National biological standards for antibiotics are critical components of the antibiotic quality control system and serve as reference materials for measuring and calibrating the biological activity of antibiotics. This article systematically reviews the classification, definition of potency units, and current research status of commercially available national antibiotic biological standards in China. At present, these standards can be categorized based on chemical structure, number of components, and development methods. The definition of potency units has evolved from an early “arbitrarily assigned unit” to “being represented by the mass of the antibiotic salt” and, more recently, to the current mainstream approach of “being represented by the mass of the active ingredient”. This evolution reflects a shift in quality control philosophy from primarily biological analysis to a system dominated by chemical analysis supplemented by biological methods. Current research focuses on optimizing potency determination methods, studying the unification of content and potency, and implementing dual quality control of both the potency and the ratio/content of active components in multi-component antibiotics. For complex multi-component antibiotics, the microbiological assay based on biological activity remains irreplaceable in quality control. Future efforts should emphasize further method optimization, ensuring batch-to-batch consistency of standards, and advancing precision quality control as key research priorities for antibiotic biological standards.

Gentianopsis barbata (G. barbata) represents a significant plant species with considerable ornamental and medicinal value in China. This investigation sought to elucidate the primary constituents within the plant and investigate their pharmacological properties. Fifty triterpenoids (1-50), including nine previously undescribed compounds (1, 2, 7, 10, 20, 28, 29, 37, and 41) were isolated and characterized from the whole plants of G. barbata. Notably, compounds 1 and 2 exhibited the novel 3,4;9,10-diseco-24-homo-cycloartane triterpenoid skeleton. The isolated triterpenoids demonstrated substantial anti-inflammatory activity through inhibition of tumor necrosis factor α (TNF-α) and interleukin-6 (IL-6) cytokine secretion in LPS-induced RAW264.7 macrophages, and hepatoprotective effects by preventing tert-butyl hydroperoxide (t-BHP)-induced oxidative injury in HepG2 cells. These results demonstrate both the presence of diverse triterpenoids in G. barbata and their therapeutic potential for inflammatory and hepatic conditions, providing scientific evidence supporting the clinical application of this traditional Mongolian medicinal plant.
Triterpenes/isolation & purification* ; Mice ; Anti-Inflammatory Agents/isolation & purification* ; Animals ; Humans ; RAW 264.7 Cells ; Hep G2 Cells ; Interleukin-6/genetics* ; Tumor Necrosis Factor-alpha/genetics* ; Medicine, Mongolian Traditional ; Macrophages/immunology* ; Protective Agents/isolation & purification* ; Liver/drug effects* ; Gentianaceae/chemistry* ; Plant Extracts/chemistry* ; Molecular Structure

Objective To verify the accuracy of a Non-Contact Sleep Monitoring Mattress(NCSMM)based on body movement during sleep in assessing sleep quality of patients before neurosurgery in order to provide a more portable and efficient assessment tool for clinical staff.Methods A single-arm trial was conducted on 114 inpatients admitted in our department selected with convenience sampling.Sleep quality data of 1 night were collected through 5 sleep quality assessment tools,including NCSMM,polysomnography(PSG),Patient-Reported Outcome Measurement Information System(PROMIS)Sleep Disturbance scale,Richards-Campbell Sleep Scale(RCSQ),and a wearable device(smart watch for body movements and sleep quality monitoring).The sleep efficiency(≤85%)obtained by PSG was used as the diagnostic standard for sleep disorders.The area under the receiver operating characteristic curve(AUC),sensitivity,specificity,positive predictive value,negative predictive value,and Youden index were calculated for the other 4 tools to evaluate and compare their diagnostic effectiveness.Results The AUC value for NCSMM,PROMIS,RCSQ and smart watch was 0.788(95%CI:0.687～0.888,P<0.001),0.664(95%CI:0.543～0.784,P=0.02),0.723(95%CI:0.600～0.846,P=0.001)and 0.750(95%CI:0.654～0.846,P<0.001),respectively.The diagnostic accuracy rate was 0.774,0.559,0.742 and 0.602,with corresponding Youden index value of 0.488,0.321,0.456,and 0.459.NCSMM demonstrated the best AUC value,sensitivity and Youden index when compared with the other 3 tools.Conclusion NCSMM shows high accuracy in assessing sleep quality in pre-neurosurgery inpatients,and it is a viable portable and efficient assessment tool in clinical practice.

