Objective:To explore the correlation between bile acid profiles and early efficacy of biologics for Crohn's disease (CD) .Methods:Patients with active CD who were treated with induction therapy with biologics (ustekinumab, vedolizumab, or combination therapy) in outpatient and inpatient clinics from January 2021 to March 2024 in Jinhua Central Hospital were included. Clinical data and serum bile acid profile of patients before treatment were collected. At the end of induction therapy, CD patients were categorized into remission and non-remission groups based on the CD activity index (CDAI) scores. Compare the clinical data of the two groups of patients with CD before induction treatment with biological agents, retrospective analysis of bile acid profiles in relation to early efficacy of biologics.Results:A total of 100 patients with CD were included, including 74 patients in remission group and 26 patients in non-remission group. Univariate analysis showed that hemoglobin [137 (119, 147) g/L vs. 121 (109, 136) g/L, P = 0.027], erythrocyte pressure volume [ (0.40 ± 0.06) % vs. (0.38 ± 0.05) %, P = 0.030], total bile acids[3.8 (2.4, 6.1) μmol/L比2.0 (1.5, 2.7) μmol/L, P < 0.001], cholic acid [0.188 (0.059, 0.597) μmol/L vs. 0.055 (0.024, 0.111) μmol/L, P < 0.001], chenodeoxycholic acid [0.812 (0.268, 1.717) μmol/L vs. 0.308 (0.087, 0.552) μmol/L, P < 0.001], and deoxycholic acid [0.042 (0.001, 0.299) μmol/L vs. 0.002 (0.001, 0.159) μmol/L, P = 0.028] were signficantly higher in remission group than those in unremission group. In addition, the pretreatment endoscopic score (SES-CD) [4.0 (0, 6.0) vs. 6.0 (3.0, 10.5), P = 0.025], erythrocyte sedimentation rate (ESR) [9.0 (2.8, 20.0) mm/1 h vs. 28.0 (12.8, 40.8) mm/1 h, P < 0.001] and C reactive protein (CRP) [0.6 (0.2, 6.7) mg/L vs. 9.1 (1.5, 23.9) mg/L, P < 0.001] in the remission group were lower than those in the non-remission group. Multirariate logistic regression analysis showed that chenodeoxycholic acid ( OR = 3.317, 95% CI: 1.270-12.437; P = 0.041) and ESR ( OR =0.979, 95% CI: 0.957-0.997; P = 0.034) were the independent influencing affecting the efficacy of biologics for the treatment of Crohn's disease in early stage. Conclusion:Chenodeoxycholic acid is an independent influencing factor of early efficacy of biologics for Crohn's disease.

Objective:To evaluate the efficacy and safety of upadacitinib in the real-world treatment of difficult-to-treat Crohn's disease (DTT-CD) .Methods:This multicenter, retrospective cohort study included patients diagnosed with DTT-CD according to the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) criteria, and treated at eight Chinese inflammatory bowel disease centers between January 2023 and March 2025. Clinical outcomes were assessed after 12 weeks of induction therapy with upadacitinib (45 mg qd), including clinical remission rate, clinical response rate, and incidence of adverse events.Results:Among 151 enrolled DTT-CD patients, the clinical remission rate was 47.0%, and the clinical response rate was 90.7% after 12 weeks of treatment. Adverse events occurred in 42 cases (27.8%) .Conclusion:Upadacitinib demonstrated favorable efficacy in inducing clinical remission in DTT-CD patients, with a good safety profile at the induction dose (45 mg qd) .

Objective:To establish a monitoring and evaluation index system for the building project of national children′s regional medical centre (shorted as the evaluation system), so as to provide quantitative supports for output hospitals to fulfil their primary responsibilities and offer guidance for project hospitals to implement target management.Methods:From April to June 2024, through searching literature and policy document, and combining with the actual situation of national regional medical center construction, the initial indicators of the evaluation system were screened. An evaluation system were constructed using two rounds of Delphi method, and the weights of indicators were determined by analytic hierarchy process.Results:This study invited 17 experts. The participation rates of experts in the two rounds of consultation exceeded 90.00%, with an expert authority coefficient of 0.96. The final evaluation system comprised 2 primary indicators, 8 secondary indicators, and 52 tertiary indicators. The primary indicators included project implementation status and project outcomes, with relative weights of 44.44% and 55.56% respectively. Project implementation status included 4 secondary indicators: project organisation, resource allocation, project progress, and safeguard mechanisms. Project outcomes encompassed 4 secondary indicators: healthcare service capacity, regional talent development outreach, and collaborative innovation.Conclusions:The evaluation system established in this study demonstrated a high degree of scientificity and feasibility. It could effectively supported the process management and outcome evaluation of establishing the national children′s regional medical centre. This system provided a scientific basis for enhancing the quality and efficiency of children′s healthcare services, optimising policy formulation and resource allocation.

