1.Clinical study on EGF and NF-κB regulating malignant progression of elderly gliomas
Yun SHAO ; Wenwen LIU ; Jing QIN ; Xinxin QI
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(9):1233-1237
Objective To explore the expression of epidermal growth factor and nuclear transcrip-tion factor kappa B(NF-κB)in elderly gliomas and their roles in malignant progression of the dis-ease.Methods A total of 240 elderly glioma patients undergoing surgical resection in our hospital from January 2020 to January 2023 were enrolled and served as an observation group.Another 100 patients receiving surgical treatment due to traumatic brain injury in our hospital during the same period were recruited and served as the control group.Immunohistochemical assay was used to detect the expression of epidermal growth factor and NF-κB in brain tissue.Cox regression analy-sis was employed to determine the independent influencing factors of malignant progression in the elderly glioma patients.Results The observation group had significantly higher epidermal growth factor expression score and NF-κB expression score than the control group(7.44±1.16 vs 3.68±0.51,6.49±1.02 vs 3.56±0.64,P<0.01).The age,tumor pathological grade,surgical approach,postoperative radiotherapy,and epidermal growth factor and NF-κB expression levels were inde-pendent factors affecting the progression of elderly glioma patients(P<0.05,P<0.01).Conclusion The epidermal growth factor and NF-κB expression levels are independent influen-cing factors of progressive disease in elderly glioma patients,and can serve as evaluation indicators for postoperative progression in the patients.
2.Establishment and optimization of the method for related substances in myristyl alcohol
Xinxin FANG ; Chuanmei HU ; Cuixia YAN ; Hong SHAO ; Luxia ZHENG
Drug Standards of China 2025;26(2):162-166
Objective:To establish a GC method for the determination of related substances in myristyl alcohol.Methods:Use a column packed with polyethylene glycol as the stationary phase(HP-INNOWAX,0.25 mm×30 m,0.25 μm).Maintain the column temperature at 90℃,raise the temperature to 180℃by 5℃per minutes,maintain for 25 minutes.The temperatures of injection port is 270℃.The temperatures of detector is 280℃.Cal-culate the content by normalization method.Result:Lauryl alcohol,myristyl alcohol,pentadecanol,cetyl alcohol,stearyl alcohol and oleyl alcohol showed good linear relationships within the ranges of 6.2-123.8,4.2-134.2,5.2-104.2,4.5-90.3,4.8-96.0,4.8-95.2 μg·mL-1,respectively,with the correlation coefficient above 0.999 8.The limit of detection of aforementioned fatty alcohols were 0.2,0.2,0.2,0.3,0.5 and 0.5 μg·mL-1,which were more sensitive than the method in USP monotherapy Myristyl Alcohol.The content of lauryl alcohol was 0.2%-0.6%and that of cetyl alcohol was 0.1%-0.9%in 5 batches of samples.Sum of re-lated fatty alcohols and unspecified impurities was 0.7%-2.5%.Conclusion:The method established in this study has good separation effect,high specificity and high sensitivity,and solved the problem of difficult identifica-tion of related fatty alcohols caused by high noise at the baseline of the method in USP monotherapy myristyl alco-hol.It can be used for the the determination of related substances in myristyl alcohol.It also provides reference and guidance for the quality management and control of other fatty alcohols.
3.A network-based prognostic prediction model for gastric signet ring cell carcinoma after laparoscopic surgery
Yujuan JIANG ; Xinxin SHAO ; Haitao HU ; Yiming LU ; Haikuo WANG ; Wangyao LI ; Yantao TIAN
Chinese Journal of General Surgery 2025;40(10):806-810
Objective:The purpose of this study was to develop a dynamic prediction model for patients with gastric signet ring cell cancer (GSRCC)following laparoscopic radical gastrectomy in order to improve the precision and usefulness of prognoses prediction for overall survival and disease-free survival.Methods:From 2011 to 2018, 914 National Cancer Center patients participated in the study. To find independent prognostic indicators and create a prognostic nomogram model, univariate and multivariate regression analyses were performed. Calibration curves, receiver operating characteristic curves, and consistency indices were used to assess the model's performance. To make clinical application more convenient, two web-based prediction tools were created.Results:A training set of 639 cases and a validation set of 275 instances were randomly selected from among the patients. Important predictive variables such as age, tumor size, location, pN and pT staging, and postoperative chemotherapy were all incorporated in the model (all P<0.05). The model's consistency index and area under the receiver operating characteristic curves were both higher than 0.7, and the calibration curves demonstrated a good fit between the expected and actual values, indicating high accuracy and consistency in postoperative survival prediction for patients with gastric signet ring cell carcinoma. Conclusion:We successfully developed two dynamic prediction models in this study, which improved its clinical practicability using web-based tools and is anticipated to be crucial to clinical practice going forward.