Objective:To screen differentially expressed genes (DEGs) associated with liver cancer by bioinformatics analysis method, and to investigate the mechanism of the minichromosome maintenance protein 2 ( MCM2) and replication factor C subunit 4 ( RFC4) genes in liver cancer in vitro. Methods:Gene expression profiling data of 80 and 36 hepatocellular carcinoma tissues and 307 and 13 cirrhotic tissues were obtained from the GSE25097 and GSE98620 datasets of the gene expression analysis (GEO) database, respectively. Gene expression profiling data of 374 liver cancer tissues and 50 normal liver tissues were downloaded from the cancer genome atlas (TCGA) database. Limma and DESeqs R software were used to process the gene expression profiling data, construct protein-protein interaction networks, and analysis the relevance of these genes to survival. Weighted gene co-expression network analysis was performed to screen out the core genes. Liver cancer SMMC7721 cells were transfected with MCM2 blank plasmid (MCM2 control group), MCM2 overexpression plasmid [MCM2 WT1 group, MCM2 WT2 (2-fold WT1) group], RFC4 blank plasmid (RFC4 control group), and RFC4 overexpression plasmid [RFC4 WT1 group, RFC4 WT2 (2-fold WT1) group], respectively. The expression of MCM2 and RFC4 in liver cancer cell lines and their transfection levels were detected by real-time fluorescence quantitative reverse transcription PCR and Western blotting. The effects of MCM2 and RFC4 on the proliferation of hepatocellular carcinoma cells were detected by MTT assay and cell cloning assay, respectively. The effects of MCM2 and RFC4 on the migration of liver cancer cells were determined by the scratch assay. The effects of MCM2 and RFC4 on liver cancer cell invasion were detected by Transwell assay.Results:By bioinformatic analysis, 9 HCC DEGs were selected, including ubiquitin conjugating enzyme E2 T ( UBE2T), aurora kinase A ( AURKA), targeting protein for Xklp2 ( TPX2), MCM2, RFC4, ribonucleoside-diphosphate reductase subunit M2 ( RRM2), serine peptidase inhibitory factor Kazal type 1 ( SPINK1), collagen type XV alpha 1 chain ( COL15A1) and C-C motif chemokine 25 ( CCL25). Among the six genes associated with clinical stages, the MCM2 and RFC4 genes were found to be strongly associated with prognosis in liver cancer. The relative protein expression of MCM2 and RFC4 in HepG2 cells (1.83±0.07, 1.44±0.09) and SMMC7721 cells (1.74±0.05, 1.43±0.08) was higher than that in MIHA cells (1.00±0.02, 1.00±0.03), and all the differences were statistically significant (all P<0.05). The relative gene expression of MCM2 and RFC4 in HepG2 cells (14.30±0.12, 5.10±0.18) and SMMC7721 cells (10.60±0.11, 7.60±0.07) was higher than that in MIHA cells (1.00±0.05, 1.00±0.03), and all the differences were statistically significant (all P<0.05). Compared with the MCM2 control group, the absorbance values [(0.28±0.01 and 0.21±0.01) vs 0.18±0.03], the number of clonal cells [(717±12 and 782±29) cells vs (389±17) cells], the percentage migration [(0.43±0.02 and 0.68±0.01) vs 0.15±0.06], and the number of cellular invasions [(933±21 and 821±11) cells vs (409±16) cells] were higher in the MCM2 WT1 and MCM2 WT2 groups, and the differences were all statistically significant (all P<0.05). Compared with the RFC4 control group, the absorbance values [(0.30±0.02 and 0.21±0.01) vs 0.17±0.02], the number of cloned cells [(571±11 and 728±9) cells vs (373±23) cells], the percentage migration [(0.75±0.11 and 0.67±0.04) vs 0.34±0.07], and the number of cell invasion [(835±26 and 818±18) cells vs (629±12) cells] were higher in the RFC4 WT1 and the RFC4 WT2 groups, and the differences were statistically significant (all P<0.05). Conclusions:MCM2 and R FC4 genes play a role in promoting tumorigenesis and growth in hepatocellular carcinoma.

