Quality control materials are crucial for assessing the validity and consistency of vaccine quality control and laboratory test results. Given the particularity of vaccine products and clinical samples, the World Health Organization(WHO) and China have issued several reference reagents and reference materials for laboratory quality control to ensure the quality of testing. In recent years, national laboratory accreditation technical documents and national technical standards have been updated and improved to enhance laboratory quality control management. This includes technical requirements for the establishment, application, and quality control rules of quality control materials. The guideline for the design, establishment, and validation of biological activity assays in the Chinese Pharmacopeia(VolumeⅣ, 2025 edition) requires continuous monitoring of the activity of quality control materials in biological activity assays. Based on the characteristics of vaccine quality control and evaluation laboratories, targeted research and application of quality control materials and quality control rules are of practical significance for improving the quality control level of vaccines and the detection level of vaccine clinical trials in China. This paper reviews and summarizes domestic and international technical guidelines and literature related to quality control materials, aiming to provide insights and recommendations for developing, establishing, and applying quality control materials in vaccine quality control and clinical sample testing.

Objective:To investigate the value of breast MRI imaging features combined with serological indicators in predicting the metastatic burden of axillary lymph nodes (ALN) in breast cancer.Methods:This cross-sectional study retrospectively enrolled 146 female patients diagnosed with breast cancer at the First Affiliated Hospital of Shihezi University from January 2020 to November 2024. Patients′ pre-treatment clinical data, serological indices, breast MRI image features, and post-surgical pathologic features were analyzed. Patients were divided into low-burden (<3 metastatic lymph nodes) group and high-burden (≥3 metastatic lymph nodes) group based on pathological ALN confirmation. Group comparisons of clinical variables were analyzed using independent samples t-tests, Mann-Whitney U tests, or χ2 tests. Indicators with statistically significant differences were included in a multivariable logistic regression analysis to screen for independent influences predicting high ALN load and construct multiple logistic regression models. The performance of these models was evaluated using receiver operating characteristic curves and area under the curve (AUC), while net clinical benefit was assessed using decision curve analysis (DCA). Results:Significant differences were observed between low and high ALN burden groups in carcinoembryonic antigen levels, CA153 levels, tumor diameter, margins, enhancement characteristics, number of peritumoral thick blood vessels (TBVs), MRI-reported ALN loading status (MRI-ALN), and lymphovascular invasion status ( P<0.05). Multivariable logistic regression analysis showed that serum CA153 level ( OR=1.056, 95% CI 1.007-1.108, P=0.024), tumor margins ( OR=3.977, 95% CI 1.561-10.131, P=0.004), TBVs ( OR=3.058, 95% CI 1.217-7.684, P=0.017), and MRI-ALN ( OR=9.424, 95% CI 3.531-25.155, P<0.001) were independent risk factors predicting high ALN load in breast cancer ( P<0.05). The logistic regression model incorporating these four risk factors yielded optimal predictive performance for high ALN burden in breast cancer (AUC=0.854). DCA demonstrated optimal net clinical benefit within the threshold probability range of 13.3% to 72.7%. Conclusions:Tumor margins, TBVs, MRI-ALN, and CA153 levels are significantly associated with high ALN metastatic burden in breast cancer. Constructing a predictive model incorporating these features can significantly improve the accuracy of identifying high ALN burden.

Objective:To explore the risk factors for malnutrition after a traumatic brain injury and to construct a model which usefully predicts that risk.Methods:This was a retrospective study of 374 patients with a craniocerebral injury for whom the relevant clinical data were available. Based on their nutritional status, they were stratified into a malnutrition group ( n=220) and a control group ( n=154). Univariate and multivariate logistic regressions were evaluated seeking to identify the independent risk factors associated with malnutrition, and a prediction model was constructed based on the results. The model′s discrimination ability and accuracy were assessed using a receiver operating characteristics (ROC) curve. Results:A total of 220 patients (58.8%) developed malnutrition. Multifactorial logistic regression analysis showed that the independent risk factors for malnutrition were: age ≥60 years, pulmonary infection, dysphagia, cognitive impairment, a GCS score ≤8, or a Barthel index ≤40. In the ROC curve analysis, the area under the curve quantifying the model′s ability to predict malnutrition was 0.924 (95% CI: 0.896, 0.951), with a sensitivity of 0.868 and a specificity of 0.857, indicating its good prediction performance. Conclusions:Age ≥60 years, pulmonary infection, dysphagia, cognitive impairment, a GCS score ≤8 or a Barthel index ≤40 are independent predictors of malnutrition after a traumatic brain injury. The prediction model constructed based on those risk factors has demonstrated useful predictive power for malnutrition.