4.Establishment of a method for determination of sialylation levels of N-glycan profiles based on ion exchange chromatography
Hongrui YIN ; Xinxin FANG ; Ying ZHANG ; Mingming XU ; Luxia ZHENG ; Hong SHAO
Drug Standards of China 2025;26(4):366-370
Objective:To establish a method for determining the sialylation levels of N-glycan profiles based on ion-exchange chromatography in glycoprotein drugs.Methods:The separation was performed in a column picking with anion-exchange resin(4.6 mm × 250 mm,5 μm,or equivalent).Mobile phase A was 20% acetonitrile solution,while mobile phase B was a 20%acetonitrile solution containing 0.1 mol·L-1 ammonium formate(pH 4.5).The flow rate was 0.60 mL·min-1.Detection was performed using a fluorescence detector with excita-tion and emission wavelengths of 330 and 420 nm,respectively.The injection volume was 5 μL.Results:Within the target loading sample range of 40% to 160%,the peak area showed a good linear relationship with protein concentration(r>0.99).The average recovery rates at three concentration levels were 106.25%,100.00%,and 106.67%,respectively.The limit of quantification was 0.03%.Conclusion:This method is suitable for detecting the sialylation levels of N-glycan profiles in various glycoprotein drugs.
5.Purity Determination and Stability Analysis of Human Epidermal Growth Factor Based on National Drug Sampling and Testing
Xinxin FANG ; Hongrui YIN ; Can WANG ; Luxia ZHENG ; Hong SHAO
Herald of Medicine 2025;44(9):1385-1389
Objective To establish a high-performance liquid chromatography method to detect the purity of human epidermal growth factor(hEGF),to compare the stability of the products of different enterprises by purity results,and to provide technical support for improving quality control and unified monitoring of hEGF based on national drug sampling and testing.Methods Agilent 300SB C8 column(250 mm×4.6 mm,5 μm)was used.Mobile phase A was 7.5 mmol·L-1 sodium phosphate buffer(pH 6.8),and mobile phase B was acetonitrile,the column temperature was 30℃,the flow rate was 0.6 mL·min-1 with gradient elution,and the detector wavelength was set at 280 nm.Results The resolution between the main peak of hEGF and the adjacent impurity peak was more than 1.5,with a detection limit of 6 ng.This method has been successfully applied to determine the purity of the bulk and final products.The results showed that the purity of the final products decreased compared with the bulk.The maximum impurity that increased significantly was the deamidation impurity identified by the mass spectrometry.Conclusion Based on the typical sample of the full chain and multi-dosage form,the established method had good specificity and resolution for the preliminary identification and purity determination of hEGF bulk and final products.
6.Construction of entrustable professional activity indicators for non-anesthesiology residents during rotation in the department of anesthesiology
Xinxin SHAO ; Jianhong YE ; Xiaodan WU ; Lu YANG ; Qingchun LIANG ; Qin ZHOU
Chinese Journal of Medical Education Research 2025;24(9):1212-1217
Objective:To establish a framework of entrustable professional activity indicators for non-anesthesiology residents during rotation in the Department of Anesthesiology, standardize the training process, and provide an effective evaluation method.Methods:Based on literature review and discussions, a preliminary expert consultation questionnaire was developed. From July to November 2024, a modified Delphi method was adopted and relevant experts were invited to assess the importance, validity, and feasibility of each indicator using a 5-point Likert scale. The results were used to screen and refine the entrustable professional activity indicators for non-anesthesiology residents during rotation in the Department of Anesthesiology.Results:In the two rounds of expert consultation, the valid questionnaire return rate reached 100.00%, with an expert judgment basis coefficient of 0.73 and a familiarity coefficient of 0.90. Based on expert feedback, the final framework retained 3 first-level indicators and 12 second-level indicators. Modifications included renaming "Anesthesia Management" to "Anesthetic Drug Management", swapping the order of "Intraoperative Emergency Management" and "Airway Management", and removing the indicator "Resuscitation Assessment".Conclusions:This study preliminarily developed a framework of entrustable professional activity indicators for non-anesthesiology residents during rotation in the Department of Anesthesiology. The framework provides a simple and practical competency evaluation method for standardized training, which can enhance training quality and effectiveness.
7.Establishment and optimization of the method for related substances in myristyl alcohol
Xinxin FANG ; Chuanmei HU ; Cuixia YAN ; Hong SHAO ; Luxia ZHENG
Drug Standards of China 2025;26(2):162-166
Objective:To establish a GC method for the determination of related substances in myristyl alcohol.Methods:Use a column packed with polyethylene glycol as the stationary phase(HP-INNOWAX,0.25 mm×30 m,0.25 μm).Maintain the column temperature at 90℃,raise the temperature to 180℃by 5℃per minutes,maintain for 25 minutes.The temperatures of injection port is 270℃.The temperatures of detector is 280℃.Cal-culate the content by normalization method.Result:Lauryl alcohol,myristyl alcohol,pentadecanol,cetyl alcohol,stearyl alcohol and oleyl alcohol showed good linear relationships within the ranges of 6.2-123.8,4.2-134.2,5.2-104.2,4.5-90.3,4.8-96.0,4.8-95.2 μg·mL-1,respectively,with the correlation coefficient above 0.999 8.The limit of detection of aforementioned fatty alcohols were 0.2,0.2,0.2,0.3,0.5 and 0.5 μg·mL-1,which were more sensitive than the method in USP monotherapy Myristyl Alcohol.The content of lauryl alcohol was 0.2%-0.6%and that of cetyl alcohol was 0.1%-0.9%in 5 batches of samples.Sum of re-lated fatty alcohols and unspecified impurities was 0.7%-2.5%.Conclusion:The method established in this study has good separation effect,high specificity and high sensitivity,and solved the problem of difficult identifica-tion of related fatty alcohols caused by high noise at the baseline of the method in USP monotherapy myristyl alco-hol.It can be used for the the determination of related substances in myristyl alcohol.It also provides reference and guidance for the quality management and control of other fatty alcohols.