Objective To investigate the correlation between the clinical characteristics of allergic rhinitis(AR)in adults located in Shenzhen area and the traditional Chinese medicine(TCM)constitutions.Methods A cross-sectional survey of adult AR patients in Shenzhen was conducted.From June 2022 to December 2023,adult AR patients admitted to the Department of Otolaryngology outpatient clinic of Bao'an Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Chinese Medicine(Shenzhen Bao'an District Hospital of Traditional Chinese Medicine)were selected as the study subjects.The clinical baseline data,Total Nasal Symptoms Score(TNSS),and Total Non-Nasal Symptoms Score(TNNSS)of the patients were collected for the analysis of clinical characteristics,and TCM constitutions were differentiated based on the information collected by TCM constitutions questionnaire.After that,the correlation between the biased TCM constitutions and clinical characteristics were explored by using analysis of variance,non-parametric test and Logistic regression analysis.Results(1)A total of 215 cases of adult AR patients from Shenzhen were included.Most of the patients were male(60.93％),and the patients were usually aged 18-29 years old(accounting for 48.84％).AR in adults often arose in the spring(33.49％)and fall(30.70％).(2)Lung qi deficiency-cold syndrome was the predominated TCM syndrome type of AR in adults,accounting for 40.93％,and then came kidney yang deficiency syndrome(26.98％),spleen qi deficiency syndrome(20.00％),and heat accumulation in lung meridian syndrome(12.09％).Lung qi deficiency-cold syndrome and heat accumulation in lung meridian syndrome were more common in young males,and kidney yang deficiency syndrome was frequently seen in middle-aged and elderly males.(3)The leading three TCM constitution types of AR in adults were qi deficiency constitution(30.23％),yang deficiency constitution(24.65％),and inherited special constitution(15.81％).In adult AR patients with lung qi deficiency-cold syndrome,the commonly-seen TCM constitution types were qi deficiency constitution,inherited special constitution,and balanced constitution.In adult AR patients with spleen qi deficiency syndrome,the commonly-seen TCM constitution types were inherited special constitution,phlegm-damp constitution,and yang deficiency constitution.In adult AR patients with kidney yang deficiency syndrome,the commonly-seen TCM constitution types were yang deficiency constitution,qi stagnation constitution,and inherited special constitution.In adult AR patients with heat accumulation in lung meridian syndrome,the commonly-seen TCM constitution types were damp-heat constitution,yin deficiency constitution,and blood-stasis constitution.The leading five TNSS scores were shown in adult AR patients with inherited special constitution,qi deficiency constitution,yang deficiency constitution,phlegm-damp constitution,and qi stagnation constitution,respectively.And the leading five TNNSS scores were shown in adult AR patients with yang deficiency constitution,inherited special constitution,qi stagnation constitution,yin deficiency constitution,and damp-heat constitution,respectively.(4)The results of statistical analysis showed that the differences in gender among the adult AR patients with various TCM constitution types were not statistically significant(P＞0.05),but the differences in age groups,TCM syndrome types,TNSS scores and TNNSS scores were statistically significant(P＜0.01 or P＜0.001).(5)The results of Logistic regression analysis showed that the TNSS scores and TNNSS scores were all positively correlated with qi deficiency constitution,yang deficiency constitution,and inherited special constitution,and spleen qi deficiency syndrome was negatively correlated with damp-heat constitution,the differences being all statistically significant(P＜0.01 or P＜0.001).Conclusion The onset of AR in adults from Shenzhen area is closely related to age,gender,season,and TCM constitutions.The adult AR patients usually have the biased constitutions,in particular qi deficiency constitution,yang deficiency constitution,and inherited special constitution.In adult AR patients,higher TNSS scores are correlated with inherited special constitution,higher TNNSS scores are correlated with yang deficiency constitution,and the primary TCM syndrome type of lung qi deficiency-cold syndrome is correlated with qi deficiency constitution.

Objective To investigate the efficacy and safety of interventional therapy for bronchopleural fistula(BPF).Methods A total of 172 patients with confirmed BPF were treated with continuous negative pressure drainage(CNPD)and/or airway stent occlusion therapy.The clinical data were collected,and its effectiveness and safety were analyzed.Results In 5-7 days after interventional treatment,the pneumonia severity index(PSI)decreased significantly,and successful drainage was achieved in 166 patients(96.5％).One month after interventional therapy,the lung volume was remarkably increased.The median clinical healing time of interventional therapy was 9.0 months(95％CI=6.18-1 1.83).Multivariate analysis of the Cox proportional hazards model showed that the diagnosis time(HR=0.53,95％CI=0.38-0.74,P＜0.01)and fistula size(HR=0.74,95％CI=0.55-0.99,P=0.04)were significantly correlated with the clinical healing time.Conclusion For the treatment of BPF,CNPD and/or airway stent occlusion has several advantages such as accurate operation,minimally invasive,safe and effective.It can quickly improve the symptoms and quality of life,and prolong survival,therefore,it is worthy of clinical promotion and application.(J Intervent Radiol,2024,33:641-645)