Objective The objective of this study was to explore the effect of knocking down CXCL8 on the efficacy of pacli-taxel chemotherapy in cervical squamous cell carcinoma and to investigate its potential mechanism of action.Methods The Hela cell model was used to specifically inhibit CXCL8 gene expression through lentivirus-mediated RNA interference(RNAi)technology.The optimal transfection conditions were HitransG P and a multiplicity of infection(MOI)of 100.The CCK-8 assay was used to screen the optimal intervention concentration of puromycin as 1.5μg/mL.The LV-CXCL8-RNAi(3 targets)and negative control lentivirus were transfected into cells under optimal transfection conditions and set up a blank control group.The qRT-PCR assay was used to select the sh-CXCL8-13 group lentivirus as the intervention sequence and virus for subsequent experiments.The experiments were divided into the blank control group,negative control group,sh-CXCL8 group,paclitaxel group,and sh-CXCL8+paclitaxel group.The prolifer-ative activity and invasive ability of cervical cancer cells were assessed by CCK-8 and cell invasion assays.The expression of CXCL8,Bcl2,Bax,and β-actin were detected by qRT-PCR and Western blot.Results Compared with the other four groups,the proliferative and invasive ability of Hela cells was significantly reduced in the sh-CXCL8+paclitaxel group,and the difference was statistically sig-nificant(P<0.01).The qRT-PCR results showed that the expression of CXCL8,Bcl2,PIK3CB,and Akt1 genes was significantly re-duced,and the expression of Bax gene was significantly increased in the sh-CXCL8+paclitaxel group.The difference between the groups was statistically significant(P<0.001).The results of Western blot showed that the expression of CXCL8,PIK3CB,and p-Akt1 proteins was reduced in the sh-CXCL8+paclitaxel group(P<0.05).Conclusion Knocking down CXCL8 can reduce the prolif-erative and invasive capacity of Hela cells,possibly by affecting the PI3K/Akt pathway to affect the drug sensitivity of Hela cells to paclitaxel.

As a critical quality attribute to ensure the accuracy and comparability of the results of reference standards in different detection systems, commutability has attracted increasing attention in related research fields. The World Health Organization(WHO) has issued several technical reports and guidelines to clarify its definition, evaluation requirements. The American Clinical and Laboratory Standards Institute(CLSI), the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC) and relevant departments in China have also successively issued relevant guidelines and specifications. At present,commutability evaluation has been widely practiced in diagnostic reference standards, but there is still a lack of systematic research in the field of vaccine and therapeutic biological product reference standards. This paper systematically sorts out the relevant documents on the research on the commutability of reference standards, and summarizes the research progress in this field, so as to provide ideas and reference for the in-depth research on the commutability of biological reference standards.

Objective To compare ovulation recovery rate and metabolic indicators between ethinyl-estradiol/drospirenone(EE/DRSP)combined with orlistat and EE/DRSP alone in overweight/obese patients with polycystic ovary syndrome(PCOS).Methods This study was a randomized controlled clinical trial conducted based on the 2004 Rotterdam criteria.From October 2020 to December 2023,180 overweight/obese PCOS patients aged 20-40 were recruited from the Department of Department of Gynecological Endocrinology,Beijing Obstetrics and Gynecology Hospital,Capital Medical University.The patients were randomly divided into two groups in a 1∶2 ratio.Among them,60 patients received treatment with EE/DRSP(EE20 μg,DRSP 3 mg),while 120 patients received a combination treatment of EE/DRSP and orlistat(360 mg/d).The height,weight,waist circumference,hip circumference,and blood pressure of the patients were measured before treatment and after 12 weeks of treatment.Laboratory tests included measurements of follicle-stimulating hormone(FSH),luteinizing hormone(LH),fasting insulin(FINS),homeostasis model assessment of insulin resistance(HOMA-IR),free androgen index(FAI),alanine transaminase(ALT),aspartate transaminase(AST),gamma-glutamyl transferase(GGT),fasting plasma glucose(FPG),total cholesterol(TC),triglycerides(TG),high density lipoprotein-cholesterol(HDL-C),low density lipoprotein-cholesterol(LDL-C),lipoprotein(a)[Lp(a)],sex hormone-binding globulin(SHBG),total testosterone(T),and free testosterone(FT).After 12 weeks of treatment,the medication was discontinued,and natural ovulation was observed.Results After 12 weeks of treatment,the ovulation rate of the EE/DRSP combined with orlistat group reached 70.8%,while the natural ovulation rate of the EE/DRSP group alone was only 35%,indicating that the ovulation rate was significantly increased after EE/DRSP combined with orlistat treatment.After 12 weeks of treatment,both groups showed a significant decrease in total testosterone,free testosterone,and low-density lipoprotein levels(all P<0.05),and the decrease in BMI,waist circumference,fasting insulin,and HOMA-IR in the EE/DRSP combined with orlistat group was greater than that in the EE/DRSP group alone(P<0.05).After treatment,both groups showed a significant increase in high-density lipoprotein and triglyceride levels(all P<0.05),with no significant changes in total cholesterol and fasting blood glucose(all P>0.05).Conclusion After 12 weeks of treatment,EE/DRSP combined with orlistat can significantly improve the ovulation rate of PCOS patients.It is superior to EE/DRSP alone in reducing androgen levels,body weight,insulin resistance,and low-density lipoprotein levels.

