need for a standardized data marking protocol and an increased number of test subjects to enhance the robustness and generalizability of fatigue driving detection models. The review also discusses the challenges and potential solutions in EEG-based fatigue driving detection. These challenges include variability in EEG signals across individuals, environmental factors, and the influence of different driving scenarios. To address these challenges, we propose solutions such as personalized models, multi-modal data fusion, and real-time implementation strategies. In conclusion, this comprehensive review provides an extensive overview of the current state of fatigue driving detection based on EEG signals. It covers various aspects, including signal acquisition, preprocessing, feature extraction, classification, performance evaluation, and challenges. The review aims to serve as a valuable resource for researchers, engineers, and practitioners in the field of driving safety, facilitating further advancements in fatigue detection technologies and ultimately enhancing road safety.

Objective To investigate the association between the serum creatinine/cystatin C ratio(SCr/Cys C)as a Sarcopenia index(SI)and the incidence of in-hospital adverse events in patients with acute myocardial infarction(AMI)undergoing emergency percutaneous coronary intervention(PCI).Additionally,we evaluate the predictive efficacy of the SI in predicting major adverse cardiovascular events(MACEs)during hospitalization.Methods A total of 306 patients with AMI who underwent emergency PCI in the 904th Hospital of PLA Joint Logistics Support Force from January 2020 to March 2023 were consecutively included in this retrospective analysis.Patients were divided into two groups based on the occurrence of MACEs during hospitalization:MACEs group(n=43)and non-MACEs group(n=263).Clinical characteristics and pre-PCI laboratory test results were collected.Univariate and multivariate logistic regression analyses were performed to identify independent risk factors for MACEs.The predictive performance of SI was assessed using receiver operating characteristic(ROC)curve analysis.Results The incidence of in-hospital MACEs in AMI patients was 14.1%.The results of the independent samples t-test showed that the SI level in MACEs group was significantly lower than that in non-MACEs group,with a statistically significant difference(P<0.001).The results of the multivariate logistic regression analysis suggested that new-onset atrial fibrillation,Killip class 2-4,SI,and TG were independent risk factors for in-hospital adverse events after emergency PCI.The ROC curve results showed that the predictive value of SI(AUC=0.741,95%CI 0.666-0.816)using the SCr/Cys C ratio was superior to that of single Cys C(AUC=0.658,95%CI 0.570-0.746)for predicting post-PCI MACEs,with a statistically significant difference(P<0.05),and the optimal cutoff value for SI was 78.14.After stratifying SI based on the cutoff value,the results of the independent samples t-test showed that compared to the higher SI group,the lower SI group had a higher occurrence of specific adverse events such as heart failure(P<0.001),malignant arrhythmias(P=0.009),and strokes(P=0.003),with statistically significant differences.Conclusions The results highlight SI as an independent risk factor for MACEs during hospitalization after emergency PCI in AMI patients.Furthermore,SI has proven to be an effective prognostic index for patient outcomes.

Objective:To study the common pathogenesis of gout and rheumatoid arthritis(RA)by bioinformatics analysis.Methods:Microarray expression profiles of peripheral blood mononuclear cells in gout and RA were obtained from the GEO public da-tabase.R language and other tools were used to re-annotates the chip,and then the differential genes(DEGs)of the two were screened and the intersection was taken.The protein-protein interaction(PPI)network and topology analysis of common differential genes(CO-DEGs)were constructed by STRING database and Cytoscape software(including CytoNCA plug-in).The HubGene was screened and validated by ROC curve.Finally,the DAVID online analysis tool was used to perform GO and KEGG functional enrichment analysis of HubGene.Results:There were 9 HubGene screened,they were TNF,RGS1,CD69,IL7R,DDX3X,SOCS3,IFIT1,IFIT3,CCL3.GO enrichment showed that HubGene was mainly involves the regulation of virus,STAT receptor signaling pathway and positive regu-lation of neuroinflammatory response.KEGG enrichment showed that HubGene was mainly involved in Toll like receptor signaling pathway,TNF signaling pathway,JAK-STAT signaling pathway,adipocytokine signaling pathway,RIG-Ⅰ-like receptor signaling pathway and osteoclast differentiation.Conclusion:Using bioinformatics analysis,nine HubGene and related signaling pathways in-volved in the pathogenesis of gout and RA have been identified,which may serve as novel biomarkers and potential targets.