Objective:To compare the antiplatelet effects of vicagrel and clopidogrel in patients with different cytochrome P450 (CYP) 2C19 genotypes.Methods:This is a post-hoc analysis of a phase Ⅱ clinical trial of vicagrel, which included patients with coronary heart disease who underwent percutaneous coronary intervention from August 2018 to June 2019 in 18 centers. Patients were categorized based on the presence of CYP 2C19 *2 or *3 loss-of-function (LOF) alleles into LOF carrier group ( n=111) and non-LOF carrier group ( n=90). Each group included patients received vicagrel 5 mg, 6 mg, 7.5 mg, or clopidogrel 75 mg for 28 days per study protocol. P2Y 12 reaction units (PRU) were measured using VerifyNow at baseline, 6 to 8 hours after loading dose, 7 to 10 days after randomization, and 28 days after randomization and the percentage inhibition of platelet aggregation (%IPA) was calculated. The primary endpoint was %IPA on day 28. Within the patients from the General Hospital of Northern Theater Command, 8 to 12 patients in each study arms were enrolled in a prespecified pharmacokinetic sub-study, measuring the time to reach maximum plasma concentration (T max), peak plasma concentration (C max), and area under the plasma concentration-time curve (AUC). Results:Among 201 patients, the age was (58.8±8.5) years, and 139 (69.2%) were male. In non-LOF carriers, there was no significant differences in PRU values and %IPA between the vicagrel 5 mg, 6 mg, 7 mg, and clopidogrel groups at all time points (all P>0.05). In LOF carriers, %IPA was significantly higher in the vicagrel-treated groups than in the clopidogrel group at 6-8 hours after loading dose (22.9 (14.2, 31.5)% vs. 19.8 (11.0, 28.6)% vs. 29.5 (20.9, 38.0)% vs. 12.9 (3.9, 21.9)%, P=0.038) and 7-10 days after randomization (22.4 (14.2, 30.5)% vs. 34.4 (26.1, 42.6)% vs. 39.8 (31.8, 47.9)% vs. 24.7 (16.3, 33.2)%, P=0.001), with a trend towards higher %IPA in the vicagrel-treated groups at day 28 (30.4 (21.3, 39.6)% vs. 36.5 (27.2, 45.7)% vs. 40.8 (31.8, 49.8)% vs. 30.7(21.2, 40.2)%, P=0.056). Pharmacokinetic results of 35 patients showed that the C max and AUC of the active metabolite M15-2 of vicagrel was similar to that of clopidogrel in non-LOF carriers, but AUC between vicagrel 5 mg, 6 mg, 7 mg and clopidogrel were significantly different in LOF carriers ((5.6±0.6) h·μg -1·L -1 vs. (6.8±2.7) h·μg -1·L -1 vs. (9.2±3.3) h·μg -1·L -1 vs. (4.2±1.9) h·μg -1·ml -1, P=0.020). Conclusion:Vicagrel and clopidogrel have similar antiplatelet effects in non-LOF carriers, but vicagrel exhibits superior antiplatelet effects in LOF carriers.

Objective:To investigate the predictive value of cardiopulmonary exercise test (CPET) indexes for major adverse cardiovascular events (MACE) in patients with coronary heart disease (CHD).Methods:This study was a retrospective cohort study. CHD patients were consecutively enrolled who procedure CPET before discharge from the Department of Cardiology, General Hospital of Northern Theater Command from November 2015 to September 2021 were enrolled. Demographic information, past medical history, CPET indexes and other baseline data were collected and the patients were followed up. Patients were divided into a MACE group and a control group according to the presence or absence of MACE. A multivariate Cox proportional hazard regression model was used to analyze the CPET indexes with predictive value for MACE in CHD patients.Results:A total of 3 800 patients were eligible for the criterion, age (57.2±8.8) years, 2 920 (76.84%) males. During a follow-up of 1 237 (695, 1 596) days, 390 (10.26%) patients were in MACE group, and 3 410 (89.74%) patients were in control group. In adjusted multivariable analysis, higher metabolic equivalent of tasks (MET) at anaerobic threshold (AT) is an independent protective factor for MACE in patients with CHD ( HR=0.75, 95% CI 0.62-0.90, P=0.002), higher VE/VCO 2 is an independent risk factor for MACE in CHD patients ( HR=1.05, 95% CI 1.02-1.07, P=0.001). Conclusion:In CPET, high MET at AT is an independent protective factor for MACE in patients with CHD, and high VE/VCO 2 is an independent risk factor for MACE in CHD patients.