Objective The effects of stachydrine(STA)on the proliferation,apoptosis and radiosensitivity of acute myeloid leukemia(AML)cells by regulating the transcription factor forkhead box protein O3(FOXO3)-forkhead box protein M1(FOXM1)signaling axis.Methods Human AML cells(HL-60)were treated with STA at a concentration of 50～1 600 μmol/L,and the activity of HL-60 cells was detected using the cell counting kit-8(CCK-8)method to screen for the optimal drug concentration;HL-60 cells were separated into Control group,low,medium,and high concentration STA groups(STA-L group,STA-M group,STA-H group),STA+lentivirus transfection control group(STA-H+LV-NC group),and high-concentration STA+FOXO3 overexpression lentiviral group(STA-H+LV-FOXO3 group).5-ethyny1-2'-deoxyuridine(Edu)was applied to detect HL-60 cell proliferation;flow cytometry(FCM)was applied to detect cell apoptosis;cell cloning experiments were applied to detect the radiotherapy sensitivity of cells;Western blot was applied to detect the expression of cell proliferation antigen markers(Ki67),Cyclin D1,Caspase-3,B-cell lymphoma2 assaciated X protein(Bax),FOXO3,and FOXM1 proteins.Results STA concentrations of 100,200 and 400 μmol/L were selected for subsequent experiments.Compared with the control group,the positive rate of Ki67,Cyclin D1,Edu,FOXO3 and FOXM1 expression levels in the STA-L,STA-M,and STA-H groups decreased sequentially(tSTA-L=2.169～5.879,tSTA-M=3.089～11.284,tSTA-H=4.572～11.502),Caspase-3 and Bax expression levels,the apoptosis rate,increased sequentially(tSTA-L=9.171,10.082,20.144;tSTA-M=5.435,7.530,7.450;tSTA-H=4.138,4.159,5.956)and the differences were statistically significant(all P<0.05),respectively.Compared with the STA-H+LV-NC group,the positive rate of Edu and the expression levels of Ki67,Cyclin D1,FOXO3 and FOXM1 were obviously increased in the STA-H+LV-FOXO3 group(t=10.055～16.267),Caspase-3 and Bax expression levels,the apoptosis rate were obviously reduced(t=5.736,5.433,8.933),and the differences were statistically significant(all P<0.05),respectively.The colony formation rate of HL-60 cells in the radiotherapy group and STA+radiotherapy group decreased with the increase of radiotherapy dose,and the differences were statistically significant(F=78.630,137.843,all P<0.05),and the colony formation rate of HL-60 cells in the STA+radiotherapy group was lower than that in the radiotherapy group at the same dose(t=1.480～11.301,all P<0.05).Conclusion Stachydrine inhibits AML cell proliferation,induces apoptosis,and enhances radiotherapy sensitivity by inhibiting the FOXO3-FOXM1 signaling axis.

Objective To assess the expression of CXCL8 in cervical cancer and its association with clinicopathological features and therapeutic efficacy of patients.Methods Bioinformatic analysis was performed using The Cancer Genome Atlas and Genotype-Tissue Expression databases to compare CXCL8 expression between cervical cancer and normal tissues.R software(version 4.4.0)was used for data analysis,with the timeROC package applied to construct time-dependent receiver operating characteristic(ROC)curves for evalua-ting the prognostic predictive efficacy of CXCL8.The survival package with the survfit function was used to compare survival differences between CXCL8 high-and low-expression groups.Clinical data and tissue specimens were collected from 94 patients with cervical squa-mous cell cancer treated at The First Affiliated Hospital of Xinjiang Medical University between January 2017 and December 2021.Immu-nohistochemical staining was used to detect CXCL8 expression levels and analyze its correlation with clinicopathological characteristics,therapeutic efficacy,and prognosis.Results Bioinformatic analysis showed that CXCL8 was highly expressed in cervical cancer tissues than in normal tissues(P＜0.05).Time-dependent ROC curves and survival analyses showed that patients with high CXCL8 expression had significantly shorter overall survival than those with low CXCL8 expression(P＜0.001).Immunohistochemical results showed that CXCL8 expression in cervical cancer tissues was significantly higher than that in adjacent tissues(P＜0.000 1).Clinical correlation analy-sis revealed that CXCL8 expression levels were associated with treatment regimen(P＜0.001)and short-term therapeutic efficacy(P=0.017).Compared to the low-expression group,the high-expression group showed a significantly lower therapeutic efficacy and shorter overall survival(P＜0.05).Conclusion CXCL8 is highly expressed in cervical cancer tissues,and patients with high CXCL8 expression have poor prognosis.Thus,CXCL8 may be an effective target for assessing the prognosis and clinical treatment of cervical cancer.