The Chinese Pharmacopoeia 2025 Edition is about to be officially released.Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission,has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volume Ⅲ.General chapter 0237,integrating the cutting-edge concepts from WHO's related guidelines and the practical experience of biological reference standards both domestically,has revised the names of this chapter,updated and improved the technical requirements for candidate reference materials,collabo-rative calibration and value assignment,as well as stability research and monitoring.It also newly proposes the cal-culation of uncertainty of biological reference materials and emphasizes to pay attention to commutability.The im-plementation of general chapter 0237 will play a guiding role in improving the research and application level of bio-logical reference materials in China.This article,by interpreting the revised content of general chapter 0237,aims to provide a reference for the researchers of biological reference materials.

Objective:To explore the correlation between bile acid profiles and early efficacy of biologics for Crohn's disease (CD) .Methods:Patients with active CD who were treated with induction therapy with biologics (ustekinumab, vedolizumab, or combination therapy) in outpatient and inpatient clinics from January 2021 to March 2024 in Jinhua Central Hospital were included. Clinical data and serum bile acid profile of patients before treatment were collected. At the end of induction therapy, CD patients were categorized into remission and non-remission groups based on the CD activity index (CDAI) scores. Compare the clinical data of the two groups of patients with CD before induction treatment with biological agents, retrospective analysis of bile acid profiles in relation to early efficacy of biologics.Results:A total of 100 patients with CD were included, including 74 patients in remission group and 26 patients in non-remission group. Univariate analysis showed that hemoglobin [137 (119, 147) g/L vs. 121 (109, 136) g/L, P = 0.027], erythrocyte pressure volume [ (0.40 ± 0.06) % vs. (0.38 ± 0.05) %, P = 0.030], total bile acids[3.8 (2.4, 6.1) μmol/L比2.0 (1.5, 2.7) μmol/L, P < 0.001], cholic acid [0.188 (0.059, 0.597) μmol/L vs. 0.055 (0.024, 0.111) μmol/L, P < 0.001], chenodeoxycholic acid [0.812 (0.268, 1.717) μmol/L vs. 0.308 (0.087, 0.552) μmol/L, P < 0.001], and deoxycholic acid [0.042 (0.001, 0.299) μmol/L vs. 0.002 (0.001, 0.159) μmol/L, P = 0.028] were signficantly higher in remission group than those in unremission group. In addition, the pretreatment endoscopic score (SES-CD) [4.0 (0, 6.0) vs. 6.0 (3.0, 10.5), P = 0.025], erythrocyte sedimentation rate (ESR) [9.0 (2.8, 20.0) mm/1 h vs. 28.0 (12.8, 40.8) mm/1 h, P < 0.001] and C reactive protein (CRP) [0.6 (0.2, 6.7) mg/L vs. 9.1 (1.5, 23.9) mg/L, P < 0.001] in the remission group were lower than those in the non-remission group. Multirariate logistic regression analysis showed that chenodeoxycholic acid ( OR = 3.317, 95% CI: 1.270-12.437; P = 0.041) and ESR ( OR =0.979, 95% CI: 0.957-0.997; P = 0.034) were the independent influencing affecting the efficacy of biologics for the treatment of Crohn's disease in early stage. Conclusion:Chenodeoxycholic acid is an independent influencing factor of early efficacy of biologics for Crohn's disease.

Objective:To evaluate the efficacy and safety of upadacitinib in the real-world treatment of difficult-to-treat Crohn's disease (DTT-CD) .Methods:This multicenter, retrospective cohort study included patients diagnosed with DTT-CD according to the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) criteria, and treated at eight Chinese inflammatory bowel disease centers between January 2023 and March 2025. Clinical outcomes were assessed after 12 weeks of induction therapy with upadacitinib (45 mg qd), including clinical remission rate, clinical response rate, and incidence of adverse events.Results:Among 151 enrolled DTT-CD patients, the clinical remission rate was 47.0%, and the clinical response rate was 90.7% after 12 weeks of treatment. Adverse events occurred in 42 cases (27.8%) .Conclusion:Upadacitinib demonstrated favorable efficacy in inducing clinical remission in DTT-CD patients, with a good safety profile at the induction dose (45 mg qd) .

The Chinese Pharmacopoeia 2025 Edition is about to be officially released. Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission, has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volume Ⅲ. General chapter 0237, integrating the cutting-edge concepts from WHO’s related guidelines and the practical experience of biological reference standards both domestically, has revised the names of this chapter, updated and improved the technical requirements for candidate reference materials, collaborative calibration and value assignment, as well as stability research and monitoring. It also newly proposes the calculation of uncertainty of biological reference materials and emphasizes to pay attention to commutability. The implementation of general chapter 0237 will play a guiding role in improving the research and application level of biological reference materials in China. This article, by interpreting the revised content of general chapter 0237, aims to provide a reference for the researchers of biological reference materials.

Objective To investigate the incidence of functional bowel disease(FBD)and its relationship with depression,anxiety and sleep in navy submarine forces.Methods A questionnaire survey on the incidence of FBD was conducted on 364 naval soldiers who were enrolled according to Rome Ⅳ classification and diagnostic criteria.The risk factors of FBD were analyzed.The incidence of specific diseases of FBD was compared among soldiers with different jobs.The depression,anxiety,and sleep quality were investigated in FBD patients.Results In the 364 participants,132(36.3%)were diagnosed with FBD according to Roman Ⅳcriteria.Military rank and marital status might be risk factors for FBD.There was no significant difference in the overall incidence of FBD among the participants with various jobs(P>0.05).The incidence of functional constipation in the submariners was significantly higher than that in the land soldiers,while the incidence of functional diarrhea in the land soldiers was higher than that in the submariners(all P<0.05).The incidences of depression,anxiety and sleep disorder in the participants with FBD were higher than those in the participants without FBD.Conclusion There is a high incidence of FBD in submariners,which may be related to their psychological states.