Objective:To investigate the changes in cardiopulmonary exercise testing (CPET) characteristics before and after the outbreak of COVID-19 in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI).Methods:This is a cross-sectional study that included ACS patients who underwent PCI at the General Hospital of the Northern Theater Command from July 2018 to February 2023. Based on the timeline of the COVID-19 pandemic, patients were divided into two groups: the pre-pandemic group and the during-pandemic group, with January 2020 as the dividing line. Clinical data were collected from both groups, and a comparative analysis was performed on their postoperative CPET outcomes, including peak oxygen uptake (peak VO 2), peak metabolic equivalents (peak MET), and other indicators. Weber′s classification was used to assess cardiac function. In addition, the 7-tiem generalized anxiety disorder scale (GAD-7) and the patient health questionnaire-9 (PHQ-9) were used to assess the patients′ psychological anxiety and depression states, respectively. Multivariate logistic regression was used to analyze the influencing factors of CPET after PCI. Results:A total of 4 310 post-PCI ACS patients were included, with an average age of (58.7±9.1) years, and 3 464 (80.37%) were male. There were 1 698 patients in the pre-pandemic group and 2 612 patients in the during-pandemic group. The main indicator of the CPET, peak VO 2 (15.04±3.93) ml·min -1·kg -1 in the during-pandemic group, was lower than that in the pre-pandemic group (15.52±3.68) ml·min -1·kg -1, and the difference was statistically significant ( P<0.001). Multivariate logistic regression analysis showed that advanced age, female gender, high body mass index, elevated high-sensitivity C-reactive protein, reduced high-density lipoprotein cholesterol, smoking history, history of myocardial infarction, more severe ACS classification, and mild to moderate degree of depression were related to poor cardiopulmonary outcomes ( P<0.05). Conclusion:The COVID-19 pandemic had a negative impact on the cardiopulmonary outcomes of ACS patients after PCI. Reduced physical activity, and increased psychological stress should be given consideration and attention regarding their impact on patients′ cardiopulmonary function.

Objective:To assess the predictive value of dosiomics in predicting the occurrence of bone marrow suppression (BMS) in patients with pelvic tumors during radiotherapy.Methods:A retrospective analysis was conducted on the clinical data and radiotherapy planning documents of 129 patients with pelvic region tumors who underwent radiotherapy at the First Affiliated Hospital of Nanjing Medical University from January 2019 to January 2023. The region of interest (ROI) was outlined for bone marrow in the pelvic region by Accu Contour software in planning CT, and the ROI was exported together with the dose distribution file. According to a stratified randomization grouping method, the patients were divided into the training set and test set in an 8 vs. 2 ratio. The dosiomic features were extracted from the ROI, and the two independent samples t-test and the least absolute shrinkage and selection operator (LASSO) algorithm was employed to identify the best predictive characteristics. Subsequently, the dosiomic scores were calculated. Clinical predictors were identified through both univariant and multivariate logistic regression analyses. Predictive models were constructed by using clinical predictors alone and combining clinical predictors and dosiomic scores. The efficacy of predictive model was assessed by plotting the receiver operating characteristic (ROC) curve and evaluating its performance through the area under the ROC curve (AUC), the calibration curve, and decision curve analysis (DCA). Results:Fourteen dosiomic features that showed a strong correlation with the occurrence of BMS were screened and utilized to calculate the dosiomic scores. Based on both univariant and multivariate logistic regression analyses, chemotherapy, planning target volume (PTV) and V 5 Gy were identified as clinical predictors. According to the combined model, the AUC values for the training set and test set were 0.911 and 0.868, surpassing those of the clinical model (AUC=0.878 and 0.824). Furthermore, the analysis of both the calibration curve and DCA suggested that the combined model had higher calibration and net clinical benefit. Conclusion:The combined model has a high diagnostic value for predicting BMS in patients with pelvic tumors during radiotherapy.