Objective To develop a new cardiac rehabilitation exercise program based on the LEARNS health education model for patients undergoing percutaneous coronary intervention(PCI),and to evaluate its effectiveness.Methods A total of 78 inpatients with acute coronary syndrome(ACS)who received PCI between February and May 2024 in a tertiary hospital were enrolled.Using a random number table,participants were assigned to either an intervention group or a control group(n=39 each).The control group received routine health education,while the intervention group received a cardiac rehabilitation exercise program developed based on the LEARNS model.The intervention started during hospitalization and lasted for two weeks.After the intervention,patients'willingness to participate in Phase II cardiac rehabilitation,exercise self-efficacy and exercise behavior,were evaluated.Results All 76 patients completed the study.After the intervention,the intervention group showed significantly higher scores in willingness to participate in rehabilitation(P<0.001)and exercise self-efficacy(P<0.001)compared with the control group.In terms of exercise behaviors,the intervention group also performed better than the control group,with statistically significant differences across related indicators(P<0.05).Conclusion The application of a new PCI postoperative rehabilitation program based on the LEARNS health education model can significantly enhance patients'willingness to participate in Phase II cardiac rehabilitation,improve their exercise self-efficacy and behavior,and effectively promote the implementation and sustainability of cardiac rehabilitation.

Objective To compare ovulation recovery rate and metabolic indicators between ethinyl-estradiol/drospirenone(EE/DRSP)combined with orlistat and EE/DRSP alone in overweight/obese patients with polycystic ovary syndrome(PCOS).Methods This study was a randomized controlled clinical trial conducted based on the 2004 Rotterdam criteria.From October 2020 to December 2023,180 overweight/obese PCOS patients aged 20-40 were recruited from the Department of Department of Gynecological Endocrinology,Beijing Obstetrics and Gynecology Hospital,Capital Medical University.The patients were randomly divided into two groups in a 1∶2 ratio.Among them,60 patients received treatment with EE/DRSP(EE20 μg,DRSP 3 mg),while 120 patients received a combination treatment of EE/DRSP and orlistat(360 mg/d).The height,weight,waist circumference,hip circumference,and blood pressure of the patients were measured before treatment and after 12 weeks of treatment.Laboratory tests included measurements of follicle-stimulating hormone(FSH),luteinizing hormone(LH),fasting insulin(FINS),homeostasis model assessment of insulin resistance(HOMA-IR),free androgen index(FAI),alanine transaminase(ALT),aspartate transaminase(AST),gamma-glutamyl transferase(GGT),fasting plasma glucose(FPG),total cholesterol(TC),triglycerides(TG),high density lipoprotein-cholesterol(HDL-C),low density lipoprotein-cholesterol(LDL-C),lipoprotein(a)[Lp(a)],sex hormone-binding globulin(SHBG),total testosterone(T),and free testosterone(FT).After 12 weeks of treatment,the medication was discontinued,and natural ovulation was observed.Results After 12 weeks of treatment,the ovulation rate of the EE/DRSP combined with orlistat group reached 70.8%,while the natural ovulation rate of the EE/DRSP group alone was only 35%,indicating that the ovulation rate was significantly increased after EE/DRSP combined with orlistat treatment.After 12 weeks of treatment,both groups showed a significant decrease in total testosterone,free testosterone,and low-density lipoprotein levels(all P<0.05),and the decrease in BMI,waist circumference,fasting insulin,and HOMA-IR in the EE/DRSP combined with orlistat group was greater than that in the EE/DRSP group alone(P<0.05).After treatment,both groups showed a significant increase in high-density lipoprotein and triglyceride levels(all P<0.05),with no significant changes in total cholesterol and fasting blood glucose(all P>0.05).Conclusion After 12 weeks of treatment,EE/DRSP combined with orlistat can significantly improve the ovulation rate of PCOS patients.It is superior to EE/DRSP alone in reducing androgen levels,body weight,insulin resistance,and low-density lipoprotein levels.