8.Establishment of a method for determination of sialylation levels of N-glycan profiles based on ion exchange chromatography
Hongrui YIN ; Xinxin FANG ; Ying ZHANG ; Mingming XU ; Luxia ZHENG ; Hong SHAO
Drug Standards of China 2025;26(4):366-370
Objective:To establish a method for determining the sialylation levels of N-glycan profiles based on ion-exchange chromatography in glycoprotein drugs.Methods:The separation was performed in a column picking with anion-exchange resin(4.6 mm × 250 mm,5 μm,or equivalent).Mobile phase A was 20% acetonitrile solution,while mobile phase B was a 20%acetonitrile solution containing 0.1 mol·L-1 ammonium formate(pH 4.5).The flow rate was 0.60 mL·min-1.Detection was performed using a fluorescence detector with excita-tion and emission wavelengths of 330 and 420 nm,respectively.The injection volume was 5 μL.Results:Within the target loading sample range of 40% to 160%,the peak area showed a good linear relationship with protein concentration(r>0.99).The average recovery rates at three concentration levels were 106.25%,100.00%,and 106.67%,respectively.The limit of quantification was 0.03%.Conclusion:This method is suitable for detecting the sialylation levels of N-glycan profiles in various glycoprotein drugs.
9.Purity Determination and Stability Analysis of Human Epidermal Growth Factor Based on National Drug Sampling and Testing
Xinxin FANG ; Hongrui YIN ; Can WANG ; Luxia ZHENG ; Hong SHAO
Herald of Medicine 2025;44(9):1385-1389
Objective To establish a high-performance liquid chromatography method to detect the purity of human epidermal growth factor(hEGF),to compare the stability of the products of different enterprises by purity results,and to provide technical support for improving quality control and unified monitoring of hEGF based on national drug sampling and testing.Methods Agilent 300SB C8 column(250 mm×4.6 mm,5 μm)was used.Mobile phase A was 7.5 mmol·L-1 sodium phosphate buffer(pH 6.8),and mobile phase B was acetonitrile,the column temperature was 30℃,the flow rate was 0.6 mL·min-1 with gradient elution,and the detector wavelength was set at 280 nm.Results The resolution between the main peak of hEGF and the adjacent impurity peak was more than 1.5,with a detection limit of 6 ng.This method has been successfully applied to determine the purity of the bulk and final products.The results showed that the purity of the final products decreased compared with the bulk.The maximum impurity that increased significantly was the deamidation impurity identified by the mass spectrometry.Conclusion Based on the typical sample of the full chain and multi-dosage form,the established method had good specificity and resolution for the preliminary identification and purity determination of hEGF bulk and final products.
10.Construction of entrustable professional activity indicators for non-anesthesiology residents during rotation in the department of anesthesiology
Xinxin SHAO ; Jianhong YE ; Xiaodan WU ; Lu YANG ; Qingchun LIANG ; Qin ZHOU
Chinese Journal of Medical Education Research 2025;24(9):1212-1217
Objective:To establish a framework of entrustable professional activity indicators for non-anesthesiology residents during rotation in the Department of Anesthesiology, standardize the training process, and provide an effective evaluation method.Methods:Based on literature review and discussions, a preliminary expert consultation questionnaire was developed. From July to November 2024, a modified Delphi method was adopted and relevant experts were invited to assess the importance, validity, and feasibility of each indicator using a 5-point Likert scale. The results were used to screen and refine the entrustable professional activity indicators for non-anesthesiology residents during rotation in the Department of Anesthesiology.Results:In the two rounds of expert consultation, the valid questionnaire return rate reached 100.00%, with an expert judgment basis coefficient of 0.73 and a familiarity coefficient of 0.90. Based on expert feedback, the final framework retained 3 first-level indicators and 12 second-level indicators. Modifications included renaming "Anesthesia Management" to "Anesthetic Drug Management", swapping the order of "Intraoperative Emergency Management" and "Airway Management", and removing the indicator "Resuscitation Assessment".Conclusions:This study preliminarily developed a framework of entrustable professional activity indicators for non-anesthesiology residents during rotation in the Department of Anesthesiology. The framework provides a simple and practical competency evaluation method for standardized training, which can enhance training quality and effectiveness.

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