Objective:To investigate the clinical manifestations, gene mutation characteristics, imaging and video electroencephalogram (VEEG) characteristics of patients with dentatorubral-pallidoluysian atrophy (DRPLA).Methods:The clinical data of 9 patients with genetically diagnosed DRPLA in the Neurology Center, Beijing Tiantan Hospital, Capital Medical University from January 2018 to January 2023 were collected, and the clinical data of DRPLA patients reported in China were retrieved and summarized.Results:A total of 45 cases were included. The clinical characteristics were summarized as follows: (1) The male to female ratio of 45 patients was 1.00∶1.25, and the age of onset was (28.11±14.58) years. (2) The main clinical symptoms of juvenile type, early-onset adult type and late-onset adult type were analyzed, and the results showed that the frequency of seizures in juvenile type (16/17) was higher than that in early-onset adult type (8/21) and late-onset adult type (2/7), with statistically significant difference (χ 2=15.971, P<0.001). In addition, the frequency of cognitive impairment in juvenile type (16/17) was also higher than that in early-onset adult type (15/21) and late-onset adult type (2/7), also with statistically significant difference (χ 2=10.177, P=0.005). Cognitive impairment, language disorder and involuntary movement were common in early-onset adult patients, and about half of the patients had ataxia. Ataxia and language disorder were more common in late-onset adult patients, while seizures and cognitive impairment were rare. (3) In imaging, cerebellum and brainstem atrophy was the most common, followed by cortical atrophy and white matter lesions. (4) The number of trinucleotide (CAG) repeats was 53-79, and there was a significant negative correlation between the number of CAG repeats and the age of onset ( r=-0.765, P<0.001), that means the younger the age of onset, the higher the number of CAG repeats. (5) In terms of electrophysiology, 21 patients provided complete VEEG data, of which slowed activity (52%, 11/21) and generalized discharge (71%, 15/21) were more common, and focal discharge (33%, 7/21) was uncommon. Conclusions:DRPLA patients can present with epilepsy, cerebellar ataxia, and other clinical manifestations. Brainstem and cerebellar atrophy and white matter lesions can be relatively characteristic in imaging. In terms of electrophysiology, slowed activity and generalized discharge are more common. DRPLA patients are easy to be misdiagnosed in clinical practice and genetic confirmation helps confirm the diagnosis.

Objective This study aimed to investigate the antimicrobial resistance profiles of bacterial strains isolated from pediatric intensive care units(PICU)in China for better antimicrobial therapy.Methods Clinical isolates were collected from 17 institutions,including tertiary care children's hospitals and pediatric department of tertiary general hospitals in China from January 1,2020 to December 31,2022.Antimicrobial susceptibility testing was carried out according to a unified protocol using Kirby-Bauer method or automated systems.Results were interpreted according to the breakpoints released by the Clinical and Laboratory Standards Institute(CLSI)in 2020.Results A total of 10 688 isolates were collected,including gram-positive organisms(39.2％)and gram-negative organisms(60.8％).The top three organisms were S.aureus(13.6％,1 453/10 688),A.baumannii(10.0％,1 067/10 688),and coagulase-negative Staphylococcus(9.9％,1 058/10 688).Multi-drug resistant organisms(MDROs)were very common in children.The prevalence of methicillin-resistant Staphylococcus aureus(MRSA),carbapenem-resistant Enterobacterales(CRE),carbapenem-resistant E.coli,carbapenem-resistant K.pneumoniae(CRKP),carbapenem-resistant A.baumannii(CRAB),and carbapenem-resistant P.aeruginosa(CRPA)was 41.1％,19.4％,8.8％,30.9％,67.4％,and 28.8％,respectively.Overall,more than 50％of Enterobacteriales isolates were resistant to cephalosporins,while nearly 25％of Enterobacteriales isolates were resistant to carbapenems.MDROs were highly resistant to commonly used antibiotics.More than 80％of CRE and CRAB strains were resistant to all beta-lactam antibiotics.CRE and CRAB showed low resistance rates to tigecycline and polymyxin.CRPA showed lower resistance rates to piperacillin,beta-lactamase inhibitor combinations than the resistance rates to third and fourth generation cephalosporins.All of the Staphylococcus and Enterococcus isolates were susceptible to vancomycin and tigecycline.None of PRSP strains isolated from meningitis and nonmeningitis samples were resistant to rifampicin,vancomycin,or linezolid.The prevalence of β-lactamase-negative ampicillin-resistant(BLNAR)strains was 43.3％in Haemophilus influenzae.Conclusions MDROs were prevalent in PICU.It is necessary to establish an effective multidisciplinary team(MDT)to control the antimicrobial